País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Naloxone hydrochloride; Oxycodone hydrochloride
Mundipharma Pty Ltd
Medicine Registered
TARGIN ® TABLETS _Oxycodone hydrochloride and naloxone hydrochloride dihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TARGIN 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 TARGIN TABLETS ARE TAKEN FOR TARGIN tablets contain two different medicines called oxycodone hydrochloride and naloxone hydrochloride dihydrate. Oxycodone belongs to a group of medicines called opioid analgesics. Naloxone is a medicine which, when taken orally, can block some of the effects of opioids in the gut, such as constipation. TARGIN tablets are used to relieve moderate to severe persistent pain when other forms of treatment have not been effective and naloxone in TARGIN tablets will help prevent and treat opioid-induced constipation. Opioid analgesics such as oxycodone hydrochloride have been used to treat pain for many years. Your doctor, however, may prescribe it for another purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you. As with all strong painkillers, your body may become used to you taking TARGIN tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking oxycodone 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 TARGIN TABLETS IF YOU: • have moderate or severe liver problems or disease • suffer from shallow breathing or have any other breathing problems such as severe asthma, Llegiu el document complet
TARGIN ® tablets PI 28 December 11 (mfptargi11211) Supersedes PI 20311 Page 1 of 22_ _ PRODUCT INFORMATION TARGIN ® TABLETS (5/2.5 MG, 10/5 MG, 20/10 MG, 40/20 MG) NAME OF THE MEDICINE Oxycodone hydrochloride and naloxone hydrochloride dihydrate. 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 pKa is 8.9 and the Partition Coefficient Log P is 0.7. The structural formula for oxycodone hydrochloride is: Naloxone hydrochloride dihydrate is an off-white powder soluble in water. The chemical name is 17-allyl-4,5 a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate (CAS No.: 51481-60-8). It is a synthetic congener of oxymorphone, with molecular formula C 19 H 21 NO 4 .HCl.2(H 2 O) and molecular weight 399.87. The pKa is 7.9 and the Partition Coefficient Log P is 1.5. The structural formula for naloxone hydrochloride dihydrate is: The inactive ingredients in TARGIN ® 5/2.5 mg tablets are lactose, hydroxypropylcellulose, ethylcellulose, stearyl alcohol, talc and magnesium stearate. The inactive ingredients in TARGIN ® 10/5 mg, 20/10 mg and 40/20 mg tablets are lactose, povidone, ethylcellulose, stearyl alcohol, talc and magnesium stearate. All tablets are coated with polyvinyl alcohol, titanium dioxide (E171), macrogol 3350 and talc. The tablet coat also contains brilliant blue CI42090 (5/2.5 mg tablets), iron oxide red CI77491 (20/10 mg tablets) and iron oxide yellow CI77492 (40/20 mg tablets). TARGIN ® tablets PI 28 Llegiu el document complet