Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Accord-UK Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5055565700365
PACKAGE LEAFLET: INFORMATION FOR THE USER BETAHISTINE DIHYDROCHLORIDE 8 MG TABLETS BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS Betahistine dihydrochloride 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, pharmacist or nurse. 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Betahistine dihydrochloride tablets is and what it is used for 2. What you need to know before you take Betahistine dihydrochloride tablets 3. How to take Betahistine dihydrochloride tablets 4. Possible side effects 5. How to store Betahistine dihydrochloride tablets 6. Contents of the pack and other information 1. WHAT BETAHISTINE DIHYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR Betahistine is a histamine analogue medicine that is used to treat symptoms of Ménière’s syndrome such as dizziness (vertigo) , ringing in the ears (tinnitus), loss of hearing and nausea. This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS: If you are allergic (hypersensitive) to betahistine dihydrochloride or any of the other ingredients of Betahistine dihydrochloride tablets (see section 6, Contents of the pack and other information). if you have high blood pressure due to adrenal tumour (phaeochromocytoma), a rare tumour of the adrenal gland. WARNING AND PRECAUTIONS if have a stomach ulcer (peptic ulcer) if you have asthma if you have nettle rash, skin rash or a cold in the nose caused by an allergy, si Izlasiet visu dokumentu
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 Izlasiet visu dokumentu