Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Topiramate
Lupin Australia Pty Limited
Medicine Registered
TOPIRAMATE-LUPIN TABLETS CONSUMER MEDICINE INFORMATION TOPIRAMATE (LUPIN AUSTRALIA PTY. LTD.) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Topiramate-Lupin tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Topiramate-Lupin tablets against the benefits it is expected to have for you. If you have any concerns about taking Topiramate-Lupin tablets, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again WHAT TOPIRAMATE-LUPIN TABLETS IS USED FOR Topiramate-Lupin tablets are used for the treatment of various types of epilepsy in adults and children over 2 years of age, and for the prevention of migraines in adults. It prevents seizures and migraines by acting on the nerves and chemicals in the brain. Your doctor may prescribe Topiramate- Lupin tablets on its own, or in addition to another medicine for controlling your seizures or migraines. Your doctor may have prescribed Topiramate-Lupin tablets for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE TOPIRAMATE-LUPIN TABLETS _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE TOPIRAMATE-LUPIN TABLETS: • if you have an allergy to it or to any of the ingredients. See Product Description at the end of this leaflet for a list of ingredients. • if the tablets are not as described under Product Description at the end of this leaflet. Do not take Topiramate-Lupin tablets if the packaging is torn or shows signs of tampering. Do not take Topiramate- Lupin t Прочитајте комплетан документ
Version 3.0, Topiramate-Lupin tablets ________________________________________________________________________________ _______________________________________________________________________________ Page 1 of 30 PRODUCT INFORMATION TOPIRAMATE-LUPIN TABLETS (LUPIN AUSTRALIA PTY. LTD) NAME OF THE MEDICINE: TOPIRAMATE Empirical formula: C 12 H 21 NO 8 S CAS-97240-79-4 Molecular weight: 339.36 DESCRIPTION: Topiramate [2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate] is a white crystalline powder with a bitter taste. Solubility of topiramate is approximately 10 mg/mL over the physiological pH range. It is freely soluble in acetone, chloroform, dimethylsulfoxide and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate-Lupin tablets contain topiramate, and the inactive ingredients lactose, pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate, colloidal silicon dioxide, magnesium stearate, and the Opadry White, Yellow, Pink, depending on the colour, contains Hypromellose, Titanium dioxide, Macrogol, Iron Oxide and polysorbate 80. Topiramate-Lupin tablets 25 mg, 50 mg, 100 mg & 200 mg also contains Opacode S-1-8152 HV Black. OPACODE contains, Shellac Glaze-47.5 % (22 % Esterified) in IMS 74 OP, Iron Oxide Black JPE, Прочитајте комплетан документ