Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Oxycodone hydrochloride
Mundipharma Pty Ltd
Medicine Registered
OXYCONTIN ® TABLETS _Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OxyContin tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OXYCONTIN TABLETS ARE TAKEN FOR OxyContin tablets contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics. OxyContin tablets are used to relieve moderate to severe chronic pain when other forms of treatment have not been effective. Your doctor, however, may prescribe it for another purpose. Ask your doctor if you have any questions about why it has been prescribed for you. As with all strong painkillers, your body may become used to you taking OxyContin tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyContin tablets suddenly, so it is important to take it exactly as directed by your doctor. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE OXYCONTIN TABLETS IF YOU: • have any breathing problems such as acute asthma, respiratory depression (breathing slows or weakens) or other obstructive airways disease • are severely drowsy or have a reduced level of consciousness • suffer from irregular heartbeats or changes in the way the heart beats • have heart disease due to long term lung disease • have just consumed a large amount of alcohol, regularly consume large amounts of alcohol, or have confusion and shaking due to alcohol withdrawal • suffer from convulsi Lire le document complet
OxyContin ® Tablets PI (03 November 11) Supersedes PI (17 February 11) mfpoxyco21111 Page 1 of 14 _ _ PRODUCT INFORMATION OXYCONTIN ® TABLETS (5 MG, 10 MG, 15 MG, 20 MG, 30 MG, 40 MG, 60 MG, 80 MG, 120 MG, 160 MG) NAME OF THE MEDICINE Oxycodone hydrochloride USP DESCRIPTION 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 4,5 a-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 structural formula for oxycodone hydrochloride is: The inactive ingredients in OxyContin ® tablets are: lactose, povidone, Eudragit RS 30D (solids), glycerol triacetate, stearyl alcohol, talc and magnesium stearate. All of the tablets are coated with hypromellose, titanium dioxide and macrogol 400. The tablet coatings also contain: hydroxypropylcellulose (10 & 80 mg tablets), polysorbate 80 (20 & 40, 60, 120 & 160 mg tablets), iron oxide red CI 77491 (15, 20, 30, 60 & 120 mg tablets), iron oxide yellow CI 77492 (15, 30, 40 & 80 mg tablets), indigo carmine CI 73015 aluminium lake (80 & 160 mg tablets), brilliant blue CI 42090 (5 mg tablets) and iron oxide black E172 (15, 30, 60 & 120 mg tablets). PHARMACOLOGY Actions Oxycodone is a full opioid agonist with no antagonist properties whose principal therapeutic action is analgesia. It has an 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 central nervous system (CNS: respiratory depression, antitussive, anxiolytic, sedative Lire le document complet