Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Sandoz Ltd
N07CA01
Betahistine dihydrochloride
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
PACKAGE LEAFLET: INFORMATION FOR THE USER BETAHISTINE DIHYDROCHLORIDE 8MG AND 16MG 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 or pharmacist. • This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Betahistine 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 These tablets contain Betahistine dihydrochloride. They are used to treat vertigo, tinnitus (ringing in the ears) and hearing loss associated with Meniere’s disease. They work by reducing the pressure in your inner ear. 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 d ihydrochloride Tablets (listed in section 6). The symptoms of an allergic reaction include itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids • if you have a phaeochromocytoma ( high blood pressure due to adrenal tumour). I f you think any of the above points apply to you, do not take the tablets. Talk to your doctor first and follow the advice given. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Betahistine tablets • if you have a stomach ulcer Lestu allt skjalið
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 Lestu allt skjalið