מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIRACETAM
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
PIRACETAM
20 Tablets; 20 Tablets
UCB PHARMA SA
Consumer Medication Information Leaflet (RiMUP) 1 NOOTROPIL TABLET Piracetam (800 mg, 1200 mg) What is in this leaflet 1. What NOOTROPIL is used for 2. How NOOTROPIL works 3. Before you use NOOTROPIL 4. How to use NOOTROPIL 5. While you are using it 6. Side Effects 7. Storage and Disposal of NOOTROPIL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision What NOOTROPIL is used for Treatment of the elderly with some degree of cerebral functional impairment such as loss of memory, a lack of concentration or alertness and feeling of dizziness. Nootropil is indicated for patients suffering from myoclonus of cortical origin, irrespective of aetiology and should be used in combination with other anti- myoclonic therapies. How NOOTROPIL works Nootropil contains the active ingredient Piracetam. It acts on the brain and nervous system and is thought to protect it against a shortness of oxygen. Nootropil is used in combination with other medicines to treat myoclonus. This is a condition in which the nervous system causes muscles, particularly in the arms and legs, to start to jerk or twitch uncontrollably. Before you use NOOTROPIL - When you must not use it Do not take Nootropil if: You are allergic (hypersensitive) to piracetam, other pyrrolidone derivatives or to any of the other ingredients of Nootropil (see section Product Description ). You have ever had serious kidney problems You have ever experienced a brain haemorrhage You suffer from Huntington’s Disease (also known as Huntington’s Chorea) If any of the above applies to you, do not take Nootropil and talk to your doctor or pharmacist. - Before you start to use it Check with your doctor before taking Nootropil if: You think your kidneys may not be working perfectly. (Your doctor may need to start you on a lower dose) You have ever had any kind of bleeding problem. If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking Nootropil קרא את המסמך השלם
NOOTROPIL Piracetam NAME OF THE MEDICINAL PRODUCT _Nootropil Tablet 800mg _ _Nootropil Tablet 1200mg _ _Nootropil Solution 20% _ _Nootropil Injection 1g/5ml _ _Nootropil Infusion (60ml) 12g/60ml _ QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Nootropil Tablet 800mg _ Each film-coated tablet contains 800mg of piracetam. _Nootropil Tablet 1200mg _ Each film-coated tablet contains 1200mg of piracetam. _Nootropil Solution 20% _ Each ml of oral solution contains 200mg of piracetam. _ _ _Nootropil Injection 1g/5ml _ Each 5 ml solution for injection contains 1g of piracetam. _Nootropil Infusion (60ml) 12g/60ml _ Each 60ml solution for infusion contains 12g of piracetam. EXCIPIENTS _Nootropil Tablet 800mg _ _Nootropil Tablet 1200mg _ Macrogol 6000, Opadry Y-1-7000 White, Opadry OY-S 29019 Clear, Sodium Croscarmellose, Colloidal anhydrous silica (Aerosil), Magnesium Stearate _Nootropil Solution 20% _ Propyl Parahydroxybenzoate, Apricot flavour 52247/A, Glacial acetic acid, Methyl Parahydroxybenzoate, Glycerol (85%), Caramel Flavour 052929A7, Purified water, sodium acetate, saccharin sodium _Nootropil Injection 1g/5ml _ Water for injection, Sodium acetate, Glacial acetic acid _Nootropil Infusion (60ml) 12g/60ml _ Water for injections, Sodium chloride, Sodium acetate, Glacial acetic acid PHARMACEUTICAL FORM _Nootropil Tablet 800mg _ _White oblong film-coated tablet imprinted with a bisect line and N/N on one side and plain on _ _the other side. _ _Nootropil Tablet 1200mg _ _White oblong scored film-coated tablet marked N/N on one side and plain on the other side. _ _ _ _Nootropil Solution 20% _ _Clear colourless solution, characteristic flavour _ _Nootropil Injection 1g/5ml _ _Nootropil Injection 1g/5ml is a clear, colourless solution_ . _Nootropil Infusion (60ml) 12g/60ml _ Nootropil Infusion 12g is clear and colourless CLINICAL INFORMATION INDICATIONS Treatment of the elderly with some degree of cerebral functional impairment such as loss of memory, a lack of concentration or alertness and vertigo. NOOTROPIL is indicated קרא את המסמך השלם