Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Arrow Generics Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
NO ARTWORK SUBMITTED TEXT APPROVED BETAHISTINE DIHYDROCHLORIDE 8MG AND 16MG TABLETS • Please read this leaflet carefully before you start to take your medicine. • It gives you important information about your medicine. • If you want to know more, or you are not sure about anything, ask your pharmacist or doctor. • Keep the leaflet until you have finished the medicine. WHAT'S IN YOUR MEDICINE Betahistine dihydrochloride tablets come in two strengths. Each tablet contains either 8mg or 16mg of the active ingredient Betahistine dihydrochloride. The tablets also contain: povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid. Betahistine dihydrochloride tablets are available in pack sizes of: 60, 84, 168* _only marketed pack size will appear _ Your tablets are manufactured by Catalent Germany Schorndorf GmbH, Steinbeisstrasse 1-2, 73614 Schorndorf, Germany. The Marketing Authorisation holder is Accord-UK Limited, Barnstaple, EX32 8NS, UK. ABOUT YOUR MEDICINE Betahistine is one of a class of medicines known as ‘antivertigo preparations’. It works by improving blood flow to the inner ear, which reduces the build up of pressure. It is this pressure within the ear which is thought to cause the vertigo (dizziness), tinnitus (ringing in the ears) and hearing loss suffered by people with Ménière’s disease. BEFORE TAKING YOUR MEDICINE DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS IF: • you know, or have been told that you are hypersensative (allergic) to betahistine dihydrochloride or any of the ingredients of betahistine dihydrochloride tablets • your doctor has told you that you have phaeochromocytoma (high blood pressure caused by an adrenal tumour) • you are breast-feeding TAKE SPECIAL CARE WITH BETAHISTINE DIHYDROCHLORIDE TABLETS IF: • you have a stomach ulcer (peptic ulcer), or have suffered from one in the past • you have, or used to have, asthma • you suffer from skin rashes • you suffer from severe low blood pressure (faint Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine Dihydrochloride 16mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Betahistine dihydrochloride 16mg Excipient(s) with known effect: Each tablet contains 100 mg lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets for oral administration. Flat white tablets, with bevelled edge. Markings: R4 on one side scoreline on the reverse. 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 is indicated for the treatment of vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Adults _(including the elderly);_ Initially two tablets three times daily, taken preferably with meals. Maintenance doses are generally in the range 24-48mg daily. 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 post-marketing experience no dose adjustment appears to be necessary. 4.3 CONTRAINDICATIONS Betahistine is contraindicated in patients with a phaeochromocytoma and hypersensitivity to betahistine dihydrochloride or any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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 s Soma hati kamili