Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Lansoprazole
IMED Healthcare Ltd.
A02BC; A02BC03
Lansoprazole
30 milligram(s)
Orodispersible tablet
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; lansoprazole
Authorised
2008-03-28
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOTON FASTAB* 30 MG ORO-DISPERSIBLE TABLETS Lansoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zoton is and what it is used for 2. What you need to know before you take Zoton 3. How to take Zoton 4. Possible side effects 5. How to store Zoton 6. Contents of the pack and other information 1. WHAT ZOTON IS AND WHAT IT IS USED FOR The active ingredient in Zoton is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Zoton for the following indications: Treatment of duodenal and stomach ulcer Treatment of inflammation in your oesophagus (reflux oesophagitis) Prevention of reflux oesophagitis Treatment of heartburn and acid regurgitation Treatment of infections caused by the bacteria _Helicobacter _ _pylori_ when given in combination with antibiotic therapy Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) Treatment of Zollinger-Ellison syndrome. Your doctor may have prescribed Zoton for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor’s instructions for taking your medicine. You must talk to a doctor if you do not feel better or if you feel worse after 14 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOTON DO NOT TAKE ZOTON: if you Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoton Fastab 30 mg Oro-dispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each oro-dispersible tablet contains 30mg of lansoprazole. Excipients Product imported from the UK: Each oro-dispersible tablet contains 30mg of lactose and 9.0mg of aspartame (E951) Product imported from Italy: Each oro-dispersible tablet contains lactose and aspartame (E951) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oro-dispersible tablet _Product imported from the UK and Italy._ White to yellowish-white, circular, flat bevelled-edge oro-dispersible tablet. Each oro-dispersible tablet contains orange to dark brown microgranules. Each oro-dispersible tablet is imprinted with '30' on one side and is strawberry flavoured. 4 CLINICAL PARTICULARS As per PA0822/101/003 5 PHARMACOLOGICAL PROPERTIES As per PA0822/101/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Microcrystalline cellulose Magnesium carbonate Low-substituted hydroxypropyl cellulose Hydroxypropyl cellulose Hypromellose Titanium dioxide Talc Mannitol (E421) Methacrylic acid – ethyl acrylate copolymer Polyacrylate dispersion Macrogol 8000 Glyceryl monostearate Polysorbate 80 Triethyl citrate Citric acid anhydrous Crospovidone Magnesium stearate 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_ _ _ _0_ _2_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _3_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r Læs hele dokumentet