• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 Oxycodone Injection is and what it is used for
2. What you need to know before you use Oxycodone Injection
3. How to use Oxycodone Injection
4. Possible side effects
5. How to store Oxycodone 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)
• 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 ongoing problems with constipation
• have elevated carbon dioxide levels in the blood
• are under 18 years of age.

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

• are elderly or weakened
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose
• have myxoedema (a thyroid disorder with dryness, coldness and swelling (‘puffiness’) of the skin affecting the face and limbs
• 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 happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting
• have a mental disorder as a result of an infection (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), e.g. Addison’s disease
• have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing
• have kidney or liver problems
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs
• you or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• are a smoker
• have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses
• have an increased sensitivity to pain
• need to use increasingly higher doses of Oxycodone to gain the same level of pain relief (tolerance).

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 Oxycodone injection may 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.

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.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Oxycodone 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 taking Oxycodone 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, 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 using Oxycodone.

If you are going to have an operation, please tell the doctor at the hospital that you are using this medicine.

You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.

Oxycodone 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.

Do not give this medicine to children under 18 years the potential benefits are not greater than the risks.

Concomitant use of opioids and benzodiazepines increase the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe benzodiazepines or related drugs with opioids the dosage and duration of concomitant treatment should be limited by your doctor.

The risk of side effects increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. If you use this injection with some other medicines, the effect of this injection or the other medicines may be changed.

Tell your doctor or pharmacist if you are taking:

• a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks
• medicines to help you sleep or stay calm (for example hypnotics or sedatives, including benzodiazepines)
• medicines to treat depression (such as paroxetine)
• medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics)
• other strong analgesics (‘painkillers’)
• muscle relaxants
• medicines to treat high blood pressure
• quinidine (a medicine to treat a fast heartbeat)
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn)
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole)
• antibiotics (such as clarithromycin, erythromycin or telithromycin)
• medicines known as ‘protease inhibitors’ to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir)
• rifampicin (to treat tuberculosis)
• carbamazepine (a medicine treat seizures, fits or convulsions and certain pain conditions)
• phenytoin (a medicine to treat seizures, fits or convulsions)
• a herbal remedy called St. John’sWort (also known as Hypericum perforatum)
• antihistamines
• medicines to treat Parkinson’s disease.

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.

Also tell your doctor if you have recently been given an anaesthetic.

Drinking alcohol during your treatment with this 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 not to drink alcohol while you’re using Oxycodone 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 using this medicine.

Pregnancy

You should not use this injection during pregnancy and labour unless you have been specifically told by your doctor. Depending on the dose and duration of therapy with oxycodone, slow and shallow breathing (respiratory depression) or withdrawal symptoms may occur in the newborn infant.

Breast-feeding

This injection should not be used while breast-feeding because the active ingredient may pass into breast milk.

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 for a full list of side effects). These are usually most noticeable when you first start using the injection, or when increasing to a higher dose. If you are affected you should not drive or use machinery.

• Do not drive whilst using this medicine until you know how this medicine affects you
• 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:
  • This 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).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

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

This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. 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 10mg 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 2mg/hour
• As a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5mg 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 7.5mg/day
• If given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03mg 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 this injection.

The lowest dose needed for symptom control should be used.

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 straight away. People who have been given an overdose may feel very sleepy, sick or dizzy. 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 injection. If you want to stop using your injection, 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 using this injection.

Very common (May affect more than 1 in 10 people)

• Constipation (your doctor can prescribe a laxative to overcome this problem)
• Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem)
• Drowsiness (this is most likely when you start using your medicine or when your dose is increased, but it should wear off after a few days)
• Dizziness
• Headache
• Itchy skin.

Common (May affect up to 1 in 10 people)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
• Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams
• Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex
• Rash
• Sweating.

Uncommon (May affect up to 1 in 100 people)

• Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste
• A feeling of dizziness or ‘spinning’, hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness in the hands or feet, seizures, fits or convulsions, blurred vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions
• Difficulty passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism’, seen in a blood test)
• Fast, irregular heartbeat, flushing of the skin
• Dehydration, thirst, chills, swelling of the hands, ankles or feet
• Dry skin, severe flaking or peeling of the skin
• Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature
• A need to use increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance)
• Colicky abdominal pain or discomfort
• A worsening of liver function tests (seen in a blood test)
• Drug withdrawal syndrome
• Dependence.

Rare (May affect up to 1 in 1,000 people)

• Low blood pressure
• A feeling of ‘faintness’ especially on standing up
• Hives (nettle rash).

Not known (Frequency cannot be estimated from the available data)

• An increased sensitivity to pain
• Aggression
• Tooth decay
• Absence of menstrual periods
• A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools
• Long term use of Oxycodone injection during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight
• Sleep apnoea (breathing pauses during sleep).
• a problem affecting a valve in the intestines that may cause severe upper abdominal pain (sphincter of Oddi dysfunction).

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, Website: 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.

Each 1ml ampoule contains oxycodone hydrochloride 10mg (equivalent to 9mg of oxycodone base). Each 2ml contains oxycodone hydrochloride 20mg (equivalent to 18mg of oxycodone base).

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

Oxycodone Injection is a clear colourless solution and is supplied in packs of 5 containing either 1ml or 2ml clear glass ampoules.