BETAHISTINE DIHYDROCHLORIDE Tablets Ref.[6460] Active ingredients: Betahistine

Adults, including the elderly

Initially 16 mg (two tablets) three times daily, taken preferably with meals. Maintenance doses are generally in the range 24 to 48 mg daily. Dosage should be altered according to clinical response.

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 postmarketing 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.

There is no specific antidote to betahistine dihydrochloride. Gastric lavage and symptomatic treatment is recommended. Treatment of overdose should include standard supportive measures.

Shelf life: 3 years.

Do not store above 25°C. Store in the original package. Keep container in the outer carton.

Blister strips consisting of 250 µm transparent PVC, a 60 g/m² PVDC layer and 20µm hard temper aluminium foil, contained in a carton.

Pack sizes: 60, 84, 90, 100 and 120 tablets.

Not applicable.