Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,3 mg/stuk
Synthon B.V. Microweg 22 6545 CM NIJMEGEN
N06DX01
MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,3 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Memantine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
M1.3.1_03.MMN.hcl.tab.101.04.NL.2697.01 1.3.1 Package Leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER MEMANTINE SYNTHON 10 MG, TABLETTEN MEMANTINE SYNTHON 20 MG, TABLETTEN MEMANTINE SYNTHON 5 MG + 10 MG +15 MG + 20 MG, 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 Memantine Synthon is and what it is used for 2. What you need to know before you take Memantine Synthon 3. How to take Memantine Synthon 4. Possible side effects 5. How to store Memantine Synthon 6. Contents of the pack and other information 1. WHAT MEMANTINE SYNTHON IS AND WHAT IT IS USED FOR HOW DOES MEMANTINE SYNTHON WORK Memantine Synthon 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 Synthon belongs to a group of medicines called NMDA-receptor antagonists. Memantine Synthon acts on these NMDA-receptors improving the transmission of nerve signals and the memory. WHAT IS MEMANTINE SYNTHON USED FOR Memantine Synthon is used for the treatment of patients with moderate to severe Alzheimer’s disease. M1.3.1_03.MMN.hcl.tab.101.04.NL.2697.01 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE SYNTHON DO NOT TAKE MEMANTINE SYNTHON if you are ALLERGIC TO MEMANTINE HY Prečítajte si celý dokument
1/12 M1.3.1_01.MMN.hcl.tab.101.04.NL.2697.01 1 NAME OF THE MEDICINAL PRODUCT Memantine Synthon 10 mg, tabletten Memantine Synthon 20 mg, tabletten Memantine Synthon 5 mg + 10 mg +15 mg + 20 mg, tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Excipient(s) with known effect: each tablet contains 144.32 mg lactose (as monohydrate). Each 20 mg film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipient(s) with known effect: each tablet contains 288.63 mg lactose (as monohydrate). Each 5 mg film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. Excipient(s) with known effect: each tablet contains 72.16 mg lactose (as monohydrate). Each 10 mg film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Excipient(s) with known effect: each tablet contains 144.32 mg lactose (as monohydrate). Each 15 mg film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. Excipient(s) with known effect: each tablet contains 216.48 mg lactose (as monohydrate). Each 20 mg film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. Excipient(s) with known effect: each tablet contains 288.63 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, film-coated, round (8 mm) biconvex tablets, scored with a wide pressure-sensitive division mark on one side and debossed with ‘M9MN’ and ‘10’ on the other side. The tablet can be divided into equal doses. Pink, film-coated, oval (13.5 x 6.6 mm) biconvex tablets, scored with a wide pressure-sensitive division mark on one side and debossed with ‘M9MN 20’ on the other side. The tablet can be divided into equal doses. Yellow, film-coated, oval (8 x 4.5 mm) biconvex tablets, debossed with ‘M9MN 5’ on one side. White, film Prečítajte si celý dokument