Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LANSOPRAZOLE
Imbat Limited
A02BC03
LANSOPRAZOLE
30 Milligram
Orodispersible Tablet
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Authorised
2013-11-25
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER LANSOPRAZOLE 30MG ORODISPERSIBLE TABLETS (lansoprazole) Your medicine is available using the above name but will be referred to as Lansoprazole Orodispersible Tablets throughout this leaflet. 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 Lansoprazole Orodispersible Tablets are and what they are used for 2. What you need to know before you take Lansoprazole Orodispersible Tablets 3. How to take Lansoprazole Orodispersible Tablets 4. Possible side effects 5. How to store Lansoprazole Orodispersible Tablets 6. Contents of the pack and other information 1. WHAT LANZOPRAZOLE ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Lansoprazole Orodispersible Tablets is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Lansoprazole Orodispersible Tablets 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 pyl Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lansoprazole 30mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 30 mg of lansoprazole. Excipients of known effect: lactose, aspartame and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet _Product imported from the United Kingdom_: White to off-white, flat bevelled round tablet debossed with "30" on one side of the tablet and plain on the other side. Each orodispersible tablet contains white to greyish gastroresistant granules. 4 CLINICAL PARTICULARS As per PA0749/024/004 5 PHARMACOLOGICAL PROPERTIES As per PA0749/024/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sugar spheres (sucrose and maize starch) Hypromellose Talc (extra fine) Magnesium carbonate Methacrylic acid-ethyl acrylate copolymer (1:1) Triethyl citrate Titanium dioxide (E171) Colloidal anhydrous silica Lactose monohydrate Maize starch Aspartame Magnesium stearate Strawberry flavour 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister strips and the outer carton of the product HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/06/2015_ _CRN 2161965_ _page number: 1_ as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer carton containing blister strips Pack size: 28 orodispersible tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2, Nor Læs hele dokumentet