Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Esomeprazole
IMED Healthcare Ltd.
A02BC05
Esomeprazole
40 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
esomeprazole
Authorised
2008-04-11
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. Adolescents a Lire le document complet
Health Products Regulatory Authority 22 December 2021 CRN00CPFX Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nexium 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40mg esomeprazole (as magnesium trihydrate) Excipient(s) with known effect: Each gastro resistant table contains sucrose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from France, and Greece:_ Pink, oblong, biconvex , film-coated gastro-resistant tablet engraved ‘40mg’ on one side and ‘A/EI’ on the other. 4 CLINICAL PARTICULARS As per PA2242/013/003 5 PHARMACOLOGICAL PROPERTIES As per PA2242/013/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Glycerol monostearate 40-55 Hyprolose Hypromellose Iron oxide (reddish-brown) (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 22 December 2021 CRN00CPFX Page 2 of 3 The shelf-life expiry date of this product is 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 Do not store above 30°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER France and Greece: Aluminium blisters with cardboard reinforcement (blister wallet) in an over-labelled cardboard carton containing 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING _Administration through gastric tube _ 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 mL water and approximately 5 mL air. For some tubes, dispersion in 50 mL water is needed to prevent the pellets Lire le document complet