国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Teva UK Ltd
N07CA01
Betahistine dihydrochloride
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5017007301042 5020220270477
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 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine Dihydrochloride 8mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Betahistine dihydrochloride 8 mg Excipient(s) with known effect: Each tablet contains 50 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: R3 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 16mg 3 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. METHOD OF ADMINISTRATION: Swallow the tablet with water. 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 dihydrochlo 阅读完整的文件