SUMMARY CMI
OxyNorm® capsules
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 OxyNorm capsules?
OxyNorm capsules contains the active ingredient oxycodone hydrochloride. OxyNorm capsules are used to relieve severe pain when other forms of treatment have failed or are otherwise inappropriate to provide sufficient management of pain.
For more information, see Section 1. Why am I taking OxyNorm capsules? in the full CMI.
2. What should I know before I take OxyNorm capsules?
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 take OxyNorm capsules? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with OxyNorm capsules and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I take OxyNorm capsules?
- Your doctor will tell you exactly how much to take.
- Follow the instructions given to you by your doctor or pharmacist exactly.
- You must only take OxyNorm capsules by mouth.
More instructions can be found in Section 4. How do I take OxyNorm capsules? in the full CMI.
5. What should I know while taking OxyNorm capsules?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while taking OxyNorm capsules? in the full CMI.
6. Are there any side effects?
OxyNorm may cause nausea, vomiting, constipation, dizziness, headache, drowsiness, skin rash, itching, new problems with your eyesight, and may become habit forming causing mental and physical dependence.
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.
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 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 using OxyNorm.
FULL CMI
OxyNorm® capsules
Active ingredient(s): oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)
Consumer Medicine Information (CMI)
This leaflet provides important information about using OxyNorm capsules. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using OxyNorm capsules.
Where to find information in this leaflet:
1. Why am I taking OxyNorm capsules?
2. What should I know before I take OxyNorm capsules?
3. What if I am taking other medicines?
4. How do I take OxyNorm capsules?
5. What should I know while taking OxyNorm capsules?
6. Are there any side effects?
7. Product details
1. Why am I taking OxyNorm capsules?
OxyNorm capsules contain the active ingredient oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.
OxyNorm capsules are used to provide the short-term management of severe pain when other forms of treatment 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 OxyNorm capsules. 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.
2. What should I know before I take OxyNorm capsules?
Warnings
Long-term use of OxyNorm capsules 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.
Do not take OxyNorm capsules if you:
- are allergic to oxycodone hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
- have any breathing problems such as acute asthma, chronic bronchitis or impaired lung function
- are severely drowsy or have a reduced level of consciousness
- suffer from irregular or fast heartbeats or changes in the way the heart beats
- have heart problems due to long-term lung disease
- have just consumed a large amount of alcohol, regularly consume large amounts of alcohol or have confusion and shaking due to alcohol withdrawal
- suffer from convulsions, fits or seizures
- have a head injury, brain tumour or have raised pressure within the head, brain or spinal cord
- have sudden severe abdominal pain
- have a condition where your stomach empties more slowly than it should, or your small bowel does not work properly
- are about to have an operation (including surgery on your spine for pain relief in the next 6 hours)
- have severe kidney or liver disease
- take a medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks.
Do not give this medicine to a child younger than 18 years of age.
Check with your doctor if you:
- have allergies to any other medicines, foods, preservatives or dyes.
- have or have had any medical conditions, especially the following:
- have sleep apnoea (temporarily stopping breathing while you sleep)
- low blood pressure
- increased prostate size or difficulty passing urine
- chronic lung, liver or kidney disease
- disease of your gall bladder or bile duct
- inflammation of the pancreas
- underactive adrenal glands
- underactive thyroid gland
- inflammatory bowel disease or recent abdominal surgery
- severe mental condition involving losing contact with reality, hearing voices or an inability to think clearly
- an addiction or history of abuse of alcohol, opioids or other drugs
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. This medicine is not recommended to be taken during labour.
Oxycodone given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Tell your doctor if you are breast feeding or planning to breastfeed. Oxycodone can pass into the breast milk and can affect the baby. Your doctor can discuss with you the risks involved.
If you have not told your doctor about any of the above, tell them before you take any OxyNorm capsules.
Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine.
Like most medicines of this kind, OxyNorm capsules are not recommended to be taken during pregnancy. Your doctor will discuss the risks of taking them if you are pregnant.
Addiction
You can become addicted to OxyNorm even if you take it exactly as prescribed. OxyNorm 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 OxyNorm. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyNorm suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to OxyNorm 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.
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 dietary supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines, dietary supplements and OxyNorm capsules may interfere with each other. These include:
- medicines to treat depression, psychiatric or mental disorders
- medicines to treat depression belonging to a group called ‘monoamine oxidase inhibitors’ must be stopped 14 days before OxyNorm capsules are taken
- antidepressants e.g. fluoxetine, paroxetine
- medicines to help you sleep
- medicines to put you to sleep during an operation or procedure
- medicines to relax your muscles
- medicines to lower blood pressure
- quinidine and other medicines to treat the heart
- medicines to treat convulsions, e.g. phenytoin and carbamazepine
- medicines to thin the blood e.g. coumarin derivatives such as warfarin
- cimetidine, a medicine to treat stomach ulcers and heartburn
- medicines to relieve stomach cramps or spasms, or to prevent travel sickness and the symptoms of allergies
- medicines to treat Parkinson's disease
- medicines to treat urinary incontinence
- medicines to stop nausea or vomiting e.g. metoclopramide
- other pain relievers including other opioids
- medicines to treat fungal infections, e.g. ketoconazole
- antibiotics, e.g. clarithromycin, rifampin
- medicines to treat HIV infection and AIDS, e.g. ritonavir
- alcohol
- St John's wort (a herbal preparation)
- grapefruit and grapefruit juice.
- medicines to treat epilepsy, pain, and anxiety e.g. gabapentin and pregabalin.
These medicines, dietary supplements or alcohol may be affected by OxyNorm capsules, may affect how well OxyNorm capsules work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect OxyNorm capsules.
4. How do I take OxyNorm capsules?
How much to take
- Your doctor will tell you exactly how much to take.
- Follow the instructions given to you by your doctor or pharmacist exactly.
How to take OxyNorm capsules
Swallow OxyNorm capsules whole with a full glass of water or other fluid.
Do not open, chew or crush them.
OxyNorm capsules are only designed to work properly if swallowed whole.
You must only take OxyNorm capsules by mouth.
If you have trouble swallowing your capsules whole, talk to your doctor.
Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health.
When to take OxyNorm capsules
Take OxyNorm capsules every 4 to 6 hours or as directed by your doctor.
If you begin to experience pain and you are taking your OxyNorm capsules as prescribed, contact your doctor as your dosage may have to be reviewed.
How long to take OxyNorm capsules
Continue taking your medicine for as long as your doctor tells you.
If you stop taking this medicine suddenly, your pain may worsen and you may experience withdrawal symptoms such as:
- body aches
- loss of appetite, nausea, stomach cramps or diarrhoea
- fast heart rate
- sneezing or runny nose
- chills, tremors, shivering or fever
- trouble sleeping
- increased sweating and yawning
- weakness
- nervousness or restlessness.
If you forget to take OxyNorm capsules
If you forget to take your capsules, contact your doctor or pharmacist for advice.
Do not take a double dose to make up for the dose you have missed.
This will increase the chance of you getting unwanted side effects.
If you take too much OxyNorm capsules (overdose)
If you or someone else receive too much (overdose), and experience one or more of the symptoms below, 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 steps even if someone other than you have accidentally used OxyNorm that was prescribed for you. If someone takes 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.
If you think you or someone else may have taken too much OxyNorm, you should immediately:
- telephone your doctor, or
- phone the Poisons Information Centre (Australia: telephone 13 11 26, New Zealand: telephone 0800 POISON or 0800 764 766), 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 any remaining capsules 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 OxyNorm capsules?
Things you should do
- Take OxyNorm capsules exactly as your doctor has prescribed.
- Before you start on a new medicine, remind your doctor and pharmacist that you are taking OxyNorm capsules.
- Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
- If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
- Keep all of your doctor's appointments so that your progress can be checked.
- Keep enough OxyNorm capsules with you to last over weekends and holidays.
- Be careful if you are elderly, unwell or taking other medicines.
- Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall. - If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
- Standing up slowly 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. - Tell your doctor if taking OxyNorm capsules causes constipation.
- Your doctor can advise about your diet, the proper use of laxatives and suitable exercise you can do to help manage this.
There is potential for abuse of oxycodone and the development of dependence. It is important that you discuss this issue with your doctor.
Call your doctor straight away if:
- you become pregnant while taking this medicine
- you feel your pain is getting worse
- Always discuss any problems or difficulties you have while you are taking OxyNorm capsules.
- Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may review your dose so that you get adequate pain relief. - Tell your doctor if you suffer from nausea or vomiting when taking OxyNorm capsules.
- If you vomit after your dose, your pain may come back, as you may not have absorbed your medicine. If this happens, speak to your doctor. Your doctor may prescribe some medicine to help you stop vomiting.
Things you should not do
- Do not take OxyNorm capsules to treat any other complaint 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, exceed the dose recommended or change the dosage without checking with your doctor.
- Over time your body may become used to oxycodone. If you stop taking it suddenly, your pain may worsen and you may have unwanted side effects such as withdrawal symptoms. This is called physical dependence.
- If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely.
Driving or using machines
Do not drive or operate machinery until you know how OxyNorm capsules affect you.
OxyNorm capsules may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. If you are affected you should not drive or operate machinery. Discuss these effects with your doctor.
Drinking alcohol
Do not drink alcohol while you are taking OxyNorm capsules.
Drinking alcohol whilst taking OxyNorm capsules may make you feel more sleepy and increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing and loss of consciousness.
Looking after your medicine
- Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the blister pack they may not keep as well.
- Keep your capsules in a cool, dry place, where the temperature stays below 30°C.
Follow the instructions on 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 window sills.
Keep it where young children cannot reach it. 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.
Less serious side effects
Less serious side effects | What to do |
Mouth, gastrointestinal and urinary related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Mouth, gastrointestinal and urinary related:
| 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. |
The above list includes serious side effects that may require medical treatment.
Other side effects not listed here may occur in some people.
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 OxyNorm capsules contains
Active ingredient (main ingredient) |
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Other ingredients (inactive ingredients) |
In addition, the capsules also contain the colourants listed below:
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Potential allergens | This medicine does not contain lactose, sucrose, gluten or tartrazine. |
Do not take this medicine if you are allergic to any of these ingredients.
What OxyNorm capsules looks like
OxyNorm® capsules come in three strengths:
- 5 mg - orange and beige, printed with "ONR 5" (Aust R 74145)
- 10 mg - white and beige, printed with "ONR 10" (Aust R 74143)
- 20 mg - pink and beige, printed with "ONR 20". (Aust R 74141)
OxyNorm® capsules 5mg, 10 mg and 20mg come in boxes containing blister packs of 10 and 20 capsules.
Who distributes OxyNorm capsules
Mundipharma Pty Limited
ABN 87 081 322 509
10 Carrington Street
Sydney, NSW, 2000
Phone: 1800 188 009
® OXYNORM is a trade mark of MUNDIPHARMA
This leaflet was updated in October 2024
OXYNORM CAPS-CMIv2-CCDSv121
Published by MIMS February 2025