Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
Pensa Pharma AB
A02BC01
OMEPRAZOLE
10 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Authorised
2011-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER OMEPRAZOLE PENSA 10 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE PENSA 20 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE PENSA 40 MG GASTRO-RESISTANT CAPSULES, HARD Omeprazole 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 Omeprazole Pensa is and what it is used for 2. What you need to know before you take Omeprazole Pensa 3. How to take Omeprazole Pensa 4. Possible side effects 5. How to store Omeprazole Pensa 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE PENSA IS AND WHAT IT IS USED FOR Omeprazole Pensa contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Omeprazole Pensa is used to treat the following conditions: In adults: - ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. - Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). - Ulcers which are infected with bacteria called ‘_Helicobacter pylori’_. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. - Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Omeprazole Pensa can also be used to stop ulcers from forming if you are taking NSAIDs. - Too much acid in the s Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole Pensa 10 mg Gastro-resistant Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule contains 10 mg omeprazole. Excipient with known effect: each gastro-resistant capsule contains 18.8-21.5 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Omeprazole Pensa 10 mg gastro-resistant capsules: Opaque white capsules marked with “OM 10”. Contains white to light beige rounded granules. Size number 4 capsules (length 14.5 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole Pensa gastro-resistant capsules, hard are indicated for: Adults Treatment of duodenal ulcers Prevention of relapse of duodenal ulcers Treatment of gastric ulcers Prevention of relapse of gastric ulcers In combination with appropriate antibiotics,_ Helicobacter pylori (H. pylori)_ eradication in peptic ulcer disease Treatment of NSAID-associated gastric and duodenal ulcers Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk Treatment of reflux esophagitis Long-term management of patients with healed reflux esophagitis Treatment of symptomatic gastro-oesophageal reflux disease Treatment of Zollinger-Ellison syndrome Paediatric population _Children over 1 year of age and_ _10 kg_ Treatment of reflux esophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease _Children and adolescents over 4 years of age_ In combination with antibiotics in treatment of duodenal ulcer caused by_ H. pylori_ H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap