Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Lansoprazole
McDermott Laboratories Ltd., T/A Gerard Laboratories
A02BC; A02BC03
Lansoprazole
30 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; lansoprazole
Not marketed
2005-04-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAZOLAGER 15 MG HARD GASTRO-RESISTANT CAPSULES RAZOLAGER 30 MG HARD GASTRO-RESISTANT CAPSULES lansoprazole 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 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 Razolager is and what it is used for 2. What you need to know before you take Razolager 3. How to take Razolager 4. Possible side effects 5. How to store Razolager 6. Contents of the pack and other information 1. WHAT RAZOLAGER IS AND WHAT IT IS USED FOR The active ingredient in your medicine is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. _ _ Razolager is used to treat adults. Your doctor may prescribe Razolager for the following conditions: - Treatment of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer) - Treatment of inflammation in your oesophagus (reflux oesophagitis) - Prevention of reflux oesophagitis - Treatment of Gastro-oesophageal reflux disease causing heartburn and acid regurgitation - Treatment of infections caused by the bacteria _Helicobacter pylori_ when given in combination with antibiotic therapy - Treatment or prevention of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer) in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) - Treatment of Zollinger-Ellison syndrome (a growth in the pancreas causing too much acid in the stomach). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAZOLAGER DO Baca dokumen lengkapnya
Health Products Regulatory Authority 11 August 2023 CRN00DP3D Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Razolager 30 mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of lansoprazole Excipients with known effect Each 30 mg capsule contains 200.95 mg of sucrose (as in sugar spheres). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule Size 1 (approx. 19 mm), opaque white hard gelatin capsule containing white or almost white spherical microgranules. 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 gastro-oesophageal reflux disease • Zollinger-Ellison syndrome. Razolager is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For optimal effect, Razolager 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 treatment 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 treatment maybe continued at the same dose for another 4 weeks. Treatment of reflux oesophagitis: The recommended dose is 30 mg once Baca dokumen lengkapnya