Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 20 mg
Mundipharma Pty Ltd
Capsule, hard
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; indigo carmine; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
20 capsules, 60 capsules, 10 Capsules
(S8) Controlled Drug
OxyNorm 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: Size 4 pink/beige opaque capsules printed with ONR and 20 in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2000-11-08
OXYNORM ® CAPSULES _Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_ CONSUMER MEDICINE INFORMATION WARNING: LIMITATIONS OF USE OxyNorm 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 OxyNorm 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 OxyNorm 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 OxyNorm 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 OXYNORM Using OxyNorm 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), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will mini- mise 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 OxyNorm. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OxyNorm capsules. 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 OXYNORM CAPSULES ARE TAKEN FOR OxyNorm capsules contain o Прочитать полный документ
OxyNorm ® Capsules and Liquid Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – OXYNORM ® (OXYCODONE HYDROCHLORIDE) CAPSULES AND LIQUID WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, OxyNorm 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 _ OxyNorm 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 OxyNorm. 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 OxyNorm. 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OxyNorm 5 mg capsules contains 5 mg of Oxycodone hydrochloride OxyNorm 10 mg capsules contains 10 mg of Oxycodone hydrochloride OxyNorm 20 mg capsules contains 20 mg Прочитать полный документ