Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Actavis Group PTC ehf
10 Milligram
Capsules Gastro-Resistant
2009-05-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole 10 mg Gastro-resistant hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 10 mg of omeprazole Excipient: sucrose. · Each 10mg capsule contains 51 to 58mg of sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Opaque yellow capsule containing off-white to cream-white spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole 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 23/04/2012_ _CRN 2108807_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is O Read the complete document