Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Nycomed GmbH
20 Milligram
Tablets Gastro-Resistant
2008-03-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Protium 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). _Excipient_ For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet (tablet). Yellow, oval biconvex film-coated tablet imprinted with “P20” in brown ink on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above_ Symptomatic gastro-oesophageal reflux disease. For long-term management and prevention of relapse in reflux oesophagitis. _Adults_ Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4). 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 Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one gastro-resistant tablet Protium 20 mg per day. Symptom relief is generally accomplished within 2 -4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment. Long-term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one gastro-resistant tablet Protium 20 mg per day is recommended, Lestu allt skjalið