Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
rivastigmine
Novartis Europharm Limited
N06DA03
rivastigmine
Psychoanaleptics,
Alzheimer Disease; Parkinson Disease; Dementia
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: 46
Authorised
1998-12-03
90 B. PACKAGE LEAFLET 91 PACKAGE LEAFLET: INFORMATION FOR THE USER PROMETAX 1.5 MG HARD CAPSULES PROMETAX 3.0 MG HARD CAPSULES PROMETAX 4.5 MG HARD CAPSULES PROMETAX 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 Prometax is and what it is used for 2. What you need to know before you take Prometax 3. How to take Prometax 4. Possible side effects 5. How to store Prometax 6. Contents of the pack and other information 1. WHAT PROMETAX IS AND WHAT IT IS USED FOR The active substance of Prometax 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, Prometax 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. Prometax 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 and oral solution can also be used for the treatment of dementia in adult patients Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prometax 1.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. Prometax 3.0 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine. Prometax 4.5 mg hard capsules Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. Prometax 6.0 mg hard capsules 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 capsules Prometax 1.5 mg hard capsules Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body. Prometax 3.0 mg hard capsules Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body. Prometax 4.5 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body. Prometax 6.0 mg hard capsules Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body. 3 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 re Lesen Sie das vollständige Dokument