País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
memantine
Actavis Group PTC ehf.
N06DX01
memantine
Psychoanaleptics, , Other anti-dementia drugs
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer’s disease.
Revision: 13
Authorised
2013-04-22
70 B. PACKAGE LEAFLET 71 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEMDATINE 5 MG FILM-COATED TABLETS 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Nemdatine is and what it is used for 2. What you need to know before you take Nemdatine 3. How to take Nemdatine 4. Possible side effects 5. How to store Nemdatine 6. Contents of the pack and other information 1. WHAT NEMDATINE IS AND WHAT IT IS USED FOR HOW DOES NEMDATINE WORK Nemdatine contains the active substance memantine hydrochloride. Nemdatine 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. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS NEMDATINE USED FOR Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEMDATINE DO NOT TAKE NEMDATINE - 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 Nemdatine - if you have a history of epileptic seizures - if you have recently experienced a myocardial infar Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nemdatine 5 mg Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. Nemdatine 10 mg Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Nemdatine 15 mg Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. Nemdatine 20 mg Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipient(s) with known effect: Nemdatine 5 mg film-coated tablets Each film-coated tablet contains 0.47 mg lactose monohydrate. Nemdatine 10 mg film-coated tablets Each film-coated tablet contains 0.95 mg lactose monohydrate. Nemdatine 15 mg film-coated tablets Each film-coated tablet contains 1.42 mg lactose monohydrate. Nemdatine 20 mg film-coated tablets Each film-coated tablet contains 1.89 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Nemdatine 5 mg film-coated tablets White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5” 3 engraved on one side. Nemdatine 10 mg film-coated tablets White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side. The tablet can be divided into equal doses. Nemdatine 15 mg film-coated tablets Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. Nemdatine 20 mg film-coated tablets Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with mo Llegiu el document complet