Important Safety Information

Do not take Oxeltra (oxycodone) if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you take oxycodone during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take oxycodone while you are breastfeeding as it passes into breast milk and will affect your baby.

You should avoid drinking grapefruit juice while you are taking Oxeltra.

Oxeltra 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.

If you take more Oxeltra tablets than you should, or if someone accidentally swallows your tablets call your doctor or hospital straight away.

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 take the package leaflet and any remaining tablets with you to show to the doctor.

Oxycodone may cause a number of side effects such as drowsiness which could affect your ability to use machinery.  If you are affected you should not use machinery.

The opioid oxycodone in this medicine can cause addiction. Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms may 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.

It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. 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.

If you are going to have an operation, please tell the doctor at the hospital that you are taking oxycodone.

Oxeltra (oxycodone) may cause a number of side effects such as drowsiness or dizziness  which could affect your ability to drive.  These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose.

Do not drive while taking this medicine until you know how it affects you. If you are affected you should not drive.

It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’)

This defence applies when:

• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

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 take Oxeltra with some other medicines, the effect of Oxeltra or the other medicine may be changed.

Drinking alcohol whilst taking Oxeltra (oxycodone) tablets 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 not to drink alcohol while you’re taking Oxeltra tablets.