Երկիր: Եվրոպական Միություն
Լեզու: անգլերեն
Աղբյուրը: EMA (European Medicines Agency)
memantine hydrochloride
Mylan Pharmaceuticals Limited
N06DX01
memantine
Other anti-dementia drugs, Psychoanaleptics,
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer’s disease.
Revision: 10
Authorised
2013-04-21
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEMANTINE MYLAN 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 Mylan is and what it is used for 2. What you need to know before you take Memantine Mylan 3. How to take Memantine Mylan 4. Possible side effects 5. How to store Memantine Mylan 6. Contents of the pack and other information 1. WHAT MEMANTINE MYLAN IS AND WHAT IT IS USED FOR Memantine Mylan contains the active substance memantine. 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 Mylan belongs to a group of medicines called NMDA-receptor antagonists. Memantine Mylan acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Memantine Mylan is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE MYLAN DO NOT TAKE MEMANTINE MYLAN: - if you are allergic to memantine 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 Mylan - if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart Կարդացեք ամբողջական փաստաթուղթը
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets Memantine Mylan 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Memantine Mylan 10 mg film-coated tablets A dark yellow film-coated, tapered oblong shaped, biconvex tablet debossed with “ME” on the left of the score and “10” on the right of the score on one side of the tablet and a score on the other side. The tablet can be divided into equal doses. Memantine Mylan 20 mg film-coated tablets A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet and “20” on the other side. 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. 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. 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 p Կարդացեք ամբողջական փաստաթուղթը