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 taking Mayne Pharma Oxycodone IR Tablets?
Mayne Pharma Oxycodone IR Tablets contain the active ingredient oxycodone hydrochloride.
Mayne Pharma Oxycodone IR Tablets are used for the short-term management of severe
pain. For more information, see Section
1. Why am I taking Mayne Pharma Oxycodone IR Tablets? in the full CMI.
2. What should I know before I take Mayne Pharma Oxycodone IR Tablets?
Do not take 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 take Mayne Pharma Oxycodone IR Tablets? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Mayne Pharma Oxycodone IR Tablets?
The usual dose is ONE tablet every six hours. Your doctor may prescribe a different
dose for you. Be sure to follow your doctor’s directions about when and how to take
Mayne Pharma Oxycodone IR Tablets. Swallow the tablet whole with a full glass of water
preferably after food or with milk. More instructions can be found in Section
4. How do I take Mayne Pharma Oxycodone IR Tablets? in the full CMI.
5. What should I know while taking Mayne Pharma Oxycodone IR Tablets?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking this medicine.
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 immediately.
Keep all of your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not take oxycodone to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
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Driving or using machines
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Do not drive or operate machinery until you know how oxycodone affects you.
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Drinking alcohol
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Do not drink alcohol while you are taking this medicine.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store this medicine in the bathroom or near a sink. Do not leave it on a windowsill
or in the car.
Keep it where children cannot reach it.
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6. Are there any side effects?
Common side effects: dizziness, confusion, drowsiness, low blood pressure, constipation,
vomiting and nausea. Serious side effects: difficulty or decreased frequency of passing
urine, dry mouth, sweating, itchy rash, muscle stiffness, face redness, loss of appetite,
faintness or feeling weak, abnormal or changes in heart rate, fall in blood pressure
on standing, decrease in body temperature, restlessness, severe headache, changes
of mood, constriction of pupils, unconsciousness, difficulty breathing, severe dizziness,
drowsiness or disorientation and symptoms of allergy. This is not a complete list
of all possible side effects. For more information, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING
Limitations of use
Mayne Pharma Oxycodone IR Tablets 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
Mayne Pharma Oxycodone IR Tablets pose 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
Mayne Pharma Oxycodone IR Tablets 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 Mayne
Pharma Oxycodone IR Tablets 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 taking Mayne Pharma Oxycodone IR Tablets
Using Mayne Pharma Oxycodone IR Tablets 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 minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation.
You must not drink alcohol while taking Mayne Pharma Oxycodone IR Tablets.
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Active ingredient(s): oxycodone hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Mayne Pharma Oxycodone IR
Tablets. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Mayne Pharma Oxycodone IR Tablets.
Where to find information in this leaflet:
1. Why am I taking Mayne Pharma Oxycodone IR Tablets?
Mayne Pharma Oxycodone IR Tablets contain the active ingredient oxycodone hydrochloride. Oxycodone belongs to a group of medicines called narcotic analgesics. Narcotic analgesics
is another name for medicines that work by binding to specific opioid receptors to
change your body’s perception of pain .
Mayne Pharma Oxycodone IR Tablets are used for the short-term management of severe
pain where other treatment options are not able to effectively manage your pain, or
you cannot tolerate them.
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.
Oxycodone can be addictive. If used for a long time Oxycodone may become habit forming
causing mental and physical dependence. If abused it may become less able to reduce
pain.
Oxycodone is available only with a doctor's prescription.
2. What should I know before I take Mayne Pharma Oxycodone IR Tablets?
Warnings
Do not use Mayne Pharma Oxycodone IR Tablets if:
you have an allergy to:
any medicine containing oxycodone hydrochloride
any of the ingredients listed at the end of this leaflet. Always check the ingredients
to make sure you can use this medicine
any other similar medicines known as narcotic analgesics e.g. morphine, codeine, opium.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have any severe breathing difficulty conditions.
Do not take this medicine if you have or have had any of the following:
heart conditions
brain cancer
head injuries
spinal or nervous system conditions
severe headaches, or headaches due to raised
pressure in the head
abdominal pain with treatment with a class of medicines called monoamine oxidase inhibitors
a history or dependence on alcohol or withdrawal from alcohol.
Do not take this medicine during pregnancy or during breastfeeding. It may cause difficulty
in breathing in an unborn or newborn child. Women who are pregnant, planning to become
pregnant or who are breastfeeding should discuss this with their doctor.
Do not give this medicine to children. Accidental ingestion or exposure of Mayne Pharma
Oxycodone IR, especially by children, can result in a fatal overdose.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering. If it has expired or is damaged, return it to
your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have any other medical conditions, in particular:
muscle weakness
underactive thyroid
kidney disease
liver disease
low blood pressure
difficulty passing urine
bowel disorders
It may not be safe for you to take oxycodone if you have these conditions. Your doctor
will need to consider all these factors when advising you about taking oxycodone.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and oxycodone may interfere with each other. These include:
anaesthetics
medicines used to thin the blood (e.g., warfarin)
medicines used to treat epilepsy
medicines used to help with sleeping
blood pressure lowering medicines
medicines used to treat mental health problems such as anxiety, depression, psychosis,
schizophrenia, or bipolar disorders
medicines used to treat 'flu' symptoms
other medicines used to relieve pain
medicines used to relieve stomach cramps or spasms
medicines, used to relieve nausea and vomiting
any medicine containing naloxone and/or naltrexone, used to reverse the effects of
narcotic analgesics. These medicines and alcohol may be affected by oxycodone or may affect how well it
works.
You may need different amounts of your medicines, or you may need to take different
medicines.
Taking Mayne Pharma Oxycodone IR Tablets 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 minimise the dose and duration of use;
and monitor you for signs and symptoms of breathing difficulties and sedation.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Mayne Pharma Oxycodone IR Tablets.
4. How do I take Mayne Pharma Oxycodone IR Tablets?
How much to take
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
The usual dose is ONE tablet every six hours.
Your doctor may prescribe a different dose for you. Be sure to follow your doctor's
directions about when and how to take oxycodone.
The length of treatment will depend on your condition. Your doctor will advise you
when to stop taking Mayne Pharma Oxycodone IR Tablets .
When to take Mayne Pharma Oxycodone IR Tablets
Oxycodone should be taken after meals or with milk.
How to take Mayne Pharma Oxycodone IR Tablets
Swallow the tablet whole with a full glass of water preferably after food or with
milk.
How long to take Mayne Pharma Oxycodone IR Tablets
Continue taking your medicine for as long as your doctor tells you
If you have been taking this medicine for a long period of time and it is no longer
needed to manage your pain, DO NOT stop taking Mayne Pharma Oxycodone IR suddenly.
Your doctor may want you to gradually reduce the amount of Mayne Pharma Oxycodone
you are taking before stopping completely in order to lessen the risk of withdrawal
symptoms
If you forget to take Mayne Pharma Oxycodone IR Tablets
If it is less than 2-3 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too many Mayne Pharma Oxycodone IR Tablets (overdose)
If you or someone else takes too much oxycodone (overdoses), and experience one or
more of the symptoms below, immediately call triple zero (000) for an ambulance. Keep
the person awake by talking to them or gently shaking them every now and then. You
should follow the above steps even if someone other than you has accidentally used
Mayne Pharma Oxycodone IR Tablets that were prescribed for you. If someone has an
overdose, they may experience one or more of the following symptoms:
Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heartbeat
Nausea or vomiting
Convulsions or fits
Clumsiness or loss of coordination
Difficulty walking
Facial drooping
Loss of vision
Personality changes
Trouble speaking
Weak muscles
If you think you or someone else may have taken too many Mayne Pharma Oxycodone IR
Tablets you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
been taken.
5. What should I know while taking Mayne Pharma Oxycodone IR Tablets?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Mayne Pharma Oxycodone IR.
Remind any doctor, dentist or pharmacist you visit that you are taking Mayne Pharma
Oxycodone IR Tablets.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Things you should not do
Do not take Mayne Pharma Oxycodone IR Tablets to treat any other complaints unless
your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Do not stop using this medicine suddenly. If you have been taking this medicine for
a long period of time and stop taking it suddenly, you may have unwanted side effects
such as withdrawal symptoms. If possible, your doctor will gradually reduce the amount
you take each day before stopping the medicine completely.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Mayne
Pharma Oxycodone IR Tablets affect you.
This medicine may cause dizziness, light-headedness, tiredness, drowsiness in some
people. It may affect alertness. If you have any of these symptoms, do not drive,
operate machinery or do anything else that could be dangerous.
Drinking alcohol
Do not drink alcohol while you are taking this medicine.
Things to be aware of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Hyperalgesia
An unexplained increased sensitivity to pain may occur with the use of opioids at
high doses. If this occurs, the dose should be reduced and a change to another medicine
may be required.
Addiction
You can become addicted to Mayne Pharma Oxycodone IR Tablets even if you take them
exactly as prescribed. Oxycodone may become habit forming causing mental and physical
dependence. If abused it may become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking
oxycodone. Taking it may result in physical dependence. Physical dependence means
that you may experience withdrawal symptoms if you stop taking Mayne Pharma Oxycodone
IR Tablets suddenly, so it is important to take the product exactly as directed by
your doctor.
Tolerance
Tolerance to Mayne Pharma Oxycodone IR Tablets may develop, which means that the effect
of the medicine may decrease. If this happens, more may be needed to maintain the
same effect.
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop having
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating.
Mayne Pharma Oxycodone IR Tablets given to the mother during labour can cause breathing
problems and signs of withdrawal in the newborn.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on a windowsill.
Keep medicines where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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difficulty passing urine
decreased frequency of passing urine
dry mouth
sweating
itchy rash
muscle stiffness
redness of the face
loss of appetite
faintness or feeling weak
slow, abnormal or fast heart rate
feeling lightheaded when standing up or when getting out of bed decrease in body temperature
central nervous system stimulation and convulsions
physical and psychological tolerance
restlessness
severe headache due to increased pressure within the head
changes of mood
constriction of pupils
unconsciousness
inability to breathe properly
severe dizziness, drowsiness or disorientation
symptoms of allergy (e.g. itchy skin rash, skin blisters or discolouration of skin
upon exposure to sunlight).
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
In long term use, physical dependence and tolerance may develop and the following
withdrawal symptoms may be observed after oxycodone is discontinued:
body aches
loose bowel motions or diarrhoea
loss of appetite
nervousness
restlessness
runny nose
sneezing
shivering
stomach cramps
nausea
trouble with sleeping
an increase in sweating and yawning
weakness
fast heart rate
unexplained fever
These symptoms are mild if withdrawal from oxycodone is gradual once it is no longer
needed.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Mayne Pharma Oxycodone IR Tablets contain
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Active ingredient
(main ingredient)
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oxycodone hydrochloride
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Microcrystalline cellulose
Maize starch
Sodium starch glycollate type A
Stearic acid
Silicon dioxide
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Potential allergens
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This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes
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Do not take this medicine if you are allergic to any of these ingredients.
What Mayne Pharma Oxycodone IR Tablets look like
Mayne Pharma Oxycodone IR Tablets are white to off-white, round tablets. One side
is plain, the other side has a visible line and the number “112” debossed above it.
The tablets come in packs of 10 and 20 (Aust R 225335).
Who distributes Mayne Pharma Oxycodone IR Tablets
Mayne Pharma International Pty Ltd
1538 Main North Road
Salisbury South SA, 5106
This leaflet was prepared in July 2024.