מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
ZUELLIG PHARMA SDN BHD
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
14tablet Tablets
ASTRAZENECA AB
AXIAGO MUPS ® _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ESOMEPRAZOLE (20MG, 40MG) WHAT IS IN THIS LEAFLET 1. What Axiago MUPS is used for 2. How Axiago MUPS works 3. Before you use Axiago MUPS 4. How to use Axiago MUPS 5. While you are using it 6. Side effects 7. Storage & Disposal of Axiago MUPS 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of Revision WHAT AXIAGO MUPS IS USED FOR Axiago MUPS is used to treat the following conditions in Adults and young people aged 12 years and above: • ‘Gastro-oesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the oesophagus (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. Axiago MUPS is used for symptomatic and long-term management of patients with healed esophagitis to prevent recurrence. Axiago MUPS is also used to treat the following conditions in Adults: • In combination with an appropriate antibacterial medication to eradicate _Helicobacter pylori_ , promote healing of these duodenal ulcers and prevent relapse of peptic ulcers in patients with _Helicobacter pylori _ associated ulcers. • Patients who need continued (Non-Steroidal Anti- Inflammatory Drugs) NSAID therapy for the healing of stomach ulcers associated with NSAID therapy and to prevent stomach and duodenal ulcers associated with NSAID therapy in patients at risk. • Prolonged treatment after intravenous induced prevention of re-bleeding of peptic ulcers. • Zollinger Ellison Syndrome, which is a rare condition where one or more tumors form in the pancreas or upper part of the small intestine (duodenum). These tumors, called gastrinomas, secrete large amounts of the hormone gastrin, which causes the stomach to produce too much acid. HOW AXIAGO MUPS WORKS Axiago MUPS contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. BEFORE YOU USE AXIAGO MUPS _-_ _ קרא את המסמך השלם
1 AXIAGO MUPS ® TABLET 20 MG & 40 MG Esomeprazole COMPOSITION Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium trihydrate). Excipients: Axiago MUPS Tablet 20 mg: Sucrose 28 mg. Axiago MUPS Tablet 40 mg: Sucrose 30 mg. For excipients see "List of excipients". PHARMACEUTICAL FORM Gastro-resistant tablets 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A EI on the other side. Each tablet contains esomeprazole as enteric-coated pellets (MUPS). DESCRIPTION AXIAGO MUPS is a proton pump inhibitor. The active ingredient in Axiago MUPS is esomeprazole magnesium trihydrate, a substituted benzimidazole. Esomeprazole is the S-isomer of omeprazole. It is optically stable _in vivo_ , with negligible conversion to the R-isomer. The chemical name is di-(S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfinyl] - 1 _H_ - benzimidazole magnesium salt trihydrate. The chemical structure of esomeprazole magnesium trihydrate is: CAS Number: 217087-09-7 Molecular formula: C 34 H 36 N 6 O 6 S 2 Mg.3H 2 O Molecular weight: 767.2 (trihydrate) THERAPEUTIC INDICATION Axiago MUPS are indicated for: 2 GASTROESOPHAGEAL REFLUX DISEASE (GERD) - treatment of erosive reflux esophagitis - long-term management of patients with healed esophagitis to prevent relapse - symptomatic treatment of gastroesophageal reflux disease (GERD) IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN FOR THE ERADICATION OF _HELICOBACTER PYLORI _AND - healing of _Helicobacter pylori _ associated duodenal ulcer and - prevention of relapse of peptic ulcers in patients with _Helicobacter pylori _ associated ulcers. PATIENTS REQUIRING CONTINUED NSAID THERAPY - healing of gastric ulcers associated with NSAID therapy. - prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULC קרא את המסמך השלם