Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
N06DX01
MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Memantine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2013-11-11
PACKAGE LEAFLET: INFORMATION FOR THE USER MARBODIN 20 MG FILMOMHULDE TABLETTEN 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 __ is and what it is used for 2. What you need to know before you take _ Đọc toàn bộ tài liệu_ 3. How to take _ _ 4. Possible side effects 5. How to store _ _ 6. Contents of the pack and other information 1. WHAT _ _ IS AND WHAT IT IS USED FOR HOW DOES _ _ WORK _ _ 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. _ _ belongs to a group of medicines called NMDA-receptor antagonists. _ _ acts on these NMDA- receptors improving the transmission of nerve signals and the memory. WHAT IS _ _ USED FOR _ _ is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ _ DO NOT TAKE _ _ • 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 _ ._ • if you have a history of epileptic seizures • if you have recently experienced a myocardia
_Ver. 03 _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Marbodin 20 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Pink, oval, biconvex, 13.5 mm – 7.3 mm, film-coated tablets. 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. For up-titration other tablet strengths are available. Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day for 7 days. Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days. _Ver. 03 _ Week 3 (day 15-21): The patient should take one 15 mg film Đọc toàn bộ tài liệu