מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXYCODONE HYDROCHLORIDE
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
OXYCODONE HYDROCHLORIDE
28Capsule Capsules
Bard Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ OXYNORM ® CAPSULES Oxycodone hydrochloride (5mg, 10mg, 20mg) 1 WHAT IS IN THIS LEAFLET 1. What OxyNorm® is used for 2. How OxyNorm®works 3. Before you use OxyNorm® 4. How to use OxyNorm® 5. While you are taking it 6. Side effects 7. Storage and Disposal of OxyNorm® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT OXYNORM® IS USED FOR These capsules have been prescribed for you by your doctor to relieve moderate to severe pain.. _ _ HOW OXYNORM® WORKS They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’. BEFORE YOU TAKE OXYNORM® _-When you must not use it _ Do not take OxyNorm ® capsules if you: - are allergic (hypersensitive) to oxycodone or any of the ingredients of the capsules (see section 7 ‘Product description’) or have previously had an allergic reaction when taking other strong analgesics or painkillers (such as morphine or other opioids); - have breathing problems, such as obstructive airways disease, acute asthma or breathing more slowly or weakly than expected; - have a heart problem after long-term lung disease (cor pulmonale), suffer from irregular or fast heartbeats or changes in the way the heart beats (cardiac arrhythmias), have decreased heart rate; - have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have sudden pain in your abdomen, persistent constipation; - have severe kidney problems; - have just drunk a large amount of alcohol, regularly drink large amounts of alcohol or have confusion and shaking due to stopping drinking alcohol; - have a head injury, a brain tumour or have raised pressure within the head, brain or spinal cord; - are severely drowsy or have a reduced level of consciousness; - suffer from convulsion, fits or seizures, have too much carbon dioxide in the blood (hypercabia); - are קרא את המסמך השלם
OxyNorm ® Capsules Composition Oxycodone hydrochloride Ph Eur Oxycodone hydrochloride is a white, crystalline odourless powder readily soluble in water, sparingly soluble in ethanol and nearly insoluble in ether. The chemical name is 4,5α -epoxy -14-hydroxy -3- methoxy -17-methylmorphinan -6-one hydrochloride (CAS No: 124 -90-3). The molecular formula is C 18 H21NO 4 HCl and molecular weight is 351.83. The inactive ingredients in OxyNorm ® capsules are: microcrystalline cellulose and magnesium stea rate. The capsule shells contain sodium lauryl sulfate and gelatin. Capsule shell is derived from animal origin (bovine source). The capsule shells also contain the following colouring materials: Strength Colouring material 5 mg 10 mg 20 mg Indigo carmine CI73015 (E132) • • • Iron oxide red CI77491 (E172) • • • Iron oxide yellow CI77492 (E172) • • • Sunset yellow FCF CI15985 (E110) • Titanium dioxide (E171) • • • Therapeutic properties Oxycodone is a full opioid agonist with no antagonist properties whose principal therapeutic action is analgesia. It has affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. Other pharmacological actions of oxycodone are in the CNS (respiratory depression, antitussive, anxiolytic, sedative and miosis), smooth muscle (constipation, reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi and transient eleva tions in serum amylase) and cardiovascular system (release of histamine and/ or peripheral vasodilation, possibly causing pruritus, flushing, red eyes, sweating and/or orthostatic hypotension). Pharmacokinetics Elimination and Metabolism Oxycodone has an elimination half life of approximately 3 hours and is metabolised principally to noroxycodone and oxymorphone. Oxymorphone has some analgesic activity but is present in plasma in low concentrations and is not considered to contribute to oxycodone’s ph armacological effect. קרא את המסמך השלם