Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Omeprazole
PCO Manufacturing Ltd.
A02BC01
Omeprazole
10 milligram(s)
Gastro-resistant tablet
omeprazole
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOSEC MUPS ® 10 MG GASTRO-RESISTANT TABLETS 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 an Read the complete document
Health Products Regulatory Authority 19 July 2023 CRN00DPDH Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec MUPS 10 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 10.3 mg omeprazole magnesium equivalent to 10 mg omeprazole. Excipient(s) with known effect: sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from Belgium:_ Losec 10 mg gastro-resistant tablets: Light-pink, oblong, biconvex, film-coated tablets engraved with logo on one side and 10 mg on the other side. 4 CLINICAL PARTICULARS As per PA2239/009/001 5 PHARMACOLOGICAL PROPERTIES As per PA2239/009/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Cellulose microcrystalline, glyceryl monostearate 40-55, Hydroxypropylcellulose, Hypromellose, Magnesium stearate, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent, Sugar spheres, Synthetic paraffin (NF), Macrogol (polyethylene glycol 6000), Polysorbate 80, Crospovidone, sodium hydroxide (for pH‑adjustment), Sodium stearyl fumarate, Talc, Triethyl citrate, Iron oxide, Titanium dioxide 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 19 July 2023 CRN00DPDH Page 2 of 2 6.3 SHELF LIFE 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 25 °C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Carton containing 4 blister strips (7 tablets per strip). Pack size: 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/423/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first autho Read the complete document