Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lansoprazole
Almus Pharmaceuticals Ltd
A02BC03
Lansoprazole
15mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LANSOPRAZOLE 15 MG & 30 MG 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 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 IN THIS LEAFLET 1. What Lansoprazole Capsules is and what it is used for 2. What you need to know before you take Lansoprazole Capsules 3. How to take Lansoprazole Capsules 4. Possible side effects 5. How to store Lansoprazole Capsules 6. Contents of the pack and other information 1. WHAT LANSOPRAZOLE CAPSULES 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 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 Lansoprazole for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor’s instructions for taking your medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE CAP Læs hele dokumentet
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. _ _ Excipient with known effect : Each capsule contains 64.8 mg sucrose (in sugar spheres) For the 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 • 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 _He Læs hele dokumentet