Expiration date: 02/2025

The composition and form of issue: 

Tablets. 1 tablet cintains active substance: 

betahistine hydrochloride 8, 16 or 24 mg

other ingredients: microcrystalline cellulose mannitol citric acid silicon dioxide talc 

in blistere 5 PCs. in cartons of 6 blister packs.

Description pharmacological action:

Betaserc (betahistine) acts mainly on histamine H1 and H3 receptors of the inner ear and the vestibular nuclei CNS. Through direct agonistic effects on H1-receptors receptacles inner ear, as well as indirectly through its effect on H3-receptors improves microcirculation and capillary permeability, normalizes pressure of endolymph in the labyrinth and the cochlea. However, betahistine increases the blood flow in the basilar arteries. Betaserc also has a pronounced Central effect due to the effect on H3-receptors in the nuclei of the vestibular nerve. Normalizes conductivity in the neurons of the vestibular nuclei at the level of the brain stem. Clinical manifestation of these properties is to reduce the frequency and intensity of vertigo, reducing tinnitus, improve hearing in the case of lowering it.

Indications:

• vestibular dizziness
  
• syndromes characterized by dizziness and headache, tinnitus, progressive hearing loss, nausea and vomiting
  
• disease/Meniere's syndrome.
  

Contraindications:

• hypersensitivity to any component of the drug
  
• pheochromocytoma
  
• ulcers disease stomach and duodenal ulcer in acute phase.
  

Side effects:

Possible gastrointestinal disorders (nausea, feeling of heaviness in the epigastrium), which can be prevented by taking the drug after meals or by dose reduction. In very rare cases it was reported about the appearance of hypersensitivity reactions with the skin, in particular skin rashes, itching, and hives.

Drug interactions:

Cases interaction or incompatibility with other drugs is unknown.

Method of application and dose:

Inside, 8-16 mg 3 times a day. Improvement is usually in the first days of treatment. Stable therapeutic effect is achieved within 2 weeks of treatment and increases in the drug within one month or more.

The dose and duration of drug intake are selected individually in accordance with the response to treatment.

Precautions:

Caution should be exercised when treating patients with peptic ulcer disease of the gastrointestinal tract in anamnesis. Patients with pheochromocytoma and asthma should be monitored regularly during treatment. Should not be prescribed Betaserc during pregnancy and lactation.

Influence on ability to driving and other mechanisms

Observations have shown that Betaserc does not affect the ability to drive or work on machines and mechanisms.