MAYNE PHARMA OXYCODONE IR oxycodone hydrochloride 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 5 mg

Available from:

Mayne Pharma International Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate type A; silicon dioxide; lactose monohydrate; maize starch; stearic acid

Administration route:

Oral

Units in package:

10, 20

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2015-06-16

Patient Information leaflet

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

Summary of Product characteristics

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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.
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2
Excipients with known effect: Mayne Pharm