Država: Nizozemska
Jezik: nizozemski
Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVASTIGMINEWATERSTOFTARTRAAT 3,199 mg/ml SAMENSTELLING overeenkomend met ; RIVASTIGMINE 2 mg/ml
Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)
N06DA03
RIVASTIGMINEWATERSTOFTARTRAAT 3,199 mg/ml SAMENSTELLING overeenkomend met ; RIVASTIGMINE 2 mg/ml
Drank
CHINOLINEGEEL (E 104) ; CITROENZUUR 0-WATER (E 330) ; NATRIUMBENZOAAT (E 211) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD,
Oraal gebruik
Rivastigmine
Hulpstoffen: CHINOLINEGEEL (E 104); CITROENZUUR 0-WATER (E 330); NATRIUMBENZOAAT (E 211); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD;
2010-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE DEMO 2 MG/ML, DRANK 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, Balaxon 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 oral solution can also be used for the treatment of dementia in adult patients with Parkinson’s disease. 2. WHAT YOU NEED TO K Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine DEMO 2 mg/ml, drank 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, yellow solution. pH 3.5-4.5 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 by the patient. Posology Rivastigmine oral solution should be administered twice a day, with morning and evening meals. The prescribed amount of solution should be withdrawn from the container using the oral dosing syringe supplied. Rivastigmine oral solution may be swallowed directly from the syringe. Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses. _Initial dose _ 1.5 mg twice a day. _Dose titration _ The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level. If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson’s disease are observed du Pročitajte cijeli dokument