Betahistine-SZ (Tablets) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Contact Information

SEVERNAYA ZVEZDA NAO (Russia)

ATC Code

N07CA01 (Betahistine)

Active Substance

Betahistine (Rec.INN registered by WHO)

Dosage Forms

	Betahistine-SZ	Tablets 8 mg: 20, 30, 60 or 100 pcs.
		Tablets 16 mg: 20, 30, 60 or 100 pcs.
		Tablets 24 mg: 20, 30, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, flat-cylindrical in shape, with a bevel.

Excipients: microcrystalline cellulose 102 – 76.5 mg, lactose monohydrate (milk sugar) – 23.75 mg, citric acid – 2.5 mg, colloidal silicon dioxide (aerosil) – 5.8 mg, talc – 1.75 mg, magnesium stearate – 1.2 mg, sodium lauryl sulfate – 2.5 mg, pregelatinized starch (starch 1500) – 3 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Tablets white or almost white, flat-cylindrical in shape, with a bevel and a score line.

Excipients: microcrystalline cellulose 102 – 153 mg, lactose monohydrate (milk sugar) – 47.5 mg, citric acid – 5 mg, colloidal silicon dioxide (aerosil) – 11.6 mg, talc – 3.5 mg, magnesium stearate – 2.4 mg, sodium lauryl sulfate – 5 mg, pregelatinized starch (starch 1500) – 6 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Tablets white or almost white, flat-cylindrical in shape, with a bevel and a score line.

Excipients: microcrystalline cellulose 102 – 229.5 mg, lactose monohydrate (milk sugar) – 71.25 mg, citric acid – 7.5 mg, colloidal silicon dioxide (aerosil) – 17.4 mg, talc – 5.25 mg, magnesium stearate – 3.6 mg, sodium lauryl sulfate – 7.5 mg, pregelatinized starch (starch 1500) – 9 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – 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 H₁ receptors of the vessels of the inner ear, as well as indirectly through action on 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 H₃ receptors of the vestibular nerve nuclei. It improves conduction in the 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

Absorbed rapidly, the degree of binding to plasma proteins is low. C_max in blood plasma after 3 hours.

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

Indications

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

ICD codes

Dosage Regimen

The drug is taken orally, with meals.

Recommended doses

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 2 weeks of treatment and may increase over several months of treatment.

Treatment is long-term. The duration of use of the drug is determined individually.

Adverse Reactions

From the digestive system gastrointestinal disorders.

Allergic reactions occurrence of hypersensitivity reactions from the skin (rash, itching, urticaria), angioedema.

Contraindications

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

With caution the drug should be prescribed for gastric or duodenal ulcer (including history), pheochromocytoma, bronchial asthma. Patients with these diseases should be regularly monitored during treatment.

Use in Pregnancy and Lactation

Insufficient data to assess the effect of the drug during pregnancy and lactation. In this regard, it is not recommended to take the drug during pregnancy. Breastfeeding should be discontinued during treatment.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years.

Special Precautions

Effect on the ability to drive vehicles and machinery

Betahistine does not have a sedative effect and does not affect the ability to drive a car or engage in other 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 drugs are unknown.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

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.