Composition
Each film coated tablet contains:
Betahistine dihydrochloride ............................................................
8 mg or 16 mg
Inactive ingredients: Lactose, avicel, plasidone XL, stearic acid, aerosil 200, polyvinyl pyrolidone (K90).

Therapeutic Indications
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

Dosage and Administration
Adults (including the elderly): Initially 16 mg three times daily taken preferably with meals.
Maintenance doses are generally in the range 24-48 mg daily.

Children: No dosage recommendations.

Contraindications
-Hypersensitivity to the active substance or to any of the excipients.

-Phaeochromocytoma.

Warnings and Precautions
Caution is advised in the treatment of patients with a history of peptic ulcer.

Clinical intolerance to betahistine dihydrochloride in bronchial asthma patients has been shown in a relatively few patients.
These patients need to be carefully monitored during the therapy.

Drug Interactions
No in-vivo interaction studies have been performed.

Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.

Although an antagonism between betahistine dihydrochloride and antihistamines could be expected on a theoretical basis, no such interactions have been reported.

Pregnancy and Lactation
Pregnancy:
There are no adequate data from the use of betahistine in pregnant women.

Betahistine should not be used during pregnancy unless clearly necessary.

Lactation:
It is not known whether betahistine is excreted in human milk.
The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child