Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
DE Pharmaceuticals
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 Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahistine dihydrochloride 8 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16mg of betahistine dihydrochloride For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Round, biplane white or almost white tablets with bevel-edges on both sides. The tablet is marked with ‘B8’ on one side. 4.1. THERAPEUTIC INDICATIONS Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including elderly):_ Initially 16 mg three times daily, taken preferably with meals. Maintenance doses are generally in the range 24-48 mg 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. _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. ROUTE OF ADMINISTRATION: Oral._ _ 4.3. CONTRAINDICATIONS Phaeochromocytoma. Hypersensitivity to the active substance or to 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 in bronchial asthma patients has been shown in relatively few patients. These patients need to be carefully monitored during the therapy. Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5. INTERACTION WITH OTHER Прочитајте комплетан документ