Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OMEPRAZOLE
ZUELLIG PHARMA SDN BHD
OMEPRAZOLE
14Tablet Tablets
ASTRAZENECA AB
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 LOSEC MUPS TABLET Omeprazole (10mg, 20mg) WHAT IS IN THIS LEAFLET 1. What LOSEC MUPS is used for 2. How LOSEC MUPS works 3. Before you use LOSEC MUPS 4. How to use LOSEC MUPS 5. While you are using it 6. Side effects 7. Storage and Disposal of LOSEC MUPS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT LOSEC MUPS IS USED FOR Losec MUPS is used to treat the following health conditions: • Ulcers in the upper part of the intestine (Duodenal ulcer). • Stomach ulcers (Gastric ulcer). • Stomach ulcers or ulcers in the upper part of the intestine caused by your medicine for pain and inflammation (NSAID associated gastric and duodenal ulcers or erosions). • Ulcers which are infected with bacteria called _Helicobacter pylori _ ( _Helicobacter _ _pylori _ eradication in peptic ulcer disease). • Disease with symptoms caused by a return flow of fluid from the stomach (Symptomatic gastro-oesophageal reflux disease or reflux oesophagitis). • Acid related upper abdominal pain or discomfort (Acid related indigestion). • Hormone producing tumours in the pancreas causing excess acid in the stomach (Zollinger-Ellison syndrome). HOW LOSEC MUPS WORKS Losec MUPS is a type of medicine called a ‘proton pump inhibitor’. It reduces the production of acid in your stomach. BEFORE YOU USE LOSEC MUPS _-_ _ _ _When you must not use it _ Do not take Losec MUPS if you are allergic to omeprazole or similar medication or any of the other ingredients. _-_ _ _ _Before you start to use it _ Inform your health care professional if, • you have any alarming symptoms (e.g. significant unintentional weight loss, recurrent vomiting, difficulty swallowing, severe or persistent diarrhoea, vomiting blood or blood in your stools) • you are taking medicines for Human Immunodeficiency Virus (HIV), such as atazanavir or if you have reduced vitamin B12 (cyanocobalamin) absorption or body stores • you have hereditary problem Прочитајте комплетан документ
QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg: Each gastro-resistant tablet contains 10.3 mg omeprazole magnesium equivalent to 10 mg omeprazole. 20 mg: Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium equivalent to 20 mg omeprazole. For a full list of excipients, see “List of excipients”. PHARMACEUTICAL FORM Losec MUPS tablets 10 mg : Light-pink, oblong, biconvex, film-coated tablets engraved with on one side and 10 mg on the other side. Each tablet contains omeprazole magnesium 10.3 mg as enteric coated pellets. Losec MUPS tablets 20 mg: Pink, oblong, biconvex, film-coated tablets, engraved with on one side and 20 mg on the other side. Each tablet contains omeprazole magnesium 20.6 mg as enteric coated pellets. THERAPEUTIC INDICATIONS Losec MUPS is indicated for the treatment of: Duodenal ulcer Gastric ulcer NSAID associated gastric and duodenal ulcers or erosions _Helicobacter pylori_ eradication in peptic ulcer disease Reflux oesophagitis Symptomatic gastro-oesophageal reflux disease Acid related dyspepsia Zollinger-Ellison syndrome _POSOLOGY AND METHOD OF ADMINISTRATION_ The tablets must be swallowed whole with at least ½ glass of liquid. They must not be chewed or crushed. The tablets may also be dispersed in water or any acidic drink (e.g. juice). The dispersion must then be taken within 30 minutes. _DUODENAL ULCER_ The recommended dosage in patients with an active duodenal ulcer is Losec MUPS 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 2 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 2 week treatment period. In patients with poorly responsive duodenal ulcer Losec MUPS 40 mg once daily is recommended and healing is usually achieved within 4 weeks. For the prevention of relapse in patients with duodenal ulcer disease the recommended dose is Losec MUPS 10 mg once daily. If needed the dose can be increased to Losec MUPS 20-40mg once daily. For NSAID associated duodenal Прочитајте комплетан документ