Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Topiramate
Lexon (UK) Ltd
N03AX; N03AX11
Topiramate
200 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antiepileptics; topiramate
Authorised
2016-12-23
• Aggression, abnormal behaviour • Difficulty falling or staying asleep • Feeling of unsteadiness when walking • Not feeling well • Decrease in potassium level in the blood • Showing and/or feeling no emotion • Watery eyes • Slow or irregular heartbeat Other side effects that may occur in children are: COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE) • Sensation of spinning (vertigo) • Vomiting • Fever UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE) • Increase in eosinophils (a type of white blood cell) in the blood • Hyperactivity • Feeling warm • Learning disability REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE TOPAMAX • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the bottle/carton. The expiry date refers to the last day of that month. • Do not store above 25°C. Store the tablets in the original package (bottle) to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture. • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT TOPAMAX CONTAINS The active substance is topiramate. - Each Topamax tablet contains 50, or 200 mg of topiramate. The other ingredients of Topamax are listed below. Core tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch, magnesium stearate. Film-coating: OPADRY ® light yellow, Pink 1 carnauba wax. 1 OP Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TOPAMAX 200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 200 mg of topiramate. Excipients with known effect: also includes lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Greece_ Salmon-coloured, round tablets, 10mm in diameter, “TOP” on one side and “200” on the other. 4 CLINICAL PARTICULARS As per PA0748/012/004 5 PHARMACOLOGICAL PROPERTIES As per PA0748/012/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS CORE TABLET: lactose monohydrate microcrystalline cellulose sodium starch glycolate pregelatinized starch magnesium Stearate FILM-COATING: carnauba wax OPADRY Pink which contains: titanium dioxide E171 hypromellose macrogol polysorbate 80 red iron oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _3_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _2_ _7_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 o C. Store the tablets in the original package (bottle) to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture. 6.5 NATURE AND CONT Baca dokumen lengkapnya