Pajjiż: Malta
Lingwa: Ingliż
Sors: Malta Medicines Authority
RIVASTIGMINE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06DA03
RIVASTIGMINE 1.5 mg
HARD CAPSULE
RIVASTIGMINE 1.5 mg
POM
PSYCHOANALEPTICS
Authorised
2012-12-05
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE AUROBINDO 1.5 MG CAPSULES, HARD RIVASTIGMINE AUROBINDO 3 MG CAPSULES, HARD RIVASTIGMINE AUROBINDO 4.5 MG CAPSULES, HARD RIVASTIGMINE AUROBINDO 6 MG CAPSULES, HARD 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, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rivastigmine Aurobindo is and what it is used for 2. What you need to know before you take Rivastigmine Aurobindo 3. How to take Rivastigmine Aurobindo 4. Possible side effects 5. How to store Rivastigmine Aurobindo 6. Contents of the pack and other information 1. WHAT RIVASTIGMINE AUROBINDO IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Aurobindo 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 Aurobindo 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 Aurobindo is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine Aurobindo 1.5 mg Capsules, Hard Rivastigmine Aurobindo 3 mg Capsules, Hard Rivastigmine Aurobindo 4.5 mg Capsules, Hard Rivastigmine Aurobindo 6 mg Capsules, Hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 2.400 mg rivastigmine tartrate equivalent to rivastigmine 1.5 mg. Each hard capsule contains 4.800 mg rivastigmine tartrate equivalent to rivastigmine 3 mg. Each hard capsule contains 7.200 mg rivastigmine tartrate equivalent to rivastigmine 4.5 mg. Each hard capsule contains 9.600 mg rivastigmine tartrate equivalent to rivastigmine 6 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard _1.5 MG: _ Yellow cap and yellow body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘67’ on body, containing white to off-white granular powder. _3 MG: _ Orange cap and orange body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘68’ on body, containing white to off-white granular powder. _4.5 MG: _ Red cap and red body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘69’ on body, containing white to off-white granular powder. _6 MG: _ Red cap and orange body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘70’ on body, containing white to off-white granular powder. 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 wil Aqra d-dokument sħiħ