Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
WPR Healthcare Limited
A02BC05
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
40 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Authorised
2014-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS esomeprazole 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 Esomeprazole gastro-resistant tablets are and what they are used for 2. What you need to know before you take Esomeprazole gastro-resistant tablets 3. How to take Esomeprazole gastro-resistant tablets 4. Possible side effects 5. How to store Esomeprazole gastro-resistant tablets 6. Contents of the pack and other information 1. WHAT ESOMEPRAZOLE GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED FOR Esomeprazole Tablets contains a medicine called esomeprazole. This belongs to a group of medicines called “proton pump inhibitors”. They work by reducing the amount of acid that your stomach produces. Esomeprazole is used to treat the following conditions Adults and young people aged 12 years and above - Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. - Ulcers that are infected with bacteria called ‘_Helicobacter pylori’_. If you have this condition, your doctor ma Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 40 mg esomeprazole as esomeprazole magnesium (amorphous). Excipient with known effect: Each tablet also contains sucrose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet _Product imported from the United Kingdom:_ Light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E6’ debossed on one side and plain on other side 4 CLINICAL PARTICULARS As per PA 408/81/2 5 PHARMACOLOGICAL PROPERTIES As per PA 408/81/2 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablets core Sugar spheres (sucrose and maize starch) Hydroxypropyl cellulose (E463) Crospovidone (Type B) Povidone (K30) Macrogol-400 Talc (E553b) Hypromellose phthalate (HP-55S) Hypromellose phthalate (HP-50) Diethylphthalate Macrogol 6000 Crospovidone (TypeA) Microcrystalline cellulose (PH 101) Microcrystalline cellulose (PH 112) Sodium stearyl fumarate Coat Macrogol-4000 Opadry 03B86651 Brown (HPMC 2910/Hypromellose 6cP (E464) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 17/11/2014_ _CRN 2152412_ _page number: 1_ Titanium Dioxide (E171), Macrogol/PEG 400 Talc (E553b) Iron Oxide red(E172)) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 30°C Store in the original package (blister) in order to protect from moisture 6.5 NATURE AND CONTENTS OF CONTAINER Blisters of 28 tablets in a cardboard carton. 6.6 SPECIAL Les hele dokumentet