Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
rivastigmine
Teva Pharma B.V.
N06DA03
rivastigmine
Anticholinesterases
Dementia; Alzheimer Disease; Parkinson Disease
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.
Revision: 4
Withdrawn
2009-04-17
B. PACKAGE LEAFLET 78 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE TEVA 1.5 MG HARD CAPSULES RIVASTIGMINE TEVA 3 MG HARD CAPSULES RIVASTIGMINE TEVA 4.5 MG HARD CAPSULES RIVASTIGMINE TEVA 6 MG HARD CAPSULES Rivastigmine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Rivastigmine Teva is and what it is used for 2. Before you take Rivastigmine Teva 3. How to take Rivastigmine Teva 4. Possible side effects 5. How to store Rivastigmine Teva 6. Further information 1. WHAT RIVASTIGMINE TEVA IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Teva is rivastigmine Rivastigmine belongs to a class of substances called cholinesterase inhibitors. Rivastigmine Teva is used for the treatment of memory disorders in patients with Alzheimer’s disease. It is also used for the treatment of dementia in patients with Parkinson’s disease. 2. BEFORE YOU TAKE RIVASTIGMINE TEVA DO NOT TAKE RIVASTIGMINE TEVA - If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva) or to any of the other ingredients of Rivastigmine Teva listed in section 6 of this leaflet - If this applies to you, tell your doctor and do not take Rivastigmine Teva. TAKE SPECIAL CARE WITH RIVASTIGMINE TEVA - if you have, or have ever had, irregular heartbeat. - if you have, or have ever had, an active stomach ulcer. - if you have, or have ever had, difficulties in passing urine. - if you have, or have ever had, seizures. - if you have, or have ever had, asthma or severe respiratory disease. - if you have, or have ever had, Preberite celoten dokument
_ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 1.5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule White cap imprinted with “R” & white body imprinted with “1.5” 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. Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole. Initial dose: 1.5 mg twice a day. Dose titration The starting dose is 1.5 mg twice a day. If the 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 during treatment, these may respond to omitting one or more doses. If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tol Preberite celoten dokument