Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion – patient leaflet, side effects, dosage

1. What Oxycodone Injection is and what it is used for

This medicine has been prescribed for you for the relief of moderate to severe pain. It contains the active ingredient 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 receiving it suddenly. Your prescriber should have explained how long you will be receiving it for and when it is appropriate to stop, how to do this safely.

2. What you need to know before you use Oxycodone Injection

Do not use Oxycodone Injection if you:

• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of this 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before treatment with Oxycodone 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 receive more of Oxycodone Injection 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 Oxycodone 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 receiving this medicine. Your doctor may adjust your dose.

You may experience hormonal changes while receiving 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

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.

Tolerance, dependence and addiction

This medicine contains oxycodone, which is an opioid. It can cause dependence and/or 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 Oxycodone 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 Oxycodone Injection, it is important that you consult your doctor. Your doctor should have explained how long you will be receiving 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.

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 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.

How do I know if I am addicted?

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 it is important you talk to your doctor.

Withdrawal

Addiction can cause withdrawal symptoms when you stop receiving 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 receiving Oxycodone Injection). Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop receiving 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. Receiving higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Other medicines and Oxycodone Injection

Using Oxycodone 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 Oxycodone 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 Oxycodone 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 Oxycodone 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 Oxycodone 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.

Oxycodone Injection with food, drink and alcohol

Drinking alcohol during your treatment with Oxycodone 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 receiving Oxycodone Injection. You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breast-feeding

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

Pregnancy

You should not be given Oxycodone Injection 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.

The following information is intended for healthcare professionals only:

PREPARATION GUIDE:

Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion

Please refer to the Summary of Product Characteristics for full prescribing and other information. Therapeutic indications

Oxycodone is indicated in adults for the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

Administration

For intravenous or subcutaneous use.

Dilution

Each ampoule is for single use in a single patient. This medicine should be given immediately after opening the ampoule and any unused portion should be discarded.

The medicinal product should be examined visually and should not be used if particulate matter or discolouration are present.

Oxycodone Injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags, over a 24 hour period at 25°C.

The 10 mg/ml injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids and containers detailed above, does not need to be protected from light over a 24 hour period.

Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------If you are given Oxycodone Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding

You should not be given Oxycodone Injection while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.

Driving and using machines

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 receiving 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 used 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 receiving this medicine.

Oxycodone Injection contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially 'sodium-free'.

3. How to use Oxycodone Injection

A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Oxycodone Injection, when and how often you will be given it, when to contact your doctor, and when you need to stop (see also if you stop receiving Oxycodone Injection).

Your doctor should have discussed with you, how long the course of Oxycodone Injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop receiving the medicine.

Adults (over 18 years of age)

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

Children and adolescents under 18 years of age should not be given the injection.

Patients with kidney or liver problems

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.

If you use more Oxycodone Injection than you should, or if someone else uses your medicine

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 also 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.

If you stop receiving Oxycodone Injection

Do not suddenly stop receiving this medicine. If you want to stop using your 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 receiving this medicine. If you have any further questions on the use of this injection, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxycodone Injection 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 expected (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 Oxycodone Injection’). 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.

Drug Withdrawal

When you stop receiving Oxycodone Injection, 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.

As with all strong painkillers, there is a risk that you may become addicted or reliant on Oxycodone Injection.

Very common side effects

(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 receiving your medicine or when your dose is increased, but it should wear off after a few days).
• Dizziness.
• Headache.
• Itchy skin.

Common side effects

(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 side effects

  (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 or unpleasant taste.
  • A feeling of dizziness or spinning (vertigo), hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, disorientation, 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 or impaired vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions or spasms.
  • Difficulty or pain passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (hypogonadism, seen in a blood test).
  • Fast, irregular heart beat, palpitations, a feeling of lightheadedness, dizziness or fainting, 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, high temperature.
  • Colicky abdominal pain or discomfort.
  • A worsening of liver function tests (seen in a blood test).

Rare side effects

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

• Low blood pressure.
• A raised, itchy rash (hives).

Frequency not known

(Frequency cannot be estimated from the available data)

• Dependence and addiction (see ‘How do I know if I am addicted?’ in section 2 of the leaflet).
• Withdrawal symptoms (see ‘Drug withdrawal’ in section 2 of the leaflet).
• A need to receive increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance).
• 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.
• A problem affecting a valve in the intestines that may cause severe upper abdominal pain (sphincter of Oddi dysfunction).
• 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).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Oxycodone Injection

Keep this medicine out of the sight and reach of children. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them. Accidental overdose by a child is dangerous and may be fatal. Do not use Oxycodone Injection after the expiry date which is stated on the ampoule label and carton. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Keep the ampoule in the outer carton in order to protect from light.

Once the ampoule is opened the medicine should be used immediately. Any unused portion should be discarded immediately.

The medicine should be examined visually and should not be used if particulate matter or discolouration are present.

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.

6. Contents of the pack and other information

What Oxycodone Injection contains

The active substance is oxycodone hydrochloride.

The other ingredients are:

• Citric acid monohydrate
• Sodium citrate dihydrate
• Sodium chloride
• Hydrochloric acid
• Sodium hydroxide
• Water for injections

What Oxycodone Injection looks like and contents of the pack

Oxycodone Injection is a clear colourless solution, practically free from visible particles supplied in colourless glass ampoules.

Each 1 ml ampoule contains 10 mg oxycodone hydrochloride (equivalent to 9 mg oxycodone). Each 2 ml ampoule contains 20 mg oxycodone hydrochloride (equivalent to 18 mg oxycodone). Pack size: 5, 10 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

hameln pharma ltd

Nexus, Gloucester Business Park

Gloucester, GL3 4AG, United Kingdom

Manufacturer

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin, Slovakia

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec, Slovakia

hameln rds s.r.o.

Horná 36

900 01 Modra, Slovakia

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 09/2025.

3686/39/25 xxxxxxx

Compatibilities

Oxycodone Injection has been shown to be compatible with the following drugs:

Hyoscine butylbromide

Hyoscine hydrobromide

Dexamethasone sodium phosphate

Haloperidol

Midazolam hydrochloride

Metoclopramide hydrochloride

Levomepromazine hydrochloride

Incompatibilities

Cyclizine at concentrations of 3 mg/ml or less, when mixed with Oxycodone Injection, either undiluted or diluted with water for injections, shows no sign of precipitation over a period of 24 hours storage at 25°C. Precipitation has been shown to occur in mixtures with Oxycodone Injection at cyclizine concentrations greater than

3 mg/ml or when diluted with 0.9% saline.

It is recommended that water for injections be used as a diluent when cyclizine and oxycodone hydrochloride are co-administered either intravenously or subcutaneously as an infusion.

Prochlorperazine is chemically incompatible with Oxycodone Injection.

Shelf life

Prepared infusion solutions:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

For instructions on dilution of the medicinal product before administration, see the section on Dilution.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------