OxyNorm 5 mg hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

OxyNorm 5 mg Hard Capsules

Oxycodone hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What OxyNorm is and what it is used for

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

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

2. What you need to know before taking OxyNorm

Do not take OxyNorm if:

• you are allergic (hypersensitive) to oxycodone or to any of the other components of OxyNorm (listed in section 6. Additional information), or have previously had an allergic reaction when taking other strong painkillers (such as morphine or other opioid analgesics);
• you have breathing problems, such as chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression. Symptoms may include shortness of breath, cough, or breathing that is slower or weaker than expected;
• you have a head injury causing severe headache or dizziness, as this medicine may worsen these symptoms or mask the extent of the injury;
• you have a condition in which 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 resulting from long-standing lung disease (cor pulmonale).

Warnings and precautions

Talk to your doctor or pharmacist before taking OxyNorm if:

• you are elderly or debilitated;
• you have low thyroid gland activity (hypothyroidism);
• you have myxoedema (a thyroid disorder with dry, cold, and swollen skin affecting the face and limbs);
• you have severe headache or dizziness, as this may indicate increased pressure in your skull;
• you have low blood pressure (hypotension);
• you have inflammation of the pancreas (which may cause severe abdominal and back pain) or problems with your gallbladder or bile ducts;
• you have an obstructive or inflammatory bowel disease;
• you have colicky abdominal pain or discomfort;
• you have an abnormally enlarged prostate causing difficulty in passing urine (in men);
• you have poor adrenal gland function (your adrenal gland does not work properly), for example Addison’s disease;
• you have breathing problems such as severely impaired respiratory function, chronic obstructive airway disease, severe lung disease, or reduced respiratory reserve. Symptoms may include shortness of breath and cough;
• you have kidney or liver problems;
• you have experienced withdrawal symptoms such as restlessness, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs;
• you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”);
• you smoke;
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses;
• you suffer from spasms, fits, or seizures;
• you experience dizziness or fainting;
• you need to increase the dose of OxyNorm 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 have taken such medicines within the last two weeks;
• you are constipated.

Sleep-related breathing disorders

OxyNorm may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses 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 your dose.

If you are undergoing surgery, inform the hospital doctor that you are taking these capsules.

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

The contents of the capsule must never be injected, as this may lead to serious adverse effects that could be fatal.

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

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of OxyNorm may also lead to dependence, abuse, and addiction, which can result in a life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it. You may feel that you need to continue taking the medicine, even when it no longer helps relieve your pain.

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

• you or a family member have a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”);
• you smoke;
• you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking OxyNorm, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than prescribed, for example, “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• You feel unwell when you stop taking the medicine and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, speak with your doctor to discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking OxyNorm).

Contact your doctor if you experience severe upper abdominal pain that may spread to your back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

Use of OxyNorm with other medicines

Concomitant use of opioids, including oxycodone, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes OxyNorm together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Please inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. Using these capsules with certain medicines may alter their effects or the effects of other medicines.

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 rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

Inform your doctor or pharmacist if you are taking:

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

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

Taking OxyNorm with food, drinks, and alcohol

These capsules may be taken with or without food.

Consuming alcohol during treatment with these capsules may cause drowsiness or increase the risk of serious adverse effects such as shallow breathing, 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use these capsules during pregnancy and childbirth unless specifically instructed by your doctor. Depending on the dose and duration of oxycodone treatment, slow and shallow breathing (respiratory depression) or withdrawal syndrome may occur in newborns.

Breastfeeding

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

Driving and using machines

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

OxyNorm contains Orange Yellow S (E110) and sodium

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

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

3. How to take OxyNorm

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again. The labelling of your medicine will tell you how you can take the capsules and how often.

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

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

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

The capsules should be swallowed whole with a little water. You must take the capsules only orally (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. If you continue to experience pain despite taking the capsules, speak with your doctor.

Use in children under 12 years of age

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

Patients with liver or kidney problems

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, stating the medicine and the amount ingested, or go immediately to hospital.

An overdose may cause:

• a decrease in the size of your pupils
• slower and weaker breathing than normal (respiratory depression)
• drowsiness or loss of consciousness
• decreased muscle tone (hypotonia)
• reduced pulse
• low blood pressure
• difficulty breathing due to fluid in the lungs (pulmonary edema)
• a brain disorder (known as toxic leukoencephalopathy)

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

If you have taken several capsules, under no circumstances should you place yourself in a situation requiring alertness, such as driving a car.

If you forget to take OxyNorm

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

If you stop taking OxyNorm

You should not stop taking these capsules suddenly unless your doctor tells you to. If you wish to stop taking this medicine, speak to your doctor first. Your doctor will advise you on how to do this by gradually reducing the dose, thus avoiding unpleasant withdrawal symptoms. Withdrawal symptoms such as yawning, abnormal pupil dilation, tearing, runny nose, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremor, or sweating may occur if you stop taking this medicine abruptly.

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

4. Possible adverse effects

Like all medicines, OxyNorm can cause adverse effects, although not everyone will experience them.

This medicine may cause allergic reactions, although serious allergic reactions reported are rare. Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, 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 of 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 vomiting if the problem persists).
• Drowsiness (more common when starting this medicine or when the dose is increased, but will disappear within a few days).
• Dizziness.
• Headache.
• Itching of the skin.

Common

(May affect up to 1 in 10 patients)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.
• Confusion, depression, unusual weakness, tremor, lack of energy, tiredness, anxiety, restlessness, difficulty sleeping, abnormal dreams and thoughts.
• Difficulty breathing, wheezing, shortness of breath.
• Difficulty urinating.
• Rash.
• Sweating, high temperature.

Uncommon

(May affect up to 1 in 100 patients)

• A condition in which your breathing is slower and weaker than normal (respiratory depression).
• Difficulty swallowing, burping, hiccups, flatulence, intestinal disorder in which the bowel does not function properly (ileus), inflammation of the stomach, altered taste, mouth ulcers or sores.
• A disorder that may cause abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Feeling dizzy or "spinning" (vertigo), hallucinations, mood changes, a feeling of extreme happiness, agitation, general malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness, seizures, epileptic fits or convulsions, abnormal gait or walking pattern, feeling detached from oneself, being exceptionally hyperactive, dizziness, reduced level of consciousness, abnormal muscle rigidity or flaccidity, involuntary muscle contractions.
• Impotence, decreased sex drive, low levels of sex hormones in the blood (hypogonadism, observed in blood tests).
• Redness of the skin.
• Dehydration, weight changes, thirst, swelling of the hands, ankles or feet.
• Dry skin.
• Disorders in tear production, blurred vision, reduction in the size of the pupils of the eye.
• Need to increase the dose to achieve the same level of pain relief (tolerance).
• Ringing or buzzing in the ears.
• Swelling and irritation inside the nose, nosebleeds, voice changes.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening of liver function tests (observed in blood tests).
• Withdrawal symptoms (see section 3 If you stop taking 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 available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it covers the entire body.

• Dental disorders.

• Colicky abdominal pain or discomfort.

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

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

• Absence of menstrual periods.

• Increased sensitivity to pain.

  • Sleep apnoea (interruptions in breathing during sleep).

• Aggression.

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of OxyNorm

Keep out of sight and reach of children. Accidental overdose in a child is dangerous and may be fatal. Store this medicine in a safe, locked place, inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

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

Do not store the capsules at temperatures above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of OxyNorm

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

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, iron oxide (E172), and propylene glycol.

The 5 mg capsules also contain sunset yellow FCF (E110).

Appearance of the product and contents of the pack

The capsules are hard gelatin capsules marked with ONR and the strength 5.

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

The capsules are packed in blisters and then placed in cartons. Each pack contains 10, 28, 30, 56 or 112 capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Mundipharma Pharmaceuticals S.L.

Bahía de Pollensa, 11

28042 Madrid, Spain

Telephone: 91 382 1870

Fax: 91 382 1871

Manufacturer: Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria OxyNorm Kapseln

Republic of Ireland OxyNorm Capsules

Spain OxyNorm 5 mg hard capsules

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

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