Vestibo of the tab. of 8 mg No. 30

Vestibo is shown for treatment of the Disease and Menyer's syndrome, characterized by three main symptoms:

• dizziness, sometimes is followed by nausea and vomiting;
• decrease in hearing (relative deafness)
• sonitus.

Also Vestibo is appointed for symptomatic treatment of vestibular dizziness of various origin.

Structure

active ingredient: betahistine;

1 tablet supports a betagistin of dihydrochloride of 8 mg;

excipients: povidone, cellulose microcrystalline, lactose, silicon dioxide colloidal, krospovidon, stearic acid.

Contraindication

Hypersensitivity to or to any of medicament excipients.

Pheochromocytoma.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy. There are no sufficient data concerning use of a betagistin to pregnant women.

for assessment of the impact on a pregnancy course, development of an embryo / fruit, childbirth and post-natal development. The potential risk for the person is unknown. Betagistin it is not necessary to apply during pregnancy, except for cases of undoubted need.

feeding Period breast. It is unknown, gets betagistin into breast milk. Researches on animals on penetration of a betagistin into milk were not conducted. Advantage of use of medicament for mother it is necessary to correlate to advantages of feeding by a breast and potential risk for the child.

Children

Due to the insufficiency of data on safety and efficiency of use of a betagistin, children are not recommended to appoint medicament (aged up to 18 years).

by

for treatment of a syndrome of Menyer that is characterized by a triad of the main symptoms: dizziness, decrease in hearing, sonitus, - and also for symptomatic treatment of vestibular dizziness. Both states can have negative effect on ability to drive the car and to work with mechanisms. According to the clinical trials studying influence on ability to drive the car and to work with other mechanisms, betagistin did not influence or had insignificant influence on this ability.

Route of administration and doses

Daily dose for adults makes 24-48 mg, evenly distributed for reception within a day.

Dose should be selected individually, depending on effect. Reduction of symptoms is sometimes observed only after two-three weeks of treatment. The best results are sometimes achieved at administration of medicament within several months. There are data that purpose of treatment at the beginning of a disease prevents its progressing and/or a hearing loss at late stages.

Overdose

Knows several cases of overdose of drug. At some patients easy and moderate symptoms (nausea, drowsiness, an abdominal pain) after administration of medicament in a dose up to 640 mg were observed. More serious complications (spasms, cardiopulmonary complications) were observed at intended reception of the raised doses of a betagistin, especially in combination with overdose of other medicines.

Treatment

Treatment of overdose has to include the standard supporting actions.

side Below-mentioned reactions were observed by

at patients with such frequency: very often (≥ 1/10), it is frequent (≥1/100 to <1/10), infrequent (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), rare (<1/10000).

from digestive tract

it is frequent: nausea and dyspepsia.

from nervous system

it is frequent: headache.

Side reactions which frequency is unknown.

from the immune system

Reaction of hypersensitivity, for example an anaphylaxis.

from digestive tract

Complaint to insignificant indigestions (vomiting, gastrointestinal pain, an abdominal distension and a meteorism). These side effects usually disappear at administration of medicament with food or after reduction of a dose.

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from skin and hypodermic cellulose

observed reactions of hypersensitivity of skin and hypodermic fatty tissue, in particular a Quincke's disease, rash, an itching and a small tortoiseshell.

Interaction with other medicines and other types of interactions

Research in Vivo directed to studying interaction with other medicines were not carried out by

. Considering these researches in vitro suppression of activity of enzymes of P450 in Vivo cytochrome is not expected.

Data obtained in the conditions of in vitro confirm oppression of metabolism of a betagistin medicaments which inhibit activity of monoamine oxidase (MAO), including the B MAO subtype (for example selegiliny). It is recommended to be careful at simultaneous use of a betagistin and MAO inhibitors (including selectively B MAO subtype).

As betagistin is a histamine analog, interaction of a betagistin with antihistaminic medicaments can theoretically affect efficiency of one of these drugs.

Storage conditions

to Store

in original packing at a temperature not above 25 °C.

to Store

in the places inaccessible for children.

Expiration date - 3 years.