Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N06DX01
MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 3000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Memantine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 3000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2013-07-02
Sandoz B.V. Page 1/9 Memantine Sandoz 10 mg/ 20 mg, filmomhulde tabletten RVG 112082, 12083 1313-v7 1.3.1.3 Bijsluiter februari 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEMANTINE SANDOZ 10 MG, FILMOMHULDE TABLETTEN MEMANTINE SANDOZ 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 [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [ NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR _ _ HOW DOES [NATIONALLY COMPLETED NAME] WORK [Nationally completed name] 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. [Nationally completed name] belongs to a group of medicines called NMDA-receptor antagonists. [Nationally completed name] acts on these NMDA- receptors improving the transmission of nerve signals and the memory. WHAT IS [NATIONALLY COMPLETED NAME] USED FOR [Nationally completed] name is used for the treatment of patients with moderate to severe Alzheimer’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] _ _ DO NO Olvassa el a teljes dokumentumot
Sandoz B.V. Page 1/12 Memantine Sandoz 10 mg/ 20 mg, filmomhulde tabletten RVG 112082, 12083 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken februari 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Memantine Sandoz 10 mg, filmomhulde tabletten Memantine Sandoz 20 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of memantine hydrochloride which is equivalent to 8.31 mg of memantine. Excipients with known effect Each tablet contains 126 mg of lactose (as monohydrate). Each tablet contains 20 mg of memantine hydrochloride which is equivalent to 16.62 mg of memantine. Excipients with known effect Each tablet contains 230.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM FILM-COATED TABLET _10 mg film-coated tablets: _ White, oval shape (6.1 x 11.6 mm) with a breaking line on both sides. The tablet can be divided into equal doses. _20 mg film-coated tablets: _ Brown-red, of round shape (diameter 11.1 mm) with two crossed breaking lines on one side. The tablet can be divided into equal quarters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with moderate to severe Alzheimer's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/12 Memantine Sandoz 10 mg/ 20 mg, filmomhulde tabletten RVG 112082, 12083 1311-v3 1.3.1.1 Samenvatting van de Productkenmerken februari 2020 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 regul Olvassa el a teljes dokumentumot