Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Esomeprazole
Primecrown 2010 Limited
A02BC; A02BC05
Esomeprazole
20 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; esomeprazole
Authorised
2010-05-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEXIUM ® 20 MG GASTRO-RESISTANT TABLETS NEXIUM ® 40 MG 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 Nexium is and what it is used for 2) What you need to know before you take Nexium 3) How to take Nexium 4) Possible side effects 5) How to store Nexium 6) Contents of the pack and other information 1) WHAT NEXIUM IS AND WHAT IT IS USED FOR Nexium 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. Nexium is used to treat the following conditions: Adults • ‘Gastroesophageal reflux disease’ (GERD). 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 in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘_Helicobacter pylori’_. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti- Inflammatory Drugs). Nexium can also be used to stop stomach ulcers from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). • Prolonged treatment after prevention of rebleeding of ulcers with intravenous Nexium. Adolesc Read the complete document
Health Products Regulatory Authority 16 March 2020 CRN009CLH Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nexium 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate) Excipient(s) with known effect Each gastro-resistant tablet contains sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet _Product imported from the UK and Croatia_ Light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and on the other side 4 CLINICAL PARTICULARS As per PA1019/012/002 5 PHARMACOLOGICAL PROPERTIES As per PA1019/012/002. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Glycerol Monostearate 40-55 Hyprolose Hypromellose Iron oxide (reddish-brown and yellow) (E172) Magnesium stearate Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent Microcrystalline cellulose Synthetic paraffin Macrogol Polysorbate 80 Crospovidone Sodium stearyl fumarate Sugar spheres (sucrose and maize starch) Talc Titanium dioxide (E171) Triethyl citrate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE Health Products Regulatory Authority 16 March 2020 CRN009CLH Page 2 of 3 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 PRODUCT IMPORTED FROM THE UNITED KINGDOM: Do not store above 30°C. Store in the original package. PRODUCT IMPORTED FROM CROATIA: Do not store above 30°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER PRODUCT IMPORTED FROM THE UNITED KINGDOM: Blister packs in wallets of 14 tablets, in an overlabelled outer carton, each containing 2 wallets (28 tablets). PRODUCT IMPORTED FROM CROATIA: Blisters of 28 gastro-resistant tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements for disposal. _Ad Read the complete document