Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Niche Generics Limited
40 Milligram
Tablets Gastro-Resistant
2009-03-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole Niche 40 mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate). Excipient: Each Pantoprazole Niche 40 mg Gastro-Resistant Tablet contains 36 mg sorbitol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. A light brownish yellow, oval, slightly biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above_ - Reflux oesophagitis. _Adults_ - Eradication of Helicobacter pylori (H. _pylori_) in combination with appropriate antibiotic therapy in patients with H. _pylori _associated ulcers. - Gastric and duodenal ulcer. - Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water. RECOMMENDED DOSE ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE _Reflux oesophagitis_ One tablet of Pantoprazole Niche 40 mg gastro-resistant tablets per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole Niche 40 mg gastro-resistant tablets daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. ADULTS Eradication of H. pylori in combination with two appropriate antibiotics In H. _pylori _positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local gu Olvassa el a teljes dokumentumot