LANSOPRAZOLE

1 Lansoprazole SPC, Labeling and Package Leaflet Common PI_Text043670_2 - Updated: Page 4 of 29 For optimal effect, <Invented name> should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.

Treatment of duodenal ulcer:

The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another 2 weeks.

Treatment of gastric ulcer:

The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.

Reflux oesophagitis:

The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. Prophylaxis of reflux oesophagitis: 15 mg once daily. The dose may be increased up to 30 mg daily as necessary.

Eradication of Helicobacter pylori:

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The recommended dose is 30 mg of <Invented name> twice daily for 7 days in combination with one of the following: clarithromycin 250−500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400−500 mg twice daily H.

pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with <Invented name> and amoxicillin or metronidazole. Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.

Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400−500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin.

Tabulated list of adverse reactions Frequencies are defined as common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). For all adverse reactions reported from post marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.

Gastric malignancy In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.

5). 1 Lansoprazole SPC, Labeling and Package Leaflet Common PI_Text043670_2 - Updated: Page 6 of 29 Influence on vitamin B12 absorption Lansoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.

This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long term therapy or if respective symptoms are observed. 2). Gastrointestinal infections caused by bacteria Lansoprazole, like all PPIs, might increase the counts of bacteria normally present in the gastrointestinal tract.

This may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter, and Clostridium difficile. In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.

If lansoprazole is used in combination with antibiotics for eradication therapy of H. pylori, then the summary of product characteristics of these antibiotics should also be followed. Long-term treatment Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.

Gastrointestinal disorders Very rarely cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered. g. g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

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