Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
MEMANTINE HYDROCHLORIDE
Ranbaxy Ireland Limited
N06DX01
MEMANTINE HYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other anti-dementia drugs
Authorised
2013-09-27
MEMANTINE 10 MG PIL PI SIZE : 140 X 400 MM MARKET : IRELAND RLL/PKGDEV : AK21/08/13-V01, CG23/08/13-V02, AK24/08/13-V03 J23/09/13-V04 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. WHAT IS IN THIS LEAFLET 1. What Memantine 10mg film-coated Tablets is and what it is used for 2. What you need to know before you take Memantine 10mg film-coated Tablets 3. How to take Memantine 10mg film-coated Tablets 4. Possible side effects 5. How to store Memantine 10mg film-coated Tablets 6. Contents of the pack and other information. 1. WHAT MEMANTINE 10MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE10MG FILM-COATED TABLETS WORK Memantine 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 brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantineacts on these NMDA-receptors improving the transmission of nerve signals and the me Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine 10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. Memantine 10 mg film coated tablets are: White to off white, capsule shaped , about 11.00 ± 0.5 mm long, 5.50 ± 0.5 mm wide, 3.95 ± 0.5 mm thick, film coated tablets, debossed with “M” and “12” on either side of breakline on one side and plain on other side. 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. Memantine 10mg Film-Coated Tablets should be administered Baca dokumen lengkapnya