What it is and what it is used for

for This injection has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or 'painkillers'. Oxycodone is indicated in adults only.

What you need to know before you take it

e Oxycodone Do not use Oxycodone:

• if you are allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6);
• if you have known sensitivity to morphine or other opioids;
• if you 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;
• if you have a heart problem after long-term lung disease (cor pulmonale);
• if you have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;
• if you have ongoing problems with constipation;
• if you are under 18 years of age.

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). Sleep-related breathing disorders Oxycodone 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. Other medicines and Oxycodone Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines 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. Concomitant use of opioids and benzodiazepines increases 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. Please follow your doctor's dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms. 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.

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 tranquillisers, hypnotics or sedatives); Warnings and precautions
• medicines to treat depression (such as paroxetine); Talk to your doctor, pharmacist or nurse before treatment with Oxycodone if you:
• medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);
• are elderly or weakened;
• other strong analgesics ('painkillers');
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose; – muscle relaxants;
• medicines to treat high blood pressure;
• have myxoedema (a thyroid disorder with
• quinidine (a medicine to treat a fast heart beat); dryness, coldness and swelling ['puffiness'] of the skin affecting the face and limbs;
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull – antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole); is increased;
• antibiotics (such as clarithromycin, erythromycin
• have low blood pressure (hypotension); or telithromycin);
• have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, – medicines known as 'protease inhibitors' to treat HIV (e.g. boceprevir, ritonavir, indinavir, severe burns, excessive sweating, severe nelfinavir or saquinavir); diarrhoea or vomiting;
• rifampicin (to treat tuberculosis);
• have a mental disorder as a result of an infection
• carbamazepine (a medicine to treat seizures, fits (toxic psychosis); or convulsions and certain pain conditions);
• have inflammation of the pancreas (which causes
• phenytoin (a medicine to treat seizures, fits or severe pain in the abdomen and back); convulsions);
• have problems with your gall bladder or bile duct;
• a herbal remedy called St. John's Wort (also
• have inflammatory bowel disease; known as Hypericum perforatum);
• have an enlarged prostate gland, which causes
• antihistamines; difficulty in passing urine (in men);
• medicines to treat Parkinson's disease.
• have poor adrenal gland function (your adrenal gland is not working properly which may cause Also tell your doctor if you have recently been given symptoms including weakness, weight loss, an anaesthetic. dizziness, feeling or being sick), e.g. Addison's disease; Oxycodone with drink and alcohol
• have breathing problems such as severe Drinking alcohol during your treatment with pulmonary disease. Your doctor will have told Oxycodone may make you sleepy or increase the you if you have this condition. Symptoms may risk of serious side effects such as shallow breathing include breathlessness and coughing; with a risk of stopping breathing, and loss of
• have kidney or liver problems; consciousness. It is recommended not to drink
• have previously suffered from withdrawal alcohol while you're taking Oxycodone. symptoms such as agitation, anxiety, shaking or You should avoid drinking grapefruit juice during sweating upon stopping taking alcohol or drugs; your treatment with this medicine.
• have an increased sensitivity to pain;
• need to take increasingly higher doses of Oxycodone to gain the same level of pain relief Pregnancy and breast‐feeding (tolerance). 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 this medicine Contact your doctor if you experience severe upper is administered to you. abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms There are limited data from the use of oxycodone in pregnant women. Prolonged use of oxycodone associated with inflammation of the pancreas during pregnancy can cause withdrawal symptoms (pancreatitis) and the biliary tract system. in newborns. Use of oxycodone during childbirth If you are going to have an operation, please tell the can cause breathing problems in the newborn. doctor at the hospital that you are taking this Breast‐feeding should be discontinued during medicine. treatment with Oxycodone. Oxycodone passes into You may experience hormonal changes while taking breast milk and may affect your suckling child, especially following the intake of multiple doses. this medicine. Your doctor may want to monitor these changes. Data concerning an influence of oxycodone on human fertility are not available. 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 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, 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') The following information is intended for healthcare professionals only: Posology The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. Adults over 18 years: The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. IV (Bolus): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1‐2 minutes. Doses should not be administered more frequently than every 4 hours. IV (Infusion): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. A starting dose of 2 mg/hour is recommended. IV (PCA): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock‐out time of 5 minutes. SC (Bolus): Use as 10 mg/ml concentration. Oxycodone 50 mg/ml dilute in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. A starting dose of 5 mg is recommended, repeated at 4‐hourly intervals as required.

Driving and using machines This injection may cause a number of side effects such as drowsiness 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 changing to a higher dose. If you are affected you should not drive or use machinery. This medicine can affect your ability to drive as it may make you sleepy or dizzy.

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

How to take it

Oxycodone 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. Before starting treatment and regularly during treatment, your doctor will discuss with you what

2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter‐patient variability requires that each patient is carefully titrated to the appropriate dose. The patient should be monitored closely until stable when switching opioid medications. Conversion of patients from IV morphine to IV oxycodone: In patients who have received IV morphine prior treatment with IV oxycodone, the daily dosage should be based on 1:1 equivalence ratio. It must be emphasised that this is a guide to the dose required. Inter patient variability requires that each patient is carefully titrated to the appropriate dose. The patient should be monitored closely until stable when switching opioid medications. Elderly patients: Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control. Patients with renal and hepatic impairment: The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation. Paediatric population: There are no data on the use of oxycodone injection in patients under 18 years of age.

SC (Infusion): Dilute in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Use in non‐malignant pain: Opioids are not first‐line therapy for chronic non‐malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non‐malignant pain should be assessed at regular intervals.

Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio:

Endocrine system: Opioids may influence the hypothalamic-pituitary-adrenal or gonadal axes.

you may expect from using Oxycodone, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also if you stop using Oxycodone). 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 than you should Call your doctor or hospital straight away. In severe cases an overdose may lead to unconsciousness or even death. 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 ampoules with you to show to the doctor. If you stop using Oxycodone You should not suddenly stop using this injection unless your doctor tells you to. If you want to stop using Oxycodone, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop using this injection. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• a problem affecting a valve in the intestines that may cause severe upper abdominal pain (sphincter of Oddi dysfunction)
• long term use of Oxycodone 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 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: 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.

How to store it

Oxycodone 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. This medicinal product does not require any special storage conditions. Do not freeze. Shelf life after first opening: After opening, this medicinal product should be used immediately. Shelf life after dilution: Chemical and physical in‐use stability has been demonstrated for 24 hours at 25 °C and at 2‐8 °C (after dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections). 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. Do not use this medicine if you notice any visible signs of deterioration (e.g. particles). Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Any unused portion should be discarded immediately. 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 protect the environment.

Contents of the pack and other information

What Oxycodone contains Oxycodone 10 mg/ml:

• The active substance is oxycodone hydrochloride. Each 1 ml ampoule contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone). Each 2 ml ampoule contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone).

Oxycodone 50 mg/ml: All medicines can cause allergic reactions, although – The active substance is oxycodone hydrochloride. Each 1 ml ampoule contains 50 mg of oxycodone serious allergic reactions are rare. Tell your doctor hydrochloride (equivalent to 45 mg of oxycodone). immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face The other ingredients are citric acid monohydrate; or lips, rash or itching especially those covering sodium citrate, sodium chloride, sodium hydroxide your whole body. (for pH adjustment), hydrochloric acid, concentrated (for pH adjustment), water for injections. The most serious side effect is a condition where you breathe more slowly or weakly than expected What Oxycodone looks like and contents of the (respiratory depression). Tell your doctor pack immediately if this happens to you. Clear, colourless solution for injection/infusion, free As with all strong painkillers, there is a risk that you from visible particles. may become addicted or reliant on this injection. Oxycodone is produced in 1 ml or 2 ml colourless Very common side effects (may affect more than glass ampoules. Ampoules are marked with a specific colour ring 1 in 10 people)

• constipation (your doctor can prescribe a laxative code for each strength and volume. Pack size: to overcome this problem)
• feeling or being sick (this should normally wear Oxycodone 10 mg/ml off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues 5, 10 or 25 ampoules of 1 ml 5 or 10 ampoules of 2 ml to be a problem)
• drowsiness (this is most likely when you start Oxycodone 50 mg/ml taking your medicine or when your dose is increased, but it should wear off after a few days) 5 or 10 ampoules of 1 ml
• dizziness Not all pack sizes may be marketed.
• headache
• itchy skin Marketing Authorisation Holder and Manufacturer Common side effects (may affect up to AS KALCEKS 1 in 10 people)
• dry mouth, loss of appetite, indigestion, abdominal Krustpils iela 71E, Rīga, LV-1057, Latvia Tel.: +371 67083320 pain or discomfort, diarrhoea E-mail: [email protected]
• confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, This leaflet was last revised in 09/2025 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
• 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 take 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) Rare side effects (may affect up to 1 in 1 000 people)
• low blood pressure
• a feeling of 'faintness' especially on standing up
• hives (nettle rash) Frequency not known (frequency cannot be estimated from the available data)
• an increased sensitivity to pain
• aggression
• sleep apnoea (breathing pauses during sleep)
• 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 Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes. Concomitant therapy: There can be an enhanced CNS depressant effect which can result in profound sedation, respiratory depression, coma and death during concomitant therapy with benzodiazepines or other drugs which affect the CNS such as tranquillisers, anaesthetics, hypnotics, antidepressants, non-benzodiazepine sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives. Duration of treatment: Oxycodone should not be used for longer than necessary.

18.09.2025. HUK/I/0/4

Instructions for use/handling Each ampoule is for single use in a single patient. The medicinal product should be used immediately after opening the ampoule and any unused portion should be discarded. Do not use if there are any visible signs of deterioration (e.g. particles). Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and at 2‐8 °C. 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.

Oxycodone 10 mg/ml, undiluted or diluted to 1 mg/ml with sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections and Oxycodone 50 mg/ml, undiluted or diluted to 3 mg/ml with sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections, is Route of administration physically and chemically stable when in contact Subcutaneous injection or infusion. with representative brands of polypropylene or Intravenous injection or infusion. polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags, over Incompatibilities a 24 hour period at room temperature (25 °C) and at Cyclizine at concentrations of 3 mg/ml or less, 2‐8 °C. when mixed with Oxycodone, either undiluted or Oxycodone, whether undiluted or diluted in the diluted with water for injections, shows no sign of infusion fluids used in these studies and contained precipitation over a period of 24 hours storage at in the various assemblies, does not need to be room temperature. Precipitation has been shown to protected from light. occur in mixtures with Oxycodone at cyclizine concentrations greater than 3 mg/ml or when diluted As well as product is compatible with following medicinal products: hyoscine butylbromide, with sodium chloride 9 mg/ml (0.9%) solution for hyoscine hydrobromide, dexamethasone sodium injection. However, if the dose of Oxycodone phosphate, haloperidol, midazolam hydrochloride, injection is reduced and the solution is sufficiently metoclopramide hydrochloride, levomepromazine diluted with water for injections, concentrations hydrochloride, glycopyrronium bromide, ketamine greater than 3 mg/ml are possible. It is hydrochloride. recommended that water for injections be used as a diluent when cyclizine and oxycodone hydrochloride are co‐administered either intravenously Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the or subcutaneously as an infusion. diluted solutions may compromise the sterility of Prochlorperazine is chemically incompatible with the product. Oxycodone. Discontinuation of treatment: When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.