OxyNorm 10 mg/ml solution for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OxyNorm 10 mg/ml injection and infusion solution

Oxycodone, hydrochloride

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

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

Leaflet contents

1. What OxyNorm injection and infusion solution is and what it is used for
2. What you need to know before using OxyNorm injection and infusion solution
3. How to use OxyNorm injection and infusion solution
4. Possible adverse effects
5. How to store OxyNorm injection and infusion solution

Pack contents and other information

1. What OxyNorm injectable solution is and what it is used for

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

OxyNorm injectable solution is used in adults and adolescents from the age of 12 for the relief of severe pain, which can only be appropriately managed with opioid analgesics.

2. What you need to know before using OxyNorm injectable solution

Do not use OxyNorm injectable solution if:

• you are allergic (hypersensitive) to any of the components of the injection (listed in section 6 “Additional information”) or have previously had an allergic reaction to other strong painkillers (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 irregular breathing, cough, or breathing that is slower or weaker than expected;
• you have a head injury causing severe headache or dizziness, because the injection may worsen these symptoms or mask the extent of the injury;
• you have a condition in which the small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have sudden severe abdominal pain (acute abdomen);
• you have heart problems due to 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 gland activity (hypothyroidism);
• you have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling (edema) of the skin, affecting the face and extremities);
• you have severe headache or dizziness, as this may indicate increased pressure in your skull;
• you have low blood pressure (hypotension);
• you have inflammation of the pancreas (which may cause severe abdominal and back pain) or problems with your gallbladder or bile duct;
• you have an obstructive or inflammatory bowel disease;
• you have colicky abdominal pain or discomfort;
• you have an enlarged prostate causing difficulty in urinating (in men);
• you have poor adrenal gland function (your adrenal gland does not work properly), for example Addison's disease;
• you have respiratory problems such as severely impaired respiratory function, chronic obstructive airway disease, severe lung disease, or reduced respiratory capacity. Symptoms may include irregular breathing and cough;
• you have kidney or liver problems;
• you experience withdrawal symptoms such as restlessness, 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 or dependence (“addiction”);
• you smoke;
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses;
• you suffer from spasms, attacks, or convulsions;
• you experience dizziness or fainting;
• you need to increase the dose of OxyNorm injectable solution to achieve the same level of pain relief (tolerance);
• you are taking a type of medicine known as monoamine oxidase inhibitors (such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, or linezolid), or if you have taken any of these medicines within the last two weeks;
• you are constipated.

Sleep-related breathing disorders

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

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

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

Opioids are not the first-line treatment for non-cancer-related pain and are not recommended as sole therapy. Other medications should be used alongside opioids in the management of chronic pain. Your doctor should closely monitor you and make necessary dose adjustments while you are taking OxyNorm injectable and infusion solution to prevent addiction and abuse.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm injection solution may also lead to dependence, misuse, and addiction, which can result in a life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

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

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

• if you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”);
• if you smoke;
• if you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking OxyNorm injection solution, this could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than prescribed, for example, “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• You feel unwell when you stop taking the medicine and feel better once you take it again (“withdrawal symptoms”).

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

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

Use of OxyNorm with other medicines

Concomitant use of opioids, including oxycodone, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes OxyNorm together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Please inform your doctor about all sedative medicines you are taking, and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. If you use this injection with another medicine, the effect of the injection or the other medicines may be altered.

The risk of side effects increases if you are using antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

Tell your doctor or pharmacist if you are taking:

• medicines known as monoamine oxidase inhibitors or have taken them within the last two weeks (see section 2 “Warnings and precautions”);
• medicines that help you sleep or stay calm (e.g., hypnotics or sedatives, including benzodiazepines);
• medicines to treat depression (e.g., paroxetine or fluoxetine);
• a herbal remedy called St. John’s wort (also known as Hypericum perforatum);
• medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);
• medicines to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• other strong painkillers;
• muscle relaxants;
• medicines to treat high blood pressure;
• quinidine (a medicine for fast heart rate);
• cimetidine (a medicine for stomach ulcers, indigestion, or heartburn);
• medicines to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin);
• a specific type of medicines known as protease inhibitors for treating HIV (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin (a medicine for treating tuberculosis);
• carbamazepine (a medicine for treating spasms, seizures, or convulsions and certain painful conditions);
• phenytoin (a medicine for treating spasms, seizures, or convulsions);
• antihistamines;
• medicines to treat Parkinson’s disease.

Also inform your doctor if you have recently received an anaesthetic.

Use of OxyNorm injection solution with food, drinks, and alcohol

Drinking alcohol during treatment with this injection may cause drowsiness or increase the risk of serious adverse effects such as irregular breathing, 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 injection.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use this injection during pregnancy and childbirth unless specifically instructed by your doctor. Depending on the dose and duration of oxycodone treatment, slow and shallow breathing (respiratory depression) or withdrawal syndrome may occur in the newborn.

Breastfeeding

This injection should not be used while breastfeeding, as the active substance may pass into breast milk.

Driving and using machines

This injection may cause several adverse effects such as drowsiness that could affect your ability to drive or use machinery (see section 4 for a more comprehensive list of adverse effects). These effects are most noticeable when starting treatment with the injection or when your dose is increased. If affected, you should not drive or operate machinery.

OxyNorm injection solution contains sodium.

This medicine contains 2.78 mg of sodium (main component of table salt for cooking) per millilitre. This corresponds to 0.139% of the maximum daily recommended sodium intake for an adult.

3. How to use OxyNorm injectable solution

Follow exactly the administration instructions for this medicine given by your doctor.

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

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

You should not exceed the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist again.

Children under 12 years of age

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

Method of administration

For intravenous use, OxyNorm injectable solution must be diluted to a concentration of 1 mg/ml of oxycodone hydrochloride. The following infusion/injection solutions may be used as diluents: 0.9% w/v sodium chloride solution, 5% w/v glucose solution, or water for injections.

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

Patients with liver or kidney problems

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the hospital.

An overdose may cause:

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

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

If you have received a high dose of the injectable solution, under no circumstances should you engage in any situation requiring alertness, such as driving a car.

If you stop treatment with OxyNorm injectable solution

Do not stop using this medicine suddenly unless advised by your doctor. If you wish to discontinue treatment, speak to your doctor first. Your doctor will instruct you how to do so, usually by gradually reducing the dose to prevent unwanted effects. Withdrawal symptoms such as yawning, abnormally dilated pupils, tearing, runny nose, restlessness, anxiety, palpitations, tremors, or sweating may occur if treatment with the injectable solution is stopped abruptly.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this injectable solution may cause adverse effects, although not everyone experiences them.

This medicine may cause allergic reactions, although serious allergic reactions occur only rarely. Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it covers your entire body.

The most serious adverse effect is when your breathing becomes slower or weaker than normal (respiratory depression, a typical risk in opioid overdose).

As with all strong analgesics, there is a risk of addiction or dependence on this injectable solution.

Very common

(may affect more than 1 in 10 patients)

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

Common

(may affect up to 1 in 10 patients)

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

Uncommon

(may affect up to 1 in 100 patients)

• A condition in which your breathing is slower and weaker than normal (respiratory depression).
• Difficulty swallowing, burping, hiccups, flatulence, intestinal disorders in which the bowel does not function properly (ileus), inflammation of the stomach, altered taste, mouth ulcers or sores.
• Conditions that may cause abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Dizziness or spinning sensation (vertigo), hallucinations, mood changes, feeling of extreme happiness, agitation, general malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, attacks, epileptic fits or convulsions, abnormal gait or walking pattern, feeling detached from oneself, unusual hyperactivity, faintness, reduced level of consciousness, unusual muscle stiffness or weakness, involuntary muscle contractions.
• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, seen in blood tests).
• Skin redness.
• Dehydration, weight changes, thirst, swelling of the hands, ankles or feet.
• Dry skin.
• Disorders in tear production, blurred vision, reduction in pupil size.
• Need to increase the dose of the injectable solution to achieve the same level of analgesia (tolerance).
• Ringing or buzzing in the ears.
• Swelling and irritation inside the nose, nosebleeds, voice changes.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening of liver function tests (seen in blood tests).
• Withdrawal symptoms (see section 3 “If you stop treatment with OxyNorm injectable solution”).

Rare

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

• Feeling faint, especially when standing.
• Low blood pressure.
• Urticaria.

Not known

(frequency cannot be estimated from available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it covers your entire body.
• Tooth loss.
• Colicky abdominal pain or discomfort.
• A problem affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).
• Blockage of bile flow from the liver. This may cause itching, yellowish skin, very dark urine and pale stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Aggressiveness.
• Prolonged use of OxyNorm during pregnancy may cause life-threatening withdrawal syndrome in newborns. Symptoms observed in babies included irritability, hyperactivity and abnormal sleep patterns, high-pitched crying, tremors, appearing unwell, diarrhoea and failure to gain weight.
• Sleep apnoea (interruptions in breathing during sleep).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OxyNorm injectable solution

Keep out of the sight and reach of children. Accidental overdose in a child is dangerous and may be fatal. Store this medicine in a safe, locked place where others cannot access it. It can cause serious harm or death in individuals for whom it has not been prescribed.

Do not use the injectable solution after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. For example, EXP 08 2020 means that you should not use the medicine after the last day of that month, i.e., August 2020.

This medicine does not require special storage temperature conditions. Store in the original container to protect from light. However, once the ampoule is opened, the injection should be administered immediately. Any unused portion must be discarded immediately.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a pharmacy’s SIGRE point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of OxyNorm injectable solution

The active substance is oxycodone hydrochloride. Each millilitre contains 10 mg of oxycodone hydrochloride.

The other components are:

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

Appearance of the product and contents of the container

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

The ampoules are packed in cartons.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mundipharma Pharmaceuticals, S.L.
Bahía de Pollensa, 11
28042 Madrid
Spain
Tel. 91 382 1870

Manufacturer

Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the name OxyNorm:

Austria OxyNorm Injektionslösung
Ireland OxyNorm solution for injection or infusion
Spain OxyNorm 10 mg/ml solution for injection and infusion

Date of the most recent review of this summary: March 2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)