Pantoprazol-BP

Pantoprazol

Each vial contains pantoprazole 40 mg (as pantoprazole sodium sesquihydrate). White or almost white lyophilised powder or porous mass.

Indication: Reflux oesophagitis. Gastric and duodenal ulcer. Zollinger-Ellison syndrome and other pathological hypersecretory conditions.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to the active substance, to benzimidazole substitutes, or to any of the excipients listed in section 6.1.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Gastric malignancy Symptomatic response to treatment with pantoprazole may mask symptoms of gastric malignancy and delay diagnosis. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded. If symptoms persist despite adequate treatment, further investigation should be conducted. Hepatic impairment In patients with severe hepatic impairment, liver enzymes should be monitored during treatment. Treatment should be discontinued if liver enzyme levels increase (see section 4.2). Concomitant use with atazanavir Concomitant use of atazanavir with proton pump inhibitors […]