Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Omeprazole
CHEPLAPHARM Arzneimittel GmbH
A02BC; A02BC01
Omeprazole
40 milligram(s)
Gastro-resistant tablet
Proton pump inhibitors; omeprazole
Marketed
1999-09-17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 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: _Ch Lire le document complet
Health Products Regulatory Authority 11 October 2023 CRN00DHC2 Page 1 of 12 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(s) with known effect Each gastro-resistant tablet contains 39–41 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Dark red-brown, 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 in: 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 oesophagitis Long-term management of patients with healed reflux oesophagitis Treatment of symptomatic gastro-oesophageal reflux disease Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and ≥ 10 kg_ Treatment of reflux oesophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal 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 Health Products Regulatory Authority 11 October 2023 CRN00DHC2 Page 2 of 12 _Adults_ _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Losec 20 mg once daily. In most patients healing occurs within two week Lire le document complet