Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIRACETAM
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
PIRACETAM
90 Tablets; 90 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 Læs hele dokumentet
NOOTROPIL Piracetam NAME OF THE MEDICINAL PRODUCT _Nootropil Tablet 800mg _ _Nootropil Tablet 1200mg _ 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. 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 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. _ _ 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 for patients suffering from myoclonus of cortical origin, irrespective of aetiology and should be used in combination with other anti-myoclonic therapies. DOSAGE AND ADMINISTRATION _ _ Piracetam may be taken with or without food. The film-coated tablets should be swallowed with liquid. It is recommended to take the daily dose in two to four sub-doses. ROUTE OF ADMINISTRATION For oral use. ADULTS The daily dosage should begin at 7.2g, increasing by 4.8g every three or four days up to a maximum of 24g, in two or three divided doses. Treatment with other anti-myoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the dosage of other such medicinal products should be reduced, if possible. Once started, treatment with piracetam should be continued for as long as the original cerebral disease persists. In patients with an acute episode, spontaneous evolution may occur over time and an attempt should be made every 6 months to decrease or discontinue the medicinal treatment. This sho Læs hele dokumentet