Leaflet: information for the user

OxyNorm 10 mg/ml injectable solution and for infusion

Oxycodone hydrochloride

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

OxyNorm injectable solution is a potent analgesic and belongs to the group of opioids.

OxyNorm injectable solution is used in adults and adolescents from 12 years old for the relief of intense pain, which can only be adequately treated with opioid analgesics.

Do not use OxyNorm injectable solution if:

• You are allergic (hypersensitive) to any of the components of the injectable (listed in section 6 “Additional information”) or have had an allergic reaction to taking other potent analgesics (such as morphine or other opioids);
• You have respiratory problems, such as chronic obstructive pulmonary disease, severe bronchial asthma, or respiratory depression. Symptoms may include shortness of breath, coughing, or slower or weaker breathing than expected;
• You have a head injury that causes severe headache or dizziness, as the injection may worsen these symptoms or mask the extent of the injury;
• You have a condition where your small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have severe, sudden abdominal pain;
• You have heart disease after a long-standing lung disease (cor pulmonale);

Warnings and precautions

Consult your doctor or pharmacist before starting to use OxyNorm if:

• You are elderly or debilitated;
• You have low thyroid activity (hypothyroidism);
• You have myxedema (a thyroid disorder, with dryness, coldness, and inflammation (swelling) of the skin, affecting the face and extremities);
• You have severe headache or dizziness, as this may indicate increased intracranial pressure;
• You have low blood pressure (hypotension);
• You have pancreatitis (inflammation of the pancreas, which may cause severe abdominal and back pain) or problems with your bile duct or gallbladder;
• You have obstructive or inflammatory bowel disease;
• You have abdominal colic or discomfort;
• You have an enlarged prostate gland, which causes difficulty urinating (in males);
• You have poor adrenal function (your adrenal gland does not function properly), such as Addison's disease;
• You have respiratory problems, such as severely impaired respiratory function, chronic obstructive pulmonary disease, severe lung disease, or reduced respiratory capacity. Symptoms may include shortness of breath and coughing;
• You have kidney or liver problems;
• You experience withdrawal symptoms such as agitation, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs;
• You or a family member has a history of alcohol, prescription medication, or illicit substance abuse (“addiction”);
• You smoke;
• You have had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental health conditions;
• You experience seizures, convulsions, or spasms;
• You experience dizziness or fainting;
• You need to increase the dose of OxyNorm injectable solution to achieve the same level of analgesia (tolerance);
• You are taking a type of medication known as monoamine oxidase inhibitors (such as tranilcipromina, fenelzina, isocarboxazida, moclobemida, and linezolid), or have taken this type of medication in the last two weeks;
• You have constipation;

Respiratory disorders related to sleep

OxyNorm may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

If you are to undergo surgery, inform the hospital doctor that you have been administered this injectable solution.

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

Opioids are not the first choice of treatment for non-cancer-related pain and are not recommended as the sole treatment. In chronic pain treatment, other medications should be used in conjunction with opioids. Your doctor should closely monitor you and make necessary adjustments to your dose while taking OxyNorm injectable solution and for infusion to prevent addiction and abuse.

Tolerance, dependence, and addiction

This medication contains oxicodone, which is an opioid medication. Repeated use of opioid analgesics may make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm injectable solution may also cause dependence, abuse, and addiction that can lead to a life-threatening overdose. The risk of these adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to take or how often you need to take it. You may feel that you need to continue taking the medication, even when it no longer helps to alleviate your pain.

The risk of becoming dependent or addicted to OxyNorm injectable solution varies from person to person. You may have a higher risk of becoming dependent or addicted to OxyNorm injectable solution:

• If you or a family member has a history of alcohol, prescription medication, or illicit substance abuse (“addiction”);
• If you smoke;
• If you have had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental health conditions;

If you notice any of the following signs while taking OxyNorm injectable solution, it could be a sign that you have become dependent or addicted.

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medication for reasons other than those prescribed, such as “to stay calm” or “to help you sleep”.
• You have made repeated, unsuccessful attempts to stop or control the use of the medication.
• You do not feel well when you stop taking the medication and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to analyze the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with OxyNorm injectable solution).

Contact your doctor if you experience severe upper abdominal pain that may extend to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis (inflammation of the pancreas) and biliary tract disease.

Using OxyNorm with other medications

The concomitant use of opioids, including oxicodone, and sedatives such as benzodiazepines or related medications increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes OxyNorm with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all sedatives you are taking, and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. If you use this injectable solution with any other medication, the effect of the injectable solution or the other medications may be modified.

The risk of adverse effects increases if you use antidepressants (such as citalopram, duloxetina, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, or venlafaxina). These medications may interact with oxicodone and cause symptoms such as involuntary muscle contractions, involuntary eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Inform your doctor or pharmacist if you are taking:

• Medications known as monoamine oxidase inhibitors or have taken them in the last two weeks (see section 2 “Warnings and precautions”);
• Sleeping or calming medications (such as hypnotics or sedatives, including benzodiazepines);
• Depression medications (such as paroxetina or fluoxetina);
• A medicinal plant called St. John's Wort (also known as Hypericum perforatum);
• Mental health or psychiatric medications (such as phenothiazines or neuroleptics);
• Epilepsy, pain, and anxiety medications, such as gabapentina and pregabalina;
• Other potent analgesics;
• Muscle relaxants;
• Blood pressure medications;
• Quinidine (a medication for rapid heart rhythm);
• Cimetidina (a medication for stomach ulcers, indigestion, or heartburn);
• Antifungal medications (such as ketoconazol, voriconazol, itraconazol, or posaconazol);
• Bacterial infection medications (such as claritromicina, eritromicina, or telitromicina);
• A specific type of medication known as protease inhibitors for HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• Rifampicina (a medication for tuberculosis);
• Carbamazepina (a medication for seizures, convulsions, or certain pain situations);
• Fenitoína (a medication for seizures, convulsions);
• Antihistamines;
• Parkinson's disease medications.

Also inform your doctor if you have recently been administered an anesthetic.

Using OxyNorm injectable solution with food, drinks, and alcohol

Consuming alcohol during treatment with this injectable solution may cause drowsiness or increase the risk of severe adverse effects such as respiratory distress and risk of respiratory arrest and loss of consciousness. It is recommended not to drink alcohol while taking OxyNorm.

You should avoid drinking grapefruit juice during treatment with this injectable solution.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use this injectable solution during pregnancy and childbirth unless your doctor has specifically told you to. Depending on the dose and duration of oxicodone treatment, you may experience slow and shallow breathing (respiratory depression) or withdrawal symptoms in the newborn.

Breastfeeding

This injectable solution should not be used while breastfeeding, as the active substance may pass through breast milk.

Driving and operating machinery

This injectable solution may cause a range of adverse effects, including drowsiness, that may affect your ability to drive or operate machinery (see section 4 for a more extensive list of adverse effects). These are more noticeable when starting treatment with the injectable solution, or when your dose is increased. If you are affected, do not drive or operate machinery.

OxyNorm injectable solution contains sodium.

This medication contains 2.78 mg of sodium (the main component of table salt for cooking) per milliliter. This is equivalent to 0.139% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from the use of injectable oxycodone, when and for how long you should take it, when to contact your doctor and when to stop taking it (see also “If you interrupt treatment with OxyNorm injectable”).

Your doctor will adjust the dose according to the intensity of pain and your individual needs. Normally a doctor or nurse will prepare and administer the medication.

You should not exceed the recommended dose by your doctor. In case of doubt, consult your doctor or pharmacist again.

Children under 12 years

The safety and efficacy of oxycodone injectable have not been sufficiently proven in children under 12 years. Therefore, treatment with oxycodone injectable is not recommended in children under 12 years.

Administration method

For intravenous use, OxyNorm injectable must be diluted to a concentration of 1 mg/ml of hydrochloride oxycodone. As a diluent, the following infusion/injection solutions can be used: sodium chloride solution 0.9% p/v, glucose solution 5% p/v or water for injectable preparations.

For subcutaneous use, if necessary, OxyNorm injectable can be diluted with the following infusion/injection solutions: sodium chloride solution 0.9% p/v, glucose solution 5% p/v or water for injectable preparations.

Patients with liver or kidney problems

Please inform your doctor if you suffer from liver or kidney problems, so that they can prescribe an alternative medication or reduce the dose depending on your situation.

If you use more OxyNorm injectable than you should, or if someone uses your injection

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested, or go to the hospital immediately.

An overdose can cause:

• a decrease in the size of your pupils
• a slower and weaker breathing than normal (respiratory depression)
• drowsiness or loss of consciousness
• a decrease in muscle tone (hypotonia)
• a decrease in pulse
• a decrease in blood pressure
• difficulty breathing due to fluid in the lungs (pulmonary edema)
• a cerebral disorder (known as toxic leukoencephalopathy)

In severe cases, an overdose can lead to unconsciousness or even death. When you need medical attention, bring this leaflet and any remaining injectable with you to show to the doctor.

If you have received a high dose of the injectable under no circumstances should you submit to a situation that requires being alert, such as driving a car.

If you interrupt treatment with OxyNorm injectable

You should not stop using this medication suddenly unless your doctor recommends it. If you want to stop treatment, talk to your doctor first. Your doctor will indicate how to do it, normally reducing the dose gradually so that you do not experience undesirable effects. You may experience withdrawal symptoms such as yawning, abnormal pupil dilation, lacrimation, nasal secretion, restlessness, anxiety, palpitations, tremors or sweating if you interrupt treatment with the injectable abruptly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this injectable can cause side effects, although not everyone will experience them.

This medicine can cause allergic reactions, although severe allergic reactions occur rarely. Inform your doctor immediately if you experience sudden shortness of breath, difficulty breathing, swelling of the eyelids, face, or lips, rash or itching on the skin, especially if it covers your entire body.

The most severe side effect is when your breathing becomes slower or weaker than normal (respiratory depression, typical risk of opioid overdose).

Like all potent analgesics, there is a risk of addiction or dependence on this injectable.

Very common

(can affect more than 1 in 10 patients)

• Constipation (your doctor will prescribe a laxative to treat this problem).
• Sensation of dizziness (these symptoms should normally disappear in a few days, however, your doctor may prescribe medication to prevent dizziness if the problem persists).
• Drowsiness (this is more likely when starting to administer this medicine or when increasing the dose, but should disappear in a few days).
• Dizziness.
• Headache.
• Itching on the skin.

Common

(can affect up to 1 in 10 patients)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea.
• Confusion, depression, feeling of unusual weakness, tremor, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams and thoughts.
• Difficulty breathing, wheezing, labored breathing.
• Difficulty urinating.
• Rash.
• Sweating, high temperature.

Uncommon

(can affect up to 1 in 100 patients)

• A condition in which your breathing becomes slower and weaker than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, gas, intestinal disorders in which the intestine does not function properly (ileus), stomach inflammation, altered taste, ulcers or sores in the mouth.
• Situations that can cause abnormal production of the antidiuretic hormone (syndrome of inadequate secretion of antidiuretic hormone).
• Sensation of dizziness or "spinning" (vertigo), hallucinations, mood changes, feeling of extreme happiness, agitation, feeling of general discomfort, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness, seizures, convulsions, abnormal gait, feeling of detachment from oneself, being exceptionally hyperactive, fainting, reduced level of consciousness, unusual muscle stiffness or laxity, involuntary muscle contractions.
• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, seen in blood tests).
• Redness of the skin.
• Dehydration, weight change, thirst, swelling of the hands, ankles, or feet.
• Dry skin.
• Disorders in tear production, blurred vision, reduced pupil size.
• Need to increase the dose of the injectable to achieve the same level of analgesia (tolerance).
• Ringing or buzzing in the ears.
• Swelling and irritation inside the nose, nasal bleeding, voice alteration.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening in liver function tests (observed in a blood test).
• Withdrawal symptoms (see section 3 "If you stop treatment with OxyNorm injectable").

Rare

(can affect up to 1 in 1,000 patients)

• Sensation of fainting, especially when standing.
• Low blood pressure.
• Urticaria.

Not known

(frequency cannot be estimated from available data)

• Sudden hissing sound while breathing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash or itching, especially if it covers the entire body.
• Loosening of teeth.
• Abdominal pain or discomfort.
• A problem affecting a valve in the intestine, which can cause severe abdominal pain (Oddi sphincter dysfunction).
• Blockage of bile flow from the liver. This can cause itching on the skin, yellowish skin color, dark urine, and light-colored stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Aggression.
• Prolonged treatment of OxyNorm during pregnancy can cause withdrawal syndrome in newborns with a life-threatening risk. Symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, loud crying, tremors, appearance of being unwell, diarrhea, and failure to gain weight.
• Sleep apnea (interruptions of breathing during sleep).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children. Accidental overdose in a child is hazardous and potentially fatal. Store this medication in a secure and closed location where others cannot access it. It can cause severe harm and be fatal to individuals who have not been prescribed it.

Do not use the injectable after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated. For example, CAD 08 2020 means do not take the medication after the last day of that month, i.e., August 2020.

This medication does not require special temperature conditions for storage. Store in the original packaging to protect it from light. However, once the ampule is opened, the injection must be administered immediately. Any unused portion must be discarded immediately.

Medications should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of OxyNorm injectable solution

The active ingredient is hydrochloride of oxycodone. Each milliliter contains 10 mg of hydrochloride of oxycodone.

The other components are:

• monohydrate citric acid,
• sodium citrate,
• sodium chloride,
• diluted hydrochloric acid,
• sodium hydroxide,
• water for injectable preparations.

Appearance of the product and content of the container

The injectable is a transparent, colorless solution, presented in transparent glass vials. It is available in 1 ml, 2 ml or 20 ml of solution (containing 10 mg, 20 mg or 200 mg of hydrochloride of oxycodone, respectively).

The vials are packaged in boxes.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Phone: 91 382 1870

Responsible for manufacturing

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

or

Fidelio Healthcare Limburg GmbH

Mundipharmastrasse 2,

65549 Limburg

Germany

This medicine is authorized in the member states of the European Economic Area with the name OxyNorm:

Austria OxyNorm Injektionslösung

Irlanda OxyNorm solution for injection or infusion

España OxyNorm 10 mg/ml solución inyectable y para perfusión

Last review date of this leaflet:March 2025.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)