Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE MAGNESIUM
PCO Manufacturing
OMEPRAZOLE MAGNESIUM
40 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
2012-12-28
PACKAGE LEAFLET: INFORMATION FOR THE USER Losec MUPS 10 mg gastro-resistant tablets Losec MUPS 20 mg gastro-resistant tablets Losec MUPS 40 mg gastro-resistant tablets Omeprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. ⋅ 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. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. ⋅ If any of the side effects gets serious, or if you notice any side effects not lised in this leaflet please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Losec is and what it is used for 2. Before you take Losec 3. How to take Losec 4. Possible side effects 5. How to store Losec 6. Further 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec MUPS 40 mg Gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 41.3 mg omeprazole magnesium equivalent to 40 mg omeprazole. Excipient: Each gastro-resistant tablet contains 39–41 mg sucrose. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from The Netherlands, The UK and Belgium:_ Dark red, oblong, biconvex, film-coated tablets, engraved with ' ' on one side and '40 mg' and a score on the other side containing enteric coated pellets_._ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losec gastro-resistant tablets are indicated for: Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, _Helicobacter pylori (H. pylori) _eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux esophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-esophageal reflux disease • Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and_ _10 kg_ • Treatment of reflux esophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro- esophageal reflux disease. _Children and adolescents over 4 years of age_ • In combination with antibiotics in treatment of duodenal ulcer caused by _H. pylori_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers_ The recommended dose in patients with Read the complete document