País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Lansoprazole
Clonmel Healthcare Ltd
A02BC; A02BC03
Lansoprazole
30 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; lansoprazole
Marketed
2005-08-26
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOMEL 15 MG GASTRO-RESISTANT CAPSULES, HARD ZOMEL 30 MG GASTRO-RESISTANT CAPSULES, HARD 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 included any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Zomel is and what it is used for 2. What you need to know before you take Zomel 3. How to take Zomel 4. Possible side effects 5. How to store Zomel 6. Contents of the pack and other information 1. WHAT ZOMEL IS AND WHAT IT IS USED FOR The active ingredient in Zomel is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Zomel 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 for pain or inflammation) • treatment of Zollinger-Ellison syndrome. Your doctor may have prescribed Zomel 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 ZOMEL DO NOT TAKE ZOMEL: • If you are allergic to lansoprazole or any of the oth Leia o documento completo
Health Products Regulatory Authority 11 August 2023 CRN00DC2P Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zomel 30 mg gastro-resistant capsule, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule, hard contains 30 mg of lansoprazole. Excipient(s) with known effect: Each 30 mg capsule contains 190.14 – 217.47 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Opaque, white hard-gelatine capsule, containing pellets with enteric coating. 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 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 For optimal effect, Zomel 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 medication is continued at the same dose for another 2 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, Leia o documento completo