Leaflet: information for the user

OxyNorm 5 mg hard capsules

Oxycodone hydrochloride

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, 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, 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 is and what it is used for

2. What you need to know before you start taking OxyNorm

3. How to take OxyNorm

4. Possible side effects

5. Storage of OxyNorm

6. Contents of the pack and additional information

OxyNorm is a strong analgesic or "pain reliever" and belongs to the opioid group.

OxyNorm is usedin adults and adolescents from 12 years oldfor the relief of intense pain, which can only be adequately treated with opioid analgesics.

Do not take OxyNorm if:

• you are allergic (hypersensitive) to oxycodone or to any of the other ingredients of OxyNorm (listed in section 6. Additional information) or have had an allergic reaction to taking other strong painkillers (such as morphine or other opioid painkillers);

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

• you have a head injury that causes severe headache or dizziness, as this medicine may worsen these symptoms or mask the extent of the injury;

• you have a condition where your small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe abdominal pain;

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

Warnings and precautions

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

• you are elderly or debilitated;

• you have low thyroid activity (hypothyroidism);

• you have myxedema (a thyroid disorder, with dryness, coldness and inflammation (swelling) of the skin, affecting the face and 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 any obstructive or inflammatory bowel disease;

• you have abdominal colic or discomfort;

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

• you have poor adrenal function (your adrenal gland does not function 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 shortness of breath and coughing;

• you have kidney or liver problems;

• you have experienced withdrawal symptoms such as agitation, anxiety, palpitations, tremors or sweating when stopping 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 spasms, seizures or convulsions;

• you experience dizziness or fainting;

• you need to increase the dose of OxyNorm to achieve the same level of pain relief;

• 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.

Respiratory disorders related to sleep

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

If you are to undergo any surgical operation, inform the hospital doctor that you are taking these capsules.

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

The contents of the capsule should never be injected as this may lead to severe adverse effects with a fatal outcome.

Opioids are not the first line of treatment for non-cancer 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.

Tolerance, dependence and addiction

This medicine contains oxycodone, which is an opioid painkiller. Repeated use of opioid painkillers may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm may also cause dependence, abuse and addiction that may lead to a overdose that puts your life at risk.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 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 to relieve your pain.

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

• 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, it may 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 stay calm" or "to help you sleep".
• You have made repeated and 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 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).

Contact your doctor if you have severe 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 medicines

The concomitant use of opioids, including oxycodone and sedatives such as benzodiazepines or related medications, increases the risk of drowsiness, breathing 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 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 medicine, including those purchased without a prescription. If you use these capsules with some medicines, the effect or that of the other medicines may be modified.

The risk of adverse effects increases if you are taking antidepressants (such as citalopram, duloxetina, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, venlafaxina). These medications may interact with oxycodone and you may experience 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 painkillers;

• 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 to treat HIV (such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);

• rifampicina to treat tuberculosis;

• carbamazepina (a medication to treat spasms, seizures or convulsions and certain situations that present pain);

• phenitoína (a medication to treat spasms, seizures or 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.

Taking OxyNorm with food, drinks and alcohol

These capsules can be taken with or without food.

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

You should avoid drinking grapefruit juice during treatment with OxyNorm.

Pregnancy and breastfeeding

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

Pregnancy

You should not use these capsules during pregnancy and childbirth unless your doctor has specified. Depending on the dose and duration of oxycodone treatment, it may cause slow and shallow breathing (respiratory depression) or withdrawal symptoms in newborns.

Breastfeeding

These capsules should not be used during breastfeeding as the active substance may pass into breast milk.

Driving and operating machinery

These capsules 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 you are affected, do not drive or operate machinery.

OxyNorm contains yellow orange S (E110) and sodium

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

This medicine contains 0.076 mg of laurilsulfato de sodio per capsule, which is less than 1 mmol of sodium (23 mg), that is, practically "sodium-free".

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 tell you how to take the capsules and how often.

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

There are different doses available for this medication. Your doctor will decide what dose of this medication is most suitable for you.

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

The capsules should be swallowed whole with a little water. You should only take the capsules orally (by mouth).

Adults and adolescents (12 years of age and older)

The usual initial dose is 5 mg 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. If you continue to have pain despite taking the capsules, 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 problems

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 than you should or if someone accidentally takes your capsules,

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, 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 drop 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 with you and have the capsules available to show to your doctor.

If you have taken many capsules, do not put yourself in a situation that requires you to be alert, such as driving a car.

If you forgot to take OxyNorm

Do not take a double dose to compensate for the missed doses. 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.

If you interrupt treatment with OxyNorm

You should not stop taking these capsules suddenly unless your doctor tells you to. If you want to stop taking 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 can cause side effects, although not everyone will experience them.

This medicine can 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, rash or itching on the skin, especially if it covers your entire body.

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

Like all strong painkillers, there is a risk of addiction or dependence on this medication.

Very common

(Can 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 in a few days, however, your doctor may prescribe medication to prevent vomiting if the problem persists).

• Drowsiness (it is more common when you start taking this medication or when your dose is increased, but it will disappear in a few days).

• Dizziness.

• Headache.

• Itching on the skin.

Common

(Can affect up to 1 in 10 patients)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea.

• Confusion, depression, feeling of unusual weakness, tremor, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams and thoughts.

• Difficulty breathing, wheezing, shortness of breath.

• Difficulty urinating.

• Rash.

• Sweating, high temperature.

Uncommon

(Can affect up to 1 in 100 patients)

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

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

• A condition that can cause an abnormal production of the antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).

• 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 taking OxyNorm).

Rare

(Can 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 of colic or discomfort.

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

• Blockage in the flow of bile from the liver. This can cause itching on the skin, 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 can cause withdrawal syndrome in newborns with a risk 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 prospectus. 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 medication.

Keep out of the sight and reach of children. Accidental overdose in a child is hazardous and can be fatal. Store this medication in a secure and closed location where other individuals cannot access it. It can 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 blister and on the carton. The expiration date is the last day of the month indicated. For example, CAD 08 2020 means that the medication should not be taken after the last day of that month, i.e., August 2020.

Do not store the capsules at a temperature above 25°C.

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

Composition of OxyNorm

The active ingredient is hydrochloride of oxycodone. Each hard capsule contains 5 mg of hydrochloride of oxycodone.

The other components are:

- microcrystalline cellulose,

- magnesium stearate,

- titanium dioxide (E171),

- iron oxide (E172),

- indigo carmine (E132),

- sodium lauryl sulfate,

- gelatin.

The printing ink contains Shellac lacquer, iron oxide (E172), and propylene glycol.

The 5 mg capsules also contain yellow-orange S (E110).

Appearance of the product and contents of the packaging

The capsules have a hard gelatin coating marked with ONR and the concentration 5.

The color of the 5 mg capsule is orange/beige.

The capsules are packaged in blisters and then placed in boxes. Each package contains 10, 28, 30, 56, or 112 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

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

Bahía de Pollensa,11

28042 Madrid. Spain

Telephone: 91 382 1870

Fax: 91 382 1871

Responsible manufacturer:Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

or

Fidelio Healthcare Limburg GmbH

Mundipharmastrasse 2,

65549 Limburg

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaOxyNorm Kapseln

Republic of IrelandOxyNorm Capsules

SpainOxyNorm 5 mg hard capsules

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

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