দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
LANSOPRAZOLE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
A02BC03
LANSOPRAZOLE 15 mg
ORODISPERSIBLE TABLET
LANSOPRAZOLE 15 mg
POM
DRUGS FOR ACID RELATED DISORDERS
Authorised
2012-08-17
PAGE 1 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS LANSOPRAZOLE 30 MG ORODISPERSIBLE TABLETS 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 Lansoprazole is and what it is used for. 2. What you need to know before you take Lansoprazole. 3. How to take Lansoprazole. 4. Possible side effects. 5. How to store Lansoprazole. 6. Contents of the pack and other information. 1. WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR The active ingredient in Lansoprazole 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 for the following: - Treatment of duodenal (gut) and stomach ulcers. - Treatment of inflammation in your food pipe (reflux oesophagitis). - Prevention of reflux oesophagitis. - Treatment of heartburn and acid regurgitation. - Treatment of infections caused by the bacteria _Helicobacter pylori_ when given together with an antibiotic. - Treatment or prevention of duodenal (gut) 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 Lansoprazole to treat another condition or with a dose different from those written in this leaflet. Please follow your doctor’s instructions for taking your medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE DO NOT TAKE LANSOPRAZOLE : - if you are a সম্পূর্ণ নথি পড়ুন
PAGE 1 OF 15 SUMMARY OF PRODUCT CHARACTERISTICS, PAGE 2 OF 15 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 3 OF 15 1. NAME OF THE MEDICINAL PRODUCT Lansoprazole 15 mg Orodispersible Tablets Lansoprazole 30 mg Orodispersible Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg of lansoprazole (as gastro-resistant pellets) Each orodispersible tablet contains 30 mg of lansoprazole (as gastro-resistant pellets) Excipients with known effect Each orodispersible tablet contains 5.97 mg of aspartame (E951) Each orodispersible tablet contains 11.93 mg of aspartame (E951) Each orodispersible tablet contains 13.8 mg of sucrose Each orodispersible tablet contains 27.6 mg of sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White to yellowish white round, approximately 11 mm in diameter, flat-faced beveled edged tablet engraved with “LP1” on one side and “M” on other side with orange to dark brown speckles. White to yellowish white round, approximately 12.7 mm in diameter, flat-faced beveled edged tablet engraved with “LP2” on one side and “M” on other side with orange to dark brown speckles. 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 non-steroidal anti-inflammatory drug (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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment of duodenal ulcer: The recommended dose is 30 mg once daily for 2 weeks. In সম্পূর্ণ নথি পড়ুন