Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Omeprazole
Bluefish Pharmaceuticals AB
A02BC; A02BC01
Omeprazole
40 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; omeprazole
Marketed
2007-06-01
PACKAGE LEAFLET: INFORMATION FOR THE USER OMEPRAZOLE BLUEFISH 10 MG GASTRO-RESISTANT CAPSULES OMEPRAZOLE BLUEFISH 20 MG GASTRO-RESISTANT CAPSULES OMEPRAZOLE BLUEFISH 40 MG GASTRO-RESISTANT CAPSULES 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Omeprazole Bluefish is and what it is used for 2. What you need to know before you take Omeprazole Bluefish 3. How to take Omeprazole Bluefish 4. Possible side effects 5. How to store Omeprazole Bluefish 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE BLUEFISH IS AND WHAT IT IS USED FOR Omeprazole Bluefish 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 Bluefish is used to treat the following conditions: In adults: • ‘Gastro-esophageal reflux disease’ (GERD). 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 Bluefish can also be used to stop ulcers from forming if you Læs hele dokumentet
Health Products Regulatory Authority 13 April 2023 CRN00DHFY Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole Bluefish 40 mg gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 40 mg of Omeprazole. Excipient with known effect Each 40 mg gastro-resistant capsule contains <160.05mg Sucrose (in sugar spheres) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard gastro-resistant capsules. Opaque blue cap and opaque orange body, containing white to beige granules. Size 0 capsule marked with O40 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole Bluefish capsules 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-esophageal reflux disease Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and ≥ 10 kg_ Treatment of reflux esophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease _Children and adolescents over 4 years of age_ In combination with antibiotics in treatment of duodenal ulcer caused by _H. pylori_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _Treatment of duodenal ulcers_ Health Products Regulatory Authority 13 April 2023 CRN00DHFY Page 2 of 12 The recommended dose in patients with an active duodenal ulcer is Omeprazole Bluefish 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial c Læs hele dokumentet