Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
memantine hydrochloride
Ratiopharm GmbH
N06DX01
memantine
Psychoanaleptics,
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer’s disease
Revision: 8
Authorised
2013-06-12
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEMANTINE RATIOPHARM 10 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 Memantine ratiopharm is and what it is used for 2. What you need to know before you take Memantine ratiopharm 3. How to take Memantine ratiopharm 4. Possible side effects 5. How to store Memantine ratiopharm 6. Contents of the pack and other information 1. WHAT MEMANTINE RATIOPHARM IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE RATIOPHARM WORK Memantine ratiopharm contains the active substance memantine hydrochloride. It 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE RATIOPHARM USED FOR Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE RATIOPHARM DO NOT TAKE MEMANTINE RATIOPHARM ● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTION Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 10 mg Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Memantine ratiopharm 20 mg Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipients with known effect: Memantine ratiopharm 10 mg Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet). Memantine ratiopharm 20 mg Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Memantine ratiopharm 10 mg White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side. The tablet can be divided into equal doses. Memantine ratiopharm 20 mg White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult 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. 3 Posology 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. Maintenanc Pročitajte cijeli dokument