Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 5 mg
Mayne Pharma International Pty Ltd
oxycodone hydrochloride
Tablet
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate type A; silicon dioxide; lactose monohydrate; maize starch; stearic acid
Oral
10, 20
(S8) Controlled Drug
Mayne Pharma Oxycodone IR 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: White to off-white, round tablet. One side is plain, the other side is scored and the number "112" is debossed above the score bar; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-06-16
Mayne Pharma Oxycodone IR Tablets 1 MAYNE PHARMA OXYCODONE IR TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING MAYNE PHARMA OXYCODONE IR TABLETS? Mayne Pharma Oxycodone IR Tablets contain the active ingredient oxycodone hydrochloride. Oxycodone tablets are used to relieve pain where other treatment options are not able to effectively manage your pain or you cannot tolerate them. For more information, see Section 1. Why am I using Mayne Pharma Oxycodone IR Tablets? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MAYNE PHARMA OXYCODONE IR TABLETS? Do not use if you have ever had an allergic reaction to oxycodone or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Mayne Pharma Oxycodone IR Tablets? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with oxycodone and affect how the tablets work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE MAYNE PHARMA OXYCODONE IR TABLETS? The usual dose is ONE tablet every six hours. Swallow the tablet whole with a full glass of water. More instructions can be found in Section 4. How do I use Mayne Pharma Oxycodone IR Tablets? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MAYNE PHARMA OXYCODONE IR TABLETS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using oxycodone. • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. • If you become pregnant while taking this medicine, tell your doctor Read the complete document
v 3.0 1 AUSTRALIAN PRODUCT INFORMATION MAYNE PHARMA OXYCODONE IR (OXYCODONE HYDROCHLORIDE) TABLETS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Mayne Pharma Oxycodone IR 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 Mayne Pharma Oxycodone IR tablets pose 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 Mayne Pharma Oxycodone IR 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 Mayne Pharma Oxycodone IR tablets. 1. NAME OF THE MEDICINE Oxycodone hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mayne Pharma Oxycodone IR tablets contain 5 mg oxycodone hydrochloride. v 3.0 2 Excipients with known effect: Mayne Pharm Read the complete document