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July 1, 2016


Company: KRKA Pharma Dublin Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Pantoprazole 20mg, 40mg.
Description: Light brownish-yellow, oval, slightly biconvex gastro-resistant tablets.
Presentations: 20mg-28, €8.18; 40mg-28, €15.12.
Indications: Nolpaza 20mg: Adults and adolescents 12 years and above: Symptomatic gastro-oesophageal reflux disease (GORD); long-term management and prevention of relapse in reflux oesophagitis (RO). Adults: Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in patients at risk with a need for continuous NSAID treatment. Nolpaza 40mg: Adults and adolescents 12 years and above: Reflux oesophagitis. Adults: Eradication of H. pylori in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers; gastric and duodenal ulcer; Zollinger-Ellison-Syndrome (ZES) and other pathological hypersecretory conditions.
Pharmacology: Proton pump inhibitor. Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on the proton pumps of the parietal cells.
Dosage: Adult: GORD: 20mg daily for 2-4 weeks; if relief not sufficient, may be taken for a further 4 weeks.  Maintenance, 20mg when required. RO (long-term, prevention of relapse): 20mg daily. Increase to 40mg daily if relapse occurs. Prevention of NSAID-induced gastroduodenal ulcers: 20mg daily. Gastric ulcer and RO: 40mg daily for 4 weeks; dose may be doubled when there has been no response to other treatment; duration may be extended by a further 4 weeks. Duodenal ulcer: 40mg daily for 2 weeks; dose may be doubled when there has been no response to other treatment; duration may be extended by a further 2 weeks. Eradication of H. pylori: 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg twice daily or clarithromycin 250-500mg + metronidazole 400-500mg (or 500mg tinidazole) twice daily or amoxicillin 1g twice daily + metronidazole 400-500mg (or 500mg tinidazole) twice daily. ZES and other hypersecretory conditions: Initially 80mg daily; with doses >80mg daily, divide dose and give twice daily; may be temporarily increased to >160mg (no longer than required for adequate acid control). Severe hepatic impairment: Maximum 20mg daily. Elderly: As per adults. Children: 12 years and above, RO and GORD only, as per adults. Under 12 years, not recommended.
Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles, sorbitol or to any of the other excipients. Pregnancy (unless necessary). 40mg tablets: Severe hepatic insufficiency or renal impairment (in combination therapy for the eradication of H. pylori).
Special precautions: Exclude malignant disease of the oesophagus or stomach prior to treatment. May lead to a slightly increased risk of GI infections (e.g. Salmonella and Campylobacter. Investigate patients who do not respond to treatment. Caution: Severe liver impairment (monitor liver enzymes regularly, discontinue if levels increase), long-term treatment (regular surveillance). May reduce vitamin B12 absorption. Lactation (only if benefit outweighs risk). Contains sorbitol.
Drug interactions: Not recommended: Atazanavir (if unavoidable close clinical monitoring recommended; increase atazanavir dose to 400mg with 100mg of ritonavir). Caution: Drugs with pH-dependent bioavailability (e.g. ketoconazole, itraconazole, posaconazole, erlotinib), coumarin-type anticoagulants.
Adverse drug reactions: Headache, diarrhoea.

Full prescribing information and references available from KRKA Pharma Dublin Ltd.