Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE
Easypharm Generika GmbH Millenium Tower, Handelskai 94-96 1200 WIEN (OOSTENRIJK)
N06DX01
MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Memantine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2013-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE EASYPHARM 10 MG, TABLETTEN MEMANTINE EASYPHARM 20 MG, TABLETTEN memantine hydrochloride 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 easypharm is and what it is used for 2. What you need to know before you take Memantine easypharm 3. How to take Memantine easypharm 4. Possible side effects 5. How to store Memantine easypharm 6. Contents of the pack and other information 1. WHAT MEMANTINE EASYPHARM IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE EASYPHARM WORK Memantine easypharm 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 easypharm belongs to a group of medicines called NMDA- receptor antagonists. Memantine easypharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE EASYPHARM USED FOR Memantine easypharm is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE EASYPHARM DO NOT TAKE MEMANTINE EASYPHARM if you are ALLERGIC TO MEMANTINE HYDROCHLORIDE OR ANY OF THE OTHER INGREDIENTS of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Memantine easypharm. Take special care with Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Memantine easypharm 10 mg, tabletten Memantine easypharm 20 mg, tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Excipient(s) with known effect: each tablet contains 144.32 mg lactose (as monohydrate). Each 20 mg film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipient(s) with known effect: each tablet contains 288.63 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, film-coated, round (8 mm) biconvex tablets, scored with a wide pressure-sensitive division mark on one side and debossed with ‘M9MN’ and ‘10’ on the other side. The tablet can be divided into equal doses. Pink, film-coated, oval (13.5 x 6.6 mm) biconvex tablets, scored with a wide pressure-sensitive division mark on one side and debossed with ‘M9MN 20’ on the 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. Discontinuati Olvassa el a teljes dokumentumot