Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
RIVASTIGMINE BASE
Teva Pharma B.V.
N06DA03
RIVASTIGMINE BASE
9.5 mg/24 hours
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Anticholinesterases
Authorised
2013-08-23
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVASTIGMINE TEVA 4.6 MG/24 H TRANSDERMAL PATCH RIVASTIGMINE TEVA 9.5 MG/24 H TRANSDERMAL PATCH Rivastigmine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Teva is and what it is used for 2. What you need to know before you use Rivastigmine Teva 3. How to use Rivastigmine Teva 4. Possible side effects 5. How to store Rivastigmine Teva 6. Contents of the pack and other 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. In patients with Alzheimer’s dementia, 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 Teva allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease. Rivastigmine Teva 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE RIVASTIGMINE TEVA _ _ DO NOT USE RIVASTIGMINE TEVA - if you are allergic to rivastigmine (the active substance in Rivasti Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 9.5mg/24h Transdermal Patches 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 9.5 mg rivastigmine per 24 hours. Each transdermal patch of 10 cm 2 contains 18 mg rivastigmine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch The drug product is a three-layer matrix transdermal roundshaped patch consisting of backing film, drug (acrylic) matrix containing drug substance, adhesive (silicone) matrix and furthermore a rectangular release liner. The outside of the backing layer is translucent, white and black-printed as follows; “Rivastigmine, 9.5 mg/24 h” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 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. Diagnosis should be made according to current guidelines. Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment. Posology Initial dose Treatment is started with 4.6 mg/24 h. Maintenance dose After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit. Dose escalation 9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to TRANSDERMAL PATCHES RIVASTIGMINE_ IN VIVO_ RELEASE RATES PER 24 H Rivastigmine Teva 4.6 mg/24 h 4.6 mg Rivastigmine Teva 9.5 mg/24 h 9.5 mg Rivastigmine Teva 13.3 mg/24 h 13.3 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ Baca dokumen lengkapnya