Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
rivastigmine hydrogen tartrate
Actavis Group PTC ehf
N06DA03
rivastigmine
Psychoanaleptics,
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: 17
Authorised
2011-06-16
49 B. PACKAGE LEAFLET 50 PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE ACTAVIS 1.5 MG HARD CAPSULES RIVASTIGMINE ACTAVIS 3 MG HARD CAPSULES RIVASTIGMINE ACTAVIS 4.5 MG HARD CAPSULES RIVASTIGMINE ACTAVIS 6 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 Actavis is and what it is used for 2. What you need to know before you take Rivastigmine Actavis 3. How to take Rivastigmine Actavis 4. Possible side effects 5. How to store Rivastigmine Actavis 6. Contents of the pack and other information 1. WHAT RIVASTIGMINE ACTAVIS IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Actavis 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 Actavis 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 Actavis is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affec Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rivastigmine Actavis 1.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. Rivastigmine Actavis 3 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine. Rivastigmine Actavis 4.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. Rivastigmine Actavis 6 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (Capsule). Rivastigmine Actavis 1.5 mg hard capsules Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body. Rivastigmine Actavis 3 mg hard capsules Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body. Rivastigmine Actavis 4.5 mg hard capsules Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body. Rivastigmine Actavis 6 mg hard capsules Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body. 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. 3 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. Diagnosi Прочетете целия документ