Krajina: Malajzia
Jazyk: angličtina
Zdroj: 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) _ 1 OXYNORM ® CAPSULES Oxycodone hydrochloride (5mg, 10mg) 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 taking a t Prečítajte si celý dokument
_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 H 21 NO 4 HCl and molecular weight is 351.83. The inactive ingredients in _OXYNORM_ ® capsules are: microcrystalline cellulose and magnesium stearate. 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 Indigo carmine CI73015 (E132) • • Iron oxide red CI77491 (E172) • • Iron oxide yellow CI77492 (E172) • • Sunset yellow FCF CI15985 (E110) • Titanium dioxide (E171) • • INDICATION The management of opioid responsive, moderate to severe pain. ADMINISTRATION AND DOSAGE _OXYNORM_ ® capsules are for oral use and should be swallowed whole and not opened, chewed or crushed. _Adults and elderly over 18 years: _ Prior to initiation and titration of doses, refer to the _Warnings and Precautions _section for information on special risk groups such as females and the elderly. _OXYNORM_ ® capsules should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. Generally, the lowest effective dose for analgesia should be selected Increasing severity of pain will require an increased dosage of _OXYNORM_ ® capsules. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. _OXYNORM_ ® capsules will generally be used in a short term trial (4-6 weeks) to determine if the pain is opioid responsive, before transferring to a Prečítajte si celý dokument