SERC Tablet Ref.[27765] Active ingredients: Betahistine

Adults (including the elderly)

Initially two tablets three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.

Paediatric population

Not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

Geriatric population

Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population.

Renal impairment

There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.

Hepatic impairment

There are no specific clinical trials available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.

3 years.

Do not store above 25°C. Store in the original package.

Blister strips of 30 tablets. The blister strips are made of PVC/PVdC film and aluminium foil. Each carton contains 120 tablets.

Grey polypropylene tablet container with white polypropylene tamper evident closure containing 500 or 1000 tablets.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.