국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
topiramate, Quantity: 50 mg
Janssen-Cilag Pty Ltd
Topiramate
Capsule, hard
Excipient Ingredients: povidone; cellulose acetate; maize starch; sucrose; titanium dioxide; sorbitan monolaurate; potable water; Gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; Shellac Glaze-45% (20% esterified) in Ethanol
Oral
60 capsules
(S4) Prescription Only Medicine
EPILEPSY TOPAMAX is 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 TOPAMAX is indicated for the prophylaxis of migraine headache in adults. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied.
Visual Identification: small white to off-white spheres in hard gelatin capsules with white opaque body and clear cap marked "TOP" and body marked "50mg".; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2010-04-30
TOPAMAX (220525) CMI TOPAMAX ® _TABLETS AND SPRINKLE CAPSULES _ _Topiramate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TOPAMAX ® tablets and Sprinkle capsules. 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 TOPAMAX 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 need to read it again. WHAT TOPAMAX IS USED FOR The name of your medicine is TOPAMAX. It contains the active ingredient topiramate. TOPAMAX belongs to a group of medicines known as antiepileptics. TOPAMAX is used for the treatment of various types of seizures in adults and children, aged 2 years and over. It can also be used for the prevention of migraines in adults. TOPAMAX is not used to treat severe migraines that come on suddenly (acute). It prevents seizures and migraines by acting on the nerves and chemicals in the brain. Your doctor may prescribe TOPAMAX on its own, or in addition to another medicine for controlling your seizures or migraines. Your doctor may have prescribed TOPAMAX for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE TOPAMAX _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TOPAMAX IF YOU HAVE AN ALLERGY (HYPERSENSITIVITY) TO: • topiramate • any of the ingredients. See Product Description at the end of this leaflet for a list of ingredients. • if the tablets or capsules are not as described under Product Description at the end of this leaflet. Symptoms of an allergic or hypersensitivity reaction may include: • rash, itching or hives on the skin • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body DO NOT TAKE TOPAMAX IF THE PACKAGING 전체 문서 읽기
CCDS211019v24 Page 1 of 30 TOPAMAX(220517)API AUSTRALIAN PRODUCT INFORMATION TOPAMAX® ( TOPIRAMATE ) TABLETS AND SPRINKLE CAPSULES 1. NAME OF THE MEDICINE Topiramate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _TOPAMAX 25 MG, 50 MG, 100 MG & 200 MG FILM-COATED TABLETS _ Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate. Excipient(s) with known effect: sugars as lactose For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. _TOPAMAX SPRINKLE 15 MG, 25 MG & 50 MG HARD CAPSULES _ Each capsule consists of sugar spheres enclosed in a gelatin capsule. The sugar spheres contain 15 mg, 25 mg or 50 mg of topiramate. Excipient with known effect: sugars For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM TABLETS TOPAMAX film-coated tablets are supplied in blisters: • 25 mg, round and white, marked “TOP” on one side and “25” on the other • 50 mg, round and light-yellow, marked “TOP” on one side and “50” on the other • 100 mg, round and yellow, marked “TOP” on one side and “100” on the other • 200 mg, round and salmon, marked “TOP” on one side and “200” on the other CAPSULES TOPAMAX Sprinkle capsules contain small, white to off-white spheres and are supplied in bottles. Each capsule consists of a clear capsule cap and a white capsule body: • 15 mg, imprinted “TOP” on cap and “15 mg” on body • 25 mg, imprinted “TOP” on cap and “25 mg” on body • 50 mg, imprinted “TOP” on cap and “50 mg” on body Product Information - Australia CCDS211019v24 Page 2 of 30 TOPAMAX(220517)API 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EPILEPSY TOPAMAX is 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-Gastau 전체 문서 읽기