Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
MEMANTINE HYDROCHLORIDE
Teva Pharma B.V.
N06DX01
MEMANTINE HYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other anti-dementia drugs
Authorised
2014-03-07
PRODUCT : AMENDS: APPROVAL: • SUBJECT TO REG. AGENCY APPROVAL • APPROVED BY REG. DEPT. FOR PRINT DESIGN DEPARTMENT Harlow Signed Signed 32540 MEMANTINE T EVA 10MG FC T ABS ALL TEI (TPW) 31-1-14 160 x 380mm 1 31-1-14 WA WA Leafl et CUTTER GUIDE PMS PROCESS BLACK PMS GREEN INDESIGN CS6 Last amend: - SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered. The only exceptions to this are: bleeds, chokes, spreads or other adjustments required for print reproduction purposes only . If you have any diffi culties please contact the T eva Artwork T eam. W e must receive a copy of the 3rd Party V endors Proof before fi nal approval can be made. Body: Univers 55 Roman/ 65 Bold/ 55 Oblique 9pts Subhead: Univers 65 Bld 11pts Header: Univers 65 Bld 13pts MEMANTINE TEVA 10 MG FILM-COATED TABLETS MEMANTINE HYDROCHLORIDE PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 leafl et. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT MEMANTINE TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE TEVA 3. HOW TO TAKE MEMANTINE TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MEMANTINE TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT MEMANTINE TEVA IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE TEVA WORK Memantine Teva belongs to a group of medicines known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brai Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine Teva 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet The 10 mg film-coated tablets are white to off-white, oval shaped film coated tablets, approximately 9.1 mm x 4.6 mm. On one side debossed with "M" on either side of the score, and on the other side with "1" on the left side of the score and with “0” on the right. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with moderate to severe Alzheimer’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidelines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. Posology Adults: Dose titration The maximum daily Прочитайте повний документ