Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
topiramate, Quantity: 25 mg
Medis Pharma Pty Ltd
Topiramate
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia
Oral
60 tablets
(S4) Prescription Only Medicine
Epilepsy. Adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome.. Migraine. Prophylaxis of migraine headache in adults.
Visual Identification: White to off-white, circular, biconvex film-coated tablets, imprinted with "25" in black ink on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-04-19
TOPIRAMATE-GA _topiramate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Topiramate-GA. 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-GA against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING TOPIRAMATE-GA, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TOPIRAMATE-GA IS USED FOR Topiramate-GA is 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-GA on its own, or in addition to another medicine for controlling your seizures or migraines. Your doctor may have prescribed Topiramate-GA for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE TOPIRAMATE- GA _ _ _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE TOPIRAMATE-GA: • if you have an allergy to topiramate or to any of the ingredients listed at the end of this leaflet • if the tablets do not look right • if the packaging is torn or shows signs of tampering. • after the expiry date (month and year) printed on the pack. _BEFORE YOU START TO TAKE IT _ _ _ YOU MUST TELL YOUR DOCTOR IF YOU: • ARE PREGNANT OR PLANNING TO BECOME PREGNANT. Topiramate has caused harm to the developing foetus when administered to a pregnant woman. Information available suggests that there may be an association between the use of topiramate in humans during pregnancy and birth defects including cleft lip/palate. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take topiramate, your doctor can help you decide whether or not to t Lue koko asiakirja
Topiramate-GA PI v5 120907 - 1 - TOPIRAMATE-GA PRODUCT INFORMATION NAME OF THE MEDICINE Topiramate 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. Empirical formula: C 12 H 21 NO 8 S CAS-97240-79-4 Molecular weight: 339.36 Topiramate-GA 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-GA tablets 25 mg, 50 mg, 100 mg & 200 mg also contains Opacode S-1-17823 Black. Opacode S-1-17823 Black contains, Shellac Glaze- 45% (20 % esterified) in Ethanol, Iron Oxide Black JPE, N-Butyl Alcohol NF, Propylene Glycol, Ammonium Hydroxide 28%, Isopropyl alcohol. 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, which is indicative of a state- dependent blockade of voltage-sensitive sodium channels. Topiramate-GA PI v5 120907 - 2 - Topiramate markedly enhances the activity of GABA at some types of GABA A receptors. This effect was not blocked by flumazenil, a benzodiazepine antagonist, nor did topiramate increase the duration of the channel open time, differentiating topiramate from barbiturates that modulate GABA A receptors. Because the antiepileptic profile of topiramate differs markedly from that of the Lue koko asiakirja