Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Waymade Healthcare Plc
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Betahistine if you have asthma if you have a stomach ulcer. OTHER MEDICINES AND BETAHISTINE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. antihistamines to treat allergies and hay fever monoamine-oxidase inhibitors (MAOI's) to treat depression and Parkinson's disease. BETAHISTINE WITH FOOD AND DRINK Swallow the tablets whole with a drink of water and take with meals. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not breast-feed while taking Betahistine unless your doctor tells you to. It is not known if Betahistine passes into breast milk. DRIVING AND USING MACHINERY There are no known effects of this medicine on your ability to drive or use machinery. However, vertigo, tinnitus and hearing loss associated with Ménière's disease can make you feel dizzy or be sick, and may affect your ability to drive or use machinery. BETAHISTINE CONTAINS LACTOSE These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. 3. HOW TO TAKE BETAHISTINE Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. PACKAGE LEAFLET: INFORMATION FOR THE USER Betahistine dihydrochloride Betahistine dihydrochloride 8mg and 16mg Tablets READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours If you get any side effects, ta read_full_document
PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 16mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16mg of betahistine dihydrochloride. One Betahistine dihydrochloride 16mg Tablet contains 140mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, circular, flat bevelled-edge uncoated tablets, impressed B16 on one face with a score line on the reverse. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Betahistine tablets are indicated in the treatment of vertigo, tinnitus and hearing loss associated with Ménière's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _ _Initial dosage:_ 1 tablet, 3 times daily, preferably with food. _Maintenance dose:_ The dose may be adjusted according to response to a maintenance dose of between 24 and 48mg daily. _Elderly:_ No adjustment in dosage is necessary. _Paediatric population: _Betahistine is not recommended for use in children below 18 years due to insufficient data on safety and efficacy. _Renal impairmen_t: 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. For oral use. Betahistine dihydrochloride tablets should be taken with a glass of water, preferably with food. 4.3 CONTRAINDICATIONS Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumour resulting in severe hypertension. Hypersensitivity to betahistine dihydrochloride or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Betahistine tablets should be administered with caution in patients with a history of peptic ulcer. Clinical intolerance to betahistine has been demonstr read_full_document