国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Lansoprazole
Pinewood Laboratories 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
2013-11-25
PACKAGE LEAFLET For medicinal products available on prescription PACKAGE LEAFLET: INFORMATION FOR THE USER LANSOPRAZOLE PINEWOOD 15 MG GASTRO-RESISTANT HARD CAPSULES LANSOPRAZOLE PINEWOOD 30 MG GASTRO-RESISTANT HARD 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 Lansoprazole Pinewood is and what it is used for 2. What you need to know before you take Lansoprazole Pinewood 3. How to take Lansoprazole Pinewood 4. Possible side effects 5. How to store Lansoprazole Pinewood 6. Contents of the pack and other information 1. WHAT LANSOPRAZOLE PINEWOOD IS AND WHAT IT IS USED FOR The active ingredient in Lansoprazole Pinewood 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 Pinewood 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 Pinewood for another indication or with a dose different from that which is written in this information 阅读完整的文件
Health Products Regulatory Authority 26 January 2023 CRN00D9Q3 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lansoprazole Pinewood 30mg Gastro-resistant Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of lansoprazole Excipient(s) with known effect: Each 30 mg capsule contains 200.949 mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Lansoprazole Pinewood 30 mg gastro-resistant capsules, hard are opaque white cap and body capsules. Each capsule contains 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 gastroesophageal reflux disease Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For optimal effect, Lansoprazole Pinewood 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. Lansoprazole Pinewood should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid. The peelable blisters are opened as described following foil opening instructions: - Remove one blister by tearing down perforations - Carefully peel back corner of foil to reveal capsule (CAPSULE CANNOT BE PUSHED THROUGH FOIL) The non peelable blisters are opened by pushing through the aluminium foil. Treatment of duodenal ulcer: The recommended dose is 30 阅读完整的文件