Land: Irland
Sprog: engelsk
Kilde: 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)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER PUGRITEX 10 MG & 20 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 Pugritex Gastro-resistant Capsules are and what they are used for 2. What you need to know before you take Pugritex Gastro-resistant Capsules 3. How to take Pugritex Gastro-resistant Capsules 4. Possible side effects 5. How to store Pugritex Gastro-resistant Capsules 6. Contents of the pack and other information 1. WHAT PUGRITEX GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR Pugritex Gastro-resistant 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. Pugritex Gastro-resistant 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 medi Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pugritex 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 Pugritex 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 14/11/2013_ _CRN 2139507_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers_ The recommended dose in patients with Læs hele dokumentet