国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
memantine hydrochloride
Merz Pharmaceuticals GmbH
N06DX01
memantine hydrochloride
Other anti-dementia drugs
Alzheimer Disease
Treatment of patients with moderate to severe Alzheimer’s disease.
Revision: 7
Authorised
2012-11-22
69 B. PACKAGE LEAFLET 70 PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE MERZ 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 Merz is and what it is used for 2. What you need to know before you take Memantine Merz 3. How to take Memantine Merz 4. Possible side effects 5. How to store Memantine Merz 6. Content of the pack and other information 1. WHAT MEMANTINE MERZ IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE MERZ WORK Memantine Merz contains the active substance memantine hydrochloride. Memantine Merz 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 Merz belongs to a group of medicines called NMDA-receptor antagonists. Memantine Merz acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE MERZ USED FOR Memantine Merz is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE MERZ DO NOT TAKE MEMANTINE MERZ - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Memantine Merz tablets (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Memantine Merz - if 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Memantine Merz 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. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" 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. 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 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) per day for 7 days. Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per d 完全なドキュメントを読む