Leaflet: information for the user

OxyNorm concentrated 10 mg/ml oral solution

Oxycodone hydrochloride

Read this leaflet carefully before you start using the medicine, as 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 others, 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.

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

2. What you need to know before starting to use OxyNorm concentrated

3. How to use OxyNorm concentrated

4. Possible side effects

5. Storage of OxyNorm concentrated

6. Contents of the pack and additional information

OxyNorm is a strong analgesic or "calming" agent and belongs to the opioid group.

OxyNorm is used in adults and adolescents aged 12 and above for the relief of intense pain, which can only be adequately treated with opioid analgesics.

No use OxyNorm concentrado if:

• is allergic (hypersensitive) to oxycodone or to any of the other components of this medicine (including those listed in section 6) or has had any previous allergic reaction to using other potent analgesics (such as morphine or other opioid analgesics);

• has respiratory problems, such as chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression. Symptoms may include shortness of breath, coughing, or breathing that is slower or weaker than expected;

• has any head injury that causes intense headache or dizziness, as this medicine may worsen these symptoms or mask the extent of the injury;

• has a disease in which the small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or has intense abdominal pain;

• has heart problems after a long-standing lung disease (cor pulmonale).

Warnings and precautions

Consult your doctor or pharmacist before starting to use OxyNorm concentrate 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 limbs);

• you have intense headache 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 may cause acute abdominal and back pain) or problems with your bile ducts or gallbladder;

• you have any obstructive or inflammatory disease of the intestine;

• you have abdominal pain or discomfort;

• you have an abnormal enlargement of the prostate gland, causing difficulty urinating (in males);

• you have poor adrenal gland function (your adrenal gland does not function properly); for example, Addison's disease;

• you have respiratory problems such as severely impaired respiratory function, chronic obstructive pulmonary disease, severe lung disease, or reduced respiratory reserve. Symptoms may include shortness of breath and coughing;

• you have kidney or liver problems;

• you have a mild liver disorder;

• • you have experienced withdrawal symptoms such as agitation, anxiety, palpitations, tremors, or sweating when stopping the use of alcohol or drugs;

• if you or a family member has a history of abuse or dependence on alcohol, prescription medications, or illicit substances ("addiction");

• if you smoke;

• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions;

• you experience seizures, convulsions, or spasms;

• you experience dizziness or fainting;

• you need to increase the dose of OxyNorm concentrate to achieve the same level of analgesia (tolerance);

• you experience increased sensitivity to pain;

• 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

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 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.

Opioids are not the first choice of treatment for non-cancer-related pain and are not recommended as the sole treatment. In the treatment of chronic pain, 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 to prevent addiction and abuse.

If you are to undergo surgery, inform the hospital doctor that you are taking this medication.

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

This medication should never be injected as this may lead to severe adverse 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 medication less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm concentrate may also cause dependence, abuse, and addiction that may 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 concentrate 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 abuse or dependence on alcohol, prescription medications, or illicit substances ("addiction").
• if you smoke.
• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking OxyNorm concentrate, it may 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 and 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 concentrate).

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

Use of OxyNorm with other medications

The concomitant use of opioids, including oxycodone, 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 to be aware of the mentioned signs and symptoms. 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 OxyNorm concentrate with some medications, the effect or that of 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 oxycodone and may cause symptoms such as involuntary muscle contractions, 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:

• monoamine oxidase inhibitors or have taken them in the last two weeks (see section "Warnings and precautions").

• sleep aids (such as hypnotics or sedatives, including benzodiazepines);

• medications to treat depression (such as paroxetina or fluoxetina);

• medications to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);

• medications to treat epilepsy, pain, and anxiety, such as gabapentina and pregabalina;

• other strong analgesics;

• muscle relaxants;

• medications to treat high blood pressure;

• quinidina (a medication for rapid heart rhythm);

• cimetidina (a medication for stomach ulcers, indigestion, or heartburn);

• medications to treat fungal infections (such as ketoconazol, voriconazol, itraconazol, or posaconazol);

• medications used to treat bacterial infections (such as claritromicina, eritromicina, or telitromicina);

• a specific type of medications known as protease inhibitors for HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);

• rifampicina to treat tuberculosis;

• carbamazepina (a medication for seizures, convulsions, or pain);

• phenitoína (a medication for seizures, convulsions);

• a medicinal herb called "St. John's Wort" (also known as Hypericum perforatum);

• antihistamines;

• medications to treat Parkinson's disease.

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

Use of OxyNorm with food, drinks, and alcohol

This medication can be used with or without food. It can be mixed with a drink to make it easier to take.

Consuming alcohol during treatment with OxyNorm concentrate 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 concentrate. You should avoid drinking grapefruit juice during treatment with OxyNorm concentrate.

Pregnancy and breastfeeding

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

Pregnancy

OxyNorm concentrate should not be used during pregnancy and childbirth unless your doctor has specified it. Depending on the dose and duration of oxycodone treatment, it may cause respiratory depression or withdrawal symptoms in newborns.

Breastfeeding

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

Driving and operating machinery

This medication may cause adverse effects such as dizziness that may affect your ability to drive and operate machinery (see section 4. "Possible adverse effects"). These are more noticeable at the beginning of treatment, or when your dose is increased. If it affects you, do not drive or operate machinery.

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

This medication contains 1.02 mg of sodium (main component of table salt/for cooking) per milliliter. This is equivalent to 0.051% of the maximum daily sodium intake recommended for an adult.

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The labeling of your medication will indicate the dose and frequency of your intake.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of concentrated oxicodone, 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 concentrated").

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

This medication should only be administered by mouth.

Adults and adolescents (12 years of age and older)

The usual initial dose is 5mg every 6 hours. The dosing interval of oxicodone can be reduced to 4 hours if necessary. Oxicodone should not be taken more than 6 times a day. However, your doctor will prescribe the necessary dose to treat your pain. A calibrated dropper or oral dispenser is included to help you measure your dose. It can be mixed with a drink to make it easier to take. If you continue to have pain despite using concentrated oxicodone, talk to your doctor.

Use in children under 12 years of age

The safety and efficacy of oxicodone have not been sufficiently proven in children under 12 years of age. Therefore, treatment with oxicodone 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 medication or reduce the dose depending on your situation.

If you take more OxyNorm concentrated than you should or if someone accidentally takes the medication

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested, or go to the hospital immediately.

A overdose may 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 of overdose, loss of consciousness or even death may occur. When you need medical attention, make sure to bring this leaflet with you and what is left of the medication to show it to your doctor. If you have taken too much medication, do not put yourself in a situation that requires you to be alert, such as driving a car.

If you forgot to take OxyNorm concentrated

If you forgot to take a dose, take the next dose as soon as you remember and then follow the treatment as usual. Do not take two doses in a 4-hour interval. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with OxyNorm concentrated

You should not stop using this medication suddenly unless your doctor tells you to.

If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, gradually reducing the dose and thus avoiding unpleasant withdrawal symptoms. Withdrawal symptoms such as yawning, abnormal pupil dilation, lacrimation, nasal secretion, restlessness, anxiety, convulsions, difficulty sleeping, palpitations, tremors, or sweating may appear if you stop taking this medication abruptly.

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

Like all medicines, OxyNorm concentrated may cause side effects, although not everyone will experience them.

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

The most severe side 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 common when you start using this medicine or when your dose is increased, but it will disappear within a few days).

• Dizziness.

• Headache.

• Itching 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 condition in which your breathing becomes slower and weaker than normal (respiratory depression).

• Difficulty swallowing, belching, hiccups, gas, disorders in which the intestine does not function properly (ileus), inflammation of the stomach, alteration of taste, ulcers or sores in the mouth.

• A condition that may cause an abnormal production of the antidiuretic hormone (SIADH syndrome).

• Feeling of dizziness or "spinning" (vertigo), hallucinations, mood changes, a 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 out of body, being exceptionally hyperactive, dizziness, reduction of consciousness, abnormal muscle rigidity or laxity, involuntary muscle contractions.

• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, seen in blood tests).

• Skin redness.

• Dehydration, weight change, thirst, swelling of the hands, ankles, or feet.

• Dry skin.

• Disorders in 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, nasal bleeding, voice alteration.

• Chills.

• Chest pain.

• Inability to completely empty the bladder.

• Worsening of liver function tests (observed in blood tests).

• Symptoms of withdrawal (see section 3 If you stop treatment with OxyNorm concentrated).

Rare

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

• Feeling of 'weakness' especially when standing.

• Low blood pressure.

• Urticaria.

Not known

(the 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 your entire body.

• Dental alterations.

• Abdominal pain of the type or discomfort.

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

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

• Absence of menstrual periods.

• Increased sensitivity to pain.

• Sleep apnea (interruptions of breathing during sleep).

• Aggression.

• Prolonged treatment of OxyNorm during pregnancy may cause withdrawal syndrome in newborns with a threat to their life. The symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, loud crying, tremors, appearance of being unwell, diarrhea, and failure to gain weight.

Reporting of side effects

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

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

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

Do not use the medication 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 do not use the medication after the last day of that month, i.e., August 2020.

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

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of OxyNorm concentrate

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

The other components are:

• sodium saccharin,

• sodium benzoate (E211),

• citric acid monohydrate,

• sodium citrate,

• hydrochloric acid,

• sodium hydroxide,

• purified water,

• yellow-orange S (E110).

Appearance of OxyNorm concentrate and contents of the container

This medicine is a clear orange-colored solution.

Each bottle contains 30 or 120 ml of solution. Some container sizes may only be marketed.

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa,11

28042 Madrid.

Spain

Tel.: 91 3821870

Responsible 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 IrelandOxyNorm concentrate

SpainOxyNorm concentrate 10 mg/ml oral solution

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

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