Tavegil tablets 1mg, No. 10

• Pollinosis (hay fever, including allergic rhinoconjunctivitis);

• Hives of various origins;

• Itching, itchy dermatoses;

• Acute and chronic eczema, contact dermatitis;

• Drug allergy;

• Insect bites.

Inside before meals with water.
Adults and children over 12 years old are prescribed 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 are prescribed 1 / 2-1 tablet before breakfast and at night.

1 tablet contains:
Active ingredient - 1.34 mg of clemastine hydrogen fumarate (equivalent to 1 mg of clemastine).
Excipients: lactose monohydrate 107.66 mg, corn starch 10.8 mg, talc 5 mg, povidone 4 mg, magnesium stearate 1.2 mg.

• Hypersensitivity

• pregnancy,

• lactation period,

• taking monoamine oxidase inhibitors (MAO),

• diseases of the lower respiratory tract (including bronchial asthma),

• children under 6 years of age (for this dosage form).

With caution
In patients with stenosing gastric ulcer, pyloroduodenal obstruction, with obstruction of the bladder neck, as well as prostatic hypertrophy, accompanied by urinary retention, with increased intraocular pressure, hyperthyroidism, diseases of the cardiovascular system, including arterial hypertension.

Trade name: TavegilЃ

INN or Generic Name: Clemastine

Chemical name: (2R) -2- (2 - ((R) -1- (4-chlorophenyl) -1-phenylethoxy) ethyl) - 1-methylpyrrolidine (E) -butenedioate

Dosage form:

pills

Composition:

1 tablet contains:
Active ingredient - 1.34 mg of clemastine hydrogen fumarate (equivalent to 1 mg of 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 white or off-white tablets with beveled edges. On one side there is a risk tablet and an engraving 'OT'.

Pharmacotherapeutic group
Antiallergic agent - H1-histamine receptor blocker.

ATX code: R06AA04.

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

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

Pharmacokinetics
After oral administration, clemastine is almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration of clemastine is reached after 2-4 hours.

The connection with plasma proteins is 95%. Excretion from plasma is two-phase, the corresponding half-lives are 3.6 ± 0.9 hours and 37 ± 16 hours. Clemastine undergoes significant liver metabolism. Metabolites are excreted mainly through the kidneys in the urine (45 - 65%); unchanged active substance is found in urine only in trace amounts. During lactation, a small amount of clemastine may pass into breast milk.

Indications for use

• Pollinosis (hay fever, including allergic rhinoconjunctivitis);

• Hives of various origins;

• Itching, itchy dermatoses;

• Acute and chronic eczema, contact dermatitis;

• Drug allergy;

• Insect bites.

Contraindications

• Hypersensitivity

• pregnancy,

• lactation period,

• taking monoamine oxidase inhibitors (MAO),

• diseases of the lower respiratory tract (including bronchial asthma),

• children under 6 years of age (for this dosage form).

With caution
In patients with stenosing gastric ulcer, pyloroduodenal obstruction, with obstruction of the bladder neck, as well as prostatic hypertrophy, accompanied by urinary retention, with increased intraocular pressure, hyperthyroidism, diseases of the cardiovascular system, including arterial hypertension.

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

Method of administration and dosage

Inside before meals with water.
Adults and children over 12 years old are prescribed 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 are prescribed 1 / 2-1 tablet before breakfast and at night.

Side effect
Classification of the 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 rare (? 1/10 000).

From the nervous system:
Often: increased fatigue, drowsiness, sedation, weakness, fatigue, lethargy, impaired coordination of movements;
Uncommon: dizziness;
Rarely: headache, tremors, stimulating action.

From the gastrointestinal tract:
Rarely: dyspepsia, nausea, vomiting, gastralgia;
Very rare: constipation, dry mouth.
Isolated cases of decreased appetite and diarrhea.

From the senses:
Rarely: impaired clarity of visual perception, diplopia, acute labyrinthitis, tinnitus.

On the part of the kidneys and urinary tract:
Very rare: frequent or difficult urination.

On the part of the respiratory system:
Rarely: thickening of bronchial secretions and difficulty in sputum discharge, a feeling of pressure in the chest, respiratory failure, nasal congestion.

From the side of the cardiovascular system:
Rarely: lowering blood pressure (more often in elderly patients), extrasystole.
Very rare: palpitations.

From the side of the blood and hematopoietic organs:
Rare: hemolytic anemia, thrombocytopenia, agranulocytosis.

On the part of the skin and subcutaneous fat:
Rarely: skin rash.

Immune system disorders:
Rarely: photosensitivity, anaphylactic shock.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Overdose
Symptoms. An overdose of antihistamines can lead to both a depressing and a stimulating effect on the central nervous system, the latter is more often observed in children. Anticholinergic phenomena may also develop: dry mouth, fixed pupil dilation, rush of blood to the upper half of the body, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).

Treatment. If the patient does not vomit spontaneously, then it should be induced artificially (only if the patient's consciousness is preserved). If 3 hours or more have passed since taking the drug, it is necessary to wash the stomach using 0.9% sodium chloride solution and activated carbon. A saline laxative may also be prescribed. Symptomatic therapy is also indicated.

Interaction with other drugs
TavegilЃ enhances the effect of drugs that depress the central nervous system (hypnotics, sedatives, anxiolytics), m-anticholinergics, and alcohol. Incompatible with the simultaneous administration of MAO inhibitors.

Special instructions
To prevent distortion of the results of skin scarification tests for allergens, the drug must be canceled 72 hours before the allergy test.

Clemastine has a slight sedative effect (from mild to moderate in intensity), therefore, persons taking TavegilЃ are advised to refrain from driving vehicles, working with mechanisms, as well as from other activities that require increased concentration of attention and speed of psychomotor reactions.

For the treatment of children aged 1 year and older, TavegilЃ solution for intravenous and intramuscular administration can be used.

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

Release form
Tablets 1 mg.
5 tablets in a blister made of a combined material (PVC / PVDC / Aluminum foil). 1, 2, 3 or 6 blisters with instructions for use in a cardboard box.
10 tablets in a blister made of a combined material (PVC / PVDC / Aluminum foil). 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 is
5 years. Do not use after the expiration date.

Terms of dispensing from pharmacies
Dispensed without a prescription.