Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Omeprazole
Actavis Group PTC ehf
A02BC; A02BC01
Omeprazole
10 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; omeprazole
Marketed
2010-03-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMEPRAZOLE ACTAVIS 10 MG GASTRO-RESISTANT HARD CAPSULES OMEPRAZOLE ACTAVIS 20 MG GASTRO-RESISTANT HARD CAPSULES OMEPRAZOLE ACTAVIS 40 MG GASTRO-RESISTANT HARD 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, 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, 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 Actavis is and what it is used for 2. What you need to know before you take Omeprazole Actavis 3. How to take Omeprazole Actavis 4. Possible side effects 5. How to store Omeprazole Actavis 6. Contents of the pack and other information 1. WHAT OMEPRAZOLE ACTAVIS IS AND WHAT IT IS USED FOR Omeprazole Actavis 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 Actavis 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 Actavis can also be used to stop ulcers from forming if you Baca dokumen lengkap
Health Products Regulatory Authority 27 September 2019 CRN008YM2 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole 10 mg gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg omeprazole. Excipient with known effect: Sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard opaque yellow capsule The capsules contain off-white (ivory) to cream-white spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole 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 _Adults_ _ _ _Treatment of duodenal ulcers_ Health Products Regulatory Authority 27 September 2019 CRN008YM2 Page 2 of 12 The recommended dose in patients with an active duodenal ulcer is Omeprazole Actavis 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patien Baca dokumen lengkap