מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 80 mg
Mundipharma Pty Ltd
oxycodone hydrochloride
Tablet, modified release
Excipient Ingredients: polyethylene oxide; magnesium stearate; hypromellose; indigo carmine; hyprolose; polysorbate 80; iron oxide yellow; macrogol 400
Oral
28, 20
(S8) Controlled Drug
Novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. Novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Novacodone is not indicated as an as-needed-(PRN) analgesia.
Visual Identification: Round, unscored, green-coloured, bi-convex tablets debossed with ON (underscored) on one side and 80 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-05-08
NOVACODONE ® TABLETS _Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_ CONSUMER MEDICINE INFORMATION WARNING: LIMITATIONS OF USE Novacodone should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. HAZARDOUS AND HARMFUL USE Novacodone poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION Novacodone can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Novacodone and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING NOVACODONE Using Novacodone with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), canna- bis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Novacodone. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Novacodone 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 NOVACODONE TABLETS ARE TAKEN FOR קרא את המסמך השלם
Novacodone ® modified release tablets 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION NOVACODONE ® (OXYCODONE HYDROCHLORIDE) MODIFIED RELEASE TABLETS 1 NAME OF THE MEDICINE Oxycodone hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Novacodone ® modified release tablets contain the following quantities of oxycodone hydrochloride: Novacodone ® 10 mg contains oxycodone hydrochloride 10 mg Novacodone ® 15 mg contains oxycodone hydrochloride 15 mg Novacodone ® 20 mg contains oxycodone hydrochloride 20 mg Novacodone ® 30 mg contains oxycodone hydrochloride 30 mg Novacodone ® 40 mg contains oxycodone hydrochloride 40 mg Novacodone ® 60 mg contains oxycodone hydrochloride 60 mg Novacodone ® 80 mg contains oxycodone hydrochloride 80 mg The inactive ingredients in the reformulated Novacodone 10 to 80 mg tablets are: polyethylene oxide and magnesium stearate. The tablets’ film coating also contains: 10mg - Opadry White Y-5R-18024-A 15mg - Opadry complete film coating system 05B97512 Gray 20mg - Opadry complete film coating system YS-1R-14518-A Pink 30mg - Opadry complete film coating system YS-1-16518-A Brown 40mg - Opadry Yellow YS-1R-12525-A 60mg - Opadry complete film coating system 15B25501 Red 80mg - Opadry Green Y-5R-11167-A 3 PHARMACEUTICAL FORM Novacodone tablets are modified release tablets designed to provide delivery of oxycodone over 12 hours. Novacodone 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg 1 and 80 mg tablets have been reformulated, and comprise a matrix formulation with a hydrogelling property (i.e. particles or whole tablets become highly viscous (gel-like) in water), intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse. The tablets have been heat-treated to increase the mechanical strength of the tablet. Novacodone ® modified release tablets 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg Page 2 of 19 The physical properties of the reformulated Novacodone tablets were examined following an ext קרא את המסמך השלם