Тавегил®

General characteristics. Structure:

Active agent - 1,34 mg of Clemastinum of a gidrofumarat (it is equivalent to 1 mg of Clemastinum).
Excipients: lactoses monohydrate of 107,66 mg, starch of corn 10,8 mg, talc of 5 mg, povidone of 4 mg, magnesium stearate of 1,2 mg.

Description. Round, flat tablets of white or almost white color with a slanted edge. On one party of a tablet of risk and an engraving "FROM".

Pharmacological properties:

Pharmacodynamics. H1-of histamine receptors blocker, derivative ethanolamine. Has strong antihistaminic and antipruritic effect with quick start of action and lasting up to 12 watch, prevents development of a vazodilatation and reduction of the unstriated muscles induced by a histamine.

Possessing antiallergic action, reduces permeability of vessels, capillaries, brakes exudation and formation of hypostasis, reduces an itch, renders m-holinoblokiruyushchy effect.

Pharmacokinetics. After intake Clemastinum is almost completely soaked up from digestive tract. The maximum concentration of Clemastinum in plasma is reached in 2-4 hours.

Communication with proteins of plasma makes 95%. Removal from plasma two-phase, the corresponding elimination half-lives make 3.6 ± 0.9 hours and 37 ± 16 hours. Clemastinum is exposed to considerable metabolism in a liver. Metabolites are removed generally through kidneys with urine (45 - 65%); not changed active agent is found in urine only in trace quantities. In the period of a lactation a small amount of Clemastinum can get into breast milk.

Indications to use:

- A pollinosis (hay fever, including allergic rinokonjyunktivit);
- Small tortoiseshell of various origin;
- Itch, pruritic dermatosis;
- Acute and chronic eczema, contact dermatitis;
- Medicinal allergy;
- Stings of insects.

Route of administration and doses:

Inside to food, washing down with water.
To adults and children 12 years are more senior appoint on 1 tablet (1 mg) in the morning and in the evening. In the cases which are difficult giving in to treatment, the daily dose can make up to 6 tablets (6 mg).
To children at the age of 6-12 years appoint on 1/2-1 tablet before a breakfast and to night.

Features of use:

For prevention of distortion of results of skin scarifying tests on allergens drug needs to be cancelled for 72 h before conducting allergological testing.

Clemastinum possesses insignificant sedation (from weak to moderated on intensity) therefore the persons accepting Tavegil® are recommended to abstain from driving of vehicles, work with mechanisms, and also from other types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

For treatment of children aged from 1 year it is possible to apply Tavegil® solution to intravenous and intramuscular administration.

The tablets Tavegil® contain lactose therefore drug is not recommended to be accepted to the patients having the rare inborn diseases connected with the broken tolerance to a galactose, a heavy lactose intolerance and disturbance of absorption of glucose galactose.

Side effects:

Classification of frequency of emergence of side reactions:
very often (≥1/10); often (≥1/100, ≤1/10); infrequently (≥1/1000, ≤1/100); seldom (≥1/10 000, ≤1/1000); very seldom (≤1/10 000).

From a nervous system:
Often: increased fatigue, drowsiness, sedation, weakness, feeling of fatigue, block, lack of coordination of movements;
Infrequently: dizziness;
Seldom: headache, tremor, promoting effect.

From digestive tract:
Seldom: dyspepsia, nausea, vomiting, gastralgia;
Very seldom: a lock, dryness in a mouth.
Separate cases of a loss of appetite and diarrhea.

From sense bodys:
Seldom: disturbance of clearness of visual perception, diplopia, acute labyrinthitis, sonitus.

From kidneys and urinary tract:
Very seldom: the speeded-up or complicated urination.

From respiratory system:
Seldom: a condensation of a bronchial secret and difficulty of an otkhozhdeniye of a phlegm, feeling of pressure in a thorax, breath disturbance, a nose congestion.

From cardiovascular system:
Seldom: a lowering of arterial pressure (is more often at elderly patients), premature ventricular contraction.
Very seldom: heartbeat.

From blood and hemopoietic bodies:
Rare: hemolitic anemia, thrombocytopenia, agranulocytosis.

From skin and a hypodermic fatty tissue:
Seldom: skin rash.

From immune system:
Seldom: photosensitization, acute anaphylaxis.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

Тавегил® strengthens effect of the medicines oppressing the central nervous system (somnolent, sedative, anxiolytics), m-holinoblokatorov, and also alcohol. It is incompatible with a concomitant use of MAO inhibitors.

Contraindications:

Hypersensitivity, pregnancy, the lactation period, reception of monoamine oxidase inhibitors (MAO), diseases of the lower respiratory tracts (including bronchial asthma), children's age up to 6 years (for this dosage form).

With care
At patients with the stenosing stomach ulcer, piloroduodenalny obstruction, with obstruction of a neck of a bladder, and also the prostatauxe which is followed by an ischuria with the increased intraocular pressure, a hyperthyroidism, diseases of cardiovascular system, including arterial hypertension.

Use at pregnancy and during breastfeeding
Use of drug at pregnancy and during breastfeeding is contraindicated.

Overdose:

Symptoms. The overdose of antihistamines can lead both to oppressing, and to a promoting effect on the central nervous system, the last is more often observed at children. Also the phenomena of anticholinergic action can develop: dryness in a mouth, the fixed expansion of pupils, rushes of blood to an upper half of a body, disturbance from digestive tract (nausea, pains in epigastriums, vomiting).

Treatment. If at the patient vomiting did not arise spontaneously, then it should be caused artificially (only if consciousness of the patient is kept). If from the moment of administration of drug there passed 3 hours or slightly more, it is necessary to carry out a gastric lavage with use of 0,9% of solution of sodium chloride and absorbent carbon. It is possible to appoint salt laxative also. Also symptomatic therapy is shown.

Storage conditions:

At a temperature not above 30 °C. To store in the place, unavailable to children. Period of validity of 5 years. Not to use after expiry date of the validity.

Issue conditions:

Without recipe

Packaging:

Tablets of 1 mg.
On 5 tablets in the blister from the combined material (PVC/PVDH / Aluminum foil). On 1, 2, 3 or 6 blisters with the application instruction in a cardboard pack.
On 10 tablets in the blister from the combined material (PVC/PVDH / Aluminum foil). On 1, 2, 3 or 6 blisters with the application instruction in a cardboard pack.