Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVASTIGMINEWATERSTOFTARTRAAT 2,4 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 1,5 mg/stuk
Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus D24 PPT3 DUBLIN 24 (IERLAND)
N06DA03
RIVASTIGMINEWATERSTOFTARTRAAT 2,4 mg/stuk SAMENSTELLING overeenkomend met ; RIVASTIGMINE 1,5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (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 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 ZWART (E 172); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZWARTE INKT;
2009-11-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RISTIDIC 1,5 MG, CAPSULE, HARD RISTIDIC 3,0 MG, CAPSULE, HARD RISTIDIC 4,5 MG, CAPSULE, HARD RISTIDIC 6,0 MG, CAPSULE, HARD 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. Do not pass it on to others. It may harm them, even if their 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 LEAFLET: 1. What Ristidic is and what it is used for 2. What you need to know before you take Ristidic 3. How to take Ristidic 4. Possible side effects 5. How to store Ristidic 6. Content of the pack and other information 1. WHAT RISTIDIC IS AND WHAT IT IS USED FOR The active substance of Ristidic 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, Ristidic 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. Ristidic 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 behaviour. The capsules can also be used for the treatment of dementia in adult patients with Parkinson’s disease. 2. WHAT YO Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL PRODUCT Ristidic 1.5 mg hard capsules Ristidic 3.0 mg hard capsules Ristidic 4.5 mg hard capsules Ristidic 6.0 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg. Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3.0 mg. Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg. Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6.0 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Ristidic 1.5 mg hard capsules, are yellow/yellow hard gelatine capsule imprinted with “RIVA 1.5mg” on body with black ink containing white to off-white granular powder of 1.5 mg of rivastigmine. Ristidic 3.0 mg hard capsules, are light orange/ light orange hard gelatine capsule imprinted with “RIVA 3mg” on body with black ink containing white to off-white granular powder of 3.0 mg of rivastigmine Ristidic 4.5 mg hard capsules, are caramel/caramel hard gelatine capsule imprinted with “RIVA 4.5mg” on body with black ink containing white to off-white granular powder of 4.5 mg of rivastigmine. Ristidic 6.0 mg hard capsules, are light orange/caramel hard gelatine capsule imprinted with “RIVA 6mg” on body with black ink containing white to off-white granular powder of 6.0 mg of rivastigmine. 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 2 only be started if a caregiver is Perskaitykite visą dokumentą