Active substanceClemastineClemastine
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  • Clemastin-Eskom
    solution w / m in / in 
    ESKOM NPK, OAO     Russia
  • Tavegil®
    pills inwards 
  • Tavegil®
    solution w / m in / in 
  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: 1.34 mg clemastine hydrofumarate (equivalent to 1 mg clemastine);

    Excipients: lactose monohydrate 107.66 mg, corn starch 10.8 mg, talc 5 mg, povidone 4 mg, magnesium stearate 1.2 mg.

    Description:Round, flat tablets white or almost white with a bevelled edge. On one side, risk pills and "OT" engraving.
    Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    A.06.A.A.04   Clemastine

    Pharmacodynamics:

    H1-gistamine receptor blocker, ethanolamine derivative. Has a strong antihistamine and antipruritic effect with a rapid onset of action and up to 12 hours, prevents the development of vasodilation and smooth muscle contractions induced by histamine.

    Possessing an antiallergic effect, reduces the permeability of blood vessels, capillaries, inhibits exudation and formation of edema, reduces itching, exerts an m-cholinoblock effect.

    Pharmacokinetics:

    After oral administration Clemastine almost completely absorbed from the gastrointestinal tract. The maximum concentration of klemastin in plasma is achieved in 2-4 hours.

    The connection with plasma proteins is 95%. The excretion from the plasma is two-phase, the corresponding half-life periods are 3.6 ± 0.9 hours and 37 ± 16 hours. Clemastine is significantly metabolized in the liver. Metabolites are excreted mainly through the kidneys with urine (45-65%); The unchanged active substance is found in urine only in trace amounts. During lactation, a small amount of klemastin can penetrate into breast milk.

    Indications:

    - Pollinosis (hay fever, including allergic rhinoconjunctivitis);

    - hives of different origin;

    - itching, itching dermatoses;

    - acute and chronic eczema, contact dermatitis;

    - drug allergy;

    - insect bites.

    Contraindications:

    Hypersensitivity, pregnancy, lactation, the intake of monoamine oxidase inhibitors (MAO), lower respiratory tract diseases (including bronchial asthma), children under 6 years (for this dosage form).

    Carefully:In patients with a stenosing ulcer of the stomach, pyloroduodenal obstruction,with obstruction of the neck of the bladder, as well as hypertrophy of the prostate accompanied by a delay in urine, with increased intraocular pressure, hyperthyroidism, cardiovascular diseases, including hypertension.
    Pregnancy and lactation:

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

    Dosing and Administration:

    Inside before eating with water.

    Adults and children over 12 years of age appoint 1 tablet (1 mg) in the morning and in the evening. In cases that are difficult to treat, the daily dose can be up to 6 tablets (6 mg).

    Children aged 6-12 years appoint a 1 / 2-1 tablet before breakfast and at night.

    Side effects:

    Classification of incidence of adverse reactions: very often (1/10); often (1/100, <1/10); infrequently (1/1000, <1/100); rarely (1/10 000, <1/1000); very rarely (<1/10 000).

    From the nervous system:

    often: increased fatigue, drowsiness, sedation, weakness, fatigue, inhibition, impaired coordination of movements;

    infrequently: dizziness;

    rarely: headache, tremor, stimulating effect.

    From the gastrointestinal tract:

    rarely: dyspepsia, nausea, vomiting, gastralgia;

    very rarely: constipation, dry mouth.

    individual cases of decreased appetite and diarrhea.

    From the sense organs:

    rarely: violation of clarity of visual perception, diplopia, acute labyrinthitis, tinnitus.

    From the side of the kidneys and urinary tract:

    very rarely: rapid or difficult urination.

    From the respiratory system:

    rarely: condensation of bronchial secretion and difficulty in sputum discharge, sensation of pressure in the chest, violation of breathing, nasal congestion.

    From the cardiovascular system:

    rarely: lowering blood pressure (more often in elderly patients), extrasystole.

    very rarely: palpitations.

    From the side of blood and blood-forming organs:

    rarely: hemolytic anemia, thrombocytopenia, agranulocytosis.

    From the skin and subcutaneous fat:

    rarely: skin rash.

    From the immune system:

    rarely: photosensitization, anaphylactic shock.

    Overdose:

    Symptoms. An overdose of antihistamines can lead to both a depressing and stimulating effect on the central nervous system, the latter more often observed in children.Also, the phenomenon of anticholinergic action may develop: dry mouth, fixed dilated pupils, flushing of blood to the upper half of the body, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).

    Treatment. If the patient does not develop vomiting spontaneously, then it should be induced artificially (only if the patient's consciousness is preserved). If from the time of taking the drug it took 3 hours or a little more, it is necessary to wash the stomach using a 0.9% solution of sodium chloride and activated carbon. You can also designate a salt laxative. Symptomatic therapy is also indicated.

    Interaction:

    Tavegil® enhances the effect of drugs that depress the central nervous system (hypnotics, sedatives, anxiolytics), m-holinoblokatorov, as well as alcohol. Incompatible with simultaneous administration of MAO inhibitors.

    Special instructions:

    To prevent distortion of skin scarification test results for allergens, the drug should be discontinued 72 hours before the allergy testing.

    For treatment of children aged 1 year, Tavegil solution for intravenous and intramuscular injection can be used.

    Tavegil® tablets contain lactose, therefore the drug is not recommended for patients suffering from rare congenital diseases associated with impaired tolerance to galactose, severe lactase deficiency and impaired absorption of glucose-galactose.

    Effect on the ability to drive transp. cf. and fur:Clemastin has a minor sedative effect (from mild to moderate in intensity), therefore it is recommended that persons taking Tavegil® refrain from driving vehicles, working with mechanisms, as well as other activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Tablets 1 mg.

    Packaging:

    5 tablets per blister of combined material (PVC / PVDC / Aluminum foil). For 1, 2, 3 or 6 blisters with instructions for use in a cardboard box.

    10 tablets per blister of combined material (PVC / PVDC / Aluminum foil). For 1, 2, 3 or 6 blisters with instructions for use in a cardboard box.

    Storage conditions:

    At a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N008878 / 01
    Date of registration:31.05.2010
    The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
    Information update date: & nbsp11.09.2012
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