Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Omeprazole
Teva Pharma B.V.
A02BC; A02BC01
Omeprazole
20 milligram(s)
Gastro-resistant capsule
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; omeprazole
Not marketed
2007-06-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMEPRAZOLE TEVA PHARMA 10 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE TEVA PHARMA 20 MG GASTRO-RESISTANT CAPSULES, HARD OMEPRAZOLE TEVA PHARMA 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 Teva Pharma is and what it is used for 2. What you need to know before you take Omeprazole Teva Pharma 3. How to take Omeprazole Teva Pharma 4. Possible side effects 5. How to store Omeprazole Teva Pharma 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE TEVA PHARMA IS AND WHAT IT IS USED FOR Omeprazole Teva Pharma 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 Teva Pharma 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 Teva Pharma can also be Les hele dokumentet
Health Products Regulatory Authority 13 January 2020 CRN008WPW Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole Teva Pharma 20 mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg omeprazole. EXCIPIENT WITH KNOWN EFFECT: Each 20 mg capsule contains 80 mg sucrose. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. 20 mg Capsules: Opaque blue cap and opaque orange body, containing white to beige granules. Size 2 capsule marked with O20. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole Teva Pharma gastro-resistant 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 oesophagitis Long-term management of patients with healed reflux oesophagitis Treatment of symptomatic gastro-oesophageal reflux disease Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and ≥ 10 kg_ Treatment of reflux oesophagitis 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 _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Health Products Regulatory Authority 13 January 2020 CRN008WPW Page 2 of 12 _Adults_ _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is 20 mg omeprazole once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the i Les hele dokumentet