Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Laboratorios Davur S.L.U.
OMEPRAZOLE
20 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
2013-12-20
PACKAGE LEAFLET: INFORMATION FOR THE USER OMEPRAZOLE 10 MG GASTRO-RESISTANT CAPSULES OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES OMEPRAZOLE 40 MG 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 symptoms 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 Omeprazole Capsules are and what they are used for 2. What you need to know before you take Omeprazole Capsules 3. How to take Omeprazole Capsules 4. Possible side effects 5. How to store Omeprazole Capsules 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Omeprazole Capsules 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 makes. Omeprazole Capsules are used for treating 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 are infected with bacteria called ‘_Helicobacter pylor_i’. 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-S Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole 20 mg Gastro-resistant Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of Omeprazole. Excipient with known effect: Each 20 mg capsule contains 88.32 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard Opaque blue cap and opaque orange body, containing white to beige granules. Size 2 capsule marked with O20. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole Gastro-resistant Capsules 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_ IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2013_ _CRN 2140456_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers_ The recommended do Lees het volledige document