מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
RIVASTIGMINE BASE
Clonmel Healthcare Ltd
N06DA03
RIVASTIGMINE BASE
9.5 Mg/day
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Anticholinesterases
Authorised
2013-06-21
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ EXIMINE XL 4.6 MG/24 H TRANSDERMAL PATCH EXIMINE XL 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 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 Eximine XL is and what it is used for 2. What you need to know before you use Eximine XL 3. How to use Eximine XL 4. Possible side effects 5. How to store Eximine XL 6. Contents of the pack and other information 1. WHAT EXIMINE XL IS AND WHAT IT IS USED FOR The active substance of Eximine XL 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, Eximine XL allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease. Eximine XL is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually a קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eximine XL 9.5 mg/24 h 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 of rivastigmine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch Round-shaped three-layer matrix tansdermal patches The outside of the backing layer is translucent, white and imprinted with black printing ink 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 Eximine XL 4.6 mg/24 h 4.6 mg Eximine XL 9.5 mg/24 h 9.5 mg HEALTH PRODUCTS REGULATORY AUTHORITY ___________________________________ קרא את המסמך השלם