Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lansoprazole
A A H Pharmaceuticals Ltd
A02BC03
Lansoprazole
15mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5025903005407 5025903092896
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lansoprazole 15mg Gastro-resistant Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15mg of Lansoprazole. Excipient with known effect Each capsule contains 81mg sucrose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard White / red-brownish capsules (size no. 3) filled with a white to light brown or slightly pink coloured pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of _Helicobacter pylori _(_H. pylori_) concurrently given with appropriate antibiotic therapy for treatment of _H.pylori_-associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 two 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 Διαβάστε το πλήρες έγγραφο