Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Teva UK Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5017007300984
The name of your medicine is Betahistine Dihydrochloride Tablets, which will be called Betahistine Tablets throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms 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. 1. WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE BETAHISTINE TABLETS 3. HOW TO TAKE BETAHISTINE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BETAHISTINE TABLETS 6. FURTHER INFORMATION WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR Betahistine Tablets contain 8 mg or 16 mg of the active ingredient betahistine dihydrochloride. Betahistine Tablets belong to a group of medicines known as histamine analogues, which means it closely resembles histamine – a chemical found naturally in the body. Betahistine works by improving blood flow in the inner ear, which reduces the build up of pressure. It is this pressure in the ear that causes vertigo (dizziness), tinnitus (ringing in the ears), and hearing loss suffered by people with Ménière's disease. BEFORE YOU TAKE BETAHISTINE TABLETS DO NOT TAKE BETAHISTINE TABLETS IF YOU: • are allergic (hypersensitive) to betahistine or any of the other ingredients of Betahistine Tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. • have a phaeochromocytoma (a very rare tumour of the adrenal gland). TAKE SPECIAL CARE WITH BETAHISTINE TABLETS IF YOU HAVE: • had a peptic ulcer. Your doctor will monitor you closely during your treatment. • asthma. Your doctor will monitor you closely during your treatment. TAK Прочитайте повний документ
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 Прочитайте повний документ