국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OMEPRAZOLE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
OMEPRAZOLE
28Capsule Capsules; 14Capsule Capsules; 70Capsule Capsules
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 OMESEC CAPSULE Omeprazole (20mg) WHAT IS IN THE LEAFLET 1. What Omesec Capsule is used for 2. How Omesec Capsule works 3. Before you use Omesec Capsule 4. How to use Omesec Capsule 5. While you are using it 6. Side effects 7. Storage and Disposal of Omesec Capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT OMESEC CAPSULE IS USED FOR Omesec is used to treat the following conditions: • ‘Gastro-oesophageal reflux disease’ (GERD). This is a condition where the acid from the stomach escapes into the throat. • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). • Ulcers associated with ‘ _Helicobacter _ _pylori’_ infection in combination with other medications such as antibiotics. • Zollinger-Ellison syndrome (overproduction of gastric acid due to tumours). HOW OMESEC WORKS Omesec contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid produced by your stomach. BEFORE YOU USE OMESEC - _When you must not use it_ Do not use Omesec if you are • allergic to omeprazole or any of the other ingredients of Omesec. • pregnant or planning to become pregnant • breast-feeding _ _ - _Before you start to use it _ _ _ Inform your doctor if: • you have any liver disease. Tell your doctor before taking this medicine, if you are due to have a specific blood test (Chromogranin A). Omesec Capsule treatment should be stopped for at least 5 days before the test. Your doctor will prepare test to exclude cancer since Omeprazole may mask symptoms and delay diagnosis. - _Taking other medicines _ _ _ Please inform your doctor if you are taking or have recently taken any other medications, as well as those you bought without a prescription, including but not limited to: • Ketoconazole (for fungal infection) • Digoxin (for heart problems) • Diazepam (for anxiety) • Phenytoin (for 전체 문서 읽기
20 mg Capsules PRODUCT DESCRIPTION Hard gelatin capsule with pink body and caramel cap, each half printed with ‘OMESEC 20’ in black, holding enteric-coated mini-tablets. COMPOSITION Active Ingredient : Omeprazole 20 mg/capsule Preservatives : None PHARMACODYNAMICS Omeprazole is a proton-pump inhibitor and thus prevents the secretion of gastric acid. Omeprazole is a weak base and is activated in acidic pH to a sulphonamide derivative that binds irreversibly to Hydrogen/Potassium Adenosine Triphosphatase (H+/K+ ATPase) enzyme system, the so called 'proton pump' that is found at the secretory surface of parietal cells. It thereby inhibits the final transport of hydrogen ions (via exchange with potassium ions) into the gastric lumen. Omeprazole inhibits both basal and stimulated acid secretion irrespective of the stimulus. It also inhibits hepatic cytochrome P-450 mixed function oxidase system. During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range. PHARMACOKINETICS Omeprazole is rapidly absorbed, but to a variable extent following oral administration. The absorption of Omeprazole is formulation-dependent and dose-dependent but it is not affected by food. Omeprazole in the form of enteric-coated mini-tablets is absorbed from the small intestines and delivered via the bloodstream to the parietal cell. Oral absorption of the enteric-coated formulation is relatively slow and may be further influenced as a result of delayed gastric emptying. Omeprazole is distributed in tissue, particularly gastric parietal cells. It is highly bound to plasma proteins, approx 전체 문서 읽기