Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE 5 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 4,15 mg/stuk
Medochemie Limited Constantinopelstreet 1-10 3011 LIMASSOL (CYPRUS)
N06DX01
MEMANTINEHYDROCHLORIDE 5 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 4,15 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Memantine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MANTOMED 5 MG, FILMOMHULDE TABLETTEN MANTOMED 10 MG, FILMOMHULDE TABLETTEN MANTOMED 15 MG, FILMOMHULDE TABLETTEN MANTOMED 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 Mantomed is and what it is used for 2. What you need to know before you take Mantomed 3. How to take Mantomed 4. Possible side effects 5. How to store Mantomed 6. Contents of the pack and other information 1. WHAT MANTOMED IS AND WHAT IT IS USED FOR Mantomed 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 belongs to a group of medicines called NMDAreceptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Mantomed is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANTOMED DO NOT TAKE MANTOMED: • 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 Mantomed • if you have a history of epileptic seizures • if you have recently exp Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mantomed 5 mg, filmomhulde tabletten Mantomed 10 mg, filmomhulde tabletten Mantomed 15 mg, filmomhulde tabletten Mantomed 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 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. The 5 mg film-coated tablets are: yellow, round, biconvex film coated tablets with diameter of nucleus 6mm. The 10 mg film-coated tablets are: yellow, oblong, biconvex, scored on both side film coated tablets with dimensions of nucleus 5.6x11.1mm. The tablet can be divided into equal doses. The 15 mg film-coated tablets are: pink, round, biconvex film coated tablets, with diameter of nucleus 9.5mm The 20 mg film-coated tablets are: yellow, round, biconvex film coated tablets with diameter of nucleus 10.3mm 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. 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 cl Baca dokumen lengkapnya