Lindinet 20 what are they for. Terms of sale in pharmacies. Conditions for dispensing from pharmacies

Owner registration certificate:
GEDEON RICHTER Plc.

ATX code for LINDYNET 20

G03AA10 (Gestodene and estrogen)

Analogues of the drug according to ATC codes:

Before using LINDINET 20 you should consult your doctor. These instructions for use are for informational purposes only. To get more complete information Please refer to the manufacturer's instructions.

Clinical and pharmacological group

23.032 (Monophasic oral contraceptive)

Release form, composition and packaging

Light-coated tablets yellow, round, biconvex, both sides without inscriptions; at the break of white or almost white with light yellow edging.

Excipients: sodium calcium edetate, magnesium stearate, colloidal silicon dioxide, povidone, corn starch, lactose monohydrate.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104), povidone, titanium dioxide, macrogol 6000, talc, sucrose.

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

Pharmacological action

Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol - synthetic analogue follicular hormone estradiol, involved together with the hormone corpus luteum in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. After a single dose, Cmax is observed after 1 hour and is 2-4 ng/ml. Bioavailability - about 99%.

Distribution

Gestodene binds to albumin and sex hormone binding globulin (SHBG). 1-2% is found in plasma in free form, 50-75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction associated with albumin decreases. Average Vd - 0.7-1.4 l/kg. The pharmacokinetics of gestodene depends on the level of SHBG. The concentration of SHBG in blood plasma under the influence of estradiol increases 3 times. When taken daily, the concentration of gestodene in the blood plasma increases 3-4 times and in the second half of the cycle reaches a state of saturation.

Metabolism and excretion

Gestodene is biotransformed in the liver. The average plasma clearance is 0.8-1 ml/min/kg. The level of gestodene in the blood serum decreases in two phases. T1/2 in the β-phase is 12-20 hours. Gestodene is excreted only in the form of metabolites, 60% in urine, 40% in feces. T1/2 of metabolites - about 1 day.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. The average Cmax in the blood serum is reached 1-2 hours after administration and is 30-80 pg/ml. Absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%.

Distribution

Completely (about 98.5%), but nonspecifically binds to albumin and induces an increase in the level of SHBG in the blood serum. Average Vd - 5-18 l/kg.

Css is established by the 3-4th day of taking the drug, and it is 20% higher than after a single dose.

Metabolism

It undergoes aromatic hydroxylation to form hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Metabolic clearance from blood plasma is about 5-13 ml.

Removal

Serum concentration decreases in two phases. T1/2 in the β-phase is about 16-24 hours. Ethinyl estradiol is excreted only in the form of metabolites, in a 2:3 ratio with urine and bile. T1/2 of metabolites - about 1 day.

LINDYNET 20: DOSAGE

Prescribe 1 tablet/day for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which withdrawal bleeding occurs. The next day after a 7-day break (i.e., 4 weeks after taking the first tablet, on the same day of the week), the drug is resumed.

The first tablet of Lindinet 20 should be taken from the 1st to the 5th day of the menstrual cycle.

When switching to Lindinet 20 from another combined oral contraceptive, the first Lindinet 20 tablet should be taken after taking the last tablet from the package of another oral hormonal contraceptive, on the first day of withdrawal bleeding.

When switching to taking Lindinet 20 from drugs containing only progestogen (mini-pill, injections, implant), when taking a “mini-pill”, taking Lindinet 20 can be started on any day of the cycle, switching from using the implant to taking Lindinet 20 is possible the day after removal of the implant, when using injections - on the eve of the last injection. In these cases, in the first 7 days you should use additional methods contraception.

After an abortion in the first trimester of pregnancy, you can start taking Lindinet 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the second trimester of pregnancy, taking the drug can be started on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. If you start taking the drug later in the first 7 days, you should use additional barrier method contraception. If sexual intercourse took place before starting contraception, pregnancy should be ruled out before starting the drug or the start of use should be delayed until the first menstruation.

If you miss a pill, take the missed pill as quickly as possible. If the dosage interval does not reduce the effect of the drug, in which case there is no need to use an additional method of contraception. The remaining tablets should be taken at the usual time. If the interval is more than 12 hours, then contraceptive effect of the drug may decrease. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, taking the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after completing the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

If vomiting and/or diarrhea begins within 3-4 hours after taking the drug, the contraceptive effect may be reduced. In such cases, you should follow the instructions for skipping pills. If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

To speed up the onset of menstruation, reduce the break in taking the drug. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

To delay the onset of menstruation, the drug must be continued from a new package without a 7-day break. Menstruation can be delayed as long as necessary until the end of taking the last tablet from the second pack. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindinet 20 can be resumed after the usual 7-day break.

Overdose

Not described severe symptoms after taking the drug in high doses.

Symptoms: nausea, vomiting, in girls - spotting from the vagina.

Treatment: symptomatic therapy is prescribed; there is no specific antidote.

Drug interactions

The contraceptive activity of Lindinet 20 is reduced when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. Contraceptive effect oral contraceptives decreases with the use of these combinations, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet 20 with the above drugs, as well as for 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used for 4 weeks after completion of the course of taking it.

When used simultaneously with Lindinet 20, any drugs that increase gastrointestinal motility reduce absorption active substances and their level in blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that are also subject to sulfation in the intestinal wall (incl. ascorbic acid), competitively inhibit the sulfation of ethinyl estradiol and thereby enhance the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, hydantoin, felbamate, rifabutin, oscarbazepine).

Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.

Ethinyl estradiol, by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation), can affect the metabolism of other drugs (including cyclosporine, theophylline); The concentration of these drugs in the blood plasma may increase or decrease.

When Lindinet 20 is used simultaneously with St. John's wort preparations (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding and pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after completing the course of taking St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with more high content ethinyl estradiol or use additional non-hormonal methods of contraception.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraception may reduce carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

In small quantities, the components of the drug are released from breast milk.

When used during lactation, milk production may decrease.

LINDYNET 20: SIDE EFFECTS

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism pulmonary artery); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss caused by otosclerosis.

Other: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common, but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/spotty vaginal discharge, amenorrhea after drug withdrawal, change in condition vaginal mucus, development inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.

From the outside digestive system: epigastric pain, nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the side of the central nervous system: headache, migraine, mood lability, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the metabolic side: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Others: allergic reactions.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 3 years.

Indications

contraception.

Contraindications

the presence of severe and/or multiple risk factors for venous or arterial thrombosis (incl.
complicated lesions of the heart valve apparatus,
atrial fibrillation,
cerebrovascular diseases or coronary arteries,
arterial hypertension severe or medium degree severity with blood pressure ≥ 160/100 mm Hg);
presence or indication in history of precursors of thrombosis (incl.
transient ischemic attack,
angina);
migraine with focal neurological symptoms,
incl.
in the anamnesis;
venous or arterial thrombosis/thromboembolism (incl.
myocardial infarction,
stroke,
deep vein thrombosis of the leg,
pulmonary embolism) currently or in history;
a history of venous thromboembolism;
surgery with prolonged immobilization;
diabetes mellitus(with angiopathy);
pancreatitis (incl.
in the anamnesis),
accompanied by severe hypertriglyceridemia;
dyslipidemia;
serious illnesses liver,
cholestatic jaundice (incl.
during pregnancy),
hepatitis,
incl.
in the anamnesis (before normalization of functional and laboratory parameters and within 3 months after their normalization);
jaundice when taking GCS;
cholelithiasis currently or in history;
Gilbert's syndrome,
Dubin-Johnson syndrome,
Rotor syndrome;
liver tumors (incl.
in the anamnesis);
severe itching,
otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone dependent malignant neoplasms genitals and mammary glands (incl.
if you suspect them);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
increased sensitivity to the components of the drug.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or disorder cerebral circulation at a young age in one of the immediate relatives), hemolytic-uremic syndrome, hereditary angioedema, liver diseases, diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea / Sydenham disease /, Sydenham chorea, chloasma), obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, extensive surgery, surgical intervention on lower limbs, severe injury, varicose veins veins and superficial thrombophlebitis, postpartum period(non-lactating women /21 days after childbirth/; lactating women after completion of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein deficiency C or S, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus, uncomplicated vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic diseases liver.

Special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) And gynecological examination(including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) with correct use is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before appointment hormonal contraceptives the benefits or possible negative effects of taking them are assessed individually. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

diseases of the hemostatic system;
conditions/diseases,
predisposing to the development of cardiovascular disease,
renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus,
not complicated by vascular disorders;
severe depression (if depression is associated with impaired tryptophan metabolism,
then vitamin B6 can be used for correction purposes);
sickle cell anemia,
in some cases (for example,
infections,
hypoxia) estrogen-containing drugs in this pathology can provoke thromboembolism;
the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptive drugs very rarely, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is observed.

The risk of arterial or venous thromboembolic disease increases:

with age;
when smoking (heavy smoking and age over 35 years are risk factors);
if there is a family history of thromboembolic diseases (for example,
from parents,
brother or sister).
If you suspect genetic predisposition,
It is necessary to consult a specialist before using the drug;
for obesity (body mass index more than 30 kg/m2);
with dislipoproteinemia;
with arterial hypertension;
for diseases of the heart valves,
complicated by hemodynamic disorders;
with atrial fibrillation;
for diabetes mellitus,
complicated vascular lesions;
with prolonged immobilization,
after the big one surgical intervention,
after surgery on the lower extremities,
after a serious injury.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment this state reduces the risk of thromboembolism. Symptoms of thromboembolism are:

sudden pain in the chest
which radiates to left hand;
sudden shortness of breath;
any unusually severe headache
ongoing for a long time or appearing for the first time,
especially when combined with sudden complete or partial loss of vision or diplopia,
aphasia,
dizziness,
collapse,
focal epilepsy,
weakness or severe numbness of half the body,
motor disorders,
severe unilateral pain in calf muscle,
acute stomach.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Play a significant role in the development of cervical cancer sexual behavior, infection with the human papillomavirus and other factors.

A meta-analysis of 54 epidemiological studies showed that there is relative increase risk of breast cancer among women taking oral hormonal contraceptives, but the higher incidence of breast cancer could be associated with more regular medical examination. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant tumor liver in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sun rays or ultraviolet radiation while taking Lindinet 20.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness birth control pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters may change ( functional indicators liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins).

Additional information

After suffering an acute viral hepatitis the drug should be taken after normalization of liver function (not earlier than 6 months).

For diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

Smoking women have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

Studies have not been conducted to study the effect of the drug Lindinet 20 on the abilities necessary to drive a car and operate machinery.

Use for renal impairment

Use for liver dysfunction

Contraindicated in case of liver dysfunction.

Lindinet 20- combined oral contraceptive drug. Reduces the secretion of gonadotropic hormones of the pituitary gland, inhibits the maturation of follicles and prevents ovulation. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of estradiol that plays important role in the regulation of the menstrual cycle. The gestagenic component of the drug - a derivative of 19-nortestosterone - gestodene, in activity and selectivity of action exceeds not only the natural hormone of the corpus luteum (progesterone) but also most synthetic gestagens. Taking this into account, it is used in minimal dosages, which eliminates the manifestation of androgenic properties and significantly reduces the effect on fat and carbohydrate metabolism. When taking the drug, the nature of the cervical mucus changes, which makes it difficult not only for sperm to penetrate into the uterus, but also reduces the susceptibility of the endometrium to the blastocyst, preventing the implantation of a fertilized egg. In addition to contraceptive properties, the drug also has positive influence during the menstrual cycle. So, with regular use of Lindinet, the cycle becomes regular, the volume of blood loss during menstruation decreases, the frequency of dysmenorrhea, the appearance of functional ovarian cysts and ectopic pregnancy. The risk of fibroadenomas and fibrocysts in the mammary glands, congestion and inflammatory processes in the pelvic organs is reduced, and the general condition acne skin.

Indications for use

Preparation Lindineth indicated for use for contraception and treatment functional impairment menstrual cycle.

Directions for use

Drugs Lindinet 20 and Lindinet 30 take, starting from the first day of the menstrual cycle, 1 tablet per day for 21 days, after which they take a 7-day break during which menstrual-like bleeding appears due to drug withdrawal. The next course must be started the day after the 7-day break, that is, on the same day of the week when the first course was started.
Switching to Lindinet after taking another oral contraceptive: the first tablet of Lindinet should be taken the day after taking the last tablet of another oral contraceptive, on the first day of menstrual bleeding.
Switching to Lindinet after using drugs containing only progestogen ("mini-pill"): switching to the drug is possible on any day of the menstrual cycle.
Taking the drug after a medical abortion performed in the 1st trimester of pregnancy: you can start taking the drug immediately after the abortion, there is no need to use additional funds contraception.

Taking the drug Lindineth after an abortion performed in the 2nd trimester of pregnancy or after childbirth: you can start taking it after 28 days. In this case, it is necessary to use additional methods of contraception during the first 7 days.
If you missed taking the drug once, the missed pill should be taken as soon as possible. If less than 12 hours have passed since the moment when it was necessary to take the drug, then the effectiveness of the drug is not reduced, and there is no need for additional contraception. The drug should continue to be taken according to the schedule at the usual time. If you take a break of more than 12 hours, the effectiveness of the drug may decrease; you can not take the missed tablet, but take the next one as normal. Within 7 days after this, it is necessary to use additional means of protection against unwanted pregnancy. If at the time of skipping there were less than 7 tablets left in the package, then taking the next package should be started without taking a 7-day break.
If vomiting or diarrhea begins within 3-4 hours after taking the pill, the contraceptive effect may be reduced. In this case, you must proceed in the same way as if you missed taking the drug.
Lindinet can also be used to change the start date of your menstrual cycle. For delay menstrual flow you must start taking the next package without interruption.

Side effects

The first time after starting to take the drug Lindineth such side effects: engorgement of the mammary glands, deterioration in health, spotting bleeding - these side effects are usually mild and disappear within 2-4 cycles of use.
From the cardiovascular system: thromboembolism, thrombosis, increased blood pressure;
From the gastrointestinal tract: nausea, vomiting, diarrhea, hepatitis, gastralgia, deterioration of bile outflow;
From the reproductive system: change in libido, change in character vaginal discharge, intermenstrual bleeding, fungal infections vagina;
From the outside endocrine system: engorgement of the mammary glands, changes in body weight, increased levels of TG and glucose in the blood;
From the central nervous system: depression, dizziness, headaches, migraines, weakness, fatigue, mood swings;
Other: pain in the lower abdomen, discomfort when wearing contact lenses, allergic reactions, changes in the concentration of sodium and calcium in the blood plasma, hair loss, reversible hearing and vision impairment.

Contraindications

Contraindications to the drug Lindineth are: hypersensitivity to the components of the drug, diseases accompanied by severe liver dysfunction ( liver failure, congenital hyperbilirubinemia).

Thrombosis and thromboembolism, including a history, increased risk of thrombosis (hypercoagulation, various types heart defects), arterial hypertension, history of ischemic stroke, ischemic heart disease, atherosclerosis, myocarditis. Violation metabolic processes in the body: diabetes mellitus, lipid metabolism disorders, sickle cell anemia. Benign and malignant tumors, including a history. History of pregnancy itch, history of gestational herpes, otosclerosis with hearing impairment during pregnancy. Inflammatory diseases female genital organs, tendency to uterine bleeding, uterine bleeding of unknown etiology. Epilepsy, pregnancy and lactation.
Use with caution for diseases of the gallbladder, including a history of cholelithiasis, depression, including a history of migraine, and age over 35 years.

Pregnancy

Lindineth contraindicated during pregnancy. If it is necessary to use the drug during lactation, it is necessary to decide on discontinuation breastfeeding, since the drug is excreted in small doses in breast milk.

Interaction with other drugs

Barbiturates and antibiotics (rifampicin, ampicillin, griseofulvin) reduce the effectiveness of the contraceptive action of the drug Lindinet, as they change the intestinal flora; breakthrough bleeding is possible when taking these drugs simultaneously. If necessary, take antibiotics simultaneously with the drug Lindineth It is necessary to use additional contraception during the course of treatment and 7 days after its completion (for rifampicin, within 4 weeks after the end of the course of treatment). Medicines that enhance intestinal motility reduce the concentration of Lindinet in the blood, which can lead to a decrease in contraceptive effect.
Ascorbic acid and liver enzyme inhibitors (fluconazole, St. John's wort preparations) increase the bioavailability of ethinyl estradiol and its concentration in the blood plasma.

Overdose

Severe symptoms of drug overdose Lindinet 20 were not observed. Possible nausea, vomiting, and rarely vaginal bleeding. There is no specific antidote; treatment is symptomatic.

Storage conditions

Store out of reach of children, in a dry place, at a temperature of 15-25 degrees Celsius.

Release form

Lindinet 20
Lindinet 30 film-coated tablets, 21 pcs. in a blister, 1 or 3 blisters in a cardboard box.

Compound

Lindinet 20: ethinyl estradiol – 0.02 mg; gestodene – 0.075 mg.
Lindinet 30: ethinyl estradiol – 0.03 mg; gestodene – 0.075 mg.

Additionally

Lindinet increases the risk of myocardial infarction. The risk increases with smoking, presence overweight body, hypertension, age over 35-40 years. The drug should be stopped immediately if symptoms of thromboembolism appear: pain in chest, which radiates behind the sternum, into left shoulder and hand severe pain in the legs, swelling of the legs, hemoptysis, bloating of the veins. It is necessary to stop taking the drug one month before elective surgery, resumption of use is possible 2 weeks after the start motor activity. Before starting to use the drug, you must undergo an examination by a gynecologist, which includes a cytological analysis and examination of the mammary glands. In the future, when using the drug Lindinet, you must undergo regular examinations every 6 months. When using the drug, the level may decrease folic acid in the blood, this has therapeutic significance only in cases where pregnancy is planned immediately after discontinuation of the drug. Use of the drug immediately before and during pregnancy early stages, does not affect fetal development. The drug does not affect the ability to drive vehicles and mechanisms.

Basic parameters

Name:	LINDINET 20

Analogs of the drug Lindinet 20 are presented, in accordance with medical terminology, called “synonyms” - drugs that are interchangeable in their effect on the body, containing one or more identical active ingredients. When selecting synonyms, consider not only their cost, but also the country of production and the reputation of the manufacturer.

Description of the drug

Lindinet 20- Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

List of analogues

Pay attention! The list contains synonyms of Lindinet 20, which have a similar composition, so you can choose a replacement yourself, taking into account the form and dose of the medicine prescribed by your doctor. Give preference to manufacturers from the USA, Japan, Western Europe, and also well-known companies from Eastern Europe: KRKA, Gedeon Richter, Actavis, Aegis, Lek, Hexal, Teva, Zentiva.

Reviews

Below are the results of surveys of site visitors about the drug Lindinet 20. They reflect the personal feelings of the respondents and cannot be used as an official recommendation for treatment with this drug. We strongly recommend that you contact a qualified medical specialist to select a personal course of treatment.

Visitor survey results

Nine visitors reported effectiveness

Four visitors reported cost estimates

	Participants		%
Not expensive	2		50.0%
Dear	2		50.0%

Nine visitors reported frequency of intake per day

How often should I take Lindinet 20?
Most respondents most often take this drug once a day. The report shows how often other survey participants take this drug.

Two visitors reported the expiration date

How long does it take to take Lindinet 20 to feel an improvement in the patient’s condition?
Survey participants in most cases felt an improvement in their condition after 1 week. But this may not correspond to the period after which you will begin to improve. Check with your doctor for how long you need to take this medicine. The table below shows the results of the survey on the initiation of effective action.

Five visitors reported appointment times

When is the best time to take Lindinet 20: on an empty stomach, before, after or with food?
Site users most often report that they take this medication after meals. However, your doctor may recommend a different time for you. The report shows when the remaining patients surveyed take their medication.

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Official instructions for use

There are contraindications! Read the instructions before use

LINDINET 20
LINDYNETTE 20

Registration number: P No. 015122/01

Trade name: LINDINET 20

International nonproprietary name:

ethinylestradiol + gestodene

Dosage form:

film-coated tablets.
Compound
Active substances: ethinyl estradiol - 0.02 mg and gestodene - 0.075 mg
Excipients:

in the core: Sodium calcium edetate; magnesium stearate; colloidal silicon dioxide; povidone; corn starch; lactose monohydrate;

in the shell: Quinoline yellow dye E 104 (D+S Yellow No. 10 E 104); povidone; titanium dioxide; macrogol 6000; talc; calcium carbonate; sucrose.

Description: round, biconvex, film-coated tablets, yellow. On the break it is white or almost white with a light yellow edging, both sides without an inscription.

Pharmacotherapeutic group:

contraceptive.

ATX code: G03AB06

Pharmacological properties

Pharmacodynamics
A combined agent, the effect of which is determined by the effects of the components included in its composition. Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is a highly effective oral drug - ethinyl estradiol (a synthetic analogue of estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle). The gestagenic component is a derivative of 19-nortestosterone - gestodene, which is superior in strength and selectivity to not only the natural hormone of the corpus luteum progesterone, but also modern synthetic gestagens (levonorgestrel, etc.). Due to its high activity, gestodene is used in very low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.
Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestodene:
Suction: when taken orally, it is quickly and completely absorbed. After taking one dose, the maximum plasma concentration is measured after an hour and is 2-4 ng/ml. Bioavailability is about 99%. Distribution: interacts with albumin and sex hormone binding globulin (SHBG). 1-2% is in a free state, 50-75% is specifically associated with SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The volume of distribution of gestodene is 0.7-1.4 l/kg.
Metabolism: corresponds to the steroid metabolism pathway. Average plasma clearance: 0.8-1.0 ml/min/kg.
Removal: The blood level decreases in two stages. Half-life in the final phase is 12-20 hours. Excreted exclusively in the form of metabolites: 60% in urine, 40% in urine feces. The half-life of metabolites is approximately 1 day.
Stable concentration: The pharmacokinetics of gestodene largely depends on the level of SHBG. Under the influence of ethinyl estradiol, the concentration of SHBG in the blood increases three times; with daily use of the drug, the level of gestodene in plasma increases three to four times and in the second half of the cycle reaches a state of saturation.
Ethinyl estradiol:
Suction: when taken orally, it is absorbed quickly and almost completely. The maximum concentration in the blood is measured after 1-2 hours and is 30-80 pg/ml. Absolute bioavailability ≈ 60% due to pre-systemic conjugation and primary metabolism in the liver.
Distribution: easily enters into a nonspecific relationship with blood albumin (about 98.5%) and causes an increase in SHBG levels. Average volume distribution 5-18 l/kg. Metabolism: carried out mainly due to aromatic hydroxylation with the formation large quantities hydroxylated and methylated metabolites, partly in free, partly in conjugated form (glucuronides and sulfates). Plasma clearance ≈ 5-13 ml/min/kg.
Removal: Serum concentration decreases in two stages. The half-life in the second phase is ≈ 16-24 hours. It is excreted exclusively in the form of metabolites in a 2:3 ratio with urine and bile. The half-life of metabolites is ≈ 1 day.
Stable concentration: A stable concentration is established by 3-4 days, while the level of ethinyl estradiol is 20% higher than after taking a single dose.

Indications for use

Contraception.
Contraindications

pregnancy or suspicion of it;

lactation;

the presence of severe or multiple risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled moderate or severe arterial hypertension with blood pressure 160/100 mmHg or more);

precursors of thrombosis (including transient ischemic attack, angina), including a history;

migraine with focal neurological symptoms, including a history;

venous or arterial thrombosis/thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) currently or in history, the presence of venous thromboembolism in relatives;

major surgery with prolonged immobilization;

diabetes mellitus (with the presence of angiopathy);

pancreatitis (including a history), accompanied by severe hypertriglyceridemia;

dyslipidemia;

severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within three months after these parameters return to normal);

jaundice due to taking drugs containing steroids;

gallstone disease currently or in history;

Gilbert, Dubin-Johnson, Rotor syndrome;

liver tumors (including history);

severe itching, otosclerosis or progression of otosclerosis during a previous pregnancy or while taking glucocorticosteroids;

hormone-dependent malignant neoplasms of the genitals, organs and mammary glands (including suspicion of them);

vaginal bleeding of unknown etiology;

smoking over the age of 35 (more than 15 cigarettes per day);

individual hypersensitivity to the drug or its components.

With caution
Conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family); hemolytic uremic syndrome, hereditary angioedema, liver disease; diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea (Sydenham's disease), Sydenham's chorea, chloasma); obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period (non-lactating women 21 days after birth; nursing women after completion of the lactation period), the presence of severe depression, incl. history, changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant).
Diabetes mellitus not complicated by vascular disorders, systemic lupus erythematosus (SLE), Crohn's disease, ulcerative colitis, sickle cell anemia; hypertriglyceridemia (including family history), acute and chronic liver diseases.

Pregnancy and lactation

The use of the drug during pregnancy and breastfeeding is contraindicated.

Directions for use and doses

Take 1 tablet per day for 21 days, if possible at the same time of day. Then, after taking a 7-day break from taking pills, resume oral contraception (i.e. 4 weeks after taking the first pill, on the same day of the week). During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal. First tablet: Taking Lindinet 20 should start from the first to the fifth day of the menstrual cycle.
Transition from a combined oral contraceptive to taking Lindinet 20: It is recommended to take the first tablet of Lindinet 20 after taking the last hormone-containing tablet of the previous drug, on the first day of withdrawal bleeding.
Transition from progestogen-containing drugs (“mini” tablets, injections, implants) to taking Lindinet 20: The transition from “mini” pills can be started on any day of the menstrual cycle; in the case of an implant - the day after its removal; in case of injections - on the eve of the last injection.
In this case, in the first 7 days of taking Lindinet 20, it is necessary to use an additional method of contraception.

Taking Lindinet 20 after an abortion in the first trimester of pregnancy: You can start taking a contraceptive immediately after an abortion, and there is no need to use an additional method of contraception.
Taking Lindinet 20 after childbirth or after an abortion in the second trimester of pregnancy: You can start taking the contraceptive 21-28 days after childbirth or abortion in the second trimester of pregnancy. If you start taking a contraceptive later, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In cases where sexual contact took place before the start of contraception, before starting to take the drug, the presence of new pregnancy or wait until the next menstruation.
Missed pills
If the next scheduled dose of the tablet was missed, then you should make up for the missed dose as soon as possible. If the delay does not exceed 12 hours, the contraceptive effect of the drug is not reduced, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual.
If there is a delay of more than 12 hours, the contraceptive effect may decrease. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then take the tablets from the next package without taking a break. In such cases, uterine withdrawal bleeding occurs only after the completion of the second package; While taking tablets from the second package, spotting or breakthrough bleeding is possible.
If, upon completion of taking the pills from the second package, withdrawal bleeding does not occur, then pregnancy should be ruled out before continuing to take the contraceptive.
Measures to be taken in case of vomiting and diarrhea:
If vomiting occurs in the first 3-4 hours after taking another tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in the section “Missed tablets”.
If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.
Delay of menstruation and acceleration of the onset of menstruation:
In order to delay menstruation, take pills from a new package without taking a break. Menstruation can be delayed at will until all the tablets from the second package are gone. If menstruation is delayed, breakthrough or spotting may occur. uterine bleeding. You can return to your usual pill intake after a 7-day break.
For the purpose of an earlier attack menstrual bleeding You can shorten the 7-day break by the desired number of days. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

Side effects

Side effects that require immediate discontinuation of the drug:

arterial hypertension;

hemolytic-uremic syndrome;

porphyria;

hearing loss due to otosclerosis.

Rarely found: arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); exacerbation of reactive systemic lupus erythematosus.
Very rare: arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; Sydenham's chorea (passing after discontinuation of the drug).
Other side effects, less severe, but more common. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

Reproductive system: acyclic bleeding/spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina (eg candidiasis), changes in libido.

Mammary glands: tension, pain, enlarged mammary glands, galactorrhea.

Gastrointestinal tract and hepato-biliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.

Skin: erythema nodosum/exudative, rash, chloasma, increased hair loss.

Central nervous system: headache, migraine, mood changes, depressive states.

Metabolic disorders: fluid retention in the body, change (increase) in body weight, increased levels of triglycerides and blood sugar, decreased tolerance to carbohydrates.

Sense organs: hearing loss, increased sensitivity of the cornea when wearing contact lenses.

Other: allergic reactions.

Overdose

Reception large doses contraception was not associated with the development of severe symptoms. Signs of overdose: nausea, vomiting, slight vaginal bleeding in young girls. There is no specific antidote, treatment is symptomatic.

Interaction with other drugs

The contraceptive effect of oral contraceptives is reduced with simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent. Similar, however, less studied interactions exist between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin and, presumably, griseofulvin, ampicillin and tetracyclines. During treatment with the above drugs, it is recommended to use an additional method of contraception (condom, spermicidal gel) simultaneously with oral contraception. After completing the course of treatment, the use of an additional method of contraception should be continued for 7 days, in the case of treatment with rifampicin - for 4 weeks.
Interactions associated with drug absorption: During diarrhea, hormone absorption is reduced due to enhanced motor skills intestines. Any drug that shortens the residence time hormonal agent in the large intestine, leads to low concentrations of the hormone in the blood.
Interactions associated with drug metabolism:
Intestinal wall: Drugs that undergo sulfation in the intestinal wall like ethinyl estradiol (eg ascorbic acid) inhibit metabolism in a competitive manner and increase the bioavailability of ethinyl estradiol.
Metabolism in the liver: Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.
Effect on intrahepatic circulation: Some antibiotics (eg, ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.
Influence on the exchange of others medicines: By blocking liver enzymes or accelerating conjugation in the liver, mainly increasing glucuronidation, ethinyl estradiol affects the metabolism of other drugs (eg, cyclosporine, theophylline), leading to an increase or decrease in their plasma concentrations.
The simultaneous use of preparations from St. John's wort (Hypericum perforatum) with Lindinet 20 tablets is not recommended due to a possible decrease in the contraceptive effect of the active substance of the contraceptive, which may be accompanied by breakthrough bleeding and unwanted pregnancy. St. John's wort activates liver enzymes; after stopping the use of St. John's wort, the effect of enzyme induction may persist for the next 2 weeks.
The simultaneous use of ritonavir and a combined contraceptive is accompanied by a decrease in average size AUC of ethinyl estradiol by 41%. During treatment with ritonavir, it is recommended to use the drug with high content ethinyl estradiol or use a non-hormonal method of contraception. It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because Oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Special instructions

Before starting to use the drug, it is recommended to collect a detailed family and personal history and subsequently every 6 months. undergo a general medical and gynecological examination (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, control blood pressure(BP), blood cholesterol concentrations, urine analysis). These studies must be repeated periodically, due to the need for timely identification of risk factors or contraindications that have arisen.
The drug is a reliable contraceptive medicine: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.
In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception. The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

diseases of the hemostatic system.

conditions/diseases predisposing to the development of cardiovascular and renal failure.

epilepsy

migraine

the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;

diabetes mellitus not complicated by vascular disorders;

severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);

sickle cell anemia, since in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism.

the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases
Epidemiological studies have shown that there is an association between taking oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.
The risk of arterial or venous thromboembolic disease increases:

with age;

when smoking (heavy smoking and age over 35 years are risk factors);

if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug.

for obesity (body mass index above 30 kg/m2);

with dislipoproteinemia;

with arterial hypertension;

for diseases of the heart valves complicated by hemodynamic disorders,

with atrial fibrillation;

with diabetes mellitus complicated by vascular lesions;

with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, a temporary cessation of use of the drug is assumed: it is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.
The risk of venous thromboembolic diseases increases in women after childbirth.
Diseases such as diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia increase the risk of developing venous thromboembolic diseases.
Biochemical abnormalities such as resistance to activated protein C, hyperchromocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.
When assessing the benefit/risk ratio of taking the drug, it must be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism.
Signs of thromboembolism are:

sudden chest pain that radiates to the left arm,

sudden shortness of breath,

any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy), weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen).

Tumor diseases
Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer. A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, women should be made aware of the possible risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian, endometrial and colon cancer).
There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when diagnosing abdominal pain, which may be associated with an increase in liver size or intra-abdominal bleeding.
The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.
If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.
The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.
Chloasma
Chloasma can occasionally occur in women who have a history of it during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking the pills. Changes in laboratory parameters
Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.
After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months). In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception). Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked. During lactation, milk secretion may decrease; small amounts of the drug are excreted in breast milk.

The effect of the drug on the ability to drive a car and other machines
Studies have not been conducted to study the possible effect of Lindinet 20 on the ability to drive a car or other machines.

Release form

Film-coated tablets.
21 tablets in a blister made of PVC/PVDC film and aluminum foil. 1 or 3 blisters in a cardboard box with instructions for use.

Best before date

3 years.
Use the drug only taking into account the expiration date indicated on the packaging.

Storage
Store at a temperature not exceeding 30°C. Keep out of the reach of children!

Conditions for dispensing from pharmacies:

available by prescription.

Send consumer complaints to:
Moscow Representative Office of JSC Gedeon Richter 119049 Moscow, 4th Dobryninsky lane, building 8

The information on the page was verified by physician-therapist E.I. Vasilyeva.

Monophasic oral contraceptive

Active ingredients

Ethinyl estradiol
- gestodene

Release form, composition and packaging

Film-coated tablets light yellow, round, biconvex, both sides without inscriptions; on the fracture it is white or almost white with a light yellow edging.

Excipients: sodium calcium edetate - 0.065 mg, magnesium stearate - 0.2 mg, colloidal silicon dioxide - 0.275 mg, - 1.7 mg, corn starch - 15.5 mg, lactose monohydrate - 37.165 mg.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104) - 0.00135 mg, povidone - 0.171 mg, titanium dioxide - 0.46465 mg, macrogol 6000 - 2.23 mg, talc - 4.242 mg, calcium carbonate - 8.231 mg, sucrose - 19.66 mg .

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

Pharmacological action

Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle. The gestagenic component is a derivative of 19-nortestosterone - gestodene, which is superior in strength and selectivity to not only the natural hormone of the corpus luteum, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. After taking one dose, Cmax is observed after 1 hour and is 2-4 ng/ml. Bioavailability - about 99%.

Distribution

Gestodene binds to and with sex hormone binding globulin (SHBG). 1-2% is found in plasma in free form, 50-75% specifically binds to SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, which leads to an increase in the fraction associated with SHBG and a decrease in the fraction associated with albumin. V d - 0.7-1.4 l/kg.

The pharmacokinetics of gestodene largely depends on the level of SHBG. Under the influence of ethinyl estradiol, the concentration of SHBG in the blood increases 3 times. When taken daily, the concentration of gestodene in the blood plasma increases 3-4 times and in the second half of the cycle reaches a state of saturation.

Metabolism

Corresponds to the steroid metabolism pathway. The average plasma clearance is 0.8-1 ml/min/kg.

Removal

The concentration of gestodene in the blood decreases in two phases. T1/2 in the final phase is 12-20 hours. It is excreted exclusively in the form of metabolites, 60% in urine, 40% in feces. T 1/2 metabolites - about 1 day.

Ethinyl estradiol

Suction

When taken orally, ethinyl estradiol is absorbed quickly and almost completely. Cmax in the blood is reached 1-2 hours after administration and is 30-80 pg/ml. Absolute bioavailability due to presystemic conjugation and primary metabolism in the liver is about 60%.

Distribution

To a high degree (about 98.5%), but nonspecifically binds to albumin and causes an increase in the level of SHBG in the blood serum. Average Vd - 5-18 l/kg.

C ss is established by the 3-4th day of taking the drug, and it is 20% higher than after a single dose.

Metabolism

Subjects to aromatic hydroxylation to form large quantity hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Plasma clearance is about 5-13 ml/min/kg.

Removal

Indications

- contraception.

Contraindications

- the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral or coronary artery disease, uncontrolled arterial hypertension severe or moderate with blood pressure ≥ 160/100 mmHg);

- presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);

- migraine with focal neurological symptoms, incl. in the anamnesis;

- venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;

- a history of venous thromboembolism in relatives;

- surgery with long-term immobilization;

— diabetes mellitus (with angiopathy);

- pancreatitis (including a history), accompanied by severe hypertriglyceridemia;

- dyslipidemia;

- severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);

- jaundice when taking medications containing steroids;

- gallstone disease currently or in history;

- Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;

- liver tumors (including in history);

- severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;

— hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);

- vaginal bleeding of unknown etiology;

- smoking over the age of 35 (more than 15 cigarettes per day);

— pregnancy or suspicion of it;

- lactation period;

- hypersensitivity to the components of the drug.

With caution the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), hemolytic uremic syndrome, hereditary angioedema, liver diseases, diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea / Sydenham disease /, Sydenham chorea, chloasma), obesity (BMI more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period (non-lactating women /21 days after childbirth/; lactating women after the end of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including . antibodies to cardiolipin, lupus), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including a family history), acute and chronic liver diseases.

Dosage

First tablet: The drug should be taken from the 1st to the 5th day of the menstrual cycle.

Switching to taking Lindinet 20 from another combined oral contraceptive: The first Lindinet 20 tablet should be taken after taking the last hormone-containing tablet from the package of the previous oral hormonal contraceptive, on the first day of withdrawal bleeding.

Switching to taking Lindinet 20 from drugs containing only gestagen ("mini-pill", injections, implant): switching from the “mini-pill” to taking Lindinet 20 can be started on any day of the menstrual cycle; You can switch from using the implant to taking Lindinet 20 the next day after removing the implant; when using injections - on the eve of the last injection. In these cases, during the first 7 days of taking Lindinet 20, an additional method of contraception should be used.

Taking Lindinet 20 after an abortion in the first trimester of pregnancy: Taking Lindinet 20 can be started immediately after an abortion. In this case, there is no need to use an additional method of contraception.

Taking Lindinet 20 after childbirth or after an abortion in the second trimester of pregnancy: Taking the drug can be started 21-28 days after childbirth or abortion in the second trimester of pregnancy. If you start taking the drug later, an additional barrier method of contraception should be used in the first 7 days. If sexual intercourse took place before starting contraception, pregnancy should be ruled out before starting the drug or the start of use should be delayed until the first menstruation.

Missed pills

If the next dose of the tablet is missed, you should make up for the missed dose as soon as possible. If the interval in taking pills was less than 12 hours, then the contraceptive effect of the drug is not reduced, and in this case there is no need to use an additional method of contraception. The remaining tablets should be taken as usual.

If the interval was more than 12 hours, then the contraceptive effect of the drug may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then taking the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after completing the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

Vomiting and diarrhea

If within 3-4 hours after taking the drug begins vomit, then the tablet is not completely absorbed. In such cases, you should follow the instructions for skipping pills. If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

Delayed menstruation and acceleration of the onset of menstruation

With a purpose delayed menstruation tablets should be taken from a new package without taking a break. Menstruation can be delayed as long as necessary until the end of taking the last tablet from the second pack. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindinet 20 can be resumed after the usual 7-day break.

With a purpose accelerating the onset of menstruation the 7-day break should be reduced by the desired number of days. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

Side effects

Side effects that require immediate discontinuation of the drug:

Arterial hypertension;

Hemolytic-uremic syndrome;

Porphyria;

Hearing loss caused by otosclerosis.

Rarely: arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); exacerbation of reactive systemic lupus erythematosus.

Very rarely: arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; Sydenham's chorea (passing after discontinuation of the drug).

Other side effects that are less severe but more common are listed below. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the outside reproductive system: acyclic bleeding/spotty discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina, candidiasis, changes in libido.

From the mammary glands: tension, pain, breast enlargement, galactorrhea.

From the digestive system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.

From the outside skin: Erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the side of the central nervous system: headache, migraine, mood changes, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased levels of triglycerides in the blood.

Others: allergic reactions.

Overdose

Taking Lindinet 20 in high doses was not accompanied by the development of severe symptoms.

Symptoms: nausea, vomiting, and in young girls, slight vaginal bleeding.

Treatment: There is no specific antidote; treatment is symptomatic.

Drug interactions

The contraceptive effect of oral contraceptives is reduced with simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent.

Similar, but less studied, interactions exist between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin and, presumably, griseofulvin, ampicillin and tetracyclines. During treatment with the drugs listed above, it is recommended to use an additional method of contraception (condom, spermicidal gel) simultaneously with oral contraception. After completing the course of treatment, the use of an additional method of contraception should be continued for 7 days, in the case of treatment with rifampicin - for 4 weeks.

Interactions associated with drug absorption

During diarrhea, the absorption of hormones is reduced due to increased intestinal motility. Any drug that shortens the time a hormonal agent remains in the large intestine leads to low concentrations of the hormone in the blood.

Interactions related to drug metabolism

Intestinal wall: drugs that undergo sulfation in the intestinal wall like ethinyl estradiol (for example), competitively inhibit metabolism and increase the bioavailability of ethinyl estradiol.

Metabolism in the liver: inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the concentration of ethinyl estradiol in the blood plasma.

Effect on intrahepatic circulation: some antibiotics (for example, ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the concentration of ethinyl estradiol in plasma.

Effect on the metabolism of other drugs: By blocking liver enzymes or accelerating conjugation in the liver, mainly increasing glucuronidation, ethinyl estradiol affects the metabolism of other drugs (for example, cyclosporine, theophylline), which leads to an increase or decrease in their plasma concentrations.

The simultaneous use of St. John's wort (Hypericum perforatum) with Lindinet 20 is not recommended due to a possible decrease in the contraceptive effect of the active substances, which may be accompanied by breakthrough bleeding and unwanted pregnancy. St. John's wort activates liver enzymes; after stopping the use of St. John's wort, the effect of enzyme induction may persist for the next 2 weeks.

Concomitant use of ritonavir and a combined contraceptive was associated with a 41% decrease in the mean AUC of ethinyl estradiol. During treatment with ritonavir, it is recommended to use a drug with a high content of ethinyl estradiol or use a non-hormonal method of contraception. It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral hypoglycemic agents.

Special instructions

Before starting to use the drug, it is recommended to collect a detailed family and personal history and subsequently undergo a general medical and gynecological examination every 6 months (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, monitoring of blood pressure, cholesterol concentrations in the blood, urine analysis). These studies must be repeated periodically, due to the need for timely identification of risk factors or contraindications that have arisen.

The drug is a reliable contraceptive drug: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception. The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

Diseases of the hemostatic system;

Conditions/diseases predisposing to the development of cardiovascular and renal failure;

Epilepsy;

Migraine;

Risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;

Diabetes mellitus not complicated by vascular disorders;

Severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used for correction);

Sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;

The appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is an association between taking oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism).

An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

With age;

When smoking (heavy smoking and age over 35 years are risk factors);

If there is a family history of thromboembolic diseases (for example, in parents, brother or sister); if a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;

For obesity (body mass index above 30 kg/m2);

For dislipoproteinemia;

For arterial hypertension;

For diseases of the heart valves complicated by hemodynamic disorders;

With atrial fibrillation;

For diabetes mellitus complicated by vascular lesions;

With prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, a temporary cessation of use of the drug is assumed: it is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.

The risk of venous thromboembolic diseases increases in women after childbirth.

Diseases such as diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia increase the risk of developing venous thromboembolic diseases.

Biochemical abnormalities such as resistance to activated protein C, hyperchromocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it must be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism.

Signs of thromboembolism are:

Sudden chest pain that radiates to the left arm;

Sudden shortness of breath;

Any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, symptom complex "acute" abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there was a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, women should be made aware of the possible risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian, endometrial and colon cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when diagnosing abdominal pain, which may be associated with an increase in liver size or intra-abdominal bleeding.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of oral contraceptives.

In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).

If the patient is concomitantly taking another drug that may reduce the effectiveness of oral contraceptives, additional methods of contraception should be used.

If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking Lindinet 20 tablets and resume it only after pregnancy has been ruled out.

Chloasma

Chloasma can occasionally occur in women who have a history of it during pregnancy. Women who are at risk of developing chloasma should avoid exposure to sunlight or ultraviolet radiation while taking Lindinet 20.

Changes in laboratory parameters

Under the influence of oral contraceptives - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional information

After acute viral hepatitis, the drug should be taken only after normalization of liver function (no earlier than 6 months).

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

Impact on the ability to drive vehicles and machinery

Studies have not been conducted to study the possible effect of Lindinet 20 on the ability to drive a car or other machines.

Pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

The components of the drug are excreted in breast milk in small quantities. When used during lactation, milk production may decrease.

For impaired renal function

For liver dysfunction

Contraindicated in case of liver dysfunction.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 25°C. Shelf life - 3 years.

Lindinet 20 (ethinyl estradiol + gestodene) is a monophasic tablet combined (estrogen + progestogen) contraceptive. Manufacturer - Hungarian pharmaceutical company"Gedeon Richter". Date of entry into the world market - 2004. The drug is valued for its ability to provide reliable contraception and effectively control the menstrual cycle. Lipndinet 20 is well tolerated and does not affect blood pressure and aldosterone concentrations, which is especially important for premenopausal and premenopausal women. menopause. Lindinet 20 is an excellent choice for women of average age reproductive age(from 22 to 35 years old) who need long-lasting, reliable and safe contraception, as well as for girls just starting to use hormonal contraceptives. Despite the low quantitative content of active ingredients, the drug reliably controls the menstrual cycle and is guaranteed to eliminate the characteristic painful sensations lower abdomen. Lindinet 20 is optimal choice in cases where a woman has developed unwanted effects caused by a high dose of estrogen or progestin component. Lindinet 20 contains a minimal dose of ethinyl estradiol and a gestagen (gestodene), which ensures a rapid drop in the concentration of estrogen in plasma. Gestodene is included in the drug in a dose that does not have clinically significant glucocorticoid activity, which helps maintain stable body weight.

This is confirmed by studies of the drug, demonstrating the absence of a significant increase in a woman’s body weight. Gestodene is one of the most powerful and highly selective progestins present on the pharmaceutical market today. Due to its high activity, this substance is used in low concentrations, in which it does not affect the metabolism of fats and carbohydrates and does not exhibit androgenic properties. In addition to contraception, the drug also has therapeutic effect, preventing the development of a number of diseases gynecological profile, incl. tumor etiology.

Before starting to use Lindinet 20, a woman must undergo medical examination, including collection of family and personal anamnestic data, measurement of blood pressure, laboratory tests, as well as gynecological examination. In the future, such an examination, provided that the woman is taking oral contraceptives, should be carried out once every six months. Before starting contraceptive therapy using hormonal contraceptives, all women are weighed possible benefits and potential risks, after which the doctor, together with the woman, makes a joint decision on choosing one or another method of contraception. If, after starting to take the drug, a woman develops or worsens diseases circulatory system, cardiovascular diseases, epilepsy, diabetes mellitus, depression, then contraceptive therapy should be discontinued.

Pharmacology

Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. After a single dose, Cmax is observed after 1 hour and is 2-4 ng/ml. Bioavailability - about 99%.

Distribution

Gestodene binds to albumin and sex hormone binding globulin (SHBG). 1-2% is found in plasma in free form, 50-75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction associated with albumin decreases. Average V d - 0.7-1.4 l/kg. The pharmacokinetics of gestodene depends on the level of SHBG. The concentration of SHBG in blood plasma under the influence of estradiol increases 3 times. When taken daily, the concentration of gestodene in the blood plasma increases 3-4 times and in the second half of the cycle reaches a state of saturation.

Metabolism and excretion

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. The average Cmax in blood serum is reached 1-2 hours after administration and is 30-80 pg/ml. Absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%.

Distribution

Completely (about 98.5%), but nonspecifically binds to albumin and induces an increase in the level of SHBG in the blood serum. Average Vd - 5-18 l/kg.

C ss is established by the 3-4th day of taking the drug, and it is 20% higher than after a single dose.

Metabolism

Removal

Release form

Light yellow film-coated tablets, round, biconvex, unprinted on both sides; on the fracture it is white or almost white with a light yellow edging.

Excipients: sodium calcium edetate - 0.065 mg, magnesium stearate - 0.2 mg, colloidal silicon dioxide - 0.275 mg, povidone - 1.7 mg, corn starch - 15.5 mg, lactose monohydrate - 37.165 mg.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104) - 0.00135 mg, povidone - 0.171 mg, titanium dioxide - 0.46465 mg, macrogol 6000 - 2.23 mg, talc - 4.242 mg, calcium carbonate - 8.231 mg, sucrose - 19.66 mg.

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

Dosage

The first tablet of Lindinet 20 should be taken from the 1st to the 5th day of the menstrual cycle.

When switching to taking Lindinet 20 from drugs containing only gestagen ("mini-pill", injections, implant), when taking the "mini-pill", taking Lindinet 20 can be started on any day of the cycle, switching from using the implant to taking Lindinet 20 is possible the day after removal of the implant, when using injections - on the eve of the last injection. In these cases, additional methods of contraception should be used in the first 7 days.

After an abortion in the first trimester of pregnancy, you can start taking Lindinet 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the second trimester of pregnancy, taking the drug can be started on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. If you start taking the drug later, an additional barrier method of contraception should be used in the first 7 days. If sexual intercourse took place before starting contraception, pregnancy should be ruled out before starting the drug or the start of use should be delayed until the first menstruation.

If you miss a pill, take the missed pill as quickly as possible. If the interval in taking the pills is less than 12 hours, then the contraceptive effect of the drug is not reduced, and in this case there is no need to use an additional method of contraception. The remaining tablets should be taken at the usual time. If the interval is more than 12 hours, the contraceptive effect of the drug may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, taking the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after completing the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

Overdose

No severe symptoms have been described after taking the drug in high doses.

Symptoms: nausea, vomiting, in girls - bleeding from the vagina.

Treatment: symptomatic therapy is prescribed; there is no specific antidote.

Interaction

The contraceptive activity of Lindinet 20 is reduced when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. The contraceptive effect of oral contraceptives is reduced when these combinations are used, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet 20 with the above drugs, as well as for 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used for 4 weeks after completion of the course of taking it.

When used simultaneously with Lindinet 20, any drug that increases gastrointestinal motility reduces the absorption of active substances and their level in the blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that are also subject to sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine).

Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher ethinyl estradiol content should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Side effects

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss caused by otosclerosis.

Other: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/bloody discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, enlarged mammary glands, galactorrhea.

From the digestive system: epigastric pain, nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the central nervous system: headache, migraine, mood lability, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the metabolic side: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Other: allergic reactions.

Indications

Contraception.

Contraindications

the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral or coronary artery disease, severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg .st.);
presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
migraine with focal neurological symptoms, incl. in the anamnesis;
venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
a history of venous thromboembolism;
surgery with prolonged immobilization;
diabetes mellitus (with angiopathy);
pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
dyslipidemia;
severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
jaundice when taking GCS;
gallstone disease currently or in history;
Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
liver tumors (including history);
severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
hypersensitivity to the components of the drug.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), hemolytic-uremic syndrome, hereditary angioedema, liver diseases, diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea / Sydenham disease /, Sydenham chorea, chloasma) , obesity (BMI more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis , postpartum period (non-lactating women /21 days after childbirth/; lactating women after the end of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including . antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including a family history), acute and chronic liver diseases.

Features of application

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation.

The components of the drug are excreted in breast milk in small quantities.

When used during lactation, milk production may decrease.

Use for liver dysfunction

Contraindicated in case of liver dysfunction.

Use for renal impairment

The drug is not recommended for use in patients with kidney disease.

Special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, it is recommended to additionally use non-hormonal methods of contraception in the first 2 weeks of taking the drug.

diseases of the hemostatic system;
conditions/diseases predisposing to the development of cardiovascular and renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus not complicated by vascular disorders;
severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B 6 can be used for correction);
sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

with age;
when smoking (heavy smoking and age over 35 years are risk factors);
if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
for obesity (BMI more than 30 kg/m2);
with dislipoproteinemia;
with arterial hypertension;
for diseases of the heart valves complicated by hemodynamic disorders;
with atrial fibrillation;
with diabetes mellitus complicated by vascular lesions;
with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

sudden chest pain that radiates to the left arm;
sudden shortness of breath;
any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, symptom complex "acute abdomen".

Tumor diseases

A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Lindinet 20.

Efficiency

The effectiveness of the drug may be reduced in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

Studies have not been conducted to study the effect of the drug Lindinet 20 on the abilities necessary to drive a car and operate machinery.