Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
LANSOPRAZOLE
Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus
A02BC03
LANSOPRAZOLE 15 mg
CAPSULE
LANSOPRAZOLE 15 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2006-08-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LASOPROL 15 MG CAPSULES LASOPROL 30 MG CAPSULES Lansoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4. IN THIS LEAFLET: 1. What Lasoprol is and what it is used for 2. Before you take Lasoprol 3. How to take Lasoprol 4. Possible side effects 5. How to store Lasoprol 6. Further information 1. WHAT IS LASOPROL IS AND WHAT IT IS USED FOR The active ingredient in Lasoprol is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Lasoprol 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 bacteria _Helicobacter pylori_ when given in combination with antibiotic therapy - Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) - Treatment of Zollinger - Ellison syndrome. Your doctor may have prescribed Lasoprol for another indication or with a dose different from that which is wr Přečtěte si celý dokument
1. NAME OF THE MEDICINAL PRODUCT Lasoprol 15 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lasoprol 15 mg capsule contains 15 mg of lansoprazole. Excipients(s): each 15 mg capsule contains 13 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM For 15 mg strength: Green and beige hard gelatin capsules containing white to off-white 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 For optimal effect, Lasoprol 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. Page 1 of 15 Lasoprol should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid. 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 usua Přečtěte si celý dokument