देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVASTIGMINE HYDROGEN TARTRATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
RIVASTIGMINE HYDROGEN TARTRATE
28 Capsule Capsules
Siegfried Barbera, S.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ EXELON ® CAPSULES _ _ Rivastigmine (1.5mg, 3.0mg, 4.5mg, 6.0mg) 1 WHAT IS IN THIS LEAFLET 1. What Exelon is used for 2. How Exelon works 3. Before you use Exelon 4. How to use Exelon 5. While you are using Exelon 6. Side effects 7. Storage and disposal of Exelon 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS EXELON USED FOR It is used for the treatment of memory disorders and dementia in people with Alzheimer’s disease or with Parkinson’s disease. HOW EXELON WORKS Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In individuals 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). This causes changes in the brain and problems with memory, thinking and behaviour. These problems gradually become worse with time. Exelon works by preventing the breakdown of acetylcholine. This chemical is needed to help keep the brain working properly. Rivastigmine helps to reduce the symptoms of Alzheimer's disease, to slow down the mental decline that happens in people with this condition, and helps to improve the ability to cope with everyday activities. It does not cure the condition. BEFORE YOU USE EXELON _-When you must not use it _ Do not take Exelon • If you know that you are allergic (hypersensitive) to rivastigmine (the active substance in Exelon) 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 any of these apply to you, do not take Exelon, and tell your doctor. _- Before you start to use it _ Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. Warning and precautions If you experience gastro- intestinal reactions such as nausea (feeling sick), vomiting पूरा दस्तावेज़ पढ़ें
Novartis Business Use Only Page 2 Malaysian Package Leaflet 12 Dec 2022 Exelon hard capsules EXELON ® Brain-selective cholinesterase inhibitor. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Hard capsules Certain dosage strengths may not be available in all countries. ACTIVE SUBSTANCE Each hard gelatin capsule contain rivastigmine hydrogen tartrate corresponding to 1.5, 3.0, 4.5 or 6.0 mg rivastigmine base. DESCRIPTION EXELON 1.5 MG: Colour : Cap-Yellow opaque, Body-Yellow opaque. Imprint : Red imprint on body, radial “EXELON 1.5mg”. EXELON 3.0 MG: Colour : Cap-Orange opaque, Body-Orange opaque. Imprint : Red imprint on body, radial “EXELON 3mg”. EXELON 4.5 MG: Colour : Cap-Red opaque, Body-Red opaque. Imprint : White imprint on body, radial “EXELON 4.5mg’. EXELON 6.0 MG: Colour : Cap-Red opaque, Body-Orange opaque. Imprint : Red imprint on body, radial “EXELON 6mg”. EXCIPIENTS CAPSULE CONTENT: microcrystalline cellulose; magnesium stearate; hypromellose; silica, colloidal anhydrous. CAPSULES SHELL: gelatin; titanium dioxide (E 171); iron oxide, yellow (E 172); printing ink, based on iron oxide, red (E 172) and shellac. Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer’s Disease or Alzheimer’s Disease. Treatment of patients with mild to moderately severe dementia associated with Parkinson’s disease. Novartis Business Use Only Page 3 Malaysian Package Leaflet 12 Dec 2022 Exelon hard capsules DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN INITIAL DOSE 1.5 mg twice a day. DOSE TITRATION The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks’ treatment at that dose level. If adverse eff पूरा दस्तावेज़ पढ़ें