Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Laboratorios Davur S.L.U.
40 Base Milligrams
Tablets Gastro-Resistant
2010-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Yellow, oval, biconvex tablets. 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 Pantoprazole Tablet per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole 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 guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combina Read the complete document