Betagis tablets 16 mg 30 pcs.

• active ingredient: betahistine dihydrochloride;
• 1 tablet contains betahistine dihydrochloride 16 mg;
• Excipients: microcrystalline cellulose; mannitol (E 421); citric acid monohydrate; colloidal anhydrous silicon dioxide; potato starch; talc.

• Increased individual sensitivity to betahistine or to any of the components of the drug.
• Pheochromocytoma.

Immune system disorders: Hypersensitivity reactions (including anaphylaxis).

Gastrointestinal: Common: nausea and dyspepsia. In some cases, minor stomach upset (vomiting, abdominal pain, bloating and flatulence) may occur. These side effects usually disappear when the drug is taken with food or after reducing the dose.

Nervous system disorders: Common: headache. In addition to clinical trial data, the following undesirable effects are known from post-marketing experience and the scientific literature.

Skin and subcutaneous tissue disorders: Frequency unknown: hypersensitivity reactions of the skin and subcutaneous tissue, including angioedema, rash, pruritus and urticaria.

Betagis tablets should be taken orally during or after meals. Minor gastrointestinal upset may occur during treatment, which can be avoided by taking the medicine with food.

The dose of the drug and the duration of the course of treatment are determined by the doctor individually for each patient, depending on the indications and severity of the disease.

Adults are usually prescribed 24 mg to 48 mg of betahistine per day (½-1 tablet 3 times a day).

Improvement is noted after 2–3 weeks. The best results are achieved with a course of treatment with Betahistine for several months. Available data indicate that prescribing the drug at the beginning of the disease prevents its progression and/or hearing loss in the later stages.

Use during pregnancy or breastfeeding

Betahistine should not be used during pregnancy unless clearly necessary.

Breastfeeding. It is not known whether betahistine is excreted in human milk. Betahistine is excreted in rat milk. Effects observed in postnatal animal studies only occurred after very high doses.

The benefit of using the drug for the mother should be weighed against the benefits of breastfeeding and the potential risk to the child.

Children

Due to insufficient data on the safety and efficacy of betahistine in pediatric practice, it is not recommended to prescribe the drug to children (under 18 years of age).

Ability to influence reaction speed when driving vehicles or other mechanisms

Betahistine is indicated for the treatment of Ménière’s syndrome, characterized by a triad of main symptoms: dizziness, hearing loss, tinnitus, and for the symptomatic treatment of vestibular vertigo. Both conditions may adversely affect the ability to drive and use machines. According to clinical studies, betahistine had no or negligible influence on the patient’s ability to perform activities requiring increased attention and psychomotor speed.

Several cases of betahistine overdose have been described. Some patients experienced mild to moderate symptoms (nausea, epigastric pain, drowsiness) after taking the drug in doses up to 640 mg. Serious complications – convulsions, cardiopulmonary disorders – are possible with intentional administration of increased doses of betahistine, especially in combination with an overdose of other drugs.

Treatment: Treatment of overdose should include standard supportive measures.

Store out of the reach of children, in the original packaging at a temperature not exceeding 25 ºС.