Find similiar products:
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 29831/0367.
Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion
Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion
The name of your medicine is Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion. In the rest of this leaflet it is called Oxycodone Injection.
1. What Oxycodone Injection is and what it is used for
2. What you need to know before you use Oxycodone Injection
3. How to use Oxycodone Injection
4. Possible side effects
5. How to store Oxycodone Injection
6. Contents of the pack and other information
This injection has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet.
Talk to your doctor, pharmacist or nurse before treatment with Oxycodone injection if you:
This medicine contains oxycodone which is an opioid medicine.
Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance).
Repeated use of Oxycodone Injection may lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Oxycodone Injection if:
If you notice any of the following signs whilst taking Oxycodone Injection, it could be a sign that you have become dependent or addicted.
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop using Oxycodone Injection).
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.
Oxycodone injection can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood).
The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor.
A dose reduction may be considered by your doctor.
Concomitant use of opioids and benzodiazepines increase 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 signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Please tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines, including those obtained without a prescription. If you use Oxycodone Injection with some other medicines, the effect of Oxycodone Injection or the other medicines may be changed.
Tell your doctor or pharmacist if you are taking:
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
Drinking alcohol during your treatment with Oxycodone 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 Oxycodone injection.
You should avoid drinking grapefruit juice during your treatment with this medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine.
Pregnancy
You should not use this injection during pregnancy and labour unless you have been specifically told by your doctor. Depending on the dose and duration of therapy with oxycodone, slow and shallow breathing (respiratory depression) or withdrawal symptoms may occur in the newborn infant.
Breast-feeding
This injection should not be used while breast-feeding because the active ingredient may pass into breast milk.
This injection may cause a number of side effects such as drowsiness or dizziness which could affect your ability to drive or use machinery (see section 4 ‘Possible side effects’ for a full list of side effects). These are usually most noticeable when you first start using the injection, or when increasing to a higher dose. If you are affected you should not drive or use machinery.
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.
This injection contains less than 1mmol sodium (23mg) per 1ml, i.e. it is essentially “sodium-free”.
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.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Oxycodone Injection, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also If you stop using Oxycodone Injection).
The usual starting dose is dependent upon how the injection is administered. The usual starting doses are as follows:
Children and adolescents under 18 years of age should not be given this injection.
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, pharmacist or nurse if you are unsure.
If you find that you are still in pain whilst being given Oxycodone Injection discuss this with your doctor.
Call your doctor or hospital straight away. People who have been given an overdose may feel very sleepy and sick. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital.
An overdose may result in a brain disorder (known as toxic leukoencephalopathy).
When seeking medical attention make sure that you take this leaflet and any remaining injection with you to show to the doctor.
Do not suddenly stop using this injection. If you want to stop using your injection, 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 Oxycodone Injection, ask your doctor or pharmacist.
Like all medicines, Oxycodone 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.
As with all strong painkillers, there is a risk that you may become addicted or reliant on Oxycodone Injection.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
If you get any side effects, talk to your doctor, or 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, Website: 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.
Keep this medicine out of the sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not use Oxycodone Injection after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light. The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.
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.
The active ingredient is oxycodone hydrochloride. The other ingredients are: Citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid (dilute), sodium hydroxide (dilute) and water for injections.
Oxycodone Injection is a clear, colourless solution practically free of particles supplied in clear glass ampoules. The 50mg/ml strength is available as 1ml of solution, containing 50mg of oxycodone hydrochloride (equivalent to 45mg of oxycodone base). It is available in packs of 5 ampoules.
Marketing Authorisation Holder
Manufacturer
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Product name Reference number
Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion 29831/0367
This is a service provided by the Royal National Institute of Blind People.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK and Ireland: Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion.
This leaflet was last revised in 01/2024.
105940/11