OxyNorm 10 mg/ml solution for injection or infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What OxyNorm injection is and what it is used for
2. What you need to know before you use OxyNorm injection
3. How to use OxyNorm injection
4. Possible side effects
5. How to store OxyNorm injection
6. Contents of the pack and other information

• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the injection (listed in section 6 of this leaflet);
• have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;
• have a heart problem after long-term lung disease (cor pulmonale);
• have increased carbon dioxide levels in the blood. Symptoms may include dizziness, drowsiness, fatigue, shortness of breath and headache;
• have moderate to severe liver problems. If you have other long-term liver problems you should only use this injection if recommended by your doctor;
• have ongoing problems with constipation;
• are under 18 years of age.

Talk to your doctor, pharmacist or nurse before treatment with OxyNorm injection if you:

• or anyone in your family are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs;
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
• feel you need to use more of this medicine to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• are elderly or weakened;
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose of injection;
• have myxoedema (a thyroid disorder associated with dryness, coldness and swelling or puffiness of the skin affecting the face and limbs);
• know you are suffering from a brain injury or tumour, or you have a head injury, severe headache or feel sick, as this may indicate that the pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia). This can occur due to severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• feel very lightheaded or faint;
• have a mental disorder following use of certain medicines (toxic psychosis);
• have inflammation of the pancreas (which causes severe pain in the abdomen and back);
• have problems with your gall bladder or bile duct;
• have inflammatory bowel disease;
• have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), for example due to Addison’s disease;
• have severely impaired lung function. Symptoms may include breathlessness and coughing;
• have long term pain unrelated to cancer;
• have a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
• have kidney or liver problems.

If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital that you are using 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.

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.

Sleep-related breathing disorders

OxyNorm 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.

Tolerance, dependence and addiction

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 OxyNorm injection can also 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.

If you have concerns that you may become dependent on OxyNorm injection, 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.

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.

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.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted to OxyNorm injection if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst using OxyNorm injection, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs it is important you talk to your doctor.

Withdrawal

Addiction can cause withdrawal symptoms when you stop using 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. 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 taking OxyNorm injection).

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. Using higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Using OxyNorm injection 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:

• other medicines used to treat pain known as opioids (such as codeine or morphine);
• medicines used to treat epilepsy (gabapentinoids) such as pregabalin;
• medicines used to treat anxiety;
• medicines used to make you feel sleepy (such as benzodiazepines);
• medicines used to treat psychiatric or mental disorders (such as phenothiazines);
• anaesthetics;
• muscle relaxants;
• medicines used to treat high blood pressure;
• a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not use OxyNorm injection if you are currently taking this type of medicine, or have taken this medicine in the last two weeks.

Because of this, your doctor will only prescribe OxyNorm injection 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.

Using OxyNorm injection 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 injection.

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:

• a type of medicine used to treat depression known as tricyclic antidepressants, such as amitriptyline, clomipramine, imipramine, lofepramine or nortriptyline;
• medicines used to treat allergies, such as cetirizine, fexofenadine or chlorphenamine;
• medicines used to treat Parkinson’s disease;
• antibiotics such as clarithromycin, erythromycin or telithromycin;
• antifungal medicines such as ketoconazole, voriconazole, itraconazole and posaconazole;
• medicines used to treat HIV known as protease inhibitors, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• cimetidine, a medicine used to treat stomach ulcers;
• rifampicin, a medicine used to treat tuberculosis;
• medicines used to treat seizures, fits or convulsions such as carbamazepine and phenytoin;
• a herbal remedy used to treat depression known as St. John’s Wort (also known as Hypericum perforatum);
• quinidine, a medicine used to treat an irregular heartbeat.

Drinking alcohol during your treatment with OxyNorm 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 that you do not drink alcohol while you are taking OxyNorm injection.

You should avoid drinking grapefruit juice during your treatment with this medicine.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not use OxyNorm injection 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 use OxyNorm injection during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding

Do not use OxyNorm injection while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.

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 changing to a higher dose.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However you would not be committing an offence if:
  • 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 or in the information provided with the medicine and;
  • It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

OxyNorm injection contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially ‘sodium- free’.

The usual starting dose is dependent upon how the injection is administered. The usual starting doses are as follows:

• As a single injection into a vein, the usual dose is 1 to 10 mg given slowly over 1 to 2 minutes. This can be repeated every 4 hours.
• As an infusion into a vein, the usual starting dose is 2 mg/hour.
• As a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5 mg repeated at 4-hourly intervals if needed.
• As an infusion through a fine needle into the tissue under the skin, the usual starting dose is 7.5 mg/day.
• If given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03 mg per kg of body weight). Your doctor or nurse will set a suitable frequency.

Children and adolescents under 18 years of age should not be given the 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 or pharmacist if you are unsure.

If you find that you are still in pain whilst being given this injection discuss this with your doctor.

Call your doctor or hospital immediately. People who have been given 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. 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 medicine. If you want to stop using 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 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.

The active ingredient is oxycodone hydrochloride.

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, dilute hydrochloric acid, sodium hydroxide and water for injections.

OxyNorm injection is a clear, colourless solution supplied in clear glass ampoules. The 10 mg/ml strength is available as either 1 ml or 2 ml of solution (containing 10 mg or 20 mg of oxycodone hydrochloride respectively). The 50 mg/ml strength is available as 1 ml of solution (containing 50 mg of oxycodone hydrochloride).