Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 80 mg
Sandoz Pty Ltd
oxycodone hydrochloride
Tablet, modified release
Excipient Ingredients: copovidone; colloidal anhydrous silica; lactose monohydrate; behenoyl polyoxyglycerides; titanium dioxide; hydrogenated castor oil; stearic acid; magnesium stearate; medium chain triglycerides; maize starch; microcrystalline cellulose; hypromellose; iron oxide black; Colour
Oral
28, 60, 20
(S8) Controlled Drug
Oxycodone Sandoz modified release tablet 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. Oxycodone Sandoz modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Oxycodone Sandoz modified release tablet is not indicated as an as-needed (PRN) analgesia.
Visual Identification: Green, round, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-01-20
OXYCODONE SANDOZ ® 1 OXYCODONE SANDOZ ® _Oxycodone hydrochloride modified release tablet _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Oxycodone Sandoz. 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 OXYCODONE SANDOZ IS USED FOR This medicine is used to relieve severe pain when other forms of treatment have failed or are otherwise inappropriate to provide sufficient management of pain. It contains the active ingredient oxycodone hydrochloride. Oxycodone hydrochloride belongs to a class of drugs known as opioid analgesics. As with all strong painkillers, your body may become used to you taking Oxycodone Sandoz tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Oxycodone Sandoz suddenly, so it is important to take it exactly as directed by your doctor. There is not enough information to recommend the use of this medicine for children under the age of 12 years. This medicine is available only with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE OXYCODONE SANDOZ Long-term use of oxycodone tablets may result in a decrease in sex WARNING: LIMITATIONS OF USE Oxycodone Sandoz should only be used when you doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. HAZARDOUS AND HARMFUL USE Oxycodone Sandoz poses risks of abuse, misuse and addiction which can lead to overdose and death. Your Przeczytaj cały dokument
200923-Oxycodone Sandoz-pi Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION OXYCODONE SANDOZ ® (OXYCODONE HYDROCHLORIDE) MODIFIED RELEASE TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Oxycodone Sandoz modified release tablets should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special warnings and precautions for use). _HAZARDOUS AND HARMFUL USE _ Oxycodone Sandoz modified release tablets poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special warnings and precautions for use). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of Oxycodone Sandoz modified release tablets. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special warnings and precautions for use). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, _ _INCLUDING ALCOHOL _ Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Oxycodone Sandoz modified release tablet. 1. NAME OF THE MEDICINE Oxycodone hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oxycodone Sandoz modified release tablets contain 5 Przeczytaj cały dokument