Country: Malta
Language: English
Source: Medicines Authority
betahistine dihydrochloride 8 mg
Abbott Healthcare Products B.V.
N07CA01
betahistine dihydrochloride
tablet
Authorised
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. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your 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 Betaserc is and what it is used for 2. Before you take Betaserc 3. How to use Betaserc 4. Possible side effects 5. How to store Betaserc 6. Further information 1. WHAT BETASERC IS AND WHAT IT IS USED FOR Betaserc contains betahistine. This medicine is called a histamine analogue. This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure. Betaserc is used to treat Ménière’s disease, which mainly shows through: - Dizziness (vertigo) - Ringing in the ears (tinnitus) - Hearing loss Betaserc is also used to treat dizziness caused by malfunction of the balance organ in the inner ear (vestibular vertigo) 2. BEFORE YOU TAKE BETASERC DO NOT TAKE BETASERC IF: - you are allergic to betahistine or any of the ingredients of Betaserc. - you have pheochromocytoma (tumour of adrenal medulla) TAKE SPECIAL CARE WITH BETASERC: - if you suffer from bronchial asthma - if you suffer from peptic ulcer PREGNANCY Consult your doctor or pha Read the complete document
Page 1 of 8 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. 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 Page 2 of 8 4.1 THERAPEUTIC INDICATIONS Ménière's Syndrome as defined by the following trias of core symptoms: - vertigo (with nausea/vomiting) - hearing loss (hardness of hearing) - tinnitus Symptomatic treatment of vestibular vertigo. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Betaserc ® tablets 8mg/ Betaserc ® tablets 16mg: The dosage for adults is 24-48 mg divided over the day. _8 mg tablets _ _16 mg tablets _ 1-2 tablets 3 times Read the complete document