Active ingredient
- oxycodone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16950/0128.
OxyNorm 10 mg/ml solution for injection or infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
OxyNorm® 10 mg/ml, solution for injection or infusion
Oxycodone hydrochloride
This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
In this leaflet:
1. What OxyNorm injection is and what it is used for
2. What you need to know before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Contents of the pack and other information
1. What OxyNorm injection is and what it is used for
This medicine has been prescribed for you for the relief of moderate to severe pain. It contains oxycodone which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.
2. What you need to know before you use OxyNorm injection
Do not use OxyNorm injection if you:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before treatment with OxyNorm injection if you:
Using this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.
Addiction can cause withdrawal symptoms when you stop using this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop using the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Using higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
If you are going to have an operation, please tell the doctor at the hospital that you are taking this medicine.
You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.
Other medicines and OxyNorm injection
Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe benzodiazepines or related drugs with opioids the dosage and duration of concomitant treatment should be limited by your doctor.
The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you use this injection with some other medicines, the effect of this injection or the other medicines may be changed.
Tell your doctor or pharmacist if you are taking:
Also tell your doctor if you have recently been given an anaesthetic.
Using OxyNorm injection with food, drink and alcohol
Drinking alcohol during your treatment with this injection may make you sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking OxyNorm injection.
You should avoid drinking grapefruit juice during your treatment with this medicine.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Do not use OxyNorm injection if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use OxyNorm injection during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Breast-feeding
Do not use OxyNorm injection while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
Driving and using machines
This injection may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start using the injection, or when changing to a higher dose. If you are affected you should not drive or use machinery.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
OxyNorm injection contains less than 1 mmol sodium (23 mg) per 1 ml, i.e. it is essentially “sodium-free”.
3. How to use OxyNorm injection
A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain.
Your doctor should have discussed with you how long the course of OxyNorm injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Adults (over 18 years of age)
The usual starting dose is dependent upon how the injection is administered.
The usual starting doses are as follows:
Children
Children and adolescents under 18 years of age should not be given the injection.
Patients with kidney or liver problems
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
The dose recommended by the doctor should not be exceeded. Check with the doctor or pharmacist if you are unsure.
If you find that you are still in pain whilst being given this injection discuss this with your doctor.
If you use more OxyNorm injection than you should, or if someone else uses your injection
Call your doctor or hospital straight away. People who have been given an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital.
When seeking medical attention make sure that you take this leaflet and any remaining injection with you to show to the doctor.
If you stop using OxyNorm injection
Do not suddenly stop using this medicine. If you want to stop using this medicine discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
If you have any further questions on the use of this injection, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this injection can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.
Drug withdrawal
When you stop using OxyNorm injection you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst using OxyNorm injection it could be a sign that you have become addicted.
If you notice any of these signs it is important you talk to your doctor.
Very common side effects
(May affect more than 1 in 10 people)
Common side effects
(May affect up to 1 in 10 people)
Uncommon side effects
(May affect up to 1 in 100 people)
Rare side effects
(May affect up to 1 in 1,000 people)
Frequency not known
(Frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store OxyNorm injection
Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.
Do not use this injection after the expiry date which is stated on the ampoule label and carton. EXP 08 2020 means that you should not use the injection after the last day of that month i.e. August 2020. There are no special precautions for storage prior to use however once the ampoule is opened the injection should be used immediately. Any unused portion should be discarded immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What OxyNorm injection contains
The active ingredient is oxycodone hydrochloride.
The other ingredients are:
What OxyNorm injection looks like and the contents of the pack
This injection is a clear, colourless solution supplied in clear glass ampoules. The 10 mg/ml strength is available as either 1 ml or 2 ml of solution (containing 10 mg or 20 mg of oxycodone hydrochloride respectively).
Marketing Authorisation Holder and Manufacturer
This injection is made by
for the Marketing Authorisation holder
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on: 0800 198 5000
You will need to give details of the product name and reference number. These are as follows:
Product name: OxyNorm solution for injection or infusion
Reference number: 16950/0128
This leaflet was last revised in July 2020
® OxyNorm, NAPP and the NAPP logo are registered trade marks.
© 2009-2020 Napp Pharmaceuticals Limited.
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