SUMMARY CMI
OXYNDONE
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 OXYNDONE?
OXYNDONE contains the active ingredient oxycodone hydrochloride. OXYNDONE is used for the short term management of severe pain.
For more information, see Section 1. Why am I using OXYNDONE? in the full CMI.
2. What should I know before I use OXYNDONE?
Do not use if you have ever had an allergic reaction to oxycodone hydrochloride 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 OXYNDONE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with OXYNDONE 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 use OXYNDONE?
- 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 OXYNDONE.
- Swallow OXYNDONE with a full glass of water after food.
More instructions can be found in Section 4. How do I use OXYNDONE? in the full CMI.
5. What should I know while using OXYNDONE?
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 using OXYNDONE? in the full CMI.
6. Are there any side effects?
There are a number of side effects associated with this medicine. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OXYNDONE, even if you do not think it is connected with this medicine.
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
OXYNDONE 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
OXYNDONE 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
OXYNDONE 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 OXYNDONE 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 OXYNDONE
Using OXYNDONE 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 OXYNDONE.
FULL CMI
OXYNDONE
Active ingredient(s): oxycodone hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using OXYNDONE. 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 OXYNDONE.
Where to find information in this leaflet:
1. Why am I using OXYNDONE?
2. What should I know before I use OXYNDONE?
3. What if I am taking other medicines?
4. How do I use OXYNDONE?
5. What should I know while using OXYNDONE?
6. Are there any side effects?
7. Product details
1. Why am I using OXYNDONE?
OXYNDONE contains the active ingredient oxycodone hydrochloride. OXYNDONE belongs to a group of medicines called narcotic analgesics.
OXYNDONE is used for the short term management of severe pain.
The active ingredient in this medicine works by binding to receptors called opioid receptors, which are in your central nervous system. This binding action changes your body's perception of pain throughout the central nervous system producing the pain relieving (analgesic) effect.
OXYNDONE is only available with a doctor's prescription.
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.
ADDICTION
You can become addicted to OXYNDONE even if you take it exactly as prescribed. OXYNDONE 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 OXYNDONE. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OXYNDONE suddenly, so it is important to take it exactly as directed by your doctor.
TOLERANCE
Tolerance to OXYNDONE may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect. Speak to your doctor if this occurs.
WITHDRAWAL
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 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.
OXYNDONE given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
2. What should I know before I use OXYNDONE?
Warnings
Do not use OXYNDONE 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.
- Any other narcotic analgesics such as morphine, codeine or 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. - You currently have or have had any of the following:
- head injury
- brain tumour
- epilepsy or other convulsive disorders
- heart problems such as an irregular and/or rapid heartbeat
- chronic obstructive pulmonary disease, asthma or any other respiratory diseases
- severe headaches, or headaches due to due to raised pressure in the head
- a history of alcohol or drug abuse
- a history of mental illness - You are pregnant.
- You are breastfeeding.
- Do not take this medicine if you are taking or have taken medicines for depression called Monoamine Oxidase Inhibitors (MAOs) within the last 14 days.
- The expiry date printed on the pack has passed 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 be taking this medicine, consult your doctor.
Check with your doctor if you:
- Have allergies to any other medicines, foods, preservatives or dyes.
- Currently have or have had any of the following conditions:
- muscle weakness
- underactive thyroid
- kidney disease
- liver disease
- low blood pressure
- prostate problems or difficulty passing urine
- bowel disorders
- prescription or illicit drug addiction. - 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
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Check with your doctor if you are pregnant or intend to become pregnant.
Do not breast-feed if you are taking this medicine.
The active ingredient in OXYNDONE passes into breast milk and there is a possibility that your baby may be affected.
Children
Do not give this medicine to children.
Safety and effectiveness in children have not been established.
Do not take this medicine if you are taking or have taken medicines for depression called Monoamine Oxidase Inhibitors (MAOs) within the last 14 days.
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 may interfere with oxycodone and these include:
- anaesthetics
- anticoagulants, medicines used to thin the blood
- medicines used to treat epilepsy
- medicines used to help with sleeping
- blood pressure lowering medicines
- medicines used to treat anxiety
- medicines used to treat depression
- medicines used to treat cold and flu symptoms
- other medicines used to relieve pain
- medicines, used to relieve nausea and vomiting
- atropine-like medicines, used to prevent travel sickness and for stomach cramps or spasms
- medicines used to treat chronic obstructive pulmonary disorder
- antipsychotic medicines, used to treat psychosis, schizophrenia or bipolar disorder
- antihistamine medicines, used to treat allergic skin conditions or hay fever
- any medicine containing naloxone and/or naltrexone, used to reverse the effects of narcotic analgesics.
These medicines may be affected by OXYNDONE or they may affect how well it works. You may need to take different amounts of these medicines, or you may need to 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 OXYNDONE.
4. How do I use OXYNDONE?
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 bottle, ask your doctor or pharmacist for help.
How much to take
- 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 OXYNDONE.
When to take OXYNDONE
- Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
- OXYNDONE should be taken after food or with milk.
How to take OXYNDONE
- Swallow OXYNDONE with a full glass of water.
How long to take OXYNDONE
- Continue taking your medicine for as long as your doctor tells you.
- If you have been using this medicine for a long period of time and it is no longer needed to control pain DO NOT suddenly stop taking OXYNDONE.
Your doctor may want you to gradually reduce the amount of OXYNDONE you are taking before stopping completely in order to lessen the risk of withdrawal symptoms.
If you forget to use OXYNDONE
If it is less than 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.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take OXYNDONE, ask your pharmacist for some hints.
If you take too much OXYNDONE
If you or someone else receives too much (overdose), 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 have accidentally used OXYNDONE 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
- 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 used too much OXYNDONE, urgent medical attention may be needed.
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 any remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which may have been taken.
5. What should I know while using OXYNDONE?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking OXYNDONE.
Tell all other doctors, dentists and pharmacists who are treating you that you are taking OXYNDONE.
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.
Call your doctor straight away if you:
- become pregnant while taking OXYNDONE.
Things you should not do
- Do not take any other medicines while you are taking oxycodone unless you have discussed this with your doctor.
This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. - Do not take OXYNDONE to treat any complaint other than that directed by your doctor.
It may not be safe to take OXYNDONE for another complaint. - Do not give OXYNDONE to anyone else, even if their symptoms seem similar to yours.
- It may not be safe for another person to take this medicine.
- Do not stop taking it or lower or increase the dose without first checking with your doctor.
If you stop taking OXYNDONE suddenly, your condition may worsen, you may have unwanted side effects, or you may experience withdrawal symptoms. Your doctor will gradually reduce the amount you take each day before stopping this medicine completely.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how OXYNDONE affects you.
This medicine may impair the mental and physical ability needed to drive a car or operate heavy machinery. OXYNDONE may cause drowsiness, sleepiness or dizziness in some people and affect alertness. Make sure you know how you react to it before you drive or operate machinery.
Drinking alcohol
Do not drink alcohol while you are taking this medicine.
Tell your doctor if you drink alcohol.
Things to be careful 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.
Looking after your medicine
- Keep OXYNDONE tablets in their container until it is time to take them.
- If you take them out of their container, they may not keep as well.
- Keep OXYNDONE tablets in a cool, dry place where the temperature stays below 25°C.
- Heat and dampness can ruin some medicines.
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 window sills.
Keep it where young children cannot reach it.
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?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OXYNDONE even if you do not think the problems are connected with the medication or they are not listed in this leaflet.
This medicine helps most people with their pain, but it may have unwanted side effects in a few people. All medicines can have side effects, Sometimes they are serious, most of the time they are not.
If you are over 65 years of age you may have an increase chance of getting 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 |
| 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 |
| Call your doctor straight away, if you notice any of these serious side effects. This list includes serious side effects that may require medical attention. |
Very serious side effects
Serious side effects | What to do |
| 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. This list includes very serious side effects. Urgent medical attention may be required to deal with these effects. |
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. The following withdrawal symptoms may be observed after OXYNDONE is discontinued:
- nervousness, restlessness, agitation, trouble sleeping or anxiety
- body aches, weakness or stomach cramps
- loss of appetite, nausea, vomiting or diarrhoea
- increase heart rate, breathing rate or pupil size
- watery eyes, runny nose, chills or yawning
- increased sweating.
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 OXYNDONE contains
Active ingredient (main ingredient) | Each OXYNDONE tablet contains oxycodone hydrochloride 5 mg. |
Other ingredients (inactive ingredients) |
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Potential allergens | This medicine contains sugars (as lactose) and soy bean products. |
Do not take this medicine if you are allergic to any of these ingredients.
What OXYNDONE looks like
OXYNDONE Is dark blue, round, vaulted, biconvex film coated tablets. (Aust R 297760).
Who distributes OXYNDONE
Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne 3121 VIC Australia
This leaflet was prepared in August 2024.
Published by MIMS October 2024