PANTOBEX DELAYED RELEASE TABLET 40MG

TABLET, DELAYED RELEASE

**4.2. Posology and method of administration** **_Pantobex Delayed Release Tablet 20_ mg** Pantobex 20 mg delayed-release tablets should not be chewed or crushed, and should be swallowed whole with water.  **_Pantobex Delayed Release Tablet 40_ mg** Pantobex 40 mg delayed-release tablets should not be chewed or crushed, and should be swallowed whole with water.  **Special Patient Populations** _**Pediatric patients:**_ The experience in children is limited. Pantoprazole 20 mg and 40 mg tablet is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group. Pantoprazole 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age. _**Impaired hepatic function:**_ A daily dose of Pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (See section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In addition, Pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin,) for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients (See section 4.3). _**Impaired renal function:**_ No dose adjustment is necessary in those with impaired renal function. In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of H. pylori in patients with impaired renal function, since currently no data are available on the efficacy and safety of pantoprazole in combination treatment for these patients. _**Elderly patients:**_ Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40mg should not be exceeded in treatment of gastric or duodenal ulcer.