Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Chemo Iberica S.A.
A02BC01
OMEPRAZOLE
40 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Transfer Pending
2015-06-12
PL-OME-IE-NL.H.0519.001-003.IA.041-clean 29.09.2015 PACKAGE LEAFLET: INFORMATION FOR THE USER LOPRAZ 10 MG GASTRO-RESISTANT CAPSULES LOPRAZ 20MG GASTRO-RESISTANT CAPSULES LOPRAZ 40MG GASTRO-RESISTANT CAPSULES 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 Lopraz is and what it is used for 2. What you need to know before you take Lopraz 3. How to take Lopraz 4. Possible side effects 5. How to store Lopraz 6. Contents of the pack and other information 1. WHAT LOPRAZ IS AND WHAT IT IS USED FOR Lopraz 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. Lopraz is used to treat the following conditions: In adults: ‘Gastro-esophageal reflux disease’ (GERD). 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 Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lopraz 40 mg Gastro-resistant Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 40 mg of omeprazole Excipient(s) with known effect: Each 40mg capsule contains 203 to 233mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Opaque blue and opaque white capsule containing off-white to cream-white spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lopraz is 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 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_ HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 21/06/2016_ _CRN 2168796_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Lopraz 20 mg once daily. In Læs hele dokumentet