Tagista^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

N07CA01 (Betahistine)

Active Substance

Betahistine (Rec.INN registered by WHO)

Dosage Forms

	Tagista®	Tablets 8 mg: 30, 50, 60 or 90 pcs.
		Tablets 16 mg: 30, 50, 60 or 90 pcs.
		Tablets 24 mg: 30, 50, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to almost white, round, flat-cylindrical, with a bevel on both sides and a score on one side.

Excipients: microcrystalline cellulose 101, povidone K-25, potato starch, citric acid, colloidal silicon dioxide (aerosil), talc, magnesium stearate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.

Tablets from white to almost white, round, flat-cylindrical, with a bevel on both sides and a score on one side.

Excipients: microcrystalline cellulose 101, povidone K-25, potato starch, citric acid, colloidal silicon dioxide (aerosil), talc, magnesium stearate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.

Tablets from white to almost white, round, flat-cylindrical, with a bevel on both sides and a score on one side.

Excipients: microcrystalline cellulose 101, povidone K-25, potato starch, citric acid, colloidal silicon dioxide (aerosil), talc, magnesium stearate.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.

Clinical-Pharmacological Group

Drug improving microcirculation of the labyrinth, used for pathology of the vestibular apparatus

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; medications for the treatment of dizziness

Pharmacological Action

A drug that improves the microcirculation of the labyrinth, used for pathology of the vestibular apparatus. Betahistine acts mainly on histamine H₁ and H₃ receptors of the inner ear and vestibular nuclei of the CNS.

Through direct agonistic action on histamine H₁ receptors of the vessels of the inner ear, as well as indirectly through action on histamine H₃ receptors, it improves microcirculation and capillary permeability, normalizes endolymph pressure in the labyrinth and cochlea.

Furthermore, Betahistine increases blood flow in the basilar artery.

It has a pronounced central effect, being an inhibitor of histamine H₃ receptors of the vestibular nerve nuclei.

It normalizes conduction in neurons of the vestibular nuclei at the level of the brainstem.

The clinical manifestation of these properties is a reduction in the frequency and intensity of dizziness, a decrease in tinnitus, and an improvement in hearing in case of its decline.

Pharmacokinetics

Absorption and Distribution

Absorbed rapidly. T_max– 3 h. Plasma protein binding is low.

Metabolism and Excretion

Almost completely excreted by the kidneys as a metabolite (2-pyridylacetic acid) within 24 h. T_1/2 – 3-4 h.

Indications

• Treatment and prevention of vestibular vertigo of various origins;
• Syndromes including dizziness and headache, tinnitus, progressive hearing loss, nausea and vomiting;
• Ménière’s disease or syndrome.

ICD codes

Dosage Regimen

The drug is administered orally, with meals.

Tablets 8 mg – 1-2 tablets 3 times/day.

Tablets 16 mg – 1/2-1 tablet 3 times/day.

Tablets 24 mg – 1 tablet 2 times/day.

Improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs after two weeks of treatment and may increase over several months of treatment. Treatment is long-term. The duration of the treatment course is determined individually.

Adverse Reactions

Possible: gastrointestinal disorders, hypersensitivity reactions (rash, itching, urticaria), angioedema.

Contraindications

• Age under 18 years (due to lack of data);
• Pregnancy (due to lack of data);
• Lactation period (due to lack of data);
• Hypersensitivity to any component of the drug.

With caution, the drug should be prescribed for gastric and duodenal ulcer (including history), pheochromocytoma, bronchial asthma. These patients should be regularly monitored during treatment.

Use in Pregnancy and Lactation

Due to lack of data, the drug is contraindicated during pregnancy and lactation.

Pediatric Use

Contraindication: age under 18 years (due to lack of data).

Special Precautions

Effect on the ability to drive vehicles and mechanisms

Betahistine does not have a sedative effect and does not affect the ability to drive a car or engage in activities requiring speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, convulsions.

Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.

Drug Interactions

Cases of interaction or incompatibility with other medicinal products are unknown.

Storage Conditions

List B. The drug should be stored out of the reach of children, in a dry, light-protected place, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.