Country: Malta
Language: English
Source: Medicines Authority
BETAHISTINE DIHYDROCHLORIDE
Actavis Group h.f. Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland
N07CA01
BETAHISTINE DIHYDROCHLORIDE 16 mg
TABLET
BETAHISTINE DIHYDROCHLORIDE 16 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2006-08-03
BETAHISTIN ACTAVIS Betahistine dihydrochloride, 8mg & 16mg tablets PACKAGE LEAFLET: INFORMATION FOR THE USER 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What betahistine is and what it is used for 2. Before you take betahistine 3. How to take betahistine 4. Possible side effects 5. How to store betahistine 6. Further information 1. WHAT BETAHISTINE IS AND WHAT IT IS USED FOR Betahistine is a medicine that is used to treat symptoms of Ménière’s syndrome such as dizziness, ringing in the ears, loss of hearing and nausea. 2. BEFORE YOU TAKE BETAHISTINE DO NOT USE BETAHISTINE • if you are allergic (hypersensitive) to betahistine or to any of the other components of the tablet (see also section 6 “Further information”) • if you have a phaeochromocytoma, a rare tumour of the adrenal gland • if you are under the age of 18 • if you are breast-feeding (see also the section on “Pregnancy and breast- feeding”). TAKE SPECIAL CARE WITH BETAHISTINE • if you suffer or if you have suffered from a stomach ulcer (peptic ulcer) • if you suffer from asthma • if you are suffering from nettle rash, skin rash or a cold in the nose caused by an allergy, since these complaints may be exacerbated • if you have low blood pressure. If you suffer from any of the above conditions, consult your doctor about whether you may take betahistine. The above group Read the complete document
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Betahistin Actavis 16mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 16 mg Betahistine dihydrochloride One tablet contains 140 mg lactose monohydrate. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White or almost white round tablet. Embossed B16 on one side, scored reverse. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine is indicated for the treatment of Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage _ Adults (including the elderly): Initial oral treatment is 8 to 16 mg three times daily, taken with food. Maintenance doses are generally in the range of 24 - 48 mg daily. Dosage can be adjusted to suit individual patient needs. Sometimes improvement can be observed after only a couple of weeks of treatment. Children and adolescents: Betahistine tablets are not recommended for use in children and adolescents below the age of 18 years due to lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS Page 2 of 5 Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension. Also contraindicated in the cases of: • hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised in the Read the complete document