Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Omeprazole
Clonmel Healthcare Ltd
A02BC; A02BC01
Omeprazole
20 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; omeprazole
Marketed
2002-06-28
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER LOSAMEL 20MG 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 Losamel is and what it is used for 2. What you need to know before you take Losamel 3. How to take Losamel 4. Possible side effects 5. How to store Losamel 6. Contents of the pack and other information 1. WHAT LOSAMEL IS AND WHAT IT IS USED FOR Losamel 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. Losamel 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). Losamel 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 disease’ (GORD). This is where a Lestu allt skjalið
Health Products Regulatory Authority 04 April 2023 CRN00DH5G Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losamel 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gastro-resistant tablet contains 20.0 mg omeprazole. Excipient(s) with known effect Each gastro-resistant tablet contains 39.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets Round, light grey coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole 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 oesophagitis – Long-term management of patients with healed reflux oesophagitis – Treatment of symptomatic gastro-oesophageal reflux disease – Treatment of Zollinger-Ellison syndrome Paediatric population _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 Adults _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Losamel 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulcer 40 mg omeprazole once daily is recommended a Lestu allt skjalið