OXYNORM 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

OxyNorm 10 mg Hard Capsules

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

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

1. What OxyNorm is and what it is used for

OxyNorm is a strong pain-relieving medicine, also known as an opioid, and belongs to a group of medicines called strong analgesics or 'painkillers'.

OxyNorm is used in adults and children aged 12 years and older for the treatment of moderate to severe pain, which can only be adequately managed with an opioid analgesic.

2. What you need to know before you take OxyNorm

Do not take OxyNorm if:

• you are allergic (hypersensitive) to oxycodone or any of the other ingredients of OxyNorm (listed in section 6. Further information) or have had an allergic reaction to any other strong painkiller (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 shortness of breath, wheezing or coughing or slow or shallow breathing;
• you have a head injury that has made you feel confused or made you lose consciousness, as this medicine may make these symptoms worse or hide the extent of the injury;
• you have a condition where your small bowel does not function properly (paralytic ileus), your stomach empties more slowly than normal (delayed gastric emptying) or you have severe abdominal pain;
• you have heart problems following long-term lung disease (cor pulmonale).

Warnings and precautions

Tell your doctor or pharmacist before you start taking OxyNorm 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 feelings of 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 gall bladder or bile duct;
• you have any obstructive or inflammatory bowel disease;
• you have abdominal pain caused by conditions such as pancreatitis or intestinal obstruction;
• you have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• you have poor adrenal function (your adrenal gland does not work properly), e.g. Addison's disease;
• you have severe respiratory problems, such as severely impaired lung function, chronic obstructive pulmonary disease, severe lung disease or reduced respiratory reserve. Symptoms may include shortness of breath and cough;
• you have a kidney or liver problem;
• you have had symptoms of withdrawal from alcohol or drug abuse in the past;
• if you or someone in your family has a history of alcohol or drug abuse or addiction;
• if you smoke;
• if you have ever had problems with your mental health, such as depression, anxiety or a personality disorder, or have been treated by a psychiatrist for any other mental health condition;
• if you have fits or seizures;
• if you have a history of fainting or feeling faint;
• if you need to take increasingly higher doses of OxyNorm to achieve the same level of pain relief (tolerance);
• if you experience increased sensitivity to pain;
• if you are taking a type of medicine known as a monoamine oxidase inhibitor (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide or linezolid), or if you have taken this type of medicine in the last two weeks;
• if you have constipation.

Breathing problems related to sleep

OxyNorm may cause breathing problems related to sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related low oxygen levels in the blood. Symptoms may include pauses in breathing during sleep, waking up during the night due to difficulty breathing, difficulty staying asleep or excessive sleepiness during the day. If you or another person observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

If you are going to have surgery, inform your 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 serious, potentially fatal, side effects.

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

Tolerance, dependence and addiction

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may make you become tolerant to the medicine so that it no longer gives you adequate pain relief (you may need to take more of the medicine to achieve the same level of pain relief). Repeated use of OxyNorm may also lead to dependence and addiction. The risk of dependence and addiction may be higher if you take more than the recommended dose, or if you take the medicine for a longer period than your doctor has advised. The risk of side effects, such as respiratory depression, may be increased if you take this medicine with other medicines that depress the central nervous system, such as sedatives, tranquilizers, or other opioids.

Dependence or addiction can happen to anyone using this medicine. You are more likely to become dependent or addicted if:

• you or someone in your family has a history of alcohol or drug abuse or addiction;
• you smoke;
• you have previously had mental health problems, such as depression, anxiety or a personality disorder, or have been treated by a psychiatrist for any other mental health condition.

If you notice any of the following signs, you may be becoming dependent or addicted:

• you need to take the medicine for longer than your doctor has advised;
• you need to take more of the medicine than your doctor has advised;
• you are taking the medicine for reasons other than to control pain, such as to feel happy or to stop feeling anxious;
• you have tried to reduce or stop the medicine and found it difficult;
• you feel unwell when you stop taking the medicine or reduce the dose, and feel better once you start taking it again (withdrawal symptoms).

If you notice any of these signs, talk to your doctor. Your doctor will be able to advise you on the best course of action and help you if you want to stop taking OxyNorm.

Contact your doctor if you experience severe abdominal pain which may radiate to your back, nausea, vomiting or fever as these may be symptoms of pancreatitis and bile duct disorders.

Using OxyNorm with other medicines

Using opioids, including oxycodone, with other medicines that act on the central nervous system, such as sedatives, tranquilizers, or other opioids, may increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes OxyNorm with a sedative, 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 dose recommendation carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms of these interactions. 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 these capsules with some other medicines, the effect of the medicine or these other medicines may be changed.

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 may cause symptoms such as muscle twitching or spasms, agitation, excessive sweating, tremor, increased muscle tone and body temperature above 38°C. Contact your doctor if you experience such symptoms.

Tell 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”);
• medicines that help you sleep (such as hypnotics or sedatives, including benzodiazepines);
• medicines for depression (such as paroxetine or fluoxetine);
• medicines for psychiatric or mental disorders (such as phenothiazines or neuroleptics);
• medicines for epilepsy, pain or anxiety, such as gabapentin and pregabalin;
• other strong painkillers;
• muscle relaxants;
• medicines for high blood pressure;
• quinidine (a medicine for irregular heart rhythm);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• medicines for fungal infections (such as ketoconazole, voriconazole, itraconazole or posaconazole);
• medicines for bacterial infections (such as clarithromycin, erythromycin or telithromycin);
• a specific type of medicine known as protease inhibitors for the treatment of HIV (such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• rifampicin for the treatment of tuberculosis;
• carbamazepine (a medicine for fits, seizures or certain types of pain);
• phenytoin (a medicine for fits or seizures);
• a herbal remedy called St John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines for Parkinson's disease.

Also, tell your doctor if you have recently been given an anaesthetic.

Taking OxyNorm with food, drink and alcohol

These capsules can be taken with or without food.

Drinking alcohol during treatment with these capsules may increase the risk of serious side effects, such as drowsiness, difficulty breathing, coma, and may be life-threatening. It is recommended not to drink alcohol while taking OxyNorm.

You should avoid drinking grapefruit juice while taking OxyNorm.

Pregnancy and breast-feeding:

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

Pregnancy

Do not take these capsules during pregnancy and childbirth unless your doctor has told you to do so. Depending on the dose and duration of treatment with oxycodone, newborns may experience breathing difficulties (respiratory depression) or withdrawal symptoms.

Breast-feeding

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

Driving and using machines

These capsules may cause side effects such as dizziness, which may affect your ability to drive or use machines (see section 4. “Possible side effects”). These are more likely to occur when you first start taking the medicine, or when your dose is increased. If you are affected, you should not drive or operate machinery.

OxyNorm contains sodium

This medicine contains 0.076 mg of sodium laurilsulfate per capsule, which is less than 1 mmol of sodium (23 mg), i.e. essentially “sodium-free”.

3. How to take OxyNorm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The label on your medicine will tell you how many capsules to take and how often.

Before you start taking this medicine and at regular intervals during treatment, your doctor will explain the treatment to you and advise you on how to take the capsules, how often and for how long.

There are different strengths of this medicine. Your doctor will decide which strength is most suitable for you.

Do not take more than the dose recommended by your doctor.

Swallow the capsules whole with a little water. Take the capsules by mouth only.

Adults and adolescents (12 years of age and older)

The usual starting dose is 5 mg every 6 hours. The dose interval of oxycodone may be reduced to 4 hours if necessary. Oxycodone should not be taken more than 6 times in any 24-hour period. However, your doctor will prescribe the dose that is right for you and your pain. If you find that you are still in pain while taking these capsules, discuss this with your doctor.

Use in children below 12 years of age

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

Patients with liver or kidney problems

Tell your doctor if you have liver or kidney problems, as your doctor may need to prescribe a lower dose or a different medicine.

If you take more OxyNorm than you should or if someone accidentally takes your capsules,

In case of overdose or accidental ingestion, contact your doctor or pharmacist or the national poison information service on 91 562 04 20, stating the name of the medicine and the amount taken, or go to the hospital immediately.

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
• 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 oedema)
• a brain disorder (known as toxic leucoencephalopathy)

In severe cases of overdose, this may lead to loss of consciousness or even death. When you need medical attention, make sure you have this leaflet and the capsules with you to show to your doctor.

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

If you forget to take OxyNorm

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take the next dose as soon as you remember and then continue as normal. Do not take two doses within a 4-hour period.

If you stop taking OxyNorm

Do not stop taking these capsules suddenly, unless your doctor has told you to do so. If you want to stop taking this medicine, discuss this with your doctor first. Your doctor will advise you on how to stop treatment by gradually reducing the dose, so that you are less likely to experience withdrawal symptoms such as yawning, dilated pupils, tears, runny nose, sweating, restlessness, irritability, anxiety, tremors, or gooseflesh. If you experience any of these symptoms, contact your doctor.

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 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 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 vomiting if the problem continues).
• Drowsiness (it is more frequent when you start taking 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, intestinal 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 discomfort, 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.
• 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.
• Dryness of the 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).

Rare

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

• Feeling of "weakness" especially when standing.
• Low blood pressure.
• Urticaria.

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 with a threat to their life. 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

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 blister pack and carton. The expiration date is the last day of the month indicated. For example, CAD 08 2020 means that you should not take the medicine after the last day of that month, i.e., August 2020.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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

OxyNorm Composition

The active ingredient is oxicodone hydrochloride. Each hard capsule (capsule) contains 10 mg of oxicodone hydrochloride.

The other ingredients are:

• microcrystalline cellulose,
• magnesium stearate,
• titanium dioxide (E171),
• iron oxide (E172),
• carmine (E132),
• sodium lauryl sulfate,
• gelatin.

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

Product Appearance and Package Contents

The capsules have a hard gelatin shell marked with ONR and the concentration 10.

The color of the 10 mg capsule is white/beige.

The capsules are packaged in blister packs and then inserted into boxes. Each package contains 10, 28, 30, 56, or 112 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:Mundipharma Pharmaceuticals S.L.

Bahía de Pollensa, 11

28042 Madrid, Spain

Phone: 91 382 1870

Fax: 91 382 1871

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 under the following names:

Austria OxyNorm Kapseln

Republic of Ireland OxyNorm Capsules

Spain OxyNorm 10 mg hard capsules

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/)