OXYNORM CONCENTRATED 10 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

OxyNorm Concentrate 10 mg/ml Oral Solution

Oxycodone, Hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

OxyNorm is a strong pain reliever, also known as an opioid. It belongs to a group of medicines called opioids.

OxyNorm is used in adults and adolescents from 12 years of age to relieve severe pain, which can only be adequately managed with opioid analgesics.

2. What you need to know before you take OxyNorm Concentrate

Do not take OxyNorm Concentrate if:

• you are allergic (hypersensitive) to oxycodone or any of the other ingredients of this medicine (listed in section 6) or have had an allergic reaction to other strong painkillers such as morphine or other opioids;
• you have breathing problems, such as chronic obstructive pulmonary disease, severe bronchial asthma or severe respiratory depression. Symptoms may include slow or shallow breathing;
• you have a head injury that causes a severe headache or confusion, as this medicine may worsen these symptoms or mask the extent of the injury;
• you have a condition where your small intestine does not work properly (paralytic ileus), your stomach empties more slowly than normal (delayed gastric emptying) or you have severe abdominal pain;
• you have a heart problem after long-term lung disease (cor pulmonale).

Warnings and precautions

Consult your doctor or pharmacist before taking OxyNorm Concentrate if:

• you are elderly or debilitated;
• you have low thyroid function (hypothyroidism);
• you have myxoedema (a thyroid disorder, with dryness, coldness and swelling of the skin, affecting the face and limbs);
• you have severe headaches or dizziness, as this may indicate that the pressure in your skull is increased;
• you have low blood pressure (hypotension);
• you have inflammation of the pancreas (which can cause severe abdominal and back pain) or problems with your gallbladder or bile ducts;
• you have any obstructive or inflammatory bowel disease;
• you have abdominal pain like colic or discomfort;
• you have an enlarged prostate gland, which causes difficulty passing urine (in men);
• you have poor adrenal gland function (your adrenal gland does not work properly); for example, Addison's disease;
• you have breathing problems such as severely impaired respiratory function, chronic obstructive pulmonary disease, severe lung disease or reduced respiratory reserve. Symptoms may include slow or shallow breathing;
• you have kidney or liver problems;
• you have a kidney or mild liver disorder;
• you have experienced withdrawal symptoms such as agitation, anxiety, palpitations, tremors or sweating when you stopped taking alcohol or drugs;
• if you or a family member have a history of abuse or dependence on alcohol, prescription drugs or illicit substances (“addiction”);
• if you smoke;
• if you have ever had problems with your mood (depression, anxiety or personality disorder) or have received psychiatric treatment for other mental health disorders;
• you have seizures, fits or convulsions;
• you have 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 tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks;
• you are constipated

Respiratory disorders related to sleep

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 pauses in breathing 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.

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

If you are going to have surgery, inform the hospital doctor that you are taking this medicine.

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

This medicine should never be injected, as this can lead to serious side effects with a fatal outcome.

Tolerance, dependence and addiction

This medicine contains oxycodone, which is an opioid medication. Repeated use of opioid analgesics may make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of OxyNorm Concentrate can also cause dependence, abuse and addiction, which can be life-threatening. The risk of these side effects may increase with higher doses and longer treatment duration.

Dependence or addiction can make you feel that you no longer have control over the amount of medicine you need to take or how often you need to take it. You may feel that you need to keep taking the medicine, even when it no longer helps to 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 have a history of abuse or dependence on alcohol, prescription drugs or illicit substances (“addiction”).
• if you smoke.
• if you have ever had problems with your mood (depression, anxiety or personality disorder) or have received psychiatric treatment for other mental health disorders.

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 more doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to calm down” or “to help you sleep”.
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• You do not feel well when you stop taking the medicine and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to 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 experience severe abdominal pain in the upper abdomen that may radiate to the back, nausea, vomiting or fever, as these may be symptoms associated with pancreatitis and biliary tract disorders.

Using OxyNorm with other medicines

Taking OxyNorm with other medicines, such as sedatives like benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be potentially life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes OxyNorm with sedative medicines, the dose and duration of concomitant treatment should 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 useful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. If you use OxyNorm Concentrate with some medicines, the effect of this medicine or the other medicines may be affected.

The risk of side effects increases if you are taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and symptoms such as muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone and body temperature above 38 °C may occur. Contact your doctor if you experience such symptoms.

Tell your doctor or pharmacist if you are taking:

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

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

Taking OxyNorm Concentrate with food, drinks and alcohol

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

Drinking alcohol during treatment with OxyNorm Concentrate may cause drowsiness or increase the risk of serious side effects such as slow or shallow breathing and 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 breastfeeding

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

Pregnancy

OxyNorm Concentrate should not be used during pregnancy and childbirth unless your doctor has specifically told you to do so. Depending on the dose and duration of treatment with oxycodone, it may cause slow and shallow breathing (respiratory depression) or withdrawal syndrome in newborns.

Breastfeeding

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

Driving and using machines

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

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 (a major component of table salt/cooking salt) per milliliter. This is equivalent to 0.051% of the maximum daily intake of sodium recommended for an adult.

This medicine contains 1 mg of sodium benzoate per milliliter. 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 can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take OxyNorm Concentrate

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again. The label on your medicine will tell you how much to take and how often.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from using oxycodone concentrate, when and for how long you should take it, when to contact your doctor and when to stop taking it (see also “If you stop taking OxyNorm Concentrate”).

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

This medicine should only be taken by mouth.

Adults and adolescents (from 12 years of age)

The usual starting dose is 5 mg every 6 hours. The dosing interval of 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 needed to treat your pain. A graduated measuring device or oral dispenser is included to help you measure your dose. It can be mixed with a soft drink to make it easier to swallow. If you continue to have pain despite using oxycodone concentrate, talk to your doctor.

Use in children under 12 years of age

The safety and efficacy of oxycodone have not been sufficiently tested 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

Tell your doctor if you have kidney or liver problems, your doctor may prescribe an alternative medicine or reduce the 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken, or go to the hospital immediately.

An overdose can cause:

• a decrease in the size of your pupils
• slower and weaker breathing than normal (respiratory depression)
• drowsiness or loss of consciousness
• a decrease in muscle tone (hypotonia)
• a decrease in heart rate
• a decrease in 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 you need 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, never put yourself in a situation that requires you to be alert, 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 with your usual treatment schedule. Do not take two doses within a 4-hour interval. Do not take a double dose to make up for a forgotten dose.

If you stop taking OxyNorm Concentrate

Do not stop taking this medicine suddenly unless your doctor tells you to.

If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do it, by gradually reducing the dose, to avoid unpleasant withdrawal symptoms. Withdrawal symptoms such as yawning, abnormal pupil dilation, lacrimation, nasal discharge, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremors or sweating may occur if you stop taking this medicine abruptly.

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

4. Possible Adverse Effects

Like all medicines, OxyNorm concentrate can cause adverse effects, although not all people suffer from them.

This medicine may cause allergic reactions, although serious allergic reactions reported are rare. Inform your doctor immediately if you suffer from sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, rash or itching of the skin, 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 reaction to an opioid overdose).

Like all strong painkillers, 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 continues).
• Drowsiness (it is more frequent when you start using this medicine or when the dose is increased, but it 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, diarrhea.
• Confusion, depression, feeling of unusual weakness, tremor, lack of energy, fatigue, anxiety, nervousness, 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 disorder in which your breathing is slower and weaker than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, gas, disorders in which the intestine does not function properly (ileus), stomach inflammation, alteration of taste, ulcers or sores in the mouth.
• A disorder that can cause abnormal production of antidiuretic hormone (inappropriate antidiuretic hormone secretion syndrome).
• Feeling of dizziness or "spinning" (vertigo), hallucinations, mood changes, a feeling of extreme happiness, agitation, feeling of general malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness, seizures, epileptic fits or convulsions, abnormal gait or walking style, feeling of being outside oneself, being exceptionally hyperactive, dizziness, reduced level of consciousness, abnormal muscle rigidity or laxity, involuntary muscle contractions.
• Impotence, decreased sexual desire, 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 of tear production, blurred vision, reduction of pupil size.
• Need to increase the dose to achieve the same level of pain relief (tolerance).
• Ringing or buzzing in the ears.
• Swelling and irritation inside the nose, nosebleeds, alteration of voice.
• Chills.
• Chest pain.
• Inability to empty the bladder completely.
• Worsening of liver function tests (observed in blood tests).
• Withdrawal symptoms (see section 3 If you stop treatment with OxyNorm concentrate).

Rare

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

• Feeling of 'weakness', especially when standing.
• Low blood pressure.
• Hives.

Not Known

(Frequency cannot be estimated from the available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially those that cover the entire body.
• Dental alterations.
• Abdominal colic-type pain or discomfort.
• A problem that affects a valve in the intestine, which can cause intense pain in the upper abdomen (Oddi's sphincter dysfunction).
• Blockage of bile flow from the liver. This can cause itching of the skin, yellowish skin, dark urine, and very pale stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Sleep apnea (interruptions of breathing during sleep).

• Aggression.
• Prolonged treatment with OxyNorm during pregnancy may produce withdrawal syndrome in newborns, which can be life-threatening. The symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, crying with high-pitched screams, tremors, sickly appearance, diarrhea, and failure to gain weight.

Reporting of Adverse Effects

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

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

5. Storage of OxyNorm Concentrate

Keep out of sight and reach of children. Accidental overdose in a child is dangerous and can be fatal. Store this medicine in a safe and closed place, where other people cannot access it. It can cause serious harm and be fatal to people when not prescribed to them.

Do not use the medicine after the expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated. For example, CAD 08 2020 means that you should not use the medicine after the last day of that month, i.e., August 2020.

Do not store this medicine at a temperature above 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of OxyNorm Concentrate

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

The other components are:

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

Appearance of OxyNorm Concentrate and Package Contents

This medicine is a clear orange solution.

Each bottle contains 30 or 120 ml of solution. Only some package sizes may be marketed.

A graduated dropper or oral dispenser is also included with the bottle in each package.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid.

Spain

Phone: 91 3821870

Manufacturer:Mundipharma Pharmaceuticals Ltd.

13 Othellos Street

Dhali Industrial Area

Nicosia

2540, Cyprus

This medicine is authorized in the Member States of the European Economic Area with the following names:

Republic of Ireland OxyNorm concentrate

Spain OxyNorm concentrado 10 mg/ml oral solution

Date of the last revision of this leaflet:March 2025.

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