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 are: PL 16950/0003, PL 16950/0004.
OxyNorm liquid 1 mg/ml oral solution and OxyNorm concentrate 10 mg/ml oral solution
OxyNorm® liquid 1 mg/ml oral solution
OxyNorm® concentrate 10 mg/ml oral solution
This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What OxyNorm oral solution is and what it is used for
2. What you need to know before you take OxyNorm oral solution
3. How to take OxyNorm oral solution
4. Possible side effects
5. How to store OxyNorm oral solution
6. Contents of the pack and other information
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 taking it for and when it is appropriate to stop, how to do this safely.
Talk to your doctor or pharmacist before taking this medicine if you:
Taking this medicine regularly, particularly for a long time, can lead to addiction and may result in life threatening overdose. If you have concerns that you may become dependent on OxyNorm oral solution, it is important that you consult your doctor. 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 taking 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 taking 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. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Sleep-related breathing disorders
OxyNorm oral solution 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.
Do not inject OxyNorm oral solution. This can cause serious side effects including tissue death at the site of injection, infection, inflammation of the lungs and damage to the heart which may be fatal.
If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital that you are taking this medicine. Your doctor may adjust your dose.
You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.
Taking OxyNorm oral solution at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include:
Because of this, your doctor will only prescribe OxyNorm oral solution where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately.
Taking OxyNorm oral solution with medicines used to treat depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a condition known as serotonin toxicity. The symptoms of this include agitation, seeing or hearing things that aren’t real (hallucinations), loss of consciousness, a fast heartbeat, blood pressure changes, increased body temperature, muscle twitching, lack of coordination, stiffness, feeling or being sick, or diarrhoea. If you are taking SSRI or SNRI medicines such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine your doctor may reduce your dose of OxyNorm oral solution.
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. Tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to adjust your dose:
Drinking alcohol during your treatment with this medicine 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 that you do not drink alcohol while you are taking OxyNorm oral solution.
You should avoid drinking grapefruit juice during your treatment with this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take OxyNorm oral solution 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 take OxyNorm oral solution during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take OxyNorm oral solution while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
This medicine 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 more noticeable when you first start taking this medicine, or when changing to a higher dose.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains 5.5 mg sodium (main component of cooking/table salt) in each 1 ml. This is equivalent to 0.275% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 1 mg sodium benzoate in each 1 ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new-born babies (up to 4 weeks old).
OxyNorm concentrate 10 mg/ml contains sunset yellow (E110) which may cause allergic reactions.
Always take this medicine exactly as your doctor has told you. The label on your medicine will tell you how much to take and how often.
Your doctor should have discussed with you how long the course of OxyNorm oral solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
The usual starting dose is 5 mg every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor.
Children and adolescents under 18 years of age should not take the medicine.
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Do not drink OxyNorm oral solution directly from the bottle. Measure out the required dose using the spoon, cup or syringe you have been provided. Drinking directly from the bottle increases the risk of overdose.
You must only take this medicine by mouth. This medicine should never be injected as this may lead to serious side effects, which may be fatal (see section 2 ‘Warnings and precautions’).
If you take more OxyNorm oral solution than you should or if someone accidentally swallows your medicine.
Call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. 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 medicine with you to show to the doctor.
If you remember within 4 hours of the time your medicine was due, take it straight away. Take your next dose at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take two doses within 4 hours. Do not take a double dose to make up for a forgotten dose.
Do not suddenly stop taking this medicine. If you want to stop taking 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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. These may be signs of a serious allergic reaction.
The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 ‘Other medicines and OxyNorm oral solution’). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms.
When you stop taking OxyNorm oral solution 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.
If you notice any of the following signs whilst taking OxyNorm oral solution 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)
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.
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 medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not store your medicine above 30 °C.
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.
Each 1 ml of OxyNorm liquid 1 mg/ml contains 1 mg of oxycodone hydrochloride.
Each 1 ml of OxyNorm concentrate 10 mg/ml contains 10 mg of oxycodone hydrochloride.
The other ingredients are saccharin sodium, sodium benzoate, citric acid, sodium citrate, hydrochloric acid, sodium hydroxide and purified water.
OxyNorm liquid 1 mg/ml also contains hypromellose.
OxyNorm concentrate 10 mg/ml also contains sunset yellow (E110) (see section 2 ‘OxyNorm concentrate 10 mg/ml contains sunset yellow (E110)’).
OxyNorm liquid 1 mg/ml is a clear, colourless/straw-coloured solution. Each bottle contains 250 ml of solution.
OxyNorm concentrate 10 mg/ml is a clear orange solution. Each bottle contains 120 ml of solution. An oral syringe is also supplied.
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 oral solution
Reference number: 16950/0003
This leaflet was last revised in March 2022
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