Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVASTIGMINE BASE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
RIVASTIGMINE BASE
60Units Units; 30Units Units; 30 Pieces
LTS LOHMANN THERAPIE-SYSTEM AG
EXELON PATCH ® _Consumer Medication Information Leaflet (RiMUP) _ Rivastigmine 4.6 mg/24 h transdermal patch (Exelon ® Patch 5) 9.5 mg/24 h transdermal patch (Exelon ® Patch 10) 13.3 mg/24 h transdermal patch (Exelon ® Patch 15) 1 WHAT IS IN THIS LEAFLET 1. What Exelon Patch is used for 2. How Exelon Patch works 3. Before you apply Exelon Patch 4. How to use Exelon Patch 5. While you are using Exelon Patch 6. Side effects 7. Storage and disposal of Exelon Patch 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT EXELON PATCH IS USED FOR It is used for the treatment of memory disorders and dementia in patients with Alzheimer’s disease or with Parkinson’s disease. HOW EXELON PATCH WORKS Exelon belongs to a class of substances called cholinesterase inhibitors. The active substance of Exelon is rivastigmine. In patients with Alzheimer's dementia or Parkinson’s disease 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, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease or Parkinson’s disease dementia. BEFORE YOU APPLY EXELON PATCH _- When you must not use it _ Do not apply Exelon Patch • If you know that you are allergic (hypersensitive) to rivastigmine (the active substance in Exelon Patch) or to any of the other ingredients listed at the end of this leaflet, • If you have ever had an allergic reaction to a similar type of medicine, • If you have had a skin reaction which has spread beyond the patch size, if there was a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it did not improve within 48 hours after removal of the transdermal patch. If any Baca dokumen lengkap
Novartis Business Use Only Page 2 Malaysia Package Leaflet 12 Dec 2022 Exelon Patch EXELON ® PATCH Brain-selective cholinesterase inhibitor. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Transdermal patch. Each patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled for each patch dose as follows: - for Exelon ® Patch 5: “AMCX” - for Exelon ® Patch 10: “BHDI” - for Exelon ® Patch 15: “CNFU” Certain dosage strengths may not be available in all countries. ACTIVE SUBSTANCE • Each patch of 5 cm 2 contains 9 mg rivastigmine base, _in vivo_ release rate of 4.6 mg/24 hours. • Each patch of 10 cm 2 contains 18 mg rivastigmine base, _in vivo_ release rate of 9.5 mg/24 hours. • Each patch of 15 cm 2 contains 27 mg rivastigmine base, _in vivo_ release rate of 13.3 mg/24 hours. EXCIPIENTS Acrylic pressure sensitive adhesive, silicone pressure sensitive adhesive, poly (butyl- methacrylate, methyl-methacrylate), polyethylene terephthalate (backing film), fluoropolymer- coated polyethylene terephthalate (release liner), silicone oil, vitamin E. Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of patients with: • Mild to moderately severe dementia of the Alzheimer’s type. • Severe dementia of the Alzheimer’s type. • Mild to moderately severe dementia associated with Parkinson’s disease. DOSAGE REGIMEN AND ADMINISTRATION POSOLOGY PATCHES RIVASTIGMINE BASE DOSE LOAD RIVASTIGMINE BASE_ IN VIVO_ RELEASE RATES PER 24 H Exelon Patch 5 9 mg 4.6 mg Exelon Patch 10 18 mg 9.5 mg Exelon Patch 15 27 mg 13.3 mg Novartis Business Use Only Page 3 Malaysia Package Leaflet 12 Dec 2022 Exelon Patch Mild to moderately severe dementia of the Alzheimer’s type OR ASSOCIATED WITH PARKINSON’S DISEASE INITIAL DOSE AND DOSE TITRATION TO THE EFFECTIVE DOSE: Treatment is started with Exelon Patch 5 once a day. After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon P Baca dokumen lengkap