Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Astellas Pharma Co. Ltd
20 Milligram
Capsules Gastro-Resistant
2006-04-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ulcid 20 mg gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 20 mg of omeprazole. Excipient: Each gastro-resistant capsule contains 116mg lactose monohydrate. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard (capsule) Opaque, white hard capsules marked with imprint '20' on the body and 'OM' on the cap. The capsules contain gastro- resistant microtablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ulcid gastro-resistant capsules are indicated for: Adults: o Treatment of duodenal ulcers o Prevention of relapse of duodenal ulcers o Treatment of gastric ulcers o Prevention of relapse of gastric ulcers o In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease o Treatment of NSAID- associated gastric and duodenal ulcers o Prevention of NSAID–associated gastric and duodenal ulcers in patients at risk o Treatment of reflux oesophagitis o Long-term management of patients with healed reflux esophagitis o Treatment of symptomatic gastro-oesophageal reflux disease o Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and_ _10 kg_ o Treatment of reflux esophagitis o Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease _Children and adolescents over 4 years of age_ o In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/03/2012_ _CRN 2091617_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Adults _Treatment of duodenal ulcers_ The recommended dose i Belgenin tamamını okuyun