Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE
Ranbaxy (UK) Limited
PANTOPRAZOLE
40 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pantoprazole Ranbaxy 40 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg Pantoprazole (as pantoprazole sodium sesquihydrate 45.2 mg). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Yellow enteric coated oval shaped, biconvex tablets imprinted with ‘IV’ on one side and plain on other side. 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 gastro-resistant tablet Pantoprazole 40 mg per day. In individual cases the dose may be doubled (increase to 2 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 guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and Pročitajte cijeli dokument