البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
Azure Pharmaceuticals Ltd
N07CA01
Betahistine dihydrochloride
Tablet
betahistine
Not 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 24 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 24 mg betahistine dihydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round, biconvex, scored tablet debossed '24/B' on one side and plain on other side with a diameter of 10 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine dihydrochloride 24 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 starting dose of betahistine is 8 to 16 mg, three times daily, taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. The 24 mg tablet can be used for twice daily dosing in patients requiring 48 mg of betahistine per day. For a lower total daily dose and for three times daily dosing lower strength tablets are available. _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 اقرأ الوثيقة كاملة