"Vicks Active": instructions (powder). "Vicks Active" (effervescent tablets): instructions for use. Vicks asset for children and adults - description of drugs, composition, instructions for use, analogues and price

Symptoms of colds and flu: headache, sore throat, other types of pain, nasal congestion, elevated temperature bodies. Before using other Vicks Active medications, read the label carefully to ensure you are using these medications correctly. Get the Ultimate Cold Symptom Relief in a Hot Drink When cold symptoms catch you by surprise, you need instant relief so you can stay on track and stay on track. Vicks Active Symptomax vitamin C, which has a powerful effect on the five main symptoms of a cold: fever, headache, joint and muscle pain, sore throat and nasal congestion. Symptoms Relieved Temporarily relieves cold symptoms: - Nasal congestion - Aches and fever - Sore throat

Contraindications to the use of Vicks active symptomax plus

Hypersensitivity to paracetamol or other components of the drug; - Arterial hypertension; - Coronary heart disease; - Impaired liver function and severe impaired renal function; - Hyperthyroidism; - Diabetes mellitus; - Phenylketonuria (because the drug contains aspartame); - Concomitant use of tricyclic antidepressants, monoamine oxidase inhibitors (MAO) or beta-blockers or their use within the last 2 weeks; - Pregnancy and lactation; - Hyperplasia prostate gland; - Glaucoma; - Age up to 18 years; - Sucrase/isomaltase deficiency; - Fructose intolerance; Glucose-galactose malabsorption. With caution Long-term use of the drug is not recommended. The simultaneous use of other cold and/or paracetamol-containing medications should be avoided. Do not take the drug at the same time as drinking alcohol. Bronchial asthma, COPD (chronic obstructive disease lungs), deficiency of glucose-6-phosphate dehydrogenase, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes), hyperoxaluria.

Vicks active symptomax plus Use during pregnancy and children

The drug should not be used during pregnancy and during breastfeeding.

Vicks active symptomax plus side effects

Paracetamol Allergic reactions Rare: skin rash, urticaria, anaphylaxis, bronchospasm, angioedema. From the central side nervous system Rarely: dizziness. From the hematopoietic system: Rarely: aplastic anemia, methemoglobinemia, increased blood pressure. Very rarely: pathological changes blood such as thrombocytopenia, agranulocytosis, hemolytic anemia, neutropenia, leukopenia, pancytopenia. From the outside digestive system Rarely: nausea, vomiting, dry oral mucosa, hepatotoxic effect. From the urinary system Rarely: urinary retention, nephrotoxicity ( papillary necrosis). Other Rarely: accommodation paresis, increased intraocular pressure, mydriasis. Phenylephrine From the outside cardiovascular system Rarely: tachycardia, increased blood pressure. From the nervous system: Rarely: insomnia, nervousness, tremor, anxiety, increased excitability, confusion, irritability and headache. From the digestive system: Often: anorexia, nausea and vomiting. From the outside immune system And skin Rarely: allergic reactions, including skin rash, urticaria, anaphylaxis and bronchospasm. Paracetamol overdose Liver damage is possible in adults who have taken 10 or more grams of paracetamol. Taking 5 grams or more of paracetamol may cause liver damage if there are risk factors: long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin or other drugs that induce liver enzymes, alcohol abuse, glutanion deficiency (eg, poor nutrition), cystic fibrosis, HIV infection, starvation, cachexia. Symptoms of paracetamol overdose in the first 24 hours: paleness, nausea, vomiting, anorexia and abdominal pain. Liver damage may appear within 12 to 48 hours after taking the drug. In case of paracetamol overdose, despite the absence primary symptoms overdose, you should seek medical attention qualified help V medical institutions. To prevent severe consequences overdoses should be taken promptly necessary measures. Symptoms may only appear partially as nausea or vomiting, and may not reflect the actual extent of overdose or the risk of organ damage. In case of severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Phenylephrine Symptoms of a phenylephrine overdose include irritability, headache, and increased blood pressure. If the above symptoms of overdose occur, you should consult a doctor. Treatment: administration of SH-group donors and precursors for the synthesis of glutathione - methionine within 8-9 hours after an overdose and acetylcysteine ​​- within 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Dosage of Vicks active symptomax plus

Dissolve the contents of one sachet in hot but not boiling water (250 ml). Allow to cool to an acceptable temperature and drink. Adults and children over 18 years old - one sachet. If necessary, repeat the dose every 4-6 hours, but no more than 4 doses (sachets) per day. The drug is not recommended for use for more than 5 days as an analgesic and 3 days as an antipyretic without consulting a doctor. If symptoms persist, you should consult a doctor.

Alpha-adrenergic receptor stimulants.

Composition of Vicks Active

100 ml of solution contains:

  • Active substance: oxymetazoline hydrochloride 0.05 g Excipients: sorbitol (70% aqueous solution) 5,0 ,
  • sodium citrate dihydrate 0.875,
  • tyloxapol 0.7,
  • chlorhexidine bigluconate (20% solution) 0.27,
  • citric acid anhydrous 0.2,
  • aloe vera 0.1,
  • benzalkonium chloride (50% solution) 0.04,
  • levomenthol 0.015,
  • acesulfame potassium 0.015,
  • cineole 0.013,
  • L-carvone 0.01,
  • disodium edetate 0.01,
  • sodium hydroxide (0.1 M solution) to pH 5.4, distilled water to 100 ml.

Manufacturers

Procter and Gamble Manufacturing GmbH (Germany)

Pharmacological action

Pharmacodynamics.

Oxymetazoline belongs to the group of alpha-agonists for topical use.

Has a vasoconstrictor effect.

When administered intranasally, it reduces swelling of the mucous membrane upper sections respiratory tract, which leads to easier nasal breathing and opening of the mouth paranasal sinuses and eustachian tubes.

The effect of the drug appears 5 minutes after use and lasts for 8-12 hours.

Pharmacokinetics.

At local application Oxymetazoline is practically not absorbed.

Side effects of Vicks Active

Sometimes burning or dryness of the mucous membranes of the nose, dry mouth and throat, sneezing, increased volume of secretions released from the nose.

IN in rare cases– after the effect of using the drug wears off, a strong feeling of “stuffiness” in the nose (reactive hyperemia).

Side effects due to systemic action drug:

  • headache,
  • dizziness,
  • strong heartbeat,
  • tachycardia,
  • increased anxiety,
  • sedative effect,
  • irritability,
  • sleep disorders (in children,
  • nausea, nausea
  • insomnia,
  • exanthema,
  • blurred vision (if in contact with eyes).

The preservative benzalkonium chloride, which is part of the drug, may cause swelling of the nasal mucosa.

If this happens, it is necessary to change the drug to another one that does not contain preservatives.

Indications for use

To facilitate nasal breathing during colds or viral infections upper respiratory tract, sinusitis, rhinitis of any etiology.

Contraindications Vicks Active

Hypersensitivity to the components of the drug; atrophic (dry) rhinitis; taking monoamine oxidase inhibitors (MAOIs) during the previous 2 weeks and within 2 weeks after their discontinuation; angle-closure glaucoma; condition after transsphenoidal hypophysectomy; childhood up to 6 years; pregnancy; lactation period.

The drug should be used with caution in patients suffering from diseases of the cardiovascular system ( arterial hypertension, ischemic disease heart failure, chronic heart failure, tachycardia, arrhythmias), violation carbohydrate metabolism (diabetes mellitus), functions thyroid gland(hyperthyroidism), pheochromocytoma, chronic renal failure, prostatic hyperplasia (urinary retention) and taking tricyclic antidepressants and bromocriptine.

Directions for use and dosage

Intranasally.

Adults and children over 10 years old - 1-2 injections into each nasal passage, maximum 2-3 times a day.

Children from 6 to 10 years old - 1 injection into each nasal passage, maximum 2-3 times a day.

With frequent or long-term use taking the drug, the feeling of difficulty in nasal breathing may reappear or worsen.

If these symptoms appear, you should stop treatment and consult a doctor.

When spraying, do not tilt your head back and do not spray while lying down.

Overdose

Symptoms:

  • nausea, nausea
  • increased blood pressure,
  • tachycardia,
  • CNS depression.

Treatment; symptomatic.

Interaction

When used simultaneously with MAO inhibitors (including the period within 14 days after their withdrawal) and tricyclic antidepressants, an increase in blood pressure may be observed.

The drug slows down the absorption of local anesthetic drugs and prolongs their effect.

Joint appointment of others vasoconstrictor drugs increases the risk of side effects.

Special instructions

If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor.

Avoid getting the drug into your eyes.

To avoid the spread of infection, it is necessary to use the drug individually.

Respiratory pathologies are most often recorded in the autumn-spring period. To relieve symptoms of illness pharmaceutical companies They offer a lot of medicines. Today, many patients are interested in the question of what Vicks Active is? Instructions for its use, indications and contraindications for use are described below.

On pharmaceutical market In our country, the presented drug is sold in the form of a spray, ointment, balm, tablets or powder. The instructions for use characterize "Vicks Active" as an effective mucolytic (thinning) agent. The medication exhibits secretomotor and secretolytic effects. Oral administration ensures a high degree of absorption of the drug.

Chemical composition of medicinal powder

The medicine contains the following ingredients:

  • paracetamol (main active ingredient);
  • phenylephrine hydrochloride;
  • sucrose;
  • guaifenesin;
  • sodium citrate;
  • citrate acid;
  • acesulfame potassium;
  • menthol flavoring;
  • ascorbic acid;
  • sodium cyclamate;
  • aspartame;
  • lemon flavoring.

"Vicks Active" is often used in the treatment of acute respiratory diseases. This drug belongs to the group of mucolytics.

Purpose

Are you assigned Vicks Active? The instructions recommend using this drug during colds (flu, sinusitis, rhinitis, bronchitis, bronchopneumonia, etc.) of viral and bacterial etiology. The medicine is also often prescribed when the following symptoms are detected:

  • runny nose;
  • chills;
  • hyperthermia;
  • sore throat;
  • migraine;
  • cough, etc.

What can replace the drug?

We reviewed the main characteristics of the drug "Vicks Active". Analogues of the drug are quite often used in therapeutic practice. Before replacing a medicine prescribed by a doctor, be sure to consult a specialist (pharmacist, therapist). Below we present the most popular analogues of the drug "Vicks Active":

  • "Adjikold".
  • "Axaflu."
  • "Antiflu".
  • "Anticataral."
  • "Antigrippin".
  • "Ascopar".
  • "Bolaren."
  • "Brustan".
  • "Daleron."
  • "Caffetin".
  • "Coldrex".
  • "Coldflu."
  • "Combinex".
  • "Kofan".
  • "Lugakold."
  • "Paravite".
  • "Rinza."
  • "Solpadeine."
  • "Trigan."
  • "Fervex".
  • "Eucasolin".
  • "Heathflu."
  • "Unispaz".

Pharmacological properties

If you decide to use Vicks Active, the instructions indicate that this product has a combined effect on the human body.

Paracetamol is an effective analgesic and antipyretic from the anilide group. The mechanism of action is associated with blocking the activity of enzymes (cyclooxygens I and II) and the synthesis of prostaglandins. The bioactive substance increases the pain threshold of excitability of the centers of the same name in the hypothalamus. At the same time, the excitability of the thermoregulation center decreases. The anti-inflammatory effect of the drug is insignificant, since paracetamol is destroyed by cellular enzymes - peroxidases.

Phenylephrine hydrochloride - effective remedy, eliminating swelling and hyperemia of the nasal mucosa. The medication eliminates the signs of rhinorrhea, while optimizing nasal breathing.

Guaifenesin is a mucolytic agent that reduces the viscosity of sputum, promotes its release from the respiratory tract, reduces the number of coughing attacks and activates the expectoration process. The maximum concentration of bioactive compounds in the blood is observed within half an hour after taking the medicine.

Contraindications

In addition to all of the above, it is worth noting that Vicks Active should not be taken together with other anti-cold medications (containing paracetamol). During the treatment period, you should refrain from drinking alcohol. The drug is prescribed with extreme caution in the presence of bronchial asthma, blood diseases, congenital hyperoxaluria, and hyperbilirubinemia.

Side effect

The product "Vicks Active", the instructions for use of which are described in sufficient detail, can provoke the development of a number of side effects:


"Vicks Active Sinex": instructions for use

The medicine is intended for intranasal use. The instructions describe "Vicks Active Sinex" as a vasoconstrictor. Immediately after using the medication, the swelling of the nasal mucosa decreases, which, in turn, helps improve nasal breathing. The product can be used by patients from the age of ten. The drug is prescribed two injections into each nostril, but no more than 3 times a day. Do not tilt your head back while using the nasal spray.

"Vicks Active": instructions (powder)

Medicinal powder is prescribed to eliminate the symptoms of ARVI. What does the instruction say about Vicks Active? The powder must be dissolved in hot water. Depending on the patient’s condition, an appointment is scheduled pharmaceutical product at six hour intervals. However, do not forget that you cannot consume more than 4 sachets per day. Doctors do not recommend similar treatment more than 3-5 days. If the desired effect is not achieved, you should seek advice from specialists.

"Vicks Active" (tablets): dosage, price and method of use

What is the dosage regimen for Vicks Active? The instructions (the price of the medicine, by the way, is directly dependent on the form of the pharmaceutical) recommends selecting the dosage specifically for a particular patient, focusing on his state of health and the presence of certain pathologies. The cost of the drug is in the price range from 150 to 350 rubles.

In each individual case, only an experienced doctor can choose effective scheme treatment and prescribe the appropriate dose of the drug "Vicks Active" ( effervescent tablets). Instructions for use indicate minimum doses, which may be ineffective in some pathologies. Each disease requires its own course of application. For adolescents (age 14 years and older), the drug "Vicks Active" is often prescribed. The instructions recommend taking effervescent tablets 2-3 times a day, 200 mg. For children of six years of age, the maximum daily dose the drug is 100 mg. Its adjustment may be required for patients with dysfunction of the liver, kidneys and adrenal glands.

The instructions recommend using effervescent tablets "Vicks Active" for pathologies of the respiratory system, as well as conditions complicated by the formation of viscous purulent mucus. The drug is effective for sinusitis, otitis, sinusitis, tracheitis, bronchial asthma, pneumonia, bronchitis and cystic fibrosis.

Conclusion

The drug is available without a doctor's prescription, but you should not always self-medicate. If you are at risk for contraindications, then treatment should be prescribed by a doctor. The medicine should be stored out of the reach of children.

LP 000098-221210

Trade name of the drug: Vicks Active SymptoMax

International nonproprietary name:

Paracetamol+Phenylephrine

Dosage form:

powder for preparing a solution for oral administration [blackcurrant, lemon].

Composition (per sachet)
Active substances - paracetamol 1000 mg, phenylephrine hydrochloride 12.20 mg.
Excipients in blackcurrant powder - ascorbic acid, sucrose, citric acid, sodium citrate, aspartame, acesulfame potassium, blackcurrant flavor S-133747, blackcurrant flavor 1007348, blackcurrant dye.
Excipients in lemon powder - ascorbic acid, sucrose, citric acid, sodium citrate, aspartame, acesulfame potassium, quinoline yellow dye, lemon flavor F/29088, lemon flavor F/29089, lemon flavor F/28151, lemon flavor F/501.476/AP0504.

Description
Blackcurrant powder: fine-crystalline powder of light purple color with a characteristic odor of blackcurrant.
Lemon powder: fine crystalline powder, light-colored yellow with a characteristic lemon scent.
Blackcurrant powder solution: red-violet in color with a characteristic blackcurrant odor.
Lemon powder solution: yellow in color with a characteristic lemon odor, with opalescence.

Pharmacotherapeutic group:

A remedy for eliminating the symptoms of acute respiratory infections and “colds” (non-narcotic analgesic + alpha-adrenergic agonist).

ATX Code: N02BE51

Pharmacological properties
Pharmacodynamics

A combined drug whose effect is determined by the composition of its constituent components.
Paracetamol has analgesic and antipyretic effects, these effects are due to inhibition of prostaglandin synthesis in the central nervous system.
Phenylephrine is a postsynaptic alpha-adrenergic receptor agonist with low cardioselective affinity for beta receptors. Decongestant, constricts blood vessels, eliminates swelling and hyperemia of the nasal mucosa.

Pharmacokinetics
Paracetamol is quickly and completely absorbed into small intestine. The maximum concentration in the blood is observed 15-20 minutes after ingestion. Systemic bioavailability is determined by first-pass metabolism and, depending on the dose, ranges from 70% to 90%. Paracetamol is rapidly distributed throughout all tissues of the body and has a half-life of approximately 2 hours. Metabolized in the liver and excreted in the urine in the form of glucuronides and sulfate compounds (>80%).
Phenylephrine is rapidly absorbed from the gastrointestinal tract. The level of primary metabolism is quite high (≈60%), so oral administration phenylephrine reduces its bioavailability (≈40%). The maximum plasma concentration is observed after 1-2 hours, and the half-life varies from 2 to 3 hours. Excreted in urine in the form of sulfate compounds. Oral phenylephrine as a decongestant should be administered at intervals of 4 to 6 hours.

Indications for use
Symptoms of colds and flu: headache, sore throat, other types of pain, nasal congestion, fever.

Contraindications

  • Hypersensitivity to paracetamol or other components of the drug;
  • Arterial hypertension;
  • Coronary heart disease;
  • Impaired liver function and severe impaired renal function;
  • Hyperthyroidism;
  • Diabetes mellitus;
  • Phenylketonuria (because the drug contains aspartame);
  • Concomitant use of tricyclic antidepressants, monoamine oxidase inhibitors (MAO) or beta-blockers or their use within the last 2 weeks;
  • Pregnancy and lactation;
  • Prostatic hyperplasia;
  • Glaucoma;
  • Age up to 18 years;
  • Sucrase/isomaltase deficiency;
  • Fructose intolerance;
  • Glucose-galactose malabsorption. With caution
    Long-term use of the drug is not recommended. The simultaneous use of other cold and/or paracetamol-containing medications should be avoided. Do not take the drug at the same time as drinking alcohol.
    Bronchial asthma, COPD (chronic obstructive pulmonary disease), glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes), hyperoxaluria. Use during pregnancy and breastfeeding
    The drug should not be used during pregnancy and breastfeeding. Directions for use and doses
    Dissolve the contents of one sachet in hot but not boiling water (250 ml). Allow to cool to an acceptable temperature and drink.
    Adults and children over 18 years old - one sachet. If necessary, repeat the dose every 4-6 hours, but no more than 4 doses (sachets) per day.
    The drug is not recommended for use for more than 5 days as an analgesic and 3 days as an antipyretic without consulting a doctor.
    If symptoms persist, you should consult a doctor. Side effects
    Paracetamol

    Allergic reactions Rare: skin rash, urticaria, anaphylaxis, bronchospasm, angioedema.
    From the central nervous system Rarely: dizziness.
    From the hematopoietic system Rarely: aplastic anemia, methemoglobinemia, increased blood pressure. Very rare: pathological changes in the blood, such as thrombocytopenia, agranulocytosis, hemolytic anemia, neutropenia, leukopenia, pancytopenia.
    Rarely: nausea, vomiting, dry oral mucosa, hepatotoxic effect.
    From the urinary system Rarely: urinary retention, nephrotoxicity (papillary necrosis).
    Others Rarely: accommodation paresis, increased intraocular pressure, mydriasis.
    Phenylephrine
    From the cardiovascular system Rarely: tachycardia, increased blood pressure.
    From the nervous system Rarely: insomnia, nervousness, tremor, anxiety, increased excitability, confusion, irritability and headache.
    From the digestive system Common: anorexia, nausea and vomiting.
    From the immune system and skin Rare: allergic reactions, including skin rash, urticaria, anaphylaxis and bronchospasm. Overdose
    Paracetamol
    Liver damage is possible in adults who have taken 10 grams or more of paracetamol. Taking 5 grams or more of paracetamol can cause liver damage if there are risk factors: long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin or other drugs that induce liver enzymes, alcohol abuse, glutanion deficiency (for example, poor diet), cystic fibrosis, HIV -infection, starvation, cachexia.
    Symptoms of paracetamol overdose in the first 24 hours: paleness, nausea, vomiting, anorexia and abdominal pain.
    Liver damage may appear within 12 to 48 hours after taking the drug. In case of an overdose of paracetamol, despite the absence of primary symptoms of overdose, it is necessary to seek qualified help from medical institutions. To prevent the severe consequences of an overdose, the necessary measures should be taken in a timely manner.
    Symptoms may only appear partially as nausea or vomiting, and may not reflect the actual extent of overdose or the risk of organ damage.
    In case of severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.
    Phenylephrine
    Symptoms of a phenylephrine overdose include irritability, headache, and increased blood pressure.
    If the above symptoms of overdose occur, you should consult a doctor.
    Treatment: administration of SH-group donors and precursors for the synthesis of glutathione - methionine within 8-9 hours after an overdose and acetylcysteine ​​- within 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration. Interaction with other drugs
    Paracetamol

    Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications.
    Paracetamol enhances the effect of anticoagulants indirect action and reduces the effectiveness of uricosuric drugs.
    The rate of absorption of paracetamol is increased by metoclopramide or domperidone, and decreased by cholestyramine.
    The anticoagulant effect of warfarin and other coumarin derivatives is enhanced by long-term use paracetamol.
    The drug enhances the effects of MAO inhibitors, sedatives, ethanol.
    Phenylephrine
    With simultaneous use of phenylephrine with antidepressants, antiparkinsonian, antipsychotics, phenothiazine derivatives may cause urinary retention, dryness of the oral mucosa, and constipation.
    When used with glucocorticosteroids, the risk of developing glaucoma increases.
    Tricyclic antidepressants increase the adrenomimetic effect of phenylephrine; simultaneous administration of halothane increases the risk of developing ventricular arrhythmia. Special instructions
    The drug should not be combined with ethanol intake.
    During the treatment period, it is necessary to refrain from taking sleeping pills, anxiolytic medications, as well as other drugs containing paracetamol.
    The drug distorts the results of laboratory tests assessing glucose concentration and uric acid in plasma.
    Contains sucrose. The drug is contraindicated in patients with rare congenital intolerance fructose, with impaired absorption of glucose-galactose or with deficiency of sucrase-isomaltase.
    Contains aspartame (E951), a source of phenylalanine. May be toxic to patients with phenylketonuria.
    When driving vehicles and occupation of others potentially dangerous species activities, it is necessary to take into account that the drug may cause such side effects like dizziness and confusion. Release form
    Powder for preparing a solution for oral administration [blackcurrant, lemon].
    5.0 g of powder in a laminated sachet.
    5 or 10 sachets along with instructions for use are placed in a cardboard box. Storage conditions
    At a temperature not higher than 25 °C. Keep out of the reach of children. Best before date
    3 years.
    Do not use after expiration date. Conditions for dispensing from pharmacies
    Over the counter. Owner registration certificate
    LLC "Procter and Gamble Distribution Company", Russia 125171, Moscow, Leningradskoe Shosse, 16A, building 2. Manufacturer
    Rafton Laboratories Limited, Rafton, Bronton, Devon, EHZZ 2DL, UK Name and address of the organization receiving complaints
    Procter and Gamble LLC, Russia 125171, Moscow, Leningradskoe Shosse, 16A, bldg. 2.
  • active ingredients: paracetamol, guaifenesin, phenylephrine hydrochloride

    1 sachet contains paracetamol 500 mg, guaifenesin 200 mg, phenylephrine hydrochloride 10 mg

    excipients: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium, aspartame (E 951), acesulfame potassium, lemon flavor 8476 (contains butylated hydroxyanisole (E 320)), flavor lemon juice, menthol flavoring, yellow quinoline (E 104).

    Dosage form. Powder for oral solution.

    Basic physical and chemical properties: almost white free-flowing powder, without large lumps or foreign particles. Has a characteristic citrus/menthol scent.

    Pharmacological group

    Other combination drugs, used for colds. ATX code R05X.

    Pharmacological properties.

    Pharmacodynamics.

    Paracetamol has analgesic and antipyretic effects, which are thought to be primarily due to inhibition of prostaglandin synthesis in the central nervous system.

    Guaifenesin is an expectorant. It acts by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi, which facilitates the release of sputum when coughing.

    Phenylephrine hydrochloride- a sympathomimetic that mainly stimulates α-adrenergic receptors. It is a decongestant and works by constricting blood vessels, reducing swelling, including swelling of the nasal mucosa and sinuses.

    The active ingredients do not cause a sedative effect.

    Pharmacokinetics.

    Paracetamol quickly and almost completely absorbed into gastrointestinal tract, passes through the placental barrier, a small part penetrates into breast milk. 95% of acetaminophen is metabolized in the liver by sulfo- and glucuronoconjugation, as well as oxidation by the cytochrome P450 system. The half-life ranges from 1 to 4:00. Duration of action - 3-4 hours. It is excreted by the kidneys, mainly in the form of metabolites, 3% of the substance is excreted unchanged.

    Guaifenesin quickly absorbed from the gastrointestinal tract and metabolized to ß-(2 methoxy-phenoxy) lactic acid, an inactive metabolite that is excreted in the urine. The half-life of guaifenesin is short - approximately 1:00.

    Phenylephrine hydrochloride is absorbed unevenly in the gastrointestinal tract and is subject to first-pass metabolism with the help of MAO in the intestines and liver. Thus, phenylephrine administered orally has reduced bioavailability.

    It is excreted almost entirely in the urine as a sulfate conjugate.

    Indications

    Treatment of cold and flu symptoms (productive cough with difficulty producing sputum, headache, body aches and pains, sore throat, nasal congestion and fever).

    Contraindications

    Hypersensitivity to paracetamol or to any of the other components of the drug. Cardiovascular diseases, arterial hypertension, diabetes mellitus, glaucoma, hyperthyroidism, urinary retention due to prostatic hyperplasia, pheochromocytoma.

    Severe liver dysfunction, acute hepatitis, pancreatitis, renal dysfunction. Alcoholism.

    Patients taking MAO inhibitors (or within two weeks after stopping such treatment), tricyclic antidepressants, beta-blockers and other vasodilators or sympathomimetics.

    Congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, blood diseases, severe anemia, leukopenia.

    Phenylketonuria.

    Interaction with other drugs and other types of interactions

    With extended regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may be enhanced with an increased risk of bleeding. rare use does not cause such an effect.

    Before using the drug, you should consult your doctor if the patient is using warfarin or similar drugs, which have an anticoagulant effect.

    The hepatotoxicity of paracetamol may be enhanced by excessive consumption alcohol.

    Metoclopramide or domperidone can increase the rate of absorption of paracetamol, and cholestyramine can reduce it. Reported pharmacological interaction, occurring between paracetamol and other drugs. These interactions are considered unlikely to be of clinical significance at recommended dosages.

    Barbiturates reduce the antipyretic effect of paracetamol.

    Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, may increase the toxic effects of paracetamol on the liver due to an increase in the degree of conversion of paracetamol to hepatotoxic metabolites. With the simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases.

    Simultaneous use high doses paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.

    Paracetamol reduces the effectiveness of diuretics.

    Probenecid inhibits the binding of paracetamol to gloucuronic acid and thus leads to a decrease in the clearance of paracetamol by almost half. When using probenecid simultaneously, the dose of paracetamol should be reduced.

    Concomitant use of paracetamol and AZT (zidovudine) increases the risk of neutropenia. Thus, the simultaneous use of paracetamol and AZT must be carried out under medical supervision.

    Existing hypertensive interactions with sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors. Phenylephrine may reduce the effectiveness of beta-blocking drugs and antihypertensive drugs. This drug may increase the likelihood of arrhythmias in patients taking digitalis medications. Conditions when these drugs are used are a contraindication for this drug.

    Phenylephrine may enhance the cardiovascular effects of other amine sympathomimetics (decongestants).

    Concomitant use with halogenated anesthetics such as chloroform, cyclopropane, haloman, enflurane or isoflurane may cause or worsen ventricular arrhythmias.

    The drug may affect the results laboratory research by the content of glucose and uric acid in the blood.

    Features of application

    If the headache becomes persistent, you should consult a doctor.

    Patients taking analgesics every day for arthritis light form, you should consult your doctor.

    Avoid taking other cold, decongestant and paracetamol medications at the same time. Before starting treatment, you should make sure that drugs containing sympathomimetics are not used simultaneously in several ways, that is, orally and locally (drugs for the nose, ears and eyes).

    Do not take with alcohol. The risk of overdose is higher in patients with non-cyrotic alcoholic disease liver.

    It is necessary to consult a doctor regarding the possibility of using the drug in patients with impaired renal function and lung liver And medium degree in the presence of persistent or chronic cough(due to smoking, asthma, chronic bronchitis or emphysema).

    Paracetamol should be used with caution in patients taking hepatotoxic drugs. medicines, digitalis preparations, methyldopa or other antihypertensive drugs; patients with chronic malnutrition ( low level glutathione), with Raynaud's phenomenon, bronchial asthma, granulocytopenia, arrhythmias, chronic diseases lungs.

    The drug should be used with caution in the following categories of patients:

    The drug contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency should not take this drug.

    The drug contains 140 mg of sodium per dose. This must be taken into account in patients on a sodium controlled diet.

    The drug contains aspartame (E 951) - a source of phenylalanine. May be harmful to people with phenylketonuria.

    Use during pregnancy and lactation

    Paracetamol passes into breast milk, but in clinically insignificant quantities. Available published data do not contain any contraindications for breastfeeding.

    Given the limited data on the use of the drug during pregnancy and lactation, it should be used only after consultation with a doctor.

    The ability to influence the reaction rate when driving vehicles or other mechanisms

    The drug has a slight effect on the reaction rate, which should be taken into account when driving vehicles and working with other mechanisms.

    Directions for use and doses

    For internal use.

    Dissolve the contents of 1 sachet in a standard cup (250 ml) of hot but not boiling water. Take warm.

    Adults, elderly people and children over 12 years old 1 sachet.

    Repeat if necessary every 4-6 hours, but no more than four doses (4 sachets) per day; the interval between doses is at least 4:00. Exceed recommended doses, especially in patients with increased coagulability blood.

    The duration of treatment is determined by the doctor. Do not use for more than 3 days without consulting a doctor. If the symptoms of the disease do not disappear, you should consult a doctor.

    Children

    Contraindicated for children under 12 years of age. For children over 12 years of age, use under medical supervision.

    Overdose

    Paracetamol.

    Liver damage is possible in adults who took 10 g or more of paracetamol, and in children who took more than 150 mg/kg body weight. Also, taking 5 g or more paracetamol can lead to liver damage if the patient: passes long-term treatment carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; constantly drinks alcohol or is suspected of having glutathione depletion, for example, in case of eating disorders, cystic fibrosis, HIV infection, fasting, cachexia.

    Symptoms

    Symptoms of overdose when using paracetamol in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12-48 hours after ingestion. Abnormal glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, cerebral edema and fatal outcome. Acute renal failure with acute tubular necrosis, indicated by low back pain, hematuria, and proteinuria, can occur even in the absence of severe liver damage. There have been reports of arrhythmia and pancreatitis.

    With long-term use of the drug in large doses On the part of the hematopoietic organs, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop. When taking large doses, the central nervous system causes dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

    Treatment.

    When treating conditions from paracetamol overdose, despite the absence of severe early symptoms, patients must be immediately hospitalized for emergency treatment medical care. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the danger of organ damage.

    Treatment should be considered activated carbon if an excessive dose of paracetamol was taken within 1:00. The concentration of paracetamol in the blood plasma should be measured 4:00 or later after administration (earlier concentrations are not reliable). It is recommended to administer SH-group donors and precursors of glutathione synthesis (such as methionine, N-acetylcysteine) intravenously, in doses that are determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration. Treatment N-acetylcysteine ​​can be applied within 24 hours after taking paracetamol, but the maximum protective effect occurs when it is used within 8:00 after taking it. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be administered N-acetylcysteine ​​intravenously, according to the established list of doses. In the absence of vomiting, oral methionine can be used as an appropriate alternative in remote areas outside the hospital.

    Phenylephrine hydrochloride.

    Signs of severe phenylephrine overdose include irritability, headache, seizures, palpitations, paresthesia, vomiting, hyperpyrexia, cardiac pain, increased blood pressure, and associated reflex bradycardia and arrhythmia. Symptoms of severe overdose include severe peripheral and visceral vasoconstriction with cardiovascular collapse.

    Therapy includes early gastric lavage, as well as symptomatic and supportive measures.

    Guafenizin.

    Overdosing with small or moderate doses may cause dizziness or vertigo, gastrointestinal disorders. Very high doses may cause symptoms such as agitation, confusion and respiratory depression.

    Adverse reactions

    From the immune system: anaphylaxis; hypersensitivity reactions, including skin itching, urticaria, angioedema, multiforme exudative erythema(including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

    From the circulatory and lymphatic systems: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, aplastic anemia, pancytopenia, thrombocytopenia, which can lead to nosebleeds and/or bleeding gums, bruising or bleeding, leukopenia, neutropenia, agranulocytosis.

    From the nervous system (usually develop when taking high doses): dizziness, headache, psychomotor agitation, disorientation, impaired consciousness, insomnia, restlessness, nervousness, tremor, irritability, anxiety.

    From the organs of vision: acute glaucoma.

    From the cardiovascular system: tachycardia, increased blood pressure, heartbeat.

    From the digestive system: a feeling of discomfort in the gastrointestinal tract, nausea, vomiting, diarrhea, loss of appetite, epigastric pain, impaired liver function, increased activity of “liver” enzymes in the blood serum, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

    From the urinary system: urinary retention or difficulty urinating (with prostate enlargement), renal colic. There are rare reports of stones bladder or kidneys in patients who have been taking large quantities guaifenesin.

    From the outside endocrine system: hypoglycemia, up to hypoglycemic coma.

    From the outside respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs.

    Best before date

    Storage conditions

    Store out of the reach of children at a temperature not exceeding 25 ° C.

    Package

    Manufacturer

    Rafton Laboratories Limited.

    Manufacturer's location and address of place of business

    Exeter Road, Wrafton, Braunton, Devon, EHZZ 2DL, UK.