Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Ergha Healthcare Ltd
10 Milligram
Capsules Gastro-Resistant
2005-05-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BySec 10 mg gastro-resistant hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule contains 10 mg of omeprazole Excipient: each capsule contains 26.20 mg of sucrose, methyl-p-hydroxybenzoate (E218) and propyl-p- hydroxybenzoate (E216). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Opaque yellow and opaque white capsule with imprint ‘10mg’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BySec 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_ 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 BySec 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully he Read the complete document