מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Omeprazole
Rowa Pharmaceuticals Limited
A02BC; A02BC01
Omeprazole
10 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; omeprazole
Marketed
2005-02-04
_MARKETED BY _ 1. WHAT OMEPRAZOLE ROWA IS AND WHAT IT IS USED FOR Omeprazole Rowa 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 Rowa 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 Rowa can also be used to stop ulcers from forming if you are taking NSAIDs. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). In children: Children over 1 year of age and ≥ 10 kg • Gastro-oesophageal 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. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain. Children and adolescents over 4 years of age • Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE ROWA DO NOT TAKE OMEPRAZOLE ROWA • If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6). • If you are allergic to medicines containing other proton pump inhibitors קרא את המסמך השלם
Health Products Regulatory Authority 20 January 2021 CRN00C0MF Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole Rowa 10 mg Gastro-resistant Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 10 mg of omeprazole. Excipient(s) with known effect: Each 10mg capsule contains 51 to 58mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque yellow capsule containing off-white to cream-white spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole Rowa is indicated in: 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 Reflux oesophagitis. Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal 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 20 January 2021 CRN00C0MF Page 2 of 12 The recommended dose in patients with an active duodenal ulcer is Omeprazole Rowa 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 קרא את המסמך השלם