Betahistine dihydrochloride 16 mg tablets
Each tablet contains
Betahistine dihydrochloride 16 mg
Excipient(s) with known effect:
Each tablet contains 100 mg lactose monohydrate
For the full list of excipients, see section 6.1.
White, round, flat, 9.0. mm tablets with bevelled edges with the inscription ‘BF’ on one side and a breakline on the other side.
The tablet can be divide into two equal halves.
Betahistine is indicated for treatment of Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea.
Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals.
Maintenance doses are generally in the range 24 – 48 mg daily. Daily dose should not exceed 48 mg. Dosage can be adjusted to suit individual patient needs. Sometimes improvement could be observed only after a couple of weeks of treatment.
There is no data available for patients with hepatic impairment.
There is no data available for patients with renal impairment.
There is limited data in the elderly, betahistine should be used with caution in this population.
Children and adolescents:
Betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.
Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension.
Also contraindicated are the following:
• hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the occasional dyspepsia encountered in patients on betahistine.
Clinical intolerance to Betahistine may occur in bronchial asthma patients (see section 4.5 and 4.8) – These patients should therefore be monitored carefully during the treatment with betahistine.
Caution is advised in prescribing betahistine to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms.
Caution is advised in patients with severe hypotension.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.