מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
rivastigmine
Krka, d.d., Novo mesto
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: 10
Authorised
2009-05-11
68 B. PACKAGE LEAFLET 69 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NIMVASTID 1.5 MG HARD CAPSULES NIMVASTID 3 MG HARD CAPSULES NIMVASTID 4.5 MG HARD CAPSULES NIMVASTID 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 or pharmacist. - 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 Nimvastid is and what it is used for 2. What you need to know before you take Nimvastid 3. How to take Nimvastid 4. Possible side effects 5. How to store Nimvastid 6. Contents of the pack and other information 1. WHAT NIMVASTID IS AND WHAT IT IS USED FOR The active substance of Nimvastid 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, Nimvastid 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. Nimvastid 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 orodispersible tablets can also be used for the treatment of dementia in a קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nimvastid 1.5 mg hard capsules Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine. Nimvastid 3 mg hard capsules Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine. Nimvastid 4.5 mg hard capsules Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine. Nimvastid 6 mg hard capsules Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Nimvastid 1.5 mg hard capsules White to almost white powder in a capsule with yellow cap and yellow body. Nimvastid 3 mg hard capsules White to almost white powder in a capsule with orange cap and orange body. Nimvastid 4.5 mg hard capsules White to almost white powder in a capsule with brownish red cap and brownish red body. Nimvastid 6 mg hard capsules White to almost white powder in a capsule with a brownish red cap and orange 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. 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. 3 Posology Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swall קרא את המסמך השלם