OXYCONTIN 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

OxyContin 80 mg prolonged-release tablets

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

1. What OxyContin is and what it is used for

OxyContin is a strong pain reliever, also known as an "analgesic" and belongs to a group of medicines called opioids.

OxyContin is used in adults and adolescents from 12 years of age to treat severe pain, which can only be adequately managed with opioid analgesics.

2. What you need to know before you take OxyContin

Do not take OxyContin if:

• you are allergic (hypersensitive) to oxycodone or any of the other ingredients of the tablets (listed in section 6) or have had an allergic reaction to other strong pain relievers 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 difficulty breathing, coughing or slow and weak breathing;
• you have a head injury that causes severe headaches or dizziness. This is because the tablets may make these symptoms worse 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 (acute abdomen);
• you have a heart problem after long-term lung disease (cor pulmonale).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking OxyContin if:

• you are elderly or debilitated;
• you have low thyroid function (hypothyroidism);
• you have severe headaches or dizziness, as this may indicate that the pressure in your skull is increased;
• you have myxoedema (a thyroid disorder, with dryness, coldness and swelling of the skin, affecting the face and limbs);
• you have low blood pressure (hypotension);
• you or a family member have a history of abuse or dependence on alcohol, prescription drugs or illegal substances ("addiction");
• you smoke;
• you have ever had problems with your mood (depression, anxiety or personality disorder) or have received psychiatric treatment for other mental health disorders;
• you have pancreatitis (which can cause severe abdominal and back pain) or problems with your gallbladder or bile duct;
• you have any blockage of the intestine or an inflammatory bowel disorder;
• you have abdominal colic pain or discomfort;
• you have an enlarged prostate gland, which causes difficulty passing urine (in men);
• you have poor adrenal gland function (your adrenal gland does not work properly), for example Addison's disease;
• you have respiratory problems such as severely impaired respiratory function, chronic obstructive pulmonary disease, severe lung injury or reduced respiratory capacity. Symptoms may include difficulty breathing and coughing;
• you have liver or kidney problems;
• you have withdrawal symptoms such as agitation, anxiety, palpitations, tremors or sweating when you stop taking alcohol or drugs;
• you have fits, seizures or convulsions;
• you feel faint or dizzy;
• you need to increase the dose of OxyContin to achieve the same level of pain relief (tolerance);
• you have increased sensitivity to pain;
• 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.
• you suffer from constipation.

Breathing difficulties while sleeping

OxyContin may cause breathing difficulties while sleeping, such as sleep apnea (pauses in breathing during sleep) and sleep-related low blood oxygen levels (hypoxemia). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty staying asleep or excessive daytime sleepiness. If you or someone else notices these symptoms, talk to your doctor. Your doctor may consider reducing the dose.

If you are going to have surgery, tell your doctor at the hospital that you are taking these tablets.

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

The tablets should never be crushed or injected as this may cause serious side effects, which can be fatal.

Opioids are not the first choice for treating non-cancer pain 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 OxyContin, to prevent addiction and abuse.

This medicine contains oxycodone, which may produce a positive result in doping tests.

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 OxyContin may also lead to dependence, abuse and addiction, which may result in a life-threatening overdose. The risk of these side effects may increase with higher doses and longer treatment duration.

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 keep 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 OxyContin:

• 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 personality disorder) or have received psychiatric treatment for other mental health disorders.

If you notice any of the following signs while taking OxyContin, 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 the medicine 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 OxyContin).

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

Taking OxyContin with other medicines

Taking opioids, including oxycodone, and sedative medicines, such as benzodiazepines or related medicines, together may increase the risk of drowsiness, breathing difficulties (respiratory depression), coma and may put your life at risk. Due to this, taking these medicines together should only be considered when other treatment options are not possible.

However, if your doctor prescribes OxyContin together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines 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 mentioned above. Contact your doctor when you experience such symptoms.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you take these tablets with some medicines, the effect of the tablets or the other medicine 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 you may experience symptoms such as involuntary muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension 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 or stay calm (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 fits, seizures or convulsions and certain conditions that cause pain);
• phenytoin (a medicine for treating fits, seizures 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 recently been given an anaesthetic.

Taking OxyContin with food, drinks and alcohol

These tablets can be taken with or without food.

Drinking alcohol while taking OxyContin tablets may make you feel more drowsy or increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing and loss of consciousness. It is recommended not to drink alcohol while taking OxyContin tablets.

You should avoid drinking grapefruit juice during treatment with OxyContin.

Pregnancy and breastfeeding

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

Pregnancy

You should not use these tablets during pregnancy and childbirth, unless your doctor has specifically advised you to do so. Depending on the dose and duration of treatment with oxycodone, the newborn may experience slow and shallow breathing (respiratory depression) or withdrawal symptoms.

Breastfeeding

You should not use these tablets while breastfeeding, as the active substance may pass into breast milk.

Driving and using machines

These tablets may cause a number of side effects such as drowsiness, which may affect your ability to drive or use machines (see section 4 for a full list of side effects). These effects are more pronounced when you start treatment with the tablets or when your dose is increased. If you are affected, you should not drive or use machines.

OxyContin contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to Take OxyContin

Follow your doctor's instructions for taking these tablets exactly. If you are unsure, consult your doctor or pharmacist again. The labeling on your medication will tell you how to take the tablets and how often.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to 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 treatment with OxyContin").

There are different doses available for this medication. Your doctor will decide which dose of OxyContin prolonged-release tabletsis most suitable for you.

Do not exceed the dose recommended by your doctor.

Swallow the tablets whole with a glass of water. Do not chew, crush, or dissolve them.

You should take your tablets every 12 hours. Therefore, if you take a tablet at 8 in the morning, you should take the next one at 8 in the evening. It is recommended to take this medication consistently in relation to meal times.

The tablets must not be crushed or injected because they can cause very serious side effects. These tablets should only be taken orally.

The OxyContin tablets are designed to work properly for 12 hours when taken whole. If the tablet is broken, crushed, dissolved, or chewed, the full 12-hour dose may be absorbed quickly by your body. This can be dangerous, causing serious problems such as an overdose, which can be fatal.

Adults and Adolescents (12 years of age and older)

The usual initial dose is one 10 mg tablet every 12 hours. In some cases, your doctor may prescribe an initial dose of 5 mg to reduce the side effects you may experience. Your doctor will prescribe the dose needed to treat your pain. If you continue to have pain despite taking the tablets, talk to your doctor.

Children under 12 years of age

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

Patients with kidney and/or liver problems

Please inform your doctor if you have kidney or liver problems, so that he can prescribe an alternative medication or reduce the dose depending on your situation.

If you take more OxyContin than you should or if someone accidentally takes the tablets

Inform your doctor immediately or go to your hospital.

An overdose can 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 pulse
• a drop in blood pressure
• difficulty breathing due to fluid in the lungs (pulmonary edema)
• a brain disorder (known as toxic leukoencephalopathy).

In some cases, an overdose can lead to unconsciousness or even death. When you need medical attention, make sure to bring this leaflet with you and the tablets you have for your doctor to see.

If you have taken too many tablets, under no circumstances should you put yourself in a situation that requires you to be alert, such as driving a car.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Phone 91 562 04 20, or go directly to the hospital.

If you forget to take OxyContin

If you forget to take a dose within 4 hours of the scheduled time, take a tablet immediately. Take your next tablet at your usual time. If the delay in taking it is more than 4 hours, consult your doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop treatment with OxyContin

Do not stop treatment with these tablets 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 by gradually reducing the daily dose, so you do not experience unpleasant effects. If you stop taking these tablets suddenly, you may experience withdrawal symptoms such as yawning, abnormal dilation of the pupils, lacrimation, nasal discharge, agitation, anxiety, convulsions, difficulty sleeping, palpitations, tremors, or sweating.

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

4. Possible Side Effects

Like all medications, these tablets can have side effects, although not everyone will experience them.

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

The most serious side effect is when your breathing becomes slower or weaker than normal (respiratory depression, a typical risk of opioid overdose).

Like all strong painkillers, there is a risk of addiction or dependence on these tablets.

Very Common

(May affect more than 1 in 10 patients)

• Constipation (your doctor will prescribe a laxative to treat this problem).
• Feeling of dizziness, vomiting (these symptoms usually disappear within a few days; however, your doctor may prescribe medication to prevent nausea if the problem continues).
• Drowsiness (which is more common when you start taking this medication or when the dose is increased, but this should disappear within a few days).
• Dizziness.
• Headache.
• Itching of the skin.

Common

(May affect 1 in 10 patients)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhea.
• Confusion, depression, feeling of unusual weakness, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams, abnormal thoughts.
• Wheezing (whistling when breathing) or difficulty breathing, shortness of breath.
• Difficulty urinating.
• Rash.
• Sweating, high temperature.

Uncommon

(May affect 1 in 100 patients)

• A disorder in which your breathing is slower and weaker than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, gas, situations where the intestine does not function properly (ileus), stomach inflammation, gastrointestinal disorders (e.g., stomach upset), altered taste, ulcers or sores in the mouth.
• A disorder that can cause abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Feeling of dizziness or "spinning" (vertigo), hallucinations, mood changes, 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 detachment from oneself, being exceptionally hyperactive, feeling of fainting, reduced level of consciousness, unusual muscle stiffness or apathy, involuntary muscle contractions.
• 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 in pupil size.
• Need to increase the dose to achieve the same level of pain relief (tolerance).
• Ringing or buzzing in the ears.
• Nasal congestion and irritation, nosebleeds, voice alteration.
• Chills.
• Chest pain.
• Inability to empty the bladder completely.
• Worsening of kidney function tests (seen in blood tests).
• Withdrawal symptoms (see section 3 "If you stop treatment with OxyContin").

Rare

(May affect 1 in 1,000 patients)

• Feeling of fainting, 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 of the skin, especially if it covers the entire body.
• Sleep apnea (interruptions in breathing during sleep).
• Tooth decay.
• Abdominal colic pain or discomfort.
• A problem that affects a valve in the intestine, which can cause severe abdominal pain (disfunction of the Oddi sphincter).
• Blockage of bile flow from the liver. This can cause itching of the skin, yellow skin, dark urine, and very pale stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Hostility.
• Prolonged treatment with OxyContin during pregnancy may produce withdrawal syndrome in newborns, which can be life-threatening. Symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, crying with high-pitched screams, tremors, ill appearance, diarrhea, and failure to gain weight.

You may observe remains of the tablets in your stool. This should not affect the functioning of the tablets.

Reporting of Side Effects

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

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

5. Storage of OxyContin

Keep this medication 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 others cannot access it. It can cause serious harm and be fatal to people when not prescribed to them.

Do not use this medication after the expiration date shown on the blister pack and carton, after CAD. The expiration date is the last day of the month indicated. CAD 08 2020 means you should not take the tablets after the last day of August 2020.

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

Do not take the tablets if they are broken or crushed, as this can be dangerous and cause serious problems such as an overdose.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of OxyContin

The active ingredient is oxycodone hydrochloride.

Each tablet contains 80 mg of oxycodone hydrochloride.

The other ingredients are:

Lactose monohydrate

Povidone

Amoniomethacrylate polymer

Sorbic acid

Glycerol triacetate

Stearic alcohol

Talc

Magnesium stearate

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol

In addition, the tablet coating contains hypromellose, iron oxide (E172), and carmine (E132).

Appearance of the Product and Package Contents

The tablets are marked with OC on one side and the dose (80) on the other. All tablets are round and biconvex. The 80 mg tablets are approximately 9 mm in diameter.

The tablets have a green film coating.

The tablets are packaged in blisters within boxes.

Each package contains 10, 28, 30, 56, or 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Phone: 913 821 870

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 under the name OxyContin:

Austria OxyContin retard 80 mg Filmtabletten

Ireland OxyContin 80 mg prolonged release tablets

Spain OxyContin 80 mg prolonged-release tablets

Italy OxyContin 80 mg prolonged-release tablets

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/)