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 16950/0106, PL 16950/0107, PL 16950/0108.
OxyNorm 5, 10, 20 mg
OxyNorm® 5 mg, 10 mg and 20 mg capsules
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 capsules are and what they are used for
2. What you need to know before you take OxyNorm capsules
3. How to take OxyNorm capsules
4. Possible side effects
5. How to store OxyNorm capsules
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 these capsules 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 capsules, 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.
Do not inject OxyNorm capsules. 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.
Sleep-related breathing disorders
OxyNorm capsules 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.
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 these capsules. Your doctor may adjust your dose.
You may experience hormonal changes while taking these capsules. Your doctor may want to monitor these changes.
Taking OxyNorm capsules 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 capsules 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 capsules 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 capsules.
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 these capsules 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 capsules.
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 capsules 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 capsules during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take OxyNorm capsules while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
These capsules may cause a number of side effects such as drowsiness or dizziness which may 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 taking the capsules, 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.
The 5 mg capsules contain sunset yellow (E110) which may cause allergic reactions.
Always take these capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Your doctor should have discussed with you how long the course of OxyNorm capsules 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 one 5 mg capsule 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 these capsules, discuss this with your doctor.
Children and adolescents under 18 years of age should not take the capsules.
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.
Swallow your capsules whole with water. Do not chew or crush them.
You must only take the capsules by mouth. The capsule contents should never be injected as this may lead to serious side effects, which may be fatal (see section 2 ‘Warnings and precautions’).
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 capsules with you to show to the doctor.
If you remember within 4 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for forgotten capsules.
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, these capsules 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 capsules’). 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 capsules 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 capsules 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 any capsules after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store your capsules 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 substance is oxycodone hydrochloride. Each capsule contains 5 mg, 10 mg or 20 mg of oxycodone hydrochloride.
The other ingredients are microcrystalline cellulose, magnesium stearate, titanium dioxide (E171), iron oxide (E172), indigo carmine (E132), sodium laurilsulphate, gelatin, shellac and propylene glycol.
The 5 mg capsules also contain sunset yellow (E110) (see section 2 ‘OxyNorm 5 mg capsules contain sunset yellow (E110)’).
The capsules are marked ONR and the strength (5, 10 or 20). The capsule colours are: 5 mg – orange/beige, 10 mg – white/beige, 20 mg – pink/beige. In each box there are 56 capsules.
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 Capsules
Reference number: 16950/0106
This leaflet was last revised in March 2022
® OxyNorm, NAPP and the NAPP logo are registered trade marks.
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