Betahistin (Vesticap) capsules 24mg, No. 30

• Treatment of Meniere's syndrome characterized by dizziness (accompanied by nausea and vomiting), hearing loss and tinnitus.

• Symptomatic treatment of vestibular vertigo (vertigo).

Inside during meals without chewing with a small amount of liquid 1 capsule (24 mg) 2 times a day.

Treatment long-term improvement is sometimes observed after a few weeks. The best results in some cases are achieved after several months of treatment. The course of treatment is determined individually.

No dose adjustment is required in the elderly.

Special studies in patients with renal / hepatic insufficiency have not been carried out, however, post-marketing experience suggests that dose adjustment in this category of patients is not required.

Each capsule contains:

active substance: betahistine dihydrochloride - 24.0 mg;

excipients: lactose monohydrate (milk sugar) - 129.0 mg, microcrystalline cellulose - 70.5 mg, potato starch - 30.0 mg, copovidone - 27.0 mg, sodium carboxymethyl starch - 15.0 mg, colloidal silicon dioxide - 1.5 mg, magnesium stearate - 3.0 mg.

The composition of the capsule cap: indigo carmine - 0.0312%, titanium dioxide - 4%, gelatin - up to 100%.

The composition of the capsule body: indigo carmine - 0.0312%, titanium dioxide - 4%, gelatin - up to 100%.

• Hypersensitivity to drug components

• pregnancy

• breastfeeding period

• children under 18 years of age (due to lack of data)

• pheochromocytoma

• lactose intolerance

• lactase deficiency

• glucose-galactose malabsorption.

Carefully:

Peptic ulcer or 12 duodenal ulcer (history) bronchial asthma.

Trade name of the drug

Westikap

International non-proprietary name

Betahistine

Dosage form

capsules

Composition

Each capsule contains:

active substance: betahistine dihydrochloride - 24.0 mg;

excipients: lactose monohydrate (milk sugar) - 129.0 mg, microcrystalline cellulose - 70.5 mg, potato starch - 30.0 mg, copovidone - 27.0 mg, sodium carboxymethyl starch - 15.0 mg, colloidal silicon dioxide - 1.5 mg, magnesium stearate - 3.0 mg.

The composition of the capsule cap: indigo carmine - 0.0312%, titanium dioxide - 4%, gelatin - up to 100%.

The composition of the capsule body: indigo carmine - 0.0312%, titanium dioxide - 4%, gelatin - up to 100%.

Description

Capsules No. 0: light blue opaque body, light blue opaque cap.

The contents of the capsules are a mixture of powder and granules of white or white with a creamy shade. It is allowed to seal the contents of the capsule in the form of a capsule, which disintegrates when pressed.

Pharmacotherapeutic group

Histamine drug

ATX code

N07CA01

Pharmacodynamics:

Agonist of H1-histamine receptors of the inner ear vessels and antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS). By relaxing the precapillary sphincters of the vessels of the inner ear, it improves blood circulation in the vascular strip of the inner ear. Increases blood flow in the brain dose-dependently reduces the generation of action potentials in the neurons of the lateral and medial vestibular nuclei.

Accelerates the restoration of vestibular function after unilateral vestibular neuroectomy, facilitating and accelerating central vestibular compensation (due to antagonism with H3-histamine receptors).

Eases symptoms of Meniere's syndrome and vertigo.

Pharmacokinetics:

It is rapidly and almost completely absorbed in the gastrointestinal tract. When taken with food, the maximum concentration of betahistine in the blood is lower than when taken on an empty stomach. However, the total absorption is the same in both cases, indicating that food intake slows absorption. The connection with plasma proteins is absorbed quickly - less than 5%. The time to reach the maximum concentration in blood plasma is 1 hour.

It is metabolized to inactive metabolites: 2-pyridylacetic acid (the main metabolite) and dimethylbetahistine. The maximum concentration of 2-pyridylacetic acid in plasma (or urine) is reached one hour after ingestion.

The half-life is approximately 35 hours. 85-90% is excreted by the kidneys in the form of 2-pyridylacetic acid during the day.

Excretion of betahistine and dimethylbetahistine by the kidneys is negligible. Only a small part (about 10%) of betahistine and its metabolites is excreted by the intestine. The clearance rate remains constant indicating linearity of pharmacokinetics.

Indications:

• Treatment of Meniere's syndrome characterized by dizziness (accompanied by nausea and vomiting), hearing loss and tinnitus.

• Symptomatic treatment of vestibular vertigo (vertigo).

Contraindications:

• Hypersensitivity to drug components

• pregnancy

• breastfeeding period

• children under 18 years of age (due to lack of data)

• pheochromocytoma

• lactose intolerance

• lactase deficiency

• glucose-galactose malabsorption.

Carefully:

Peptic ulcer or 12 duodenal ulcer (history) bronchial asthma.

Pregnancy and lactation:

There are insufficient data to assess the effects of the drug during pregnancy and breastfeeding. In this connection, the drug is contraindicated in pregnancy. Breastfeeding should be discontinued for the duration of treatment.

Method of administration and dosage:

Inside during meals without chewing with a small amount of liquid 1 capsule (24 mg) 2 times a day.

Treatment long-term improvement is sometimes observed after a few weeks. The best results in some cases are achieved after several months of treatment. The course of treatment is determined individually.

No dose adjustment is required in the elderly.

Special studies in patients with renal / hepatic insufficiency have not been carried out, however, post-marketing experience suggests that dose adjustment in this category of patients is not required.

Side effects:

The frequency of side effects was determined, respectively, by the following gradation of the frequency of occurrence of side effects: very frequent (? 1/10); frequent (? 1/100 <1/10); infrequent (? 1/1000 <1/100); rare (? 1/10000 <1/1000); very rare (<1/10000); unknown (no estimate based on available data).

From the digestive system : very often - nausea, vomiting, abdominal pain; frequency unknown - heartburn epigastric pain.

Allergic reactions: frequency unknown - hypersensitivity, incl. anaphylactic reactions angioedema.

From the side of the skin: the frequency is unknown - urticaria, itching, rash, redness.

From the nervous system : often - headache, weakness, fatigue, dizziness, lethargy, drowsiness, insomnia.

From the side of the cardiovascular system: rarely - a feeling of heat, palpitations.

Overdose:

Symptoms: nausea vomiting headache flushing of the skin of the face dizziness tachycardia lowering blood pressure bronchospasm; drowsiness (when taken in a dose of up to 640 mg); convulsions, cardiopulmonary complications (when taken in a dose of more than 640 mg or in combination with other drugs).

Treatment: gastric lavage; intake of activated charcoal is symptomatic.

Interaction:

Antihistamines reduce the effect of betahistine. The interaction of betahistine with blockers of H1-histamine receptors with simultaneous use can theoretically influence the effectiveness of one of these agents.

Cases of interaction or incompatibility with other drugs are unknown.

Based on in vitro data, it can be assumed that there is no inhibition of the activity of cytochrome P450 isoenzymes in vivo.

In vitro data have shown inhibition of betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) including MAO subtype B (eg selegiline).

Special instructions:

The therapeutic effect in some cases increases within a few months from the start of treatment.

Impact on the ability to drive vehicles. Wed and fur .:

The effect on the ability to drive vehicles and work with mechanisms is absent or insignificant.

Release form / dosage:

Capsules 24 mg.

Packaging:

On 10 20 30 capsules in a blister strip packaging from a film of varnished polyvinyl chloride aluminum foil.

10 20 30 40 50 or 100 capsules in a polymer container for medicines.

One container or 1 2 3 4 or 5 blisters together with instructions for use are placed in a cardboard box.

A complete set of 2 or 3 cardboard packages (packs) in a group packaging (shipping container) made of cardboard is allowed.

Storage conditions:

In a dry, dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Vacation conditions

On prescription.