Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
topiramate, Quantity: 25 mg
Sun Pharma ANZ Pty Ltd
Topiramate
Tablet
Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400
Oral
60
(S4) Prescription Only Medicine
1. EPILEPSY. RBX TOPIRAMATE tablets are indicated in 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.. 2. MIGRAINE. RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine headache in adults.
Visual Identification: White, film-coated, circular tablets debossed with 'TP1' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2010-05-10
RBX TOPIRAMATE RBX TOPIRAMATE _Topiramate 25/50/100/200 mg Tablets _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RBX TOPIRAMATE (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 RBX TOPIRAMATE 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 RBX TOPIRAMATE IS USED FOR The name of your medicine is RBX TOPIRAMATE. RBX TOPIRAMATE 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. RBX TOPIRAMATE is used for the treatment of various types of epilepsy in adults and children over 2 years of age. RBX TOPIRAMATE is also used for the prevention of migraines in adults. Your doctor may prescribe RBX TOPIRAMATE on its own, or in combination with other medicine for controlling your seizures or migraines. Your doctor may have prescribed RBX TOPIRAMATE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY RBX TOPIRAMATE HAS BEEN PRESCRIBED FOR YOU. RBX TOPIRAMATE is available only with a doctor’s prescription. BEFORE YOU TAKE RBX TOPIRAMATE _WHEN YOU MUST NOT TAKE IT _ • DO NOT TAKE RBX TOPIRAMATE 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, swelling Læs hele dokumentet
RBX TOPIRAMATE PI V6 Page 1 of 33 AUSTRALIAN PRODUCT INFORMATION – RBX TOPIRAMATE (TOPIRAMATE) TABLETS 1 NAME OF THE MEDICINE Topiramate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of RBX TOPIRAMATE contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate. Excipient with known effect: Lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM RBX TOPIRAMATE 25 mg tablets are available as white, film-coated, circular tablets debossed with ‘TP1’ on one side and plain on the other side. RBX TOPIRAMATE 50 mg tablets are available as yellow-coloured, film-coated, circular tablets debossed with ‘TP2’ on one side and plain on the other side. RBX TOPIRAMATE 100 mg tablets are available as yellow-coloured, film-coated, circular tablets debossed with ‘TP3’ on one side and plain on the other side. RBX TOPIRAMATE 200 mg tablets are available as peach-coloured, film-coated, circular tablets debossed with ‘TP4’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS _EPILEPSY _ RBX TOPIRAMATE tablets are indicated in 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 _ RBX TOPIRAMATE tablets are indicated for the prophylaxis of migraine headache in adults. 4.2 D OSE AND METHOD OF ADMINISTRATION RBX TOPIRAMATE tablets should be swallowed whole. RBX TOPIRAMATE PI V6 Page 2 of 33 RBX TOPIRAMATE tablets can be taken without regard to meals. For optimum seizure control in both adults and children, it is recommended that therapy should be initiated at a low dose followed by slow titration to an effective dose. Dose titration should be guided by clinical outcome. The recommended dosages of topiramate in adults and c Læs hele dokumentet