Owner registration certificate:
BAYER SCHERING PHARMA AG

Produced:
SCHERING GmbH & Co. Products KG

ATX code for YARINA

G03AA12 (Drospirenone and estrogen)

Analogues of the drug according to ATC codes:

You should consult your doctor before using YARINA. These instructions for use are for informational purposes only. For more information, please refer to the manufacturer's annotation.

Clinical and pharmacological group

23.035 (Monophasic oral contraceptive with antiandrogenic properties)

Release form, composition and packaging

Light yellow film-coated tablets, engraved with the letters "DO" in a hexagon on one side.

Excipients: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate, hypromellose (hydroxypropyl methylcellulose), macrogol 6000, talc (magnesium hydrosilicate), titanium dioxide (E171), iron (II) oxide (E172).

21 pcs. - blisters (1) - packs of cardboard.21 pcs. - blisters (3) - packs of cardboard.

pharmachologic effect

Low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Yarina is carried out through complementary mechanisms, the most important of which include the suppression of ovulation and the increase in the viscosity of cervical mucus.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, less often observed painful menstruation, reduces the intensity of bleeding, resulting in a decrease in the risk of iron deficiency anemia. In addition, there is evidence that the risk of endometrial cancer and ovarian cancer is reduced.

Drospirenone, contained in Yarin, has an antimineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (for example, edema) associated with hormone-induced fluid retention. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (blackheads), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne(acne) and seborrhea.

At correct application the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or misuse, the Pearl index may increase.

Pharmacokinetics

Drospirenone

Suction

After oral administration, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. After a single dose of the drug, Cmax of drospirenone in plasma is reached after 1-2 hours and is 37 ng / ml. Bioavailability ranges from 76% to 85%. Eating does not affect bioavailability.

Distribution

After oral administration, a two-phase decrease in the concentration of drospirenone in serum is observed.

Drospirenone binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). The increase in SHBG induced by estradiol does not affect the binding of drospirenone to plasma proteins.

During cycle treatment, Cssmax of drospirenone is reached in the second half of the cycle.

A further increase in concentration is noted after approximately 1-6 cycles of taking the drug, a subsequent increase in concentration is not observed.

Metabolism

After oral administration, drospirenone is completely metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the participation of isoenzymes of the cytochrome P450 system.

breeding

It is excreted in the form of metabolites with feces and urine in a ratio of approximately 1.2-1.4. T1 / 2 metabolites is approximately 40 hours.

Ethinylestradiol

Suction

After oral administration, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract.

Cmax in plasma is reached after 1-2 hours and is 54-100 pg / ml. Ethinylestradiol undergoes a "first pass" effect through the liver, as a result of which its oral bioavailability averages 45%.

Distribution

Binding to plasma proteins (albumin) - about 98%.

Ethinylestradiol induces the synthesis of SHBG.

The decrease in the concentration of ethinylestradiol in the blood serum is biphasic.

Css is established during the second half of the first cycle of taking the drug.

Metabolism

Ethinylestradiol undergoes presystemic conjugation in the mucosa small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation.

breeding

Ethinylestradiol is excreted as metabolites in the urine and bile in a ratio of approximately 4:6. T1 / 2 metabolites about 24 hours.

YARINA: DOSAGE

Tablets should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Take 1 tablet / day continuously for 21 days. Taking the tablets from the next package begins after a 7-day break, during which menstrual-like bleeding (withdrawal bleeding) usually develops. As a rule, it begins 2-3 days after taking last pill and may not end before you start taking pills from a new package.

Start taking Yarina®

In the absence of taking any hormonal contraceptives in the previous month, Yarina starts on the 1st day menstrual cycle(i.e. on the 1st day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use barrier method contraception during the first 7 days of taking the tablets from the first package.

When switching from other combination lanes oral contraceptives, vaginal ring or contraceptive patch it is preferable to start taking Yarina the next day after taking the last active tablet from the previous package, but in no case later than next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Yarina's reception should be started on the day the vaginal ring or patch is removed, but no later than the day when a new ring should be inserted or a new patch should be pasted.

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena). You can switch from a “mini-pill” to Yarina any day (without a break), from an implant or an intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection is to be given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

After an abortion in the first trimester of pregnancy. You can start taking the drug immediately - on the day of the abortion. If this condition is met, the woman does not need additional contraception.

After childbirth or abortion in the second trimester of pregnancy. You should start taking the drug no earlier than 21-28 days after birth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Yarina, or it is necessary to wait for the first menstruation.

Taking missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next pill is taken at the usual time.

If the delay in taking the drug was more than 12 hours, contraceptive protection is reduced. How more pills missed, and the closer the pass is to the 7-day break in taking the pills, the greater the likelihood of pregnancy.

In this case, you can be guided by the following two basic rules:

1. The drug should never be interrupted for more than 7 days.

2. 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, one can give following tips if the delay in taking the tablets exceeds 12 hours (the interval from the moment the last tablet was taken is more than 36 hours).

First week of taking the drug

It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the possibility of pregnancy should be taken into account.

Second week of taking the drug

It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Provided that the woman has taken her pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming break in taking the pills. A woman must strictly adhere to one of the two following options. Moreover, if within 7 days preceding the first missed correctly, there is no need to use additional contraceptive methods.

1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next pills are taken at the usual time until the pills from the current package run out. The next pack should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. You can stop taking the pills from the current pack, thus starting a 7-day break (including the day you missed the pills), and then start taking the pills from the new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.

In case of vomiting or diarrhea up to 4 hours after taking the tablets, absorption may not be complete and additional precautions should be taken to prevent unwanted pregnancy. In such cases, you should be guided by the above recommendations when skipping tablets.

Changing the start date of the menstrual cycle

In order to postpone the onset of menstruation, it is necessary to continue taking the tablets from the new Yarina package without a 7-day break. Tablets from a new package can be taken for as long as necessary, including until the package runs out. On the background of taking the drug from the second package, spotting is possible. bloody issues from the vagina or breakthrough uterine bleeding. Resume taking Yarina from the next package should be after the usual 7-day break. In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will experience spotting and breakthrough bleeding during the second pack (just as she would like to delay the onset of her period).

Additional information for special categories of patients

For children and adolescents, Yarina® is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

After the onset of menopause, Yarina® is not indicated.

Yarina® is contraindicated in women with severe liver disease until liver function tests return to normal.

Yarina is contraindicated in women with severe renal insufficiency or acute renal failure.

Overdose

Serious violations in case of overdose have not been reported. Based on overall experience with combined oral contraceptives, symptoms that may occur in overdose include nausea, vomiting, spotting vaginal discharge or metrorrhagia.

Treatment: carry out symptomatic therapy. There is no specific antidote.

drug interaction

Interactions of oral contraceptives with other medicines may lead to breakthrough bleeding and/or decreased contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Yarina®, or choose another method of contraception.

The following types of interaction have been reported in the literature.

Effect on hepatic metabolism

The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or reduce the reliability of contraception. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also felbamate, griseofulvin, and preparations containing St. John's wort.

HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, ) and combinations thereof can also potentially affect hepatic metabolism.

Effects on enterohepatic circulation

According to individual studies, some antibiotics (eg, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol. While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

While taking antibiotics (such as penicillins and tetracyclines) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking the tablets from the next package of Yarina without the usual break in taking the tablets.

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the influence of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Oral combined contraceptives may interfere with the metabolism of other drugs, resulting in increased (eg, cyclosporine) or decreased (eg, lamotrigine) plasma and tissue concentrations.

Based on in vitro interaction studies, as well as an in vivo study in female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drug substances is unlikely.

There is a theoretical possibility of an increase in serum potassium levels in women receiving Yarina concomitantly with other drugs that can increase serum potassium levels. These drugs include angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium levels compared with placebo.

Pregnancy and lactation

The drug is not prescribed during pregnancy and during lactation.

If pregnancy is detected while taking Yarina, the drug should be immediately discontinued. However, extensive epidemiological studies have not identified increased risk developmental defects in children born of women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were taken through negligence in early dates pregnancy.

At the same time, data on the results of taking Yarina® during pregnancy are limited, which does not allow us to draw any conclusions about the negative effect of the drug on pregnancy, the health of the newborn and the fetus. There are currently no significant epidemiological data available.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

YARINA: SIDE EFFECTS

Against the background of taking combined oral contraceptives in women, other unwanted effects who have classified in the following way: often (≥1/100), sometimes (≥1/1000, but

From the side digestive system: often - nausea, abdominal pain; sometimes - vomiting, diarrhea.

From the reproductive system: often - engorgement, soreness of the mammary glands; sometimes - hypertrophy of the mammary glands; rarely - vaginal discharge, discharge from the mammary glands.

From the side of the central nervous system: often - headache, decreased mood, mood swings; sometimes - decreased libido, migraine; rarely - increased libido.

On the part of the organ of vision: rarely - intolerance contact lenses (discomfort while wearing them).

From the side of metabolism: often - weight gain; sometimes - fluid retention in the body; rarely - weight loss.

Dermatological reactions: sometimes - rash, urticaria; rarely - erythema nodosum, erythema multiforme.

Other: allergic reactions.

As with other combined oral contraceptives in rare cases possible development of thrombosis and thromboembolism.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years.

Indications

• contraception.

Contraindications

• thrombosis (venous and arterial) at present or in history (including
• deep vein thrombosis,
• pulmonary embolism,
• myocardial infarction,
• cerebrovascular disorders);
• states,
• previous thrombosis (incl.
• transient disorders cerebral circulation,
• angina pectoris) at present or in history;
• migraine with focal neurological symptoms currently or in history;
• diabetes with vascular complications;
• multiple or pronounced risk factors for venous or arterial thrombosis (incl.
• complicated lesions of the valvular apparatus of the heart,
• atrial fibrillation,
• cerebrovascular disease or coronary arteries; uncontrolled arterial hypertension,
• serious surgical intervention with prolonged immobilization
• smoking over the age of 35);
• pancreatitis with severe hypertriglyceridemia at present or in history;
• liver failure and severe liver disease (before normalization of liver tests);
• liver tumors (benign or malignant) at present or in history;
• severe and / or acute renal failure;
• identified hormone-dependent malignant diseases(incl.
• genital organs or mammary glands) or suspicion of them;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• lactation (breastfeeding);
• hypersensitivity to the components of the drug.

If any of the above diseases or conditions develop for the first time while taking the drug, then it should be immediately canceled.

Carefully

The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases / conditions and risk factors:

• risk factors for thrombosis and thromboembolism (smoking,
• obesity,
• dyslipoproteinemia,
• arterial hypertension,
• migraine,
• valvular heart disease,
• prolonged immobilization,
• major surgery,
• major trauma,
• hereditary predisposition to thrombosis / thrombosis,
• myocardial infarction or cerebrovascular accident at a young age in one of the next of kin/);
• other diseases
• in which peripheral circulatory disorders (diabetes mellitus,
• hemolytic uremic syndrome,
• Crohn's disease,
• sickle cell anemia,
• phlebitis of superficial veins);
• hereditary angioedema;
• hypertriglyceridemia;
• liver disease;
• diseases,
• first occurring or aggravated during pregnancy or against the background of a previous intake of sex hormones (for example,
• jaundice,
• cholestasis,
• gallbladder disease,
• otosclerosis with hearing impairment,
• porphyria,
• herpes pregnant,
• chorea of ​​Sydenham);
• postpartum period.

special instructions

Before starting or resuming the use of the drug Yarina®, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and cytological examination of scrapings from the cervix (Papanicolaou test), exclude pregnancy. Volume additional research and the frequency of follow-up examinations is determined individually. In general, follow-up examinations should be carried out at least once a year.

A woman should be informed that Yarina® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases and risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. With weighting, strengthening, or at the first manifestation of risk factors, drug withdrawal may be required.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease) when taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (

Venous thromboembolism (VTE), manifested as deep vein thrombosis or pulmonary embolism, can occur with any combined oral contraceptive.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include: unilateral edema lower limb or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized temperature rise in the affected leg, redness or discoloration of the skin on the leg.

Symptoms of thromboembolism pulmonary thromboembolism(PE) the following: difficult or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as symptoms of other more or less severe events (eg, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems speaking and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache without apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.

Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, great weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be fatal.

The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

• with age;
• in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases,
• especially in women over 35 years of age);
• with obesity (body mass index more than 30 kg/m2);
• with a family history (for example,
• venous or arterial thromboembolism ever in close relatives or parents at a relatively young age).
• In case of hereditary or acquired predisposition,
• a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
• with prolonged immobilization,
• major surgery,
• any leg surgery or major injury.
• In these situations, it is advisable to discontinue the use of combined oral contraceptives (in the case of a planned operation,
• at least,
• four weeks before it) and do not resume reception within two weeks after the end of immobilization;
• with dyslipoproteinemia;
• with arterial hypertension;
• with migraine;
• with diseases of the heart valves;
• with atrial fibrillation.

Question about a possible role varicose veins veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. An increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders can also be observed in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory diseases intestines (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

To biochemical parameters, indicating a hereditary or acquired predisposition to venous or arterial thrombosis, include: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin III, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

In assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the respective condition may reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use combined oral contraceptives. However, the relationship with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these data are related to screening for cervical pathology or to sexual behavior (more rare use barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women currently taking combined oral contraceptives or who have recently taken it is insignificant in relation to the overall risk of this disease. The relationship between the development of breast cancer and the use of combined oral contraceptives has not been proven. The observed increase in risk may also be due to close monitoring and more early diagnosis breast cancer in women using combined oral contraceptives. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare - malignant tumors liver, which in some cases led to life-threatening intra-abdominal bleeding. In case of appearance severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other states

Clinical studies have shown no effect of drospirenone on the concentration of potassium in the blood serum in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function and initial potassium levels at the ULN level or while taking medications that lead to potassium retention in the body.

In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.

Despite the fact that a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant arterial hypertension has rarely been observed. However, if a persistent, clinically significant increase blood pressure, these drugs should be discontinued and hypertension treated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in gallbladder; porphyria; SLE; hemolytic uremic syndrome; chorea of ​​Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and UC are also described against the background of the use of combined oral contraceptives.

In women with hereditary forms angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

For acute or chronic disorders liver function may require discontinuation of the drug until liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (

When using the drug, the development of chloasma is possible, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

The effectiveness of combined oral contraceptives may be reduced by missed pills, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular (acyclic) bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, should be carried out thorough examination to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during their pill break. If combined oral contraceptives were taken as directed, then pregnancy is unlikely. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, then pregnancy must be excluded before continuing to take the drug.

Impact on lab test scores

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, parameters of coagulation and fibrinolysis. Changes usually don't go beyond normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect.

Influence on the ability to drive vehicles and control mechanisms

Not found.

Results of experimental studies

Preclinical data obtained in the course of standard studies in order to study toxicity with repeated administration of the drug, as well as hepatotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be borne in mind that sex steroids may promote the growth of certain hormone-dependent tissues and tumors.

Use for impaired renal function

Contraindicated in acute kidney failure and severe renal failure.

Use in violation of liver function

The use of the drug is contraindicated if there is currently or in history severe forms liver disease (until liver tests return to normal), current or history of benign or malignant liver tumors;

Time-tested contraceptive Yarina ® important female vitamin to take care of the unborn child

Yarina plus - official instruction by application

Registration number:

LP-001186 - 230118

Trade name of the drug:

Yarina® Plus

International non-proprietary name:

drospirenone + ethinylestradiol + [calcium levomefolate]

Dosage form:

Film-coated tablets

Compound:

Composition per tablet with a combination of active ingredients
Nucleus
Active ingredients: drospirenone (micronized) 3,000 mg; ethinylestradiol betadex clathrate (micronized) in terms of ethinylestradiol 0.030 mg, calcium levomefolate [Metafolin®] (micronized) 0.451 mg;
Excipients: lactose monohydrate 45.319 mg, microcrystalline cellulose 24.800 mg, croscarmellose sodium 3.200 mg, hyprolose (5 cp) 1.600 mg, magnesium stearate 1.600 mg.
Shell
Varnish orange 2.0000 mg or (alternatively): hypromellose (5 cP) 1.0112 mg, macrogol-6000 0.2024 mg, talc 0.2024 mg, titanium dioxide 0.5271 mg, iron dye yellow oxide 0.0446 mg , iron dye red oxide 0.0123 mg.

Composition per one auxiliary vitamin pill
Nucleus
Active substance: calcium levomefolate [Metafolin®] (micronized) 0.451 mg;
Excipients: lactose monohydrate 48.349 mg, microcrystalline cellulose 24.800 mg, croscarmellose sodium 3.200 mg, hyprolose (5 cp) 1.600 mg, magnesium stearate 1.600 mg.
Shell
Lacquer light orange 2.0000 mg or (alternatively): hypromellose (5 cP) 1.0112 mg, macrogol-6000 0.2024 mg, talc 0.2024 mg, titanium dioxide 0.5723 mg, iron dye yellow oxide 0, 0089 mg, iron dye red oxide 0.0028 mg.

Description:

Tablets with a combination of active ingredients: round, biconvex, orange film-coated tablets, embossed with "Y+" on one side in a regular hexagon.
Auxiliary tablets: round, biconvex, film-coated tablets, light orange in color, on one side embossed "M +" in a regular hexagon.

Pharmacotherapeutic group:

Combined contraceptive (estrogen + gestagen + calcium levomefolate)

ATX code:

G03AA12

Pharmacological properties

Pharmacodynamics
Yarina® Plus is a low-dose monophasic combined estrogen-gestagen contraceptive drug, consisting of tablets containing hormones and calcium levomefolate, and tablets containing only calcium levomefolate. The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which are the suppression of ovulation, increased viscosity of the cervical secretion and changes in the endometrium.
In women taking COCs, the menstrual cycle becomes more regular, the pain, intensity and duration of menstrual-like bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.
Drospirenone, which is part of Yarina® Plus, has antimineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral edema, which ensures good tolerability of the drug. Drospirenone has positive impact on the premenstrual syndrome. In combination with ethinylestradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in lipoproteins. high density. Drospirenone also has antiandrogenic activity and helps reduce acne (acne), oily skin and hair (seborrhea). These features of drospirenone should be considered when choosing a contraceptive for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. With the correct use of the drug, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or misuse the drug, the Pearl index may increase.
The acid form of calcium levomefolate is structurally identical to natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration of L-5-methyltetrahydrofolate in the blood plasma of people who do not eat food enriched with folic acid is about 15 nmol / l. Levomefolate, unlike folic acid, is the biologically active form of folate. Because of this, it is absorbed better than folic acid. Folate deficiency is correlated with an increased risk of fetal neural tube defects. Calcium levomefolate is recommended for women before pregnancy to meet the increased need for folate in the early stages of pregnancy. For achievement optimal level folate levels may take several weeks.

Pharmacokinetics

Drospirenone

Absorption
When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration, the maximum concentration (Cmax) of drospirenone in the blood plasma, equal to 38 ng / ml, is reached after 1-2 hours. Food intake does not affect bioavailability, which ranges from 76 to 85%.
Distribution
Drospirenone binds to plasma albumin and does not bind to sex hormone-binding globulin (SHB1) or corticosteroid-binding globulin (CBG). Only 3-5% of the total concentration of the substance in the blood plasma is present as free hormone, 95-97% non-specifically binds to albumin. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins. The average apparent volume of distribution is 3.7±1.2 l/kg.
Metabolism
After oral administration, drospirenone is extensively metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the CYP 3A4 isoenzyme.
The clearance rate of drospirenone from blood plasma is 1.5±0.2 ml/min/kg.
breeding
Plasma drospirenone concentration decreases biphasically. The second, final phase has a half-life (T1 / 2) of about 31 hours. In unchanged form, drospirenone is excreted in trace amounts. Its metabolites are excreted through the gastrointestinal tract and by the kidneys in a ratio of approximately 1.2:1.4. The half-life of drospirenone metabolites is approximately 40 hours.
Equilibrium concentration
The concentration of SHBG does not affect the pharmacokinetics of drospirenone. With daily use of the drug inside, the concentration of drospirenone in the blood plasma increases by 2-3 times, the equilibrium concentration is reached after 8 days of taking the drug.
In case of impaired renal function
Studies have shown that the plasma concentration of drospirenone in women with renal mild insufficiency degrees (creatinine clearance (CC) - 50-80 ml / min) when an equilibrium state is reached and in women with normal kidney function (CC - more than 80 ml / min) are comparable. However, in women with kidney failure medium degree severity (CC - 30-50 ml / min), the average concentration of drospirenone in plasma was 37% higher than in patients with normal renal function. There was no change in the concentration of potassium in the blood plasma when using drospirenone. The pharmacokinetics of drospirenone has not been studied in patients with severe renal insufficiency.
In violation of liver function
In women with moderate hepatic insufficiency (Child-Pugh class B), the area under the concentration-time curve (AUC) is comparable to that in healthy women with close values ​​of Cmax in the phase of absorption and distribution. T½ of drospirenone in patients with moderate hepatic insufficiency was 1.8 times higher than in healthy volunteers with normal liver function.
In patients with moderate hepatic insufficiency, a decrease in the clearance of drospirenone by approximately 50% was noted compared with women with normal liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. When diabetes mellitus is detected and the concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma was not established. Drospirenone is well tolerated in women with mild to moderate hepatic impairment (Child-Pugh class B).
The pharmacokinetics of drospirenone has not been studied in patients with severe hepatic impairment.

Ethinylestradiol

Absorption
After oral administration, ethinylestradiol is rapidly and completely absorbed. Cmax - 100 pg / ml, achieved within 1-2 hours. During absorption and "first pass" through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability averaging about 45% with high inter-individual variability - from 20 to 65%. Simultaneous food intake in some cases is accompanied by a decrease in the bioavailability of ethinylestradiol by 25%.
Distribution
Ethinylestradiol non-specifically but strongly binds to plasma albumin (about 98%) and induces an increase in plasma concentration of SHBG. The estimated volume of distribution is 5 l/kg.
Metabolism
Ethinylestradiol undergoes significant primary metabolism in the intestine and liver. Ethinylestradiol and its oxidative metabolites are primarily conjugated to glucuronides or sulfate. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg.
breeding
The decrease in the concentration of ethinylestradiol in the blood plasma is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 20 hours. Ethinylestradiol is excreted only as metabolites by the kidneys and through the intestines in a ratio of 4:6 with a half-life of about 24 hours.
Equilibrium concentration
The equilibrium state is reached in the second half of the cycle of taking the drug, when the concentration of ethinylestradiol in the blood plasma increases by 40-110% compared with the use of a single dose.
Ethnicity
The influence of ethnicity (the study was conducted on cohorts of Caucasian women and Japanese women) on the pharmacokinetic parameters of drospirenone and ethinyl estradiol has not been established.

Calcium levomefolate

Absorption
After oral administration of calcium, levomefolate is rapidly absorbed and incorporated into the body's folate pool. After a single oral administration of 0.451 mg calcium levomefolate after 0.5 - 1.5 hours, Cmax becomes 50 nmol / l higher than the initial concentration.
Distribution
The pharmacokinetics of folates has a biphasic character: a pool of folates with a fast and a slow metabolism is determined. The rapidly metabolizing pool is likely to represent newly ingested folates, which is consistent with the half-life of calcium levomefolate, which is about 4-5 hours after a single oral dose of 0.451 mg. The slow metabolizing pool reflects the conversion of folate polyglutamate, which has a T½ of about 100 days. Externally supplied folates and folates passing through the enterohepatic cycle maintain a constant concentration of L-5-methyl-THF in the body.
L-5-methyl-THF represents the main form of folate in the body, in which it is delivered to peripheral tissues to participate in cellular folate metabolism.
Metabolism
L-5-methyl-THF is the major transportable form of folate in plasma. When comparing 0.451 mg calcium levomefolate and 0.4 mg folic acid, similar mechanisms metabolism and for other important folates.
Folate coenzymes are involved in 3 main conjugated cycles of metabolism in the cytoplasm of cells. These cycles are necessary for the synthesis of thymidine and purines, precursors of deoxyribonucleic (DNA) and ribonucleic (RNA) acids, as well as for the synthesis of methionine from homocysteine ​​and the conversion of serine to glycine.
breeding
L-5-methyl-THF is excreted by the kidneys unchanged and as metabolites, as well as through the intestines.
Equilibrium concentration

The equilibrium state of L-5-methyl-THF in plasma after ingestion of 0.451 mg calcium levomefolate is achieved after 8-16 weeks and depends on its initial concentration. In erythrocytes, the equilibrium concentration is reached in more late dates due to the lifespan of red blood cells, which is about 120 days.

Indications for use

Oral contraception.
The drug is indicated for use in women who prefer to use an oral contraceptive as a method of contraception, to increase the concentration of folic acid in order to reduce the risk of a neural tube defect in the fetus during pregnancy that occurs while taking the drug or shortly after its discontinuation.

Contraindications

Yarina® Plus is contraindicated in the presence of any of the conditions/diseases/risk factors listed below. If any of these conditions / diseases / risk factors develop for the first time while taking the drug, the drug should be stopped immediately.

• Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
• Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
• Identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).
• The presence of a high risk of venous or arterial thrombosis (see section " special instructions»).
• Migraine with focal neurological symptoms at present or in history.
• Pancreatitis with severe hypertriglyceridemia at present or in history.
• Diabetes mellitus with vascular complications.
• Liver failure, acute or severe chronic diseases liver (until normalization of liver tests).
• Joint application with direct-acting antiviral drugs (DAA) containing ombitasvir, paritaprevir, dasabuvir or a combination of these substances (see section "Interaction with other medicinal products and other forms of interaction").
• Severe and/or acute renal failure.
• Liver tumors (benign or malignant) at present or in history.
• Identified hormone-dependent malignant neoplasms(including genitals or mammary gland) or suspicion of them.
• Bleeding from the vagina of unknown origin.
• Pregnancy or suspicion of it.
• breastfeeding period.
• Hypersensitivity or intolerance to drospirenone, ethinyl estradiol, levomefolate calcium, or any of excipients drug Yarina® Plus.
• Yarina® Plus contains lactose, therefore it is contraindicated in patients with rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully

The potential risk and expected benefit of using Yarina® Plus should be assessed in each individual case in the presence of the following diseases / conditions and risk factors:

• Risk factors for the development of thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, a hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at the age of less than 50 years in one of the closest relatives);
• Other diseases in which peripheral circulatory disorders may occur: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
• Hereditary angioedema;
• Hypertriglyceridemia;
• Diseases lung liver and moderate severity in history normal functional tests liver
• Diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• postpartum period.

Use during pregnancy and during breastfeeding

The drug is contraindicated during pregnancy. If pregnancy is detected while taking Yarina® Plus, the drug should be stopped immediately. Data on the results of taking Yarina® Plus during pregnancy are limited and do not allow any conclusions to be drawn about the negative effect of the drug on pregnancy, the health of the fetus and newborn. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took COCs before pregnancy, or a teratogenic effect in cases of inadvertent use of COCs in early pregnancy.
No specific epidemiological studies have been conducted with Yarina® Plus.
breastfeeding period

The drug is contraindicated during breastfeeding. Taking the drug can reduce the amount of breast milk and change its composition, so the use of the drug is contraindicated until the cessation of breastfeeding. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the health of the child.

Dosage and administration

How and when to take the pills
Tablets should be taken orally in the order indicated on the package, every day at the same time, without chewing, with a small amount of water. Take 1 tablet per day continuously for 28 days. Taking the tablets from the next package begins immediately after the completion of taking the tablets from the previous package. "Withdrawal" bleeding usually begins 2-3 days after the start of hormone-free pills and may not end before the next pack of pills is started.
Taking pills from the first package of Yarina® Plus

When no hormonal contraceptive did not apply in the previous month

Yarina® Plus should be taken on the first day of the cycle, that is, on the first day of menstrual bleeding. It is allowed to start taking the drug on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from other combined contraceptive drugs (COC, contraceptive vaginal ring or contraceptive transdermal patch)

It is preferable to start taking Yarina® Plus the next day after taking the last tablet containing hormones from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last tablet , not containing hormones (for preparations containing 28 tablets per pack). Yarina® Plus should be started after the usual break in taking active tablets in case of switching from contraceptive drugs with a prolonged regimen of use. Taking Yarina® Plus should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is pasted.

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from an intrauterine device therapeutic system with progestogen release

You can switch from mini-pill to Yarina® Plus on any day (without a break), from an implant or IUD with a progestogen - on the day they are removed, from an injectable contraceptive - on the day when the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

After an abortion (including spontaneous) in the first trimester of pregnancy

You can start taking the drug immediately. If this condition is met, additional contraceptive measures are not required.

After childbirth (in the absence of breastfeeding) or termination of pregnancy (including spontaneous) in the second trimester of pregnancy

It is recommended to start taking the drug on the 21st - 28th day after childbirth (in the absence of breastfeeding) or termination of pregnancy in the second trimester. If the drug is started later, it is necessary to use a barrier method of contraception during the first 7 days of use. If sexual intercourse took place before the start of taking the drug Yarina Plus, it is necessary to exclude pregnancy or wait for the first menstruation.
How to handle the packaging of Yarina® Plus

The package of Yarina® Plus includes 1 or 3 blisters, which contain 21 tablets containing hormones and 7 auxiliary tablets(the last row). The package also contains a self-adhesive appointment calendar, consisting of 7 self-adhesive strips with the names of the days of the week marked on them. It is necessary to select the strip, where the first day of the week is indicated on which the pills are taken. For example, if you start taking your pills on Wednesday, you should use a strip that starts with "Wed." (see fig. 1).


The strip is glued along the top of the package so that the designation of the first day is above the tablet to which the arrow with the inscription "Start" is directed (Fig. 2).


Now you can see on which day of the week you should take each pill (Fig. 3).


Discontinuation of Yarina® Plus

You can stop taking Yarina® Plus at any time. If pregnancy is not planned, you should take care of other methods of contraception. If pregnancy is planned, you should simply stop taking Yarina® Plus.
Taking missed pills

Skipping pills that do not contain hormones can be ignored. However, they should be discarded so as not to accidentally prolong the period of taking hormone-free pills. The following recommendations apply only to skipping pills containing hormones:

• If the delay in taking a tablet containing hormones is less than 12 hours, contraceptive action drug Yarina Plus is preserved. You should take the missed pill as soon as possible and take the next one at the usual time.
• If the delay in taking a pill containing hormones is more than 12 hours, contraceptive protection may be reduced. The more pills missed in a row, and the closer this gap is to the start of the intake or to the end of the intake, the higher the risk of pregnancy.

In this case, you can be guided by the following two basic rules:

• the drug should never be interrupted for more than 7 days;
• to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of tablets containing hormones.

Accordingly, if the delay in taking tablets containing hormones is more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours), the following can be recommended:

First week of taking the drug

You should take the missed pill as soon as you remember (even if it means taking two pills at the same time). The following tablets should be taken at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.

Second week of taking the drug

You should take the missed pill as soon as you remember (even if it means taking two pills at the same time). The following tablets should be taken at the usual time.
Provided that the tablet-taking regimen is observed within 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception for 7 days.

Third week of taking the drug

The risk of reducing the reliability of contraception is inevitable due to the approaching phase of taking pills that do not contain hormones.
In this case, you must adhere to the following algorithms:

• if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Follow steps 1 or 2 to take the missed pills.
• if during the 7 days preceding the first missed tablet, the tablets were taken incorrectly, then during the next 7 days it is necessary to additionally use a barrier method of contraception (for example, a condom) and in this case point 1 should be followed for taking the missed tablets.

1. Take the missed pill as soon as possible, as soon as the woman remembers (even if it means taking two pills at the same time). The next pills are taken at the usual time until the orange (hormone-containing) pills in the package run out. The seven light orange (helper) pills should be discarded and the orange (hormone-containing) pills from the new pack should be started immediately. Until the orange (hormone-containing) pills from the second pack run out, "withdrawal" bleeding is unlikely, but "spotting" discharge and/or "breakthrough" bleeding may occur.
2. Stop taking the orange (hormonal) tablets from the current package, then take a break of 7 days or less ( including missed pill days), after which you should start taking the drug from a new package.

If a woman misses the orange (hormone-containing) pills and does not experience withdrawal bleeding while taking the light orange (auxiliary) pills, it is necessary to make sure that she is not pregnant.

With severe gastrointestinal disorders absorption may be incomplete, so additional contraceptive measures should be taken.
If vomiting or diarrhea occurs within 3-4 hours after taking a pill containing hormones, you should be guided by the recommendations when skipping pills. If a woman does not want to change her usual regimen and transfer the start of her period to another day of the week, extra pill containing hormones should be taken from another package.
Delaying the onset of menstrual bleeding
To delay the onset of menstrual bleeding, you should skip taking 7 light orange (hormone-free) tablets from the current package and continue taking orange (hormone-containing) tablets from the next package of Yarina® Plus. If you have taken all 21 orange tablets from the second package, in this case you should also take 7 light orange tablets and immediately start taking the tablets from the new package. Thus, the cycle can be extended, if desired, for any period, up to 3 weeks until all the orange tablets from the second package are taken. If you want menstrual bleeding to start sooner, you should stop taking the orange pills from the second pack, throw it away and stop taking all the pills for no more than 7 days, and then start taking the pills from the new pack. In this case, menstrual bleeding will begin approximately 2-3 days after taking the last orange pill from the second package. While taking the drug Yarina® Plus from the second package, there may be "spotting" discharge and / or "breakthrough" bleeding on the days of taking the active tablets.
Changing the day of onset of menstrual bleeding
If you take the pills as recommended, you will have menstrual bleeding on about the same day every 4 weeks.
If you want to change the day your period starts, shorten the period of taking the light orange pills by the number of days you want to change the start of your period.
For example, if your cycle usually starts on Friday, and in the future you want it to start on Tuesday (3 days earlier), you should start taking the tablets from the next pack 3 days earlier than usual, that is, do not use the last 3 light days. orange pills from the current pack and start taking the orange pills from the next pack. The fewer light orange pills you take, the more likely it is that menstrual bleeding will not occur.
While taking Yarina Plus tablets from the following package, “spotting” discharge and / or “breakthrough” bleeding may occur.
Application at individual groups female patients
In teenage girls
The drug Yarina® Plus is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
In the elderly
Yarina® Plus is not used after menopause.
For impaired liver function
The drug is contraindicated for use in women with severe violations liver function (see also sections "Contraindications" and "Pharmacological properties").
For impaired renal function
The drug is contraindicated for use in women with severe renal impairment and in acute renal failure (see also sections "Contraindications" and "Pharmacological properties").

Side effect

Serious adverse events when taking COCs are also described in the "Special Instructions" section.
When taking Yarina® Plus, the following symptoms were noted: adverse reactions.

System Organ Classes (MedDRA)	Often (from > 1/100 to<1/10)	Infrequently (from > 1/1 000 to<1/100)	Rarely (from > 1/10,000 to<1/1 000)
Immune System Disorders			Hypersensitivity reaction Bronchial asthma
Mental disorders	Depressed mood	Increased libido Decreased libido
Nervous System Disorders	Headache
Hearing and labyrinth disorders			Hypoacusia
Vascular disorders	Migraine	Increased blood pressure (BP) Decreased blood pressure	Venous thromboembolism Arterial thromboembolism
Gastrointestinal disorders	Nausea	Vomit Diarrhea
Skin and subcutaneous tissue disorders		acne Eczema Itching Alopecia	erythema nodosum Erythema multiforme
Genital and breast disorders	Menstrual irregularities Intermenstrual bleeding Pain in the mammary glands Breast engorgement Vaginal discharge Vulvovaginal candidiasis	Breast enlargement vaginal infection	Discharge from the mammary glands
General disorders		Fluid retention Weight gain Weight loss

Description of individual adverse reactions
Patients taking COCs have an increased risk of developing arterial and venous thrombotic and thromboembolic disorders, including myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis and pulmonary embolism, which are described in more detail in the "Special Instructions" section.
The following serious adverse reactions have been reported in women using COCs. These adverse reactions are described in the section "Special Instructions":

• Venous thromboembolic disorders
• Arterial thromboembolic disorders
• Increase in blood pressure
• Tumors of the liver
• Development or worsening of conditions for which the association with the use of COCs is not undeniable: Crohn's disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria, systemic lupus erythematosus, herpes during pregnancy, Sydenham's chorea, hemolytic uremic syndrome, cholestatic jaundice
• Chloasma
• Acute or chronic disorders of liver function, which may require the abolition of COCs until the normalization of liver function tests
• In women with hereditary angioedema, exogenous estrogens may cause or exacerbate the symptoms of angioedema.

The frequency of diagnosing breast cancer in women using oral contraceptives is increased very slightly. Breast cancer is rarely observed in women under 40 years of age, the excess frequency is insignificant in relation to the overall risk of breast cancer. A causal relationship between breast cancer and COC use has not been established. For more information, see the section "Contraindications" and "Special Instructions". Interaction
Interactions of other drugs (enzyme inducers) with oral contraceptives can lead to "breakthrough" bleeding and / or a decrease in the contraceptive effect (see section "Interaction with other medicinal products and other forms of interaction").

Overdose

No cases of Yarina Plus overdose have been reported.
Symptoms that may occur with overdose: nausea, vomiting and withdrawal bleeding. The latter can occur in girls who have not reached the age of menarche, when taking the drug through negligence.
There is no specific antidote, symptomatic treatment should be carried out.
Calcium levomefolate and its metabolites are identical to folates, which are part of food products, the daily consumption of which does not harm the body. Taking calcium levomefolate at a dose of 17 mg/day (a dose 37 times higher than that contained in 1 tablet of Yarina® Plus) for 12 weeks was well tolerated.

Interaction with other drugs

The influence of other drugs on the drug Yarina®Plus

Interaction with drugs that induce microsomal enzymes is possible, as a result of which the clearance of sex hormones may increase, which, in turn, may lead to "breakthrough" uterine bleeding and / or a decrease in the contraceptive effect.
Induction of microsomal liver enzymes can be observed after a few days of treatment. The maximum induction of microsomal liver enzymes is usually observed within a few weeks. After discontinuation of the drug, the induction of microsomal liver enzymes may persist for 4 weeks.
Short term therapy
Women who receive treatment with these drugs in addition to Yarina® Plus are recommended to temporarily use a barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their withdrawal. If the use of the inducer drug must be continued after taking the orange (hormone-containing) tablets, you should skip the light orange (auxiliary) tablets and start taking Yarina® Plus tablets from a new package.
Long term therapy
Women who take drugs - inducers of microsomal liver enzymes for a long time, it is recommended to use another reliable non-hormonal method of contraception.

Substances that increase the clearance of the drug Yarina® Plus (weaken the effectiveness by inducing enzymes):

phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.

Substances with different effects on the clearance of Yarina® Plus

When used together with Yarina® Plus, many inhibitors of HIV or hepatitis C proteases and non-nucleoside reverse transcriptase inhibitors can either increase or decrease the concentration of estrogen or progestogen in blood plasma. In some cases, this effect may be clinically significant.

Substances that reduce the effectiveness of calcium levomefolate

Effect on folate metabolism: Some drugs reduce plasma folate concentration and reduce folate efficacy by inhibiting the enzyme dihydrofolate reductase (eg, methotrexate, trimethoprim, sulfasalazine, and triamterene) or by decreasing folate absorption (eg, cholestyramine) or by unknown mechanisms (eg, antiepileptic drugs : carbamazepine, phenytoin, phenobarbital, primidone and valproic acid).

Substances that reduce the clearance of COCs (enzyme inhibitors)

Strong and moderate CYP3A4 inhibitors such as azole antimycotics (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen or progestogen, or both. It was shown that etoricoxib at doses of 60 and 120 mg / day, when taken together with COCs containing 0.035 mg of ethinylestradiol, increases the concentration of ethinylestradiol in blood plasma by 1.4 and 1.6 times, respectively.
The effect of COCs or calcium levomefolate on other drugs

COCs can interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
In vitro, drospirenone is able to weakly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
Based on in vivo interaction studies in female volunteers treated with omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of drospirenone 3 mg on cytochrome P450 enzyme-mediated drug metabolism is unlikely. In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1, and CYP1A2, and an irreversible inhibitor of CYP3A4/5, CYP2C8, and CYP2J2. In clinical studies, the administration of a hormonal contraceptive containing ethinylestradiol did not lead to any increase or only a slight increase in plasma concentrations of CYP3A4 substrates (eg, midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (eg, theophylline ) or moderately (eg, melatonin and tizanidine).
Folates can alter the pharmacokinetics or pharmacodynamics of some drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (mostly reversible, subject to an increase in the dose of the drug affecting folate metabolism) of their therapeutic effect. The use of folate during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.
Pharmacodynamic Interactions
It has been shown that the combined use of ethinylestradiol-containing drugs and direct-acting antiviral drugs containing ombitasvir, paritaprevir, dasabuvir, or a combination of them, is associated with an increase in the concentration of ALT (alanine aminotransferase) more than 20 times the upper limit of normal in healthy and infected with hepatitis C virus women (see section "Contraindications").
Other forms of interaction
In patients with intact renal function, the combined use of drospirenone and angiotensin-converting enzyme inhibitors or non-steroidal anti-inflammatory drugs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Yarina® Plus with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug.

special instructions

If any of the conditions, diseases and risk factors listed below are currently present, the potential risk and expected benefit of using Yarina® Plus should be carefully weighed in each individual case and discussed with the woman before she decides to start taking of this drug.
For disorders of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking COCs. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is highest in the first year of COC use. An increased risk is present after the initial use of COCs or the resumption of the use of the same or another COC (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show that this increased risk is predominantly present during the first 3 months.
General risk of VTE in women taking low-dose COCs (VTE may be life-threatening or fatal (in 1-2% of cases).
VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any COC.
Very rarely, when using COCs, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis: unilateral swelling of the lower limb or along a vein in the lower limb, pain or discomfort in the lower limb only in an upright position or when walking, local temperature increase in the affected lower limb, redness or discoloration of the skin of the lower limb.
Symptoms of pulmonary embolism: difficulty or rapid breathing; sudden cough, including hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions/diseases (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without seizures. Other signs of vascular occlusion: sudden pain, swelling and slight cyanosis of the extremities, an "acute" abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal.
In women with a combination of several risk factors or a high severity of one of them (for example, complicated diseases of the valvular apparatus of the heart, uncontrolled arterial hypertension, extensive surgical interventions with prolonged immobilization, etc.), the possibility of their mutual reinforcement should be considered. In such cases, the total value of the existing risk factors increases. In this case, taking the drug Yarina® Plus is contraindicated (see section "Contraindications").
The risk of developing thrombosis (venous and / or arterial), thromboembolism or cerebrovascular disorders increases:

• with age;
• in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);

in the presence of:

• obesity (body mass index more than 30 kg/m2);
• family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking Yarina® Plus;
• prolonged immobilization, major surgery, any lower limb surgery, or major trauma. In these situations, taking Yarina® Plus should be stopped (in the case of a planned operation at least four weeks before it) and not resumed within two weeks after the end of immobilization. Temporary immobilization (eg, air travel longer than 4 hours) may also be a risk factor for venous thromboembolism, especially if other risk factors are present;
• dyslipoproteinemia;
• arterial hypertension;
• migraine;
• heart valve disease;
• atrial fibrillation.

The use of any combined hormonal contraceptive increases the risk of VTE. The use of drugs containing levonorgestrel, norgestimate or norethisterone causes the lowest risk of developing VTE. The use of other drugs, such as Yarina® Plus, can lead to a two-fold increase in risk. The choice in favor of the use of COCs with a higher risk of developing VTE can only be made after consulting the patient to make sure that she fully understands the risk of developing VTE associated with the use of Yarina® Plus, the effect of the drug on her existing risk factors and that The risk of developing VTE is highest during the first year of using the drug. The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
An increased risk of thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of the drug Yarina® Plus (which may precede cerebrovascular disorders) is the basis for the immediate discontinuation of this drug.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).
When evaluating the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<0,05 мг этинилэстрадиола).
Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with the use of COCs has not been proven. The possibility of the relationship of these data with the screening of diseases of the cervix and with the peculiarities of sexual behavior (more rare use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently taking COCs or have recently taken them is insignificant in relation to the overall risk of this disease. Its association with COC use has not been proven. The observed increase in risk may be due to close monitoring and earlier diagnosis of breast cancer in women using COCs, the biological action of sex hormones, or a combination of both factors. In women who have ever used COCs, earlier stages of breast cancer are detected than in women who have never used them.
In rare cases, against the background of the use of COCs, the development of benign, and in extremely rare cases, malignant neoplasms of the liver, which in some patients led to life-threatening intra-abdominal bleeding, was observed. If there is severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
Clinical studies have shown no effect of drospirenone on the concentration of potassium in the plasma of patients with mild to moderate renal insufficiency. However, in patients with impaired renal function and an initial concentration of potassium at the upper limit of normal, the risk of developing hyperkalemia while taking drugs that lead to potassium retention in the body cannot be excluded.
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking COCs.
Although a slight increase in blood pressure (BP) has been described in many women taking COCs, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking Yarina® Plus, this drug should be discontinued and treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. There are also described cases of worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis against the background of the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of Yarina® Plus until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or a previous intake of sex hormones, requires discontinuation of Yarina® Plus.
Although COCs may have an effect on insulin resistance and glucose tolerance, the need for dose adjustment of hypoglycemic drugs in diabetic patients using low-dose oral contraceptives (< 0,05 мг этинилэстрадиола), как правило, не возникает. Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема КОК. Иногда может развиться хлоазма, особенно у женщин с наличием в анамнезе хлоазмы беременных. Женщины со склонностью к хлоазме во время приема препарата Ярина® Плюс должны избегать длительного пребывания на солнце и воздействия ультрафиолетового излучения.
Folates can mask a lack of vitamin B12.
Laboratory tests
Taking Yarina® Plus may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein concentrations, carbohydrate metabolism, blood coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values. Drospirenone increases plasma renin activity and aldosterone concentration, which is associated with its antimineralocorticoid effect.
There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving the drug Yarina® Plus simultaneously with other drugs that can increase the content of potassium in the blood plasma. These drugs include angiotensin II receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with angiotensin-converting enzyme (ACE) inhibitors or indomethacin, no significant difference was found between plasma potassium concentrations compared with placebo.
Reduced efficiency
The contraceptive effectiveness of Yarina Plus may be reduced in the following cases: if you miss a dose or gastrointestinal disorders while taking pills containing hormones (orange pills), or as a result of drug interactions.
Frequency and severity of menstrual bleeding
Against the background of taking Yarina® Plus, irregular (acyclic) bleeding from the vagina (“spotting” spotting or “breakthrough” uterine bleeding) may occur during the first few months. You should apply hygiene products and continue taking the tablets as usual. Evaluation of any irregular bleeding should be carried out after an adaptation period of about 3 cycles of the drug.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.
Absence of regular menstrual bleeding
Some women may not experience "withdrawal" bleeding while taking the light orange relief pills. If Yarina® Plus was taken as recommended, it is unlikely that the woman is pregnant. However, if the Yarina® Plus regimen is not followed and there are no two consecutive “withdrawal” bleedings, the drug cannot be continued until pregnancy is excluded.
Medical examinations
Before starting or resuming the use of the drug, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough physical examination (including measurement of blood pressure, heart rate, determination of body mass index, examination of the mammary glands), gynecological examination, cytological examination of the cervix (Papanicolaou test ), rule out pregnancy. When you resume taking the drug Yarina® Plus, the volume of additional studies and the frequency of follow-up examinations are determined individually, but at least 1 time in 6 months.
It must be borne in mind that Yarina® Plus does not protect against HIV infection and other sexually transmitted diseases!

Conditions requiring medical advice

• Any changes in health, especially the occurrence of conditions listed in the sections "Contraindications" and "With caution";
• Local compaction in the mammary gland;
• Simultaneous use of other drugs (see also the section "Interaction with other drugs and other types of interaction");
• If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least 4 weeks before the proposed operation);
• unusually heavy bleeding from the vagina;
• Missed a pill in the first week of taking the pack and had intercourse seven days or less before;
• Absence of another menstrual-like bleeding twice in a row or suspicion of pregnancy (do not start taking pills from the next package before consulting a doctor).

You should stop taking the tablets and seek immediate medical attention if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; sudden onset of shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe pain in the abdomen; severe pain in the lower limb or sudden swelling of any of the lower limbs.

Influence on the ability to drive vehicles and mechanisms

Not studied.
There were no cases of adverse effects on the ability to drive vehicles and mechanisms when taking the drug.

Release form

Film-coated tablets. Set: 21 tablets with a combination of active ingredients with 7 auxiliary vitamin tablets in a blister pack (blister) made of a multilayer material - PVC-PE-EVOH-PE-PCTFE sealed with aluminum foil. 1 or 3 blisters (sets) complete with a block of self-adhesive stickers for registration of the appointment calendar, together with instructions for use, are placed in a cardboard box.

Storage conditions

At a temperature not higher than 25°C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiry date stated on the packaging.

Holiday conditions

On prescription.

Manufacturer

Bayer AG, Müllerstraße 178, 13353 Berlin, Germany
Bayer AG, Mullerstrasse 178, 13353 Berlin, Germany

Legal entity in whose name the registration certificate is issued
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany
Bayer AG, Kaiser-Wilhelm-Allee, 1, 51373 Leverkusen, Germany

For more information and complaints, please contact:
107113 Moscow, 3rd Rybinskaya st., 18 building 2

Yarina is deservedly considered one of the best contraceptives to date. The drug not only effectively eliminates the risk of an unplanned pregnancy, but also has a good effect on appearance, eliminating skin imperfections and puffiness, and, importantly, keeps weight within the same limits. But, like all serious drugs, a contraceptive requires not only compliance with the rules of admission, but also the knowledge of refusing it. So that the cancellation of Yarina does not cause a shock reaction of the body and does not bring unpleasant surprises, you need to know how to stop drinking pills correctly.

Take and cancel: reasons for not taking the drug

There are a lot of motives for refusing a contraceptive, but basically there are several good reasons:

• The career is done, and the financial situation allows you to acquire offspring
• The age for the birth of a child is approaching a critical
• Tired of being on hormones
• I broke up with my husband (boyfriend), and now there is no need to protect
• I want to try other contraceptives
• There are health problems in which you can not drink OK
• Pregnancy.

In addition to these factors, a lady may have other motives for not taking birth control pills. But it happens differently when there are all signs that you need to stop drinking Yarina, but the woman continues to take the pills, motivating her fear of getting better, getting old problems with hair, skin or the monthly cycle, etc.

But having decided one day to stop using protection, she wants to do it as soon as possible - preferably in one day. Is it possible to do this, and what will follow in the event of a cardinal refusal?

When is emergency drug withdrawal justified?

The contraceptive is a low-dose drug, since the active substances are not presented in small quantities: 30 μg of the synthetic hormone ethinyl estradiol and 3 mg of drospirenone. Therefore, as a rule, the drug is well tolerated. However, there are diseases for which Yarina birth control pills should not be taken. If the patient was not examined before the appointment of a contraceptive or it was done negligently, then the disease may manifest itself already during the protection cycle. In this case, continuing the course can cause serious damage to health, and in some women provoke death. In such situations, an emergency refusal from Yarina is justified.

Diseases and conditions that are incompatible with taking a contraceptive include:

• Severe liver pathology
• Diabetes mellitus with vascular damage
• lipid metabolism disorder
• Varicose veins
• Oncological neoplasms
• A sharp decrease in vision
• Surgical operations
• Pregnancy.

Also, a quick rejection of Yarina may be necessary if contraindications were not recognized in time:

• PE or venous thrombosis: presence at the time of Yarina's appointment, as well as history, existing predisposition and risk factors
• Migraine with concomitant focal neurological deficit (incl. in medical history)
• Pancreatitis (including in the past)
• Severe renal failure
• Undiagnosed vaginal bleeding
• Suspicion of pregnancy
• Strong manifestation of individual allergy to OK elements
• Lactose intolerance, congenital lactase deficiency, GH malabsorption syndrome (due to the presence of milk sugar in the tablets).

In all these cases, a sharp rejection of Yarina is justified.

It may also be necessary to urgently stop the drug if adverse symptoms occur during the appointment in the form of:

• Chest pain radiating to left arm
• Unexplained severe cough, severe shortness of breath
• Unusually severe head pain
• Sudden loss of vision, hearing loss
• Speech disorder
• Paresthesia in certain parts of the body
• Pain in the legs, the appearance of edema.

Symptoms may appear if no contraindications were found at the time of the appointment or the patient did not report illnesses and seizures that happened in the past for any reason. Then, during the course, their relapse is not excluded, which can provoke a sharp deterioration in well-being. Therefore, if the above symptoms have developed, it is impossible to postpone the provision of medical care. To avoid fatal consequences, it is better to call an ambulance.

Possible consequences of an ill-conceived refusal from Yarina

Like any hormonal remedy, it is extremely undesirable to cancel the contraceptive on your own, without coordinating the actions with the gynecologist, and even more so spontaneously. Otherwise, the cancellation of OK leads to a sharp activation of the ovaries, the functioning of which was previously suppressed by synthetic hormones.

The body will no longer receive the usual dose of hormones, and its own production has not yet recovered. As a result, this will cause a shock reaction, the ovaries will begin to intensively make up for their own supply of hormones, and such a stormy work will cause a failure of the body's usual state and pull other chain reactions. In addition to an unplanned pregnancy, health problems will arise.

The most striking manifestation of OK withdrawal syndrome is breakthrough bleeding and recurrence of gynecological diseases due to hormonal imbalance.

To fully restore all functions, normalize the menstrual cycle, the ratio of hormones, eliminate internal "malfunctions" caused by a surge in hormones - all this will take time.

Therefore, it is impossible to stop drinking Yarina on your own in any case. If the doctor prescribes the drug based on the examination data, then it must be canceled in the same way - with the selection of dosage, substitution agents, or the appointment of other measures that will facilitate the transition period.

To avoid numerous possible troubles after refusing OK, it is better to contact a gynecologist. In this case, he will calculate the scheme for gradually reducing the dosage of Yarin's birth control pills. A smooth cancellation will help the body, without shock, adapt to the gradual decrease in incoming hormones and start its own "production".

In such a scenario, it will be possible to protect the body from a difficult test. During the restructuring, he will be able to:

• Normalize the menstrual cycle
• Eliminate atrophic phenomena in the endometrium and restore its functioning
• Resuscitate the ability of the endometrium to implant a fertilized egg
• Restore the previous state of the vaginal microflora
• Restore the normal density of cervical mucus.

If the rejection scheme is calculated and applied correctly, then the woman will easily endure the rejection of the contraceptive.

But another scenario cannot be ruled out either: until the body considers that it has fully returned its functions to the “pre-pill” time, and continues to restore the functioning of the genital organs, various symptoms will appear during this transitional period. This usually happens if Yarina was not taken for contraception, but was recommended for the treatment of various gynecological problems.

Then it is impossible to exclude the exacerbation of undertreated pathologies: a surge of endometriosis, a recurrence of uterine fibroids, a return of amenorrhea or dysfunctional bleeding. To eliminate them, a new prescription of drugs to help cope with the disease will be required.

Therefore, you will have to stock up on time after giving up Yarina, and of course, periodically check with a doctor.

How to stop contraception

The contraceptive effect of Yarina begins with the first pill taken. The entire course is designed for 21 days, during which you need to regularly drink OK at one hour. Therefore, the blister is equipped with just such a number of tablets. After its completion, a week-long break is necessarily made to stimulate bleeding like menstruation, and then, after a week-long respite, proceed to the contents of the next blister.

If the need to abandon Yarina arose in the middle of the course, then it is better to finish the cycle of taking it to the end by drinking the remaining tablets in the blister. And after a week break, do not take them anymore.

But what if the reception has just begun, and only a couple of pieces have been drunk? And is it possible to throw Yarina after one pill if her action is disappointing?

If taking OK caused negative consequences in the form of nausea, apathy or other side symptoms, then first of all it is necessary to determine the origin of the ailment. It is possible that it was just a coincidence, and the deterioration in health happened for other reasons, and not because of Yarina.

Secondly, the intake of hormonal substances from the outside wedges into the habitual work of the body, replacing natural substances, and thereby causes responses. As a rule, the adaptation period can be delayed for several months. During this time, ovarian function will be suppressed, and the body will adapt to hormones coming from outside. After he gets used to the new conditions, rebuilds his functions, the painful symptoms will go away.

Only a doctor can understand what really affected health after 2-3 months of taking and getting used to it. Then he will be able to give advice on whether to drink Yarina further.

If, during the course of OK, diseases developed, side effects that are not compatible with Yarina, then the drug can be canceled immediately, and in order to avoid the development of a withdrawal syndrome, it is immediately replaced by another OK.

Gynecologists advise to adhere to the gradual rejection of birth control pills. This is done in several ways: the dosage of OK is reduced: depending on the characteristics of the patient, the doctor may recommend reducing the amount by half or a quarter of a tablet per week. Or replace Yarina with other OKs with the same ingredients, but at a lower concentration. In some cases, such a refusal can be delayed for several months. This method is especially justified if a woman has been taking Yarina for many years.

Refusal of Yarina due to pregnancy

If for some reason pregnancy nevertheless happened, and the woman decided to keep it, then it is simply necessary to stop taking OK. Moreover, this must be done as soon as the ultrasound confirms the birth of a new life.

It is believed that in the early stages, tablets cannot affect the development of the fetus, and besides, all experiments on animals have not yet revealed harmful effects. But it is still impossible to completely exclude the negative effect of synthetic hormones.

How to cancel Yarina quickly and without consequences - the gynecologist will tell you immediately after receiving the examination data.

Is it necessary to give up Yarina after missing the pills

If during the course there was a hitch with taking the next pill, then a woman who is going to refuse OK may be tempted to do so. But gynecologists do not advise giving up Yarina, just because another pill is missed.

To restore the normal course, it must be drunk immediately if less than 12 hours have passed since the last pill.

In case of a more serious delay - more than 12 hours - they take the forgotten pill and the next one according to the schedule (if the time coincides, two are drunk at once). With such a delay, the contraceptive concentration of OK in the body decreases, so you will have to additionally protect yourself with the help of condoms. You will have to use it within a week after making up for the omission.

If closer to the end of the course it was necessary to replenish the concentration of substances with the help of 1 or several tablets, then to complete the full course, the missing pills will need to be taken from the next blister. Having finished a full course of OK, you can refuse it after a break, or discuss with your doctor the features of taking another remedy.

The modern contraceptive Yarina protects women from many problems: unnecessary pregnancy, hormonal imbalance and the conditions caused by it. But all this is possible only with the correct use of tablets, which implies the correct intake and cancellation.

Modern medicine offers a wide range of contraceptives: condoms, hormonal pills, spirals, caps, and more. It remains for a man and a woman to choose the best option for themselves, which will suit both and will not harm health. One of the popular contraceptives is Yarina (Yarina Plus, Yasmina).

Yarin birth control pills contain 30 micrograms of ethinyl estradiol and 3 mg of drospirenone. Also in the composition there are additional substances: macrogol 6000, magnesium stearate, iron oxide, titanium dioxide, talc, hypromellose, povidone K25, corn starch, lactose monohydrate, gelled starch.

Folic acid is also added to Yarina Plus. This is the only difference between these drugs.

Hormonal pills Yarina light yellow, blister contains 21 pcs. One package contains 1 or 3 blisters.

Pharmacological properties

The drug has a contraceptive and estrogen-progestin effect on the body.

In Yarin, the composition of hormones is minimal, so the medicine belongs to low-dose hormonal drugs. The contraceptive contains two hormones: gestagen and estrogen. Each tablet contains the same amount of hormones, so they are referred to as monophasic drugs.

The action of the drug is to block ovulation and increase the viscosity of mucus in the woman's cervix. It turns out that when taking pills, the egg cannot mature, and viscous mucus prevents sperm from entering the uterus, detaining them in the cervix.

Indications for use

Before you buy Yarina in a pharmacy, you should consult your gynecologist. Hormonal drugs should be prescribed only by a specialist. Before writing a prescription, a qualified doctor must conduct an examination and prescribe tests to select the appropriate contraceptive.

Basically, this drug is prescribed for:

• Prevention of unwanted pregnancy;
• Normalization of the menstrual cycle.

In addition to the main indications, the drug has other positive effects.

Contraindications and side effects

Contraindications:

Like any medicine, both Yarina and Yarin Plus have side effects. If any of the negative signs appear after taking the drug, you should consult a doctor to prescribe another means of protection.

Possible side effects of the drug:

• Nausea and vomiting.
• Decreased libido.
• Severe headache, including migraine.
• Thrombus formation.
• Mood swings.
• Bloody spotting from the vagina, or even bleeding that looks like menstruation.
• Increase in body weight.
• Pain in the lower abdomen and in the region of the mammary glands.

Instructions for use

How to drink tablets correctly is written in the instructions for use of the drug.

The tablet should be taken daily at the same time with a small amount of water. You should start taking it on the 1st day of the menstrual cycle and so on until the 21st day. Then there is a break of 7 days. Usually 2-3 days after stopping the drug, a new menstrual cycle begins.

Many are interested in the question of when birth control pills begin to work in order to stop using alternative contraceptives. Yarin's hormonal tablets begin to protect against pregnancy on the 7th day after the start of the drug. Therefore, during the first week of using the drug, it is necessary to resort to other methods of protection.

Yarina, like other combined oral contraceptives (COCs), can be taken for a long time, but how much you can drink these pills, the attending physician will tell. Usually after two or three years it is necessary to change the drug or take a short break in its use.

In this article, you can read the instructions for using the drug Yarina. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Yarina in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Yarina analogues in the presence of existing structural analogues. Use for contraception in healthy women, as well as the treatment of acne or acne. Scheme and effects of withdrawal after taking the drug. The onset of pregnancy and tactics of behavior.

Yarina- low-dose monophasic oral combined estrogen-progestin contraceptive drug.

The contraceptive effect of Yarina is carried out through complementary mechanisms, the most important of which include the suppression of ovulation and the increase in the viscosity of cervical mucus.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence that the risk of endometrial cancer and ovarian cancer is reduced.

Drospirenone, contained in Yarin, has an antimineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (for example, edema) associated with hormone-induced fluid retention. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (blackheads), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the female body. This should be considered when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne (acne) and seborrhea.

When used correctly, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl Index may increase.

Compound

Ethinylestradiol + Drospirenone + excipients (Yarina).

Ethinylestradiol (micronized) + Drospirenone (micronized) + Calcium levomefolate (micronized) + excipients (Yarina plus).

Pharmacokinetics

After oral administration, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. After oral administration, drospirenone is completely metabolized. It is excreted in the form of metabolites with feces and urine in a ratio of approximately 1.2-1.4.

After oral administration, ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. Ethinylestradiol is excreted as metabolites in the urine and bile in a ratio of approximately 4:6.

Indications

• contraception;
• contraception and treatment of moderate acne (acne vulgaris or acne, pimples);
• contraception in women with folate deficiency (Yarina Plus).

Release forms

Film-coated tablets 3 mg + 30 mcg.

Film-coated tablets 3 mg + 30 mcg + 451 mcg.

Instructions for use and dosage regimen

Tablets should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Take 1 tablet per day continuously for 21 days. Taking the tablets from the next package begins after a 7-day break, during which menstrual-like bleeding (withdrawal bleeding) usually develops. As a rule, it starts 2-3 days after taking the last pill and may not end before taking the pills from the new package.

Start taking Yarina

In the absence of taking any hormonal contraceptives in the previous month, Yarina's intake begins on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). It is allowed to start taking on the 2-5th day

When switching from other combined oral contraceptives, a vaginal ring or a contraceptive patch, it is preferable to start taking Yarina the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Yarina's reception should be started on the day the vaginal ring or patch is removed, but no later than the day when a new ring should be inserted or a new patch should be pasted.

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena). You can switch from "mini-pill" to Yarina on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

After an abortion in the 1st trimester of pregnancy. You can start taking the drug immediately - on the day of the abortion. If this condition is met, the woman does not need additional contraception.

After childbirth or abortion in the 2nd trimester of pregnancy. You should start taking the drug no earlier than 21-28 days after childbirth (in the absence of breastfeeding) or abortion in the 2nd trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Yarina, or it is necessary to wait for the first menstruation.

Taking missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next pill is taken at the usual time.

If the delay in taking the drug was more than 12 hours, contraceptive protection is reduced. The more pills missed, and the closer the missed pill is to the 7-day break in taking pills, the greater the chance of pregnancy.

In this case, you can be guided by the following two basic rules:

1. The drug should never be interrupted for more than 7 days.
2. 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given if the delay in taking the tablets is more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours).

First week of taking the drug

It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before the pill was missed, the possibility of pregnancy should be taken into account.

Second week of taking the drug

It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next tablet is taken at the usual time. Provided that the woman has taken her pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

The risk of pregnancy increases due to the upcoming break in taking the pills. A woman must strictly adhere to one of the two following options. Moreover, if during the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.

1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers about it (even if this requires taking two tablets at the same time). The next pills are taken at the usual time until the pills from the current package run out. The next pack should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. You can stop taking the pills from the current pack, thus starting a 7-day break (including the day you missed the pills), and then start taking the pills from the new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.

In case of vomiting or diarrhea up to 4 hours after taking the tablets, absorption may not be complete and additional precautions should be taken to prevent unwanted pregnancy. In such cases, you should be guided by the above recommendations when skipping tablets.

Changing the start date of the menstrual cycle

In order to postpone the onset of menstruation, it is necessary to continue taking the tablets from the new Yarina package without a 7-day break. Tablets from a new package can be taken for as long as necessary, including until the package runs out. On the background of taking the drug from the second package, spotting from the vagina or breakthrough uterine bleeding is possible. Resume taking Yarina from the next package should be after the usual 7-day break. In order to move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will experience spotting and breakthrough bleeding during the second pack (just as she would like to delay the onset of her period).

Additional information for special categories of patients

For children and adolescents, Yarina is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

After the onset of menopause, Yarina is not indicated.

Yarina is contraindicated in women with severe liver disease until liver function tests return to normal.

Yarina is contraindicated in women with severe renal insufficiency or acute renal failure.

Differences from Yarina Plus

The composition of the combined preparation Yarina Plus contains an additional component - Calcium levomefolinate, which in its structure is folate, that is, a derivative of folic acid, a vitamin that is most often deficient in women.

Side effect

• nausea;
• abdominal pain;
• vomiting, diarrhea;
• engorgement, soreness of the mammary glands;
• vaginal discharge;
• discharge from the mammary glands;
• headache;
• decreased mood, mood swings;
• decrease or increase in libido;
• weight gain;
• rash, hives.

As with other combined oral contraceptives, in rare cases, thrombosis and thromboembolism may develop.

Contraindications

• thrombosis (venous and arterial) at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
• conditions preceding thrombosis (including transient disorders of cerebral circulation, angina pectoris) at the present time or in history;
• migraine with focal neurological symptoms at present or in history;
• diabetes mellitus with vascular complications;
• multiple or severe risk factors for venous or arterial thrombosis (including complicated valvular heart disease, atrial fibrillation, cerebrovascular or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years) ;
• pancreatitis with severe hypertriglyceridemia at present or in history;
• liver failure and severe liver disease (before normalization of liver tests);
• liver tumors (benign or malignant) at present or in history;
• severe and / or acute renal failure;
• identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• lactation (breastfeeding);
• hypersensitivity to the components of the drug.

If any of the above diseases or conditions develop for the first time while taking the drug, then it should be immediately canceled.

Use during pregnancy and lactation

The drug is not prescribed during pregnancy and during lactation.

If pregnancy is detected while taking Yarina, the drug should be immediately discontinued. However, extensive epidemiological studies have not found an increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken early in pregnancy.

At the same time, data on the results of taking Yarina during pregnancy are limited, which does not allow us to draw any conclusions about the negative effect of the drug on pregnancy, the health of the newborn and the fetus. There are currently no significant epidemiological data available.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

special instructions

Before starting or resuming the use of the drug Yarina, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and a cytological examination of a scraping from the cervix (test for Papanicolaou), exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. In general, follow-up examinations should be carried out at least once a year.

A woman should be informed that Yarina does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Despite the fact that a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant arterial hypertension has rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; SLE; hemolytic uremic syndrome; chorea of ​​Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and UC are also described against the background of the use of combined oral contraceptives.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (< 50 мкг этинилэстрадиола). Тем не менее, женщинам с сахарным диабетом необходим тщательный контроль во время приема препарата.

The effectiveness of combined oral contraceptives may be reduced by missed pills, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular (acyclic) bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during their pill break. If combined oral contraceptives were taken as directed, then pregnancy is unlikely. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, then pregnancy must be excluded before continuing to take the drug.

Impact on lab test scores

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect.

Influence on the ability to drive vehicles and control mechanisms

Not found.

Results of experimental studies

Preclinical data obtained in the course of standard studies in order to study toxicity with repeated administration of the drug, as well as hepatotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be borne in mind that sex steroids may promote the growth of certain hormone-dependent tissues and tumors.

drug interaction

Interactions of oral contraceptives with other medicinal products may result in breakthrough bleeding and/or reduced contraceptive reliability. Women taking these drugs should temporarily use barrier methods in addition to Yarina, or choose another method of contraception.

Effect on hepatic metabolism

The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or reduce the reliability of contraception. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.

HIV protease inhibitors (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and combinations thereof also have the potential to interfere with hepatic metabolism.

Effects on enterohepatic circulation

According to separate studies, some antibiotics (eg, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol. While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

While taking antibiotics (such as penicillins and tetracyclines) and within 7 days after their withdrawal, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking the tablets from the next package of Yarina without the usual break in taking the tablets.

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the influence of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Oral combined contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.

Based on interaction studies in female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drug substances is unlikely.

There is a theoretical possibility of an increase in serum potassium levels in women receiving Yarina concomitantly with other drugs that can increase serum potassium levels. These drugs include angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentrations compared with placebo.

Yarina's analogues

Structural analogues for the active substance:

• Dailla;
• Jess;
• Dimia;
• Midian;
• Yarina Plus.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.