Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Omeprazole
IMED Healthcare Ltd.
A02BC; A02BC01
Omeprazole
20 milligram(s)
Gastro-resistant tablet
Proton pump inhibitors; omeprazole
2006-09-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOSEC ® MUPS ® 20 MG GASTRO-RESISTANT TABLETS omeprazole 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 Losec is and what it is used for 2. What you need to know before you take Losec 3. How to take Losec 4. Possible side effects 5. How to store Losec 6. Contents of the pack and other information 1. WHAT LOSEC IS AND WHAT IT IS USED FOR Losec gastro-resistant tablets contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Losec is used to treat the following conditions: In adults: • ‘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 in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). • Ulcers which 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. • Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). In children: _Children over 1 year of age and ≥ 10 kg _ • ‘Gastro-oesophageal reflux dis Lestu allt skjalið
Health Products Regulatory Authority 24 January 2022 CRN00CQT1 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec MUPS 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium equivalent to 20 mg omeprazole Excipients with known effect: sucrose (contained in sugar spheres). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from Belgium_ Pink, oblong, biconvex, film-coated tablets engraved with a logo on one side and '20 mg' on the other side containing enteric coated pellets. 4 CLINICAL PARTICULARS As per PA2239/009/002 5 PHARMACOLOGICAL PROPERTIES As per PA2239/009/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Glycerol monostearate Hyprolose Hypromellose Magnesium stearate Methacrylic acid co-polymer C Sugar spheres (contain sucrose) Paraffin Macrogol Polysorbate Crospovidone Sodium stearyl fumarate Sodium hydroxide* Talc Triethyl citrate Iron oxide (E172) Titanium dioxide (E171) * May be added as a pH adjuster 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 24 January 2022 CRN00CQT1 Page 2 of 2 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER _Belgium: _Blisters in an outer cardboard carton. Pack size: 28 tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/141/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8th September 2006 Date of last renewal: 8th S Lestu allt skjalið