Composition, form of production and packaging
? Tablets are white or almost white in color, round, flat, with a bevelled edge, with a risk and engraving "OT" on one side.
Clemastine hydrofumarate 1.34 mg,
which corresponds to the content of clemastine 1 mg
[PRING] lactose monohydrate - 107.66 mg, corn starch - 10.8 mg, talc - 5 mg, povidone - 4 mg, magnesium stearate - 1.2 mg.
5 pieces. - blisters (2, 3, 6) - packs of cardboard.
10 pieces. - blisters (1, 2, 3, 6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The blocker of histamine H 1 -receptors, ethanolamine derivative. Has a strong antihistamine and antipruritic effect with a rapid onset of action and duration of up to 12 hours, prevents the development of vasodilation and contraction of smooth muscles, 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.
After ingestion, clemustine is almost completely absorbed from the digestive tract. C max in blood plasma is achieved in 2-4 h.
The binding of clemastine to plasma proteins is 95%. Is allocated with breast milk in a small amount.
Metabolism and excretion
The elimination from the plasma has a two-phase character, the corresponding T 1/2 is 3.6 В± 0.9 h and 37 В± 16 h. Clemastin undergoes significant metabolism in the liver. Metabolites in the main (45-65%) are excreted in the urine; The unchanged active substance is found in urine only in trace amounts.
- Pollinosis (hay fever, including allergic rhinoconjunctivitis);
hives of different origin;
- itching, itching dermatoses;
- acute and chronic eczema, contact dermatitis;
- drug allergy;
- Insect bites.
Inside adults and children over 12 years of age appoint 1 tab. (1 mg) in the morning and evening. In cases that are difficult to treat, the daily dose can be up to 6 tab.(6 mg).
Children aged 6-12 years are prescribed 1 / 2-1 tab. before breakfast and at night.
Tablets should be taken before meals, washed down with water.
Determination of the frequency 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 side of the nervous system: often - increased fatigue, drowsiness, sedation, weakness, fatigue, inhibition, impaired coordination of movements; infrequently - dizziness; rarely - headache, tremor, stimulating effect.
From the digestive system: rarely - dyspepsia, nausea, vomiting, gastralgia; very rarely - constipation, dry mouth; in some cases - a decrease in appetite, diarrhea.
On the part of the respiratory system: rarely - thickening of the bronchial secretion and difficulty in separating the sputum, a feeling of pressure in the chest and difficulty breathing, nasal congestion.
From the cardiovascular system: rarely - lowering blood pressure (usually in elderly patients), extrasystole; very rarely - palpitations.
From the senses: rarely - violation of the clarity of visual perception, diplopia, acute labyrinthitis, tinnitus.
From the urinary system: very rarely - frequent urination, difficulty urinating.
From the hemopoietic system: rarely - hemolytic anemia, thrombocytopenia, agranulocytosis.
Dermatological reactions: rarely - skin rash, photosensitivity.
Allergic reactions: rarely anaphylactic shock.
- diseases of the lower parts of the respiratory tract (including bronchial asthma);
- simultaneous use of MAO inhibitors;
- children's age till 6 years;
- lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
Caution should be applied Tavegil В® in patients with a stenosing ulcer of the stomach, with 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, diseases of the cardiovascular system (including with arterial hypertension).
PREGNANCY AND LACTATION
Contraindicated use of Tavegil В® in pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
Contraindication: children under 1 year of age (tablets should not be used in children under 6 years of age).
To prevent distortion of skin scarification test results for allergens, the drug should be discontinued 72 hours before the allergy testing.
The tablets contain lactose, so the drug is not recommended for patients suffering from rare congenital diseases associated with intolerance to galactose, severe lactase deficiency and impaired absorption of glucose-galactose.
Use in Pediatrics
Tavegil В® in the form of tablets is contraindicated in children under the age of 6 years . For treatment of children aged 1 year , Tavegil В® can be used in the form of a solution for intravenous and / or intravenous administration.
Impact on the ability to drive vehicles and manage mechanisms
Clemastin has a slight sedative effect (from mild to moderate in intensity), so patients receiving patients with Tavegil В® are advised to refrain from driving vehicles, working with mechanisms, as well as from other activities requiring increased attention and speed of psychomotor reactions.
Symptoms: an overdose of antihistamines can lead to both depressing and stimulating effects on the central nervous system. Stimulation of the central nervous system is more common in children. Also, manifestations of anticholinergic action may develop: dry mouth, fixed dilatation of the pupils, blood rushes to the upper half of the trunk, abnormalities of the gastrointestinal tract (nausea, epigastric pain, vomiting).
Treatment: if a patient does not develop vomiting spontaneously, then it should be induced artificially (only if the patient's consciousness is preserved). If you take 3 hours or a little more after taking the drug, you can wash the stomach using an isotonic sodium chloride solution. You can also designate a salt laxative. Symptomatic therapy is also indicated.
Tavegil В® potentiates the effect of drugs that depress the central nervous system (hypnotics, sedatives, tranquilizers), m-holinoblokatorov, as well as ethanol.
Incompatible with simultaneous administration of MAO inhibitors.
TERMS OF RELEASE FROM PHARMACY
The drug in the form of tablets is allowed for use as an OTC product.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 5 years.