Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVASTIGMINEWATERSTOFTARTRAAT 4,8 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 3 mg/stuk
Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)
N06DA03
RIVASTIGMINEWATERSTOFTARTRAAT 4,8 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 3 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Rivastigmine
Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); GELATINE (E 441); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZWARTE INKT;
2010-04-20
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE DEMO 1.5 MG HARD CAPSULES RIVASTIGMINE DEMO 3.0 MG HARD CAPSULES, RIVASTIGMINE DEMO 4.5 MG HARD CAPSULES RIVASTIGMINE DEMO 6.0 MG HARD CAPSULES Rivastigmine 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rivastigmine DEMO is and what it is used for 2. What you need to know before you take Rivastigmine DEMO 3. How to take Rivastigmine DEMO 4. Possible side effects 5. How to store Rivastigmine DEMO 6. Contents of the pack and other information 1. WHAT RIVASTIGMINE DEMO IS AND WHAT IT IS USED FOR The active substance of Rivastigmine DEMO is rivastigmine. Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease. Rivastigmine DEMO is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behavior. The capsules and Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine DEMO 1.5 mg hard capsules Rivastigmine DEMO 3.0 mg hard capsules Rivastigmine DEMO 4.5 mg hard capsules Rivastigmine DEMO 6.0 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule 1.5 mg hard capsules Hard gelatin capsule, with a yellow coloured body and a yellow coloured cap. The cap is imprinted radially with “R9VS” above “1.5” in black ink. 3.0 mg hard capsules Hard gelatin capsule, with a yellow coloured body and a orange coloured cap. The cap is imprinted radially with “R9VS” above “3” in black ink. 4.5 mg hard capsules Hard gelatin capsule, with a red coloured body and a red coloured cap. The cap is imprinted radially with “R9VS” above “4.5” in black ink. 6.0 mg hard capsules Hard gelatin capsule, with a yellow coloured body and a red coloured cap. The cap is imprinted radially with “R9VS" above "6" in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’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 or dementia associated with Parkinson’s disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product Lire le document complet