Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
topiramate, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Topiramate
Tablet, film coated
Excipient Ingredients: iron oxide yellow; hyprolose; hypromellose; methylcellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; colloidal anhydrous silica; macrogol 8000
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: Light yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP" over "50" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2007-07-20
APO-TOPIRAMATE TABLETS _Topiramate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about topiramate. 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 using this medicine against the benefits they expect it will 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Topiramate is used to: • treat various types of epilepsy in adults and children over 2 years of age • prevent migraines in adults – it is not used to treat severe migraines that come on suddenly (acute) Topiramate belongs to a group of medicines called antiepileptic drugs. _HOW IT WORKS_ Topiramate prevents seizures and migraines by acting on the nerves and chemicals in the brain. Your doctor may prescribe topiramate on its own, or in addition to another medicine for controlling your seizures or migraines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. This medicine may be used to treat epilepsy in children aged 2 years or older. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • topiramate • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT BREASTFEED IF YOU ARE TAKING THIS MEDICINE. It is not recommended to breastfeed whilst taking this medicine, Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION APO-TOPIRAMATE (TOPIRAMATE) TABLETS 1 NAME OF THE MEDICINE Topiramate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate, as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-TOPIRAMATE TABLETS: 25 MG TABLETS: White to off-white, round, unscored, film coated tablet, imprinted “APO” on one side and “TP over “25” on the other side. 50 MG TABLETS: Light-yellow, round, unscored, film coated tablet, imprinted “APO” on one side and “TP over “50” on the other side. 100 MG TABLETS: Mustard yellow, round, unscored, film coated tablet, imprinted “APO” on one side and “TP over “100” on the other side. 200 MG TABLETS: Reddish-brown, round, unscored, film coated tablet, imprinted “APO” on one side and “TP over “200” on the other side. 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. The usefulness of topiramate in the acute treatment of migraine headache has not been studied. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Topiramate tablets are intended for oral administration DOSAGE Topiramate tablets should be swallowed whole. Topiramate 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 children for epilepsy are summarised in Table 1. MONOTHERAPY – EPILEPSY In n Přečtěte si celý dokument