OxyNorm Concentrate 10 mg/ml, oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OxyNorm concentrated 10 mg/ml oral solution

Oxycodone, hydrochloride

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

• Keep this leaflet as 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What OxyNorm concentrated is and what it is used for
2. What you need to know before using OxyNorm concentrated
3. How to use OxyNorm concentrated
4. Possible side effects
5. How to store OxyNorm concentrated
6. Contents of the pack and other information

1. What OxyNorm concentrate is and what it is used for

OxyNorm is a strong painkiller or "analgesic" and belongs to the group of opioids.

OxyNorm 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 Concentrate

Do not use OxyNorm Concentrate if:

• you are allergic (hypersensitive) to oxycodone or to any of the other ingredients of this medicine (listed in section 6), or have previously had an allergic reaction when using other strong painkillers (such as morphine or other opioid analgesics);
• you have respiratory problems, such as chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression. Symptoms may include shortness of breath, cough, or slower or weaker breathing than expected;
• you have a head injury causing severe headache or dizziness, as this medicine 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 severe abdominal pain;
• you have heart disease secondary to long-standing lung disease (cor pulmonale).

Warnings and precautions

Talk to your doctor or pharmacist before using OxyNorm Concentrate if:

• you are elderly or debilitated;
• you have low thyroid gland activity (hypothyroidism);
• you have myxoedema (a thyroid disorder causing dryness, coldness, and swelling (edema) of the skin, affecting the face and limbs);
• 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 ducts;
• you have an obstructive or inflammatory bowel disease;
• you have colicky abdominal pain or discomfort;
• you have an abnormally enlarged prostate causing difficulty in passing urine (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 breathing, chronic obstructive airway disease, severe lung disease, or reduced respiratory reserve. Symptoms may include shortness of breath and cough;
• you have kidney or liver problems;
• you suffer from kidney disorder or mild liver disorder;
• you have experienced 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 medicine, or illicit substance abuse or dependence (“addiction”);
• you smoke;
• 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;
• you suffer from spasms, fits, or convulsions;
• you suffer from dizziness or fainting;
• you need to increase the dose of OxyNorm Concentrate to achieve the same level of pain relief (tolerance);
• you experience increased sensitivity to pain;
• you are taking a type of medicine known as monoamine oxidase inhibitors (such as tranilcipromine, phenelzine, isocarboxazide, moclobemide, and linezolid), or if you have taken any of these medicines within the last two weeks;
  • you have constipation

Sleep-related breathing disorders

OxyNorm may cause sleep-related breathing disorders such as sleep apnoea (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 sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing your dose.

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

If you are undergoing surgery, inform the hospital doctor that you are taking this medicine.

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

This medicine must never be injected, as this may lead to serious adverse effects with fatal outcome.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm Concentrate may also lead to dependence, abuse 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 Concentrate:

• 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 Concentrate, it 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 your 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 Concentrate).

Contact your doctor if you have 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.

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, including those obtained without a prescription. If you use OxyNorm Concentrate with certain medicines, its effect or the effect of the other medicines may be altered.

The risk of side effects increases if you take 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.

Inform 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 “Warnings and precautions”);
• medicines that help you sleep (e.g. hypnotics or sedatives, including benzodiazepines);
• medicines to treat depression (e.g. paroxetine or fluoxetine);
• 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 analgesics;
• muscle relaxants;
• medicines to treat high blood pressure;
• quinidine (a medicine used to treat fast heart rate);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• medicines used 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 used to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• rifampicin for the treatment of tuberculosis;
• carbamazepine (a medicine used to treat spasms, seizures or convulsions and certain painful conditions);
• phenytoin (a medicine used to treat spasms, seizures or convulsions);
• a herbal remedy called “St John’s wort” (also known as Hypericum perforatum);
• antihistamines;
• medicines to treat Parkinson’s disease.

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

Taking OxyNorm Concentrate with food, drinks and alcohol

This medicine may be taken with or without food. It may be mixed with a soft drink to make it easier to drink.

Consumption of alcohol during treatment with OxyNorm Concentrate 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 Concentrate. You should avoid drinking grapefruit juice during treatment with OxyNorm Concentrate.

Pregnancy and breast-feeding

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

Pregnancy

OxyNorm Concentrate should not be used during pregnancy and childbirth unless specifically instructed by your doctor. Depending on the dose and duration of oxycodone treatment, newborns may experience slow and shallow breathing (respiratory depression) or withdrawal syndrome.

Breast-feeding

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

Driving and using machines

This medicine may cause adverse effects such as dizziness that may affect your ability to drive or operate machinery (see section 4, “Possible side effects”). These effects are more noticeable at the beginning of treatment or when your dose is increased. If affected, you should not drive or operate machinery.

OxyNorm Concentrate contains sodium saccharin, sodium citrate, sodium benzoate (E211), sodium hydroxide and orange yellow S (E110)

This medicine contains 1.02 mg of sodium (main component of table/cooking salt) per millilitre. This corresponds to 0.051% of the maximum daily recommended sodium intake for an adult.

This medicine contains 1 mg of sodium benzoate per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine may cause allergic reactions because it contains orange yellow S (E110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take OxyNorm Concentrate

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. The labelling on your medicine will indicate your dose and how often you should take it.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using concentrated oxycodone, 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 taking OxyNorm Concentrate”).

Do not take a higher dose than that recommended by your doctor.

This medicine must be taken only by mouth.

Adults and adolescents (from 12 years of age)

The usual starting dose is 5 mg every 6 hours. The dosing interval for oxycodone may be reduced to 4 hours if necessary. Oxycodone should not be taken more than 6 times a day. However, your doctor will prescribe the dose necessary to treat your pain. A graduated dropper or oral dispenser is provided to help you measure your dose. The medicine may be mixed with a soft drink to make it easier to swallow. If you continue to experience pain despite using concentrated oxycodone, speak with your doctor.

Use in children under 12 years of age

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

Patients with liver or kidney disorders

Inform your doctor if you have kidney or liver problems. Your doctor may prescribe an alternative medicine or reduce your dose, depending on your condition.

If you take more OxyNorm Concentrate than you should or if someone accidentally takes the medicine

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, stating the name of the medicine and the amount ingested, or go immediately to 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 of overdose, loss of consciousness or even death may occur. When seeking medical attention, make sure to bring this leaflet and any remaining medicine with you to show your doctor. If you have taken too much medicine, under no circumstances should you place yourself in a situation requiring alertness, such as driving a car.

If you forget to take OxyNorm Concentrate

If you forget to take a dose, take the next dose as soon as you remember, and then continue your treatment as usual. Do not take two doses within a 4-hour interval. Do not take a double dose to make up for a missed dose.

If you stop taking OxyNorm Concentrate

Do not stop using this medicine suddenly unless instructed by your doctor.

If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do this by gradually reducing the dose, thus avoiding unpleasant withdrawal symptoms. Withdrawal symptoms such as yawning, abnormal dilation of the pupils, tearing, runny nose, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremor, or sweating may occur if you stop taking this medicine 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, OxyNorm concentrated may cause adverse effects, although not everyone experiences them.

This medicine may cause allergic reactions, although serious allergic reactions reported are rare. 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 spreads all over your body.

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

Like all strong analgesics, there is a risk of addiction or dependence on this medicine.

Very common

(may affect more than 1 in 10 patients)

• Constipation (your doctor may prescribe a laxative to treat this problem).
• Feeling dizzy or nauseous (these symptoms usually disappear within a few days; however, your doctor may prescribe medication to prevent nausea if the problem persists).
• Drowsiness (more common when starting this medicine or when the dose is increased, but will disappear 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, tiredness, anxiety, restlessness, difficulty sleeping, abnormal dreams and thoughts.
• Difficulty breathing, wheezing, shortness of breath.
• 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, belching, hiccups, flatulence, a disorder in which the intestine does not function properly (ileus), inflammation of the stomach, altered taste, mouth ulcers or sores.
• A disorder that may cause abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Feeling dizzy or "spinning" (vertigo), hallucinations, mood changes, a feeling of extreme happiness, agitation, general malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, attacks, epileptic seizures or convulsions, abnormal gait or walking pattern, feeling detached from oneself, being unusually hyperactive, dizziness, reduced level of consciousness, abnormal muscle stiffness or floppiness, involuntary muscle contractions.
• Impotence, decreased sex drive, low levels of sex hormones in the blood (hypogonadism, observed 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, reduction in the size of the pupils of the eye.
• Need to increase the dose to achieve the same level of pain relief (tolerance).
• Ringing or buzzing in the ears.
• Nasal congestion and irritation, 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 taking OxyNorm concentrated).

Rare

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

• Feeling of 'weakness', especially when standing.
• Low blood pressure.
• Urticaria (hives).

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 widespread across the body.

• Dental abnormalities.

• Colicky abdominal pain or discomfort.

• A problem affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).

• Blockage in the flow of bile from the liver. This may cause itching of the skin, yellowing of the skin, very dark urine and very pale stools.

• Absence of menstrual periods.

• Increased sensitivity to pain.

  • Sleep apnoea (interruptions in breathing during sleep).

• Aggression.

• Prolonged use of OxyNorm during pregnancy may result in life-threatening withdrawal syndrome in newborns. Symptoms observed in babies included irritability, hyperactivity and abnormal sleep patterns, high-pitched crying, tremors, appearance of illness, diarrhoea and failure to gain weight.

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 Medicines: www.notificaRAM.es.

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

5. Storage of OxyNorm concentrate

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

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

Do not store this medicine above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OxyNorm concentrate

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

The other components are:

• sodium saccharin,
• sodium benzoate (E211),
• citric acid monohydrate,
• sodium citrate,
• hydrochloric acid,
• sodium hydroxide,
• purified water,
• orange yellow S (E110).

Appearance of OxyNorm concentrate and contents of the container

This medicine is a clear orange-coloured solution.

Each bottle contains 30 ml or 120 ml of solution. Only certain pack sizes may be marketed.

A graduated dropper or an oral dispenser is also included with each bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Tel.: 91 3821870

Manufacturer: Mundipharma Pharmaceuticals Ltd.

13 Othellos Street

Dhali Industrial Area

Nicosia

2540, Cyprus

This medicinal product is authorised in the European Economic Area member states under the following names:

Republic of Ireland: OxyNorm concentrate

Spain: OxyNorm concentrado 10 mg/ml oral solution

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

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