Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rivastigmine
Novartis Pharmaceuticals UK Ltd
N06DA03
Rivastigmine
4.6mg/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5050650120011
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROMETAX ® 4.6 MG/24 H TRANSDERMAL PATCH PROMETAX ® 9.5 MG/24 H TRANSDERMAL PATCH PROMETAX ® 13.3 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 Prometax is and what it is used for 2. What you need to know before you use Prometax 3. How to use 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, 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. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROMETAX DO NOT USE PROMETAX - if you are allergic to rivastigmine (the active substance in Prometax) or any of the other ingredients of this medicine (listed in sect Baca dokumen lengkapnya
OBJECT 1 PROMETAX 4.6 MG/24 H TRANSDERMAL PATCH Summary of Product Characteristics Updated 30-May-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Prometax ® 4.6 mg/24 h transdermal patch Prometax ® 9.5 mg/24 h transdermal patch Prometax ® 13.3 mg/24 h transdermal patch 2. Qualitative and quantitative composition Prometax 4.6 mg/24 h transdermal patch Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 5 cm 2 contains 9 mg of rivastigmine. Prometax 9.5 mg/24 h transdermal patch Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours. Each transdermal patch of 10 cm 2 contains 18 mg of rivastigmine. Prometax 13.3 mg/24 h transdermal patch Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours. Each transdermal patch of 15 cm 2 contains 27 mg of rivastigmine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Prometax 4.6 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “4.6 mg/24 h” and “AMCX”. Prometax 9.5 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “9.5 mg/24 h” and “BHDI”. Prometax 13.3 mg/24 h transdermal patch Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled with “Prometax”, “13.3 mg/24 h” and “CNFU”. 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 t Baca dokumen lengkapnya