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 16950/0098, PL16950/0141, PL16950/0139 , PL 16950/0097, PL 16950/0099, PL16950/0150, PL 16950/0123, PL16950/0140.
OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets
OxyContin® 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets
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 OxyContin tablets are and what they are used for
2. What you need to know before you take OxyContin tablets
3. How to take OxyContin tablets
4. Possible side effects
5. How to store OxyContin tablets
6. Contents of the pack and other information
This medicine has been prescribed for you for the relief of moderate to severe pain over a period of 12 hours. 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 tablets 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 OxyContin tablets, 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 OxyContin tablets. 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
OxyContin tablets 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 tablets. Your doctor may adjust your dose.
You may experience hormonal changes while taking these tablets. Your doctor may want to monitor these changes.
Taking OxyContin tablets 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 OxyContin tablets 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 OxyContin tablets 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 OxyContin tablets.
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 feel more 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 OxyContin tablets.
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 OxyContin tablets 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 OxyContin tablets during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take OxyContin tablets while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
These tablets 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 taking the tablets, 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.
These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.
Your doctor should have discussed with you how long the course of OxyContin tablets 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 10 mg tablet every 12 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 tablets, discuss this with your doctor.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Swallow your tablets whole with water. Do not crush, dissolve or chew them.
OxyContin tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.
You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal (see section 2 ‘Warnings and precautions’).
Children and adolescents under 18 years of age should not take the tablets.
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
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 tablets with you to show to the doctor.
If you remember within 4 hours of the time your tablet was due, take your tablet straight away.
Take your next tablet 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 a forgotten tablet.
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 tablets 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 OxyContin tablets’). 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 OxyContin tablets 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 OxyContin tablets 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)
You may see the remains of the tablets in your faeces. This should not affect how the tablets work.
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 tablets 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 tablets above 25°C.
Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
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 tablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg or 120 mg of oxycodone hydrochloride.
The other ingredients are lactose monohydrate, povidone, ammoniomethacrylate co-polymer, sorbic acid, triacetin, stearyl alcohol, talc, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol.
In addition, the tablet coatings contain the following:
5 mg – brilliant blue (E133)
10 mg – hydroxypropylcellulose
15 mg – iron oxide (E172)
20 mg, 30 mg, 40 mg, 60 mg and 120 mg – polysorbate 80 (E433), and iron oxide (E172)
80 mg – hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132)
The tablets are marked OC on one side and the strength on the other (5, 10, 15, 20, 30, 40, 60, 80 or 120). All strengths are round, bi-convex, film coated tablets.
The tablets are all film coated in the following colours: 5 mg – light blue, 10 mg – white, 15 mg – grey, 20 mg – pink, 30 mg – brown, 40 mg – yellow, 60 mg – red, 80 mg – green, 120 mg – purple.
In each box there are 28 or 56 tablets. Not all pack sizes may be marketed.
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: OxyContin
Reference number: 16950/0123
This leaflet was last revised in March 2022
® OxyContin, NAPP and the NAPP device logo are registered trade marks.
© 2009-2022 Napp Pharmaceuticals Limited.