Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
BETAHISTINE DIHYDROCHLORIDE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
N07CA01
BETAHISTINE DIHYDROCHLORIDE 8 mg
TABLET
BETAHISTINE DIHYDROCHLORIDE 8 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2006-05-23
PACKAGE LEAFLET: INFORMATION FOR THE USER BETASERC 8 MG TABLETS BETASERC 16 MG TABLETS BETASERC 24 MG 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 signs of illness 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 Betaserc is and what it is used for 2. What you need to know before you use Betaserc 3. How to use Betaserc 4. Possible side effects 5. How to store Betaserc 6. Contents of the pack and other information 1. WHAT BETASERC IS AND WHAT IT IS USED FOR The group of medicines, to which Betaserc belongs, are medicines for the treatment of dizziness. Betaserc is used in Ménière’s disease. The symptoms of this are: • feeling dizzy and feeling or being sick • ringing in the ears • hearing loss or hearing problems. Feeling dizzy – caused when the part of your inner ear which controls your balance is not working properly (called “vestibular vertigo”). HOW BETASERC WORKS The mechanism of action of Betaserc is only partially known. Research shows that Betaserc can prevent an attack of Meniere’s disease or reduce the severity of attacks. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETASERC DO NOT TAKE BETASERC : • if you are allergic (hypersensitive) to betahistine (dichloride) or any of the ingredients of Betaserc (see section 6). • if you have pheochromocytoma (a rare adrenal gland disorder). Do not take this medicine if any of the above points apply to you. If you are not sure, ask your doctor or pharmacist for advice before taking Betaserc. WARNINGS AND PRECAUTIONS. Please note the following points befor Đọc toàn bộ tài liệu
Page 1 of 7 _SUMMARY OF PRODUCT CHARACTERISTICS _ 1. NAME OF THE MEDICINAL PRODUCT Betaserc ® 8 mg tablets Betaserc ® 16 mg tablets Betaserc ® 24 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betaserc ® tablets contain 8, 16 or 24 mg betahistine dihydrochloride equivalent to 5.21, 10.42 or 15.63 mg betahistine. For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Betaserc ® tablet, 8 mg: A round, flat, white to almost white tablet with bevelled edges. The diameter is 7 mm; the tablet weight is about 125 mg. The inscription is 256 on one tablet-side Betaserc ® tablet, 16 mg: A round, biconvex, scored, white to almost white tablet with bevelled edges. The diameter is 8.5 mm; the tablet weight is about 250 mg. The inscription is 267 on either side of the score on one tablet-side. _ _ The tablet can be divided into equal halves Betaserc ® tablet, 24 mg: A round, biconvex, scored, white to almost white tablet with bevelled edges and relevant inscriptions. The diameter is 10 mm; the tablet weight is about 375 mg. The inscription is 289 on either side of the score on one tablet-side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ménière's Syndrome as defined by the following triad of core symptoms: - vertigo (with nausea/vomiting) - hearing loss (hardness of hearing) - tinnitus Symptomatic treatment of vestibular vertigo. Page 2 of 7 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Betaserc ® tablets 8mg/ Betaserc ® tablets 16 mg: The dosage for adults is 24-48 mg divided over the day. _8 mg tablets _ _16 mg tablets _ 1-2 tablets 3 times/day 1/2-1 tablet 3 times/day Betaserc ® tablets 24mg: The dosage for adults is 48mg divided over the day. _24 mg tablets_ 1 tablet 2 times/day The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. Đọc toàn bộ tài liệu