Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)
Consumer Medicine Information
This leaflet answers some common questions about OxyNorm capsules.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
OxyNorm capsules contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.
OxyNorm capsules are used to relieve moderate to severe 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.
This medicine is only available with a doctor's prescription.
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:
Do not take OxyNorm capsules if you are allergic to oxycodone, opioid painkillers, or any of the ingredients listed at the end of this leaflet.
Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work very well.
Do not take it if the packaging is torn or shows signs of tampering.
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 and benefits of taking them if you are pregnant.
Do not give this medicine to a child younger than 18 years of age. Safety and effectiveness in children younger than 18 years of age have not been established.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
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 breastfeeding or planning to breastfeed. Oxycodone can pass into the breast milk and can harm the baby. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you take any OxyNorm capsules.
Tell your doctor if you are taking any other medicines or dietary substances, including any 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:
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.
Your doctor or pharmacist has more information on medicines and dietary supplements to be careful with or avoid while taking this medicine.
Your doctor will tell you exactly how much to take.
Follow the instructions given to you by your doctor or pharmacist exactly.
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.
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.
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:
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.
Immediately telephone your doctor, or the Poisons Information Centre (Australia: telephone 13 11 26, New Zealand: telephone 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too many OxyNorm capsules.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
You should also follow the above steps if someone other than you has accidently taken the tablets that were prescribed for you.
If someone takes an overdose they may experience difficulties in breathing, become drowsy and tired, lack muscle tone, have cold or clammy skin, have constricted pupils, have very low blood pressure or slow heart rate, and possibly may even become unconscious or die.
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.
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. 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.
Tell your doctor if 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.
Keep enough OxyNorm capsules with you to last over weekends and holidays.
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.
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.
Do not drive or operate machinery until you know how OxyNorm capsules affects 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.
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 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.
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.
All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for other medicines of this type, that is opioid analgesics, side effects tend to reduce over time, with the exception of constipation. This means that the longer you take this medicine, the less it may cause problems for you. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects. Not everybody experiences them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OxyNorm capsules. This medicine helps people with moderate to severe pain, but it may have unwanted side effects in some people. Other side effects not listed here may also occur in some people.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
Tell your doctor as soon as possible if you notice any of the following and they worry you:
The above list includes serious side effects that may require medical treatment.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
When seeking medical attention, take this leaflet and any remaining capsules with you to show the doctor.
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.
Do not store it or any other medicine in the bathroom, near a sink or on a window sill.
Do not leave it in the car on hot days. Heat and damp can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking the capsules or the capsules have passed their expiry date, ask your pharmacist how to dispose of medicines no longer required.
OxyNorm® capsules come in three strengths:
OxyNorm® capsules come in boxes containing blister packs of 20 capsules.
In addition, the capsules also contain the colourants listed below:
This medicine does not contain lactose, sucrose, gluten or tartrazine.
OxyNorm® capsules are supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
50 Bridge Street
Sydney, NSW, 2000
Phone: 1800 188 009
OxyNorm® capsules are supplied in New Zealand on behalf of Mundipharma New Zealand Limited by:
Pharmaco (NZ) Ltd
PO BOX 4079
Phone: (09) 377-3336
Medical enquiries: 0800 773 310
®: OXYNORM is a Registered Trademark.
This leaflet was updated in September 2014. Please check with your pharmacist that this is the latest version of the leaflet available.
Australian Registration Numbers for OxyNorm® capsules:
5 mg: AUST R 74145
10 mg: AUST R 74143
20 mg: AUST R 74141
Orbis RA-0071 Jul 2014
Published by MIMS May 2015