Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Universal Farma S.L.
20 Milligram
Capsules Gastro-Resistant
2003-11-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lopraz 20 mg gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg omeprazole Excipients: Contains sucrose, see section 4.4 -Each 20mg omeprazole capsule contains 102 to 116mg of sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard Opaque yellow capsule containing off-white to cream-white enteric coated spherical microgranules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lopraz 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 Lopraz 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after Przeczytaj cały dokument