Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
Azure Pharmaceuticals Ltd
N07CA01
Betahistine dihydrochloride
Tablet
betahistine
Marketed
2022-01-21
Health Products Regulatory Authority 21 January 2022 CRN009JZY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round, flat, bevel-edged tablet debossed '8' on one side and 'B' on other side with a diameter of 7 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine dihydrochloride 8 mg tablet is indicated for vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly):_ The usual dose is 8 to 16 mg, three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. _Paediatric population:_ Betahistine should not be used in children aged below 18 years due to insufficient data on safety and efficacy. _Elderly:_ 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. Method of administration. Oral use. The tablets should be swallowed without being chewed with a glass of water during meals. 4.3 CONTRAINDICATIONS Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 21 January 2022 CRN009JZY Page 2 of 5 Caution is advised in the treatment of patients with a history of peptic ulcer. Les hele dokumentet