Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
memantine hydrochloride
Accord Healthcare S.L.U.
N06DX01
memantine
Other anti-dementia drugs
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer’s disease.
Revision: 7
Authorised
2013-12-03
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Memantine Accord 3. How to take Memantine Accord 4. Possible side effects 5. How to store Memantine Accord 6. Contents of the pack and other information 1. WHAT MEMANTINE ACCORD IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE ACCORD WORK Memantine Accord contains the active substance memantine hydrochloride. Memantine Accordbelongs 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 Accord belongs to a group of medicines called NMDA-receptor antagonists. Memantine Accord acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE ACCORD USED FOR Memantine Accordis used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE ACCORD DO NOT TAKE MEMANTINE ACCORD: - 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 Accor Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Memantine Accord 10 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. Excipientwith known effect: each film coated tablet contains 183.13 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and "10" divided by the score 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 _ _ Posology 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. _Adults _ Dose titration The maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg Lesen Sie das vollständige Dokument