Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BETAHISTINE DIHYDROCHLORIDE
Abbott Healthcare Products Ltd
BETAHISTINE DIHYDROCHLORIDE
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
BETAHECON® 8MG TABLETS/16MG TABLETS BETAHISTINE DIHYDROCHLORIDE 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 any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Betahecon is and what it is used for 2. Before you take Betahecon 3. How to take Betahecon 4. Possible side effects 5. How to store Betahecon 6. Further information 1. WHAT BETAHECON IS AND WHAT IT IS USED FOR Betahecon contains betahistine dihydrochloride. Betahecon is a type of medicine called a “histamine analogue”. Betahecon is used for: Ménière’s disease – the signs of this include: • feeling dizzy (vertigo), • ringing in the ears (tinnitus) • hearing loss or hearing difficulty Betahecon works by improving blood flow in the inner ear. This lowers the build up of pressure. BEFORE YOU TAKE BETAHECON DO NOT TAKE BETAHECON IF: • you are allergic (hypersensitive) to betahistine or any of the other ingredients in the tablets (see section 6 for further details) • You have high blood pressure due to an adrenal gland tumour (phaeochromocytoma) If any of the above applies to you, do not take this medicine and talk to your doctor. TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF: • you have ever had a stomach ulcer • you have asthma • you are pregnant or planning to become pregnant • you are breast-feeding. If any of the a Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betahecon 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white, round, flat tablet, imprinted ‘256' on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual daily dose is 8 to 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. Paediatric population: Betahecon is 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients Use in phaeochromocytoma 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with bronchial asthma and history of peptic ulcer need to be carefully monitored during the therapy. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/09/2014_ _CRN 2151943_ _page number: 1_ Read the complete document