PROTON PANTOPRAZOLE Anti-Ulcerative     COMPOSITION Each gastro-resistant tablet contains: Pantoprazole sodium equivalent to 40mg pantoprazole. PHARMACOLOGICAL PROPERTIES : Pantoprazole is selective proton pump inhibitor, substituted benzimidazole.     INDICATIONS - Gastric ulcer - Duodenal ulcer - Moderate and severe reflux oesophagitis     DOSAGE AND ADMINISTRATION Benign gastric ulcer or gastro-oesophageal reflux disease : One Proton tablet (40mg) daily in the morning for 4 weeks, followed by further 4 weeks if not fully healed. Duodenal ulcer : One Proton tablet (40mg) daily in the morning for 2 weeks, followed by further 2 weeks if not fully healed. GENERAL INSTRUCTIONS FOR USE : * The suitable dosing and duration of therapy will be prescribed by the Physician. * Proton gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with water 1 hour before breakfast. * As experience with long term administration in human is insufficient, treatment with Proton should not exceed 8 weeks. * The daily dose of 40mg Proton should not be exceeded in elderly patients or in those with impaired renal function.     PRECAUTIONS - Proton should be used with caution in patients with severe liver impairment. The dose has to be reduced to 1 tablet (40mg) every other day also the liver enzymes should be monitored during therapy. In case of a rise of the liver enzymes, Proton should be discontinued. - As clinical experience in pregnant women is limited, Proton should be used with caution in pregnancy and breast feeding and should only be used when the potential benefits outweighs risks . - Before treatment, the presence of gastric or oesophageal malignancy should be excluded. - To date, there has been no experience with treatment in children. - There are no known effects on the ability to drive and use machines.     CONTRAINDICATIONS Known hypersensitivity to one of the constituents of Proton.     SIDE EFFECTS Treatment with Proton can occasionally lead to headache or diarrhoea. Rare cases of skin rash, pruritus, dizziness, nausea and increased liver enzymes have been reported.     DRUG INTERACTIONS Proton may reduce the absorption of drugs whose bioavailability is pH-dependent (e.g. Ketoconazole). Proton is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of Proton with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. Noteworthy plasma concentration of digoxin possibly increased.     PRESENTATIONS Proton is available as gastro-resistant tablets of 40 mg Pantoprazole.