Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
LANSOPRAZOLE
Laboratorios Davur S.L.U.
LANSOPRAZOLE
15 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Withdrawn
2014-04-01
Lansoprazole - PT/H/113/01-02/II/026 - Type II to add Cutaneous lupus erythematosus PACKAGE LEAFLET : INFORMATION FOR THE PATIENT LANSOPRAZOLE 15 MG & 30 MG [AND ASSOCIATED NAMES] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lansoprazole [and associated names] Capsules are and what they are used for 2. What you need to know before you take Lansoprazole [and associated names] Capsules 3. How to take Lansoprazole [and associated names] Capsules 4. Possible side effects 5. How to store Lansoprazole [and associated names] Capsules 6. Contents of the pack and other information 1. WHAT LANSOPRAZOLE [AND ASSOCIATED NAMES] CAPSULES ARE AND WHAT THEY ARE USED FOR The active ingredient in Lansoprazole [and associated names] is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Lansoprazole [and associated names] for the following indications: • Treatment of duodenal and stomach ulcer • Treatment of inflammation in your oesophagus (reflux oesophagitis) • Prevention of reflux oesophagitis • Treatment of heartburn and acid regurgitation • Treatment of infections caused by the Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lansoprazole 15 mg gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 15 mg of lansoprazole. Excipients: Each capsule contains 64.8 mg sucrose (in sugar spheres) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard Capsules number 3, cap opaque white coloured marked with “L” in black ink, body opaque white coloured marked with “15” in black ink, filled with white to beige micropellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of duodenal and gastric ulcer o Treatment of reflux oesophagitis o Prophylaxis of reflux oesophagitis o Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment o Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy o Symptomatic gastroesophageal reflux disease o 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. IRISH MEDICINES BOARD _____________________________________________________________________________ Прочитајте комплетан документ