Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Topiramate 200mg; ;
Janssen-Cilag (New Zealand) Ltd
Topiramate 200 mg
200 mg
Film coated tablet
Active: Topiramate 200mg Excipient: Carnauba wax Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink YS-1-1456-G as Opadry Pink YS-1-1759-G Sodium starch glycolate Starch
Blister pack, Alu-Alu, 60 tablets
Prescription
Prescription
Siegfried Ltd
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, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
Package - Contents - Shelf Life: Blister pack, Alu-Alu - 60 tablets - 36 months from date of manufacture stored at or below 25°C. Store in original package. Store in a dry place. - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. Store in original package. Store in a dry place.
1995-10-24
TOPAMAX ® 230323 ACMI 1 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 PACKAG Lestu allt skjalið
26.221109 1 TOPAMAX (230323) ADS TOPAMAX ® TABLETS AND SPRINKLE CAPSULES TOPIRAMATE NEW ZEALAND DATA SHEET 1. PRODUCT NAME TOPAMAX ® 25 mg, 50 mg, 100 mg & 200 mg film-coated tablets TOPAMAX ® Sprinkle 15 mg, 25 mg & 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _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. _SPRINKLE CAPSULES _ Each capsule contains 15 mg, 25 mg or 50 mg of topiramate. Excipients with known effect: Sugar For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM _TABLETS _ 25 mg: Round, white, film-coated tablets, marked “TOP” on one side and “25” on the other. 50 mg: Round, light-yellow, film-coated tablets, marked “TOP” on one side and “50” on the other 100 mg: Round, yellow, film-coated tablets, marked “TOP” on one side and “100” on the other 200 mg: Round, salmon, film-coated tablets, marked “TOP” on one side and “200” on the other. _SPRINKLE CAPSULES _ Hard capsules enclosing small, white to off-white spheres. Each gelatin capsule consists of a clear (natural) capsule cap and a white capsule body. 15 mg: imprinted with “TOP” on cap and “15 mg” on body 25 mg: imprinted with “TOP” on cap and “25 mg” on body 50mg: imprinted with “TOP” on cap and “50mg” on body (not marketed). 26.221109 2 TOPAMAX (230323) ADS 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, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome. MIGRAINE TOPAMAX is indicated in adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied. 4.2 DOSE AND METHOD OF AD Lestu allt skjalið