OXYNORM 5 mg HARD CAPSULES

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 other strong pain relievers (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 slow or shallow breathing;
• you have a head injury that causes a severe headache or confusion, as this medicine may worsen these symptoms or mask the extent of the injury;
• you have a condition where your small intestine does not work properly (paralytic ileus), your stomach empties more slowly than normal (delayed gastric emptying) or you have severe abdominal pain;
• you have heart problems caused by 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 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 ducts;
• you have any obstructive or inflammatory bowel disease;
• you have abdominal pain associated with constipation;
• you have an enlarged prostate gland, which causes 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 pulmonary disease, severe lung disease or reduced respiratory reserve. Symptoms may include slow or shallow breathing;
• you have kidney or liver problems;
• you have experienced symptoms of withdrawal, such as agitation, anxiety, palpitations, tremors or sweating, when you stopped taking alcohol or drugs;
• if you or a family member have a history of abuse or dependence on alcohol, prescription drugs or illegal substances (“addiction”);
• if you smoke;
• if you have ever had problems with your mood (depression, anxiety or a personality disorder) or have received treatment from a psychiatrist for other mental health problems;
• if you suffer from seizures, fits or convulsions;
• if you suffer from dizziness or fainting;
• 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 and linezolid), or if you have taken this type of medicine in the last two weeks;
• if you have constipation.

Breathing difficulties during sleep

OxyNorm may cause breathing difficulties during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related low blood oxygen levels. Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep or excessive sleepiness during the day. If you or another person observes these symptoms, consult 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 side effects, which can be fatal.

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

Tolerance, dependence and addiction

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

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

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

• if you or a family member have a history of abuse or dependence on alcohol, prescription drugs or illegal substances (“addiction”);
• if you smoke;
• if you have ever had problems with your mood (depression, anxiety or a personality disorder) or have received treatment from a psychiatrist for other mental health problems.

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

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

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

Using OxyNorm with other medicines

Taking OxyNorm with other medicines, such as sedatives, benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, taking these medicines together 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 dose recommendations carefully. It may be useful 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 taking, have recently taken or might take any other medicines, including those obtained without a prescription. If you use these capsules with some medicines, the effect of this medicine or the other medicine may be affected.

The risk of side effects increases if you are taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and symptoms such as muscle spasms, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone and body temperature above 38°C may occur. Contact your doctor if you experience these 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 treating depression (such as paroxetine or fluoxetine);
• medicines for treating psychiatric or mental disorders (such as phenothiazines or neuroleptics);
• medicines for treating epilepsy, pain and anxiety, such as gabapentin and pregabalin;
• other strong pain relievers;
• muscle relaxants;
• medicines for treating high blood pressure;
• quinidine (a medicine for treating irregular heart rhythm);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• medicines for treating fungal infections (such as ketoconazole, voriconazole, itraconazole or posaconazole);
• medicines used for treating bacterial infections (such as clarithromycin, erythromycin or telithromycin);
• a specific type of medicine known as protease inhibitors for treating HIV (such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• rifampicin for treating tuberculosis;
• carbamazepine (a medicine for treating seizures, fits or convulsions and certain conditions that cause pain);
• phenytoin (a medicine for treating seizures, fits or convulsions);
• a herbal remedy called St. John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines for treating Parkinson's disease.

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

Taking OxyNorm with food, drinks and alcohol

These capsules can be taken with or without food.

Drinking alcohol while taking these capsules may cause drowsiness or increase the risk of serious side effects, such as slow or shallow breathing, and risk of respiratory failure and loss of consciousness. 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, it may cause slow or shallow breathing (respiratory depression) or withdrawal symptoms in newborns.

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, that can 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 use machines.

OxyNorm contains sunset yellow FCF (E110) and sodium

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially 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., 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 starting treatment and at regular intervals 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 to stop taking it (see also “If you stop taking OxyNorm”).

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

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

The capsules should be swallowed whole with a little water. You should only take the capsules 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 have pain despite taking the capsules, talk to your doctor.

Use in children under 12 years of age

The safety and efficacy of oxycodone have not been sufficiently studied 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

Tell your doctor if you have liver or kidney problems, your doctor may prescribe a different medicine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, stating 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 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 your doctor.

If you have taken many capsules, never put yourself in a situation that requires you 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 with your normal schedule. Do not take two doses in a 4-hour interval.

If you stop taking OxyNorm

Do not stop taking these capsules suddenly unless your doctor tells you to do so. If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do this, by gradually reducing the dose, to avoid unpleasant withdrawal symptoms. Withdrawal symptoms, such as yawning, dilated pupils, tears, runny nose, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremors or sweating, may occur if you stop taking this medicine abruptly.

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

4. Possible Adverse Effects

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

This medication may cause allergic reactions, although severe 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 medication.

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 medication 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 malaise, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness, seizures, epileptic fits or convulsions, abnormal gait or walking style, feeling of being outside oneself, being exceptionally hyperactive, dizziness, reduced level of consciousness, abnormal muscle rigidity or laxity.
• Impotence, decreased sexual desire, low levels of sex hormones in the blood (hypogonadism, seen in blood tests).
• Redness of the skin.
• Dehydration, weight change, thirst, swelling of the hands, ankles, or feet.
• Dry skin.
• Disorders of tear production, blurred vision, reduction of pupil size.
• Need to increase the dose to achieve the same level of pain relief (tolerance).
• Ringing or buzzing in the ears.
• Swelling and irritation inside the nose, nosebleeds, alteration of voice.
• Chills.
• Chest pain.
• Inability to empty the bladder completely.
• Worsening of liver function tests (observed in blood tests).
• Withdrawal symptoms (see section 3 If you stop treatment with OxyNorm).

Rare

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

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

Not Known

(Frequency cannot be estimated from the available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, 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 produce itching of the skin, yellowish skin, very dark urine, and very pale stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Sleep apnea (interruptions of breathing during sleep).

• Aggressiveness.
• 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 medication.

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 medication 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 medication after the expiration date that appears on the blister 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 medication 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 thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications 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 5 mg of oxicodone hydrochloride.

The other components are:

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

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

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

Product Appearance and Package Contents

The capsules have a hard gelatin shell 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 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 medication is authorized in the Member States of the European Economic Area with the following names:

Austria OxyNorm Kapseln

Republic of Ireland OxyNorm Capsules

Spain OxyNorm 5 mg hard capsules

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

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