Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 5 mg
Boucher & Muir Pty Ltd
oxycodone hydrochloride
Capsule, hard
Excipient Ingredients: Gelatin; microcrystalline cellulose; iron oxide red; sodium laureth sulfate; titanium dioxide; indigo carmine; iron oxide yellow; magnesium stearate
Oral
10, 20, 60
(S8) Controlled Drug
Oxycodone BNM is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
Visual Identification: Dark pink body brown cap, printed with 5 on body OXY on cap; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-11-18
OXYCODONE BNM 1 OXYCODONE BNM _Oxycodone hydrochloride _ _Capsules 5 mg, 10 mg and 20 mg _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Oxycodone BNM. This leaflet answers some common questions about Oxycodone BNM. 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 Oxycodone BNM 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 BNM IS USED FOR Oxycodone BNM contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics. Oxycodone BNM is used for short- term management of severe pain for which other treatment options have failed or are otherwise inappropriate to provide sufficient management of pain. 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 Oxycodone BNM. 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 OXYCODONE BNM Long-term use of Oxycodone BNM may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycle in females. Talk to your doctor if you have any concerns. Oxycodone BNM is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ Do not take Oxycodone BNM if you: • suffer from shallow breathing or have any breathing problems such WARNING: LIMITATIONS OF USE Oxycodone BNM should only be used when your doctor decides t Leggi il documento completo
OXYCODONE BNM 1 AUSTRALIAN PRODUCT INFORMATION OXYCODONE BNM OXYCODONE HYDROCHLORIDE CAPSULE WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Oxycodone BNM capsules 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 BNM capsules 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 BNM capsules. 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 BNM capsules. OXYCODONE BNM 2 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxycodone BNM capsules contain 5 mg, 10 mg or 20 mg oxycodone hydrochloride, respectively. For the full list of excipients, see Section 6.1 List of excipients. Leggi il documento completo