Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
topiramate
Sun Pharma ANZ Pty Ltd
Topiramate
Registered
TOPIRAMATE AN TOPIRAMATE 25/50/100/200 MG TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Topiramate AN (topiramate). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Topiramate AN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TOPIRAMATE AN IS USED FOR The name of your medicine is Topiramate AN . Topiramate AN contains topiramate. Topiramate belongs to a group of medicines called antiepileptics. Topiramate prevents seizures and migraines by affecting chemicals in the brain that are involved in sending signals to the nerves. Topiramate AN is used for the treatment of various types of epilepsy in adults and children over 2 years of age. Topiramate AN is also used for the prevention of migraines in adults. Your doctor may prescribe Topiramate AN on its own, or in combination with other medicine for controlling your seizures or migraines. Your doctor may have prescribed Topiramate AN for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TOPIRAMATE AN HAS BEEN PRESCRIBED FOR YOU. Topiramate AN is available only with a doctor’s prescription. Topiramate AN CMI v3.0 Page 1 of 9 BEFORE YOU TAKE TOPIRAMATE AN _WHEN YOU MUST NOT TAKE IT_ _ _ • DO NOT TAKE TOPIRAMATE AN IF YOU ARE ALLERGIC TO TOPIRAMATE OR ANY OF THE INACTIVE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: wheezing, swellin Lesen Sie das vollständige Dokument
PRODUCT INFORMATION TOPIRAMATE AN TOPIRAMATE 25/50/100/200 MG TABLETS NAME OF THE MEDICINE Topiramate Structural formula: Molecular formula _: _ C 12 H 21 NO 8 S Chemical name: 2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate Molecular weight: 339.36 CAS Number: 97240-79-4 DESCRIPTION Topiramate is a white crystalline powder with a bitter taste. It is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. 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. Each film-coated tablet of TOPIRAMATE AN contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate, and the inactive ingredients microcrystalline cellulose, lactose, pregelatinised maize starch, sodium starch glycollate type A and magnesium stearate. In addition the 25 mg tablet contains OPADRY complete film coating system 12B58956 White (Proprietary ingredient no. 13153), the 50 mg and 100 mg tablets contain OPADRY complete film coating system 12B52749 Yellow (Proprietary ingredient no. 13152), and the 200 mg tablet contains OPADRY complete film coating system 12B56662 Brown (Proprietary ingredient no. 13151). OPADRY complete film coating system 12B58956 White contains hypromellose, titanium dioxide, macrogol 400 and polysorbate 80. OPADRY complete film coating system 12B52749 Yellow contains hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and iron oxide yellow. Topiramate AN v3.0 Page 1 of 32 OPADRY complete film coating system 12B56662 Brown contains hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and iron oxide red. PHARMACOLOGY PHARMACODYNAMICS Topiramate is classified as a sulfamate substituted monosaccharide. Three pharmacological properties of topiramate have been identified that may contribute to its anticonvulsant activity: • Topiramate reduces the frequency at which action potentials are generated when neurons are subjected to a sustained depolarisation, Lesen Sie das vollständige Dokument