Label: Information for the User

OxyContin 40 mg Extended-Release Tablets

Oxycodone Hydrochloride

Read this entire label carefully before taking this medication, as it contains important information for you.

- Keep this label, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is OxyContin and how is it used

2. What you need to know before starting OxyContin

3. How to take OxyContin

4. Possible adverse effects

5. Storage of OxyContin

6. Contents of the package and additional information

OxyContin is a strong pain reliever or "pain reliever" and belongs to the group of opioids.

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

Do not take OxyContin if:

• you are allergic (hypersensitive) to oxycodone or to any of the other components of the tablets (listed in section 6) or have had an allergic reaction to taking other strong painkillers (such as morphine or other opioids);

• you have breathing problems, such as chronic obstructive pulmonary disease, severe asthma or severe respiratory depression. Symptoms may include difficulty breathing, coughing or slower and weaker breathing than expected;

• you have a head injury that causes intense headache 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 it should (delayed gastric emptying) or you have intense sudden abdominal pain (acute abdomen);

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

Warnings and precautions

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

• you are elderly or debilitated;

• you have low thyroid activity (hypothyroidism);

• you have intense headache or dizziness, as this may indicate that the pressure in your skull is increased;

• you have myxedema (a thyroid disorder, with dryness, coldness and inflammation (swelling) of the skin, affecting the face and limbs);

• you have low blood pressure (hypotension);

•if you or a member of your family has a history of alcohol, prescription medication or illicit substance abuse (“addiction”);

•if you smoke;

•if you have ever had problems with your mood (depression, anxiety or personality disorder) or have received treatment from a psychiatrist for other mental health conditions;

• you have inflammation of the pancreas (which may cause intense abdominal and back pain) or problems with your gallbladder or bile duct;

• you have intestinal obstruction or inflammatory bowel disease;

• you have abdominal colic or discomfort;

• you have an enlarged prostate gland, which causes difficulty urinating (in men);

• you have poor adrenal function (your adrenal gland does not work correctly), for example Addison's disease;

• you have breathing problems such as severely impaired respiratory function, chronic obstructive pulmonary disease, severe lung injury or reduced lung 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 stopping alcohol or drugs;

• you experience dizziness or fainting;

• 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 medication known as monoamine oxidase inhibitors (such as tranilcipromina, fenelzina, isocarboxazida, moclobemida and linezolid), or have taken this type of medication in the last two weeks;

• you have constipation.

Respiratory disorders related to sleep

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

If you are to undergo surgery, tell your hospital doctor that you are taking these tablets.

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

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

Opioids are not the first line of treatment for non-cancer pain and are not recommended as the sole treatment. In the treatment of chronic pain, other medications should be used in conjunction with opioids. Your doctor should closely monitor you and make necessary adjustments to your dose while taking OxyContin to prevent addiction and abuse.

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

Tolerance, dependence and addiction

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

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

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

- if you or a member of your family has a history of alcohol, prescription medication or illicit substance abuse (“addiction”).

- if you smoke.

- if you have ever had problems with your mood (depression, anxiety or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking OxyContin, it may be a sign that you have become dependent or addicted.

– You need to take the medication for longer than recommended by your doctor.

– You need to take more doses than recommended.

– You are using the medication for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep”.

– You have made repeated and unsuccessful attempts to stop or control the use of the medication.

– You do not feel well when you stop taking the medication and feel better once you take the medication again (“withdrawal symptoms”).

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

Contact your doctor if you have intense upper abdominal pain that may extend to your back, nausea, vomiting or fever, as these may be symptoms associated with pancreatitis (inflammation of the pancreas) and biliary tract disease.

Taking OxyContin with other medications

The concomitant use of opioids, including oxycodone, and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (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 OxyContin with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Inform your doctor or pharmacist if you are using, have recently used or may need to use any other medication.

If you take these tablets with some medications, the effect or that of the other medications may be modified.

The risk of side effects increases if you use antidepressants (such as citalopram, duloxetina, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, venlafaxina). These medications may interact with oxycodone and you may experience symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension and body temperature above 38 °C. Contact your doctor if you experience these symptoms.

Inform your doctor or pharmacist if you are taking:

• monoamine oxidase inhibitors or have taken them in the last two weeks (see section “Warnings and precautions”);

• sleep aids or sedatives (such as hypnotics or sedatives, including benzodiazepines);

• medications to treat depression (such as paroxetina or fluoxetina);

• medications to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);

• medications to treat epilepsy, pain and anxiety, such as gabapentina and pregabalina;

• other strong painkillers;

• muscle relaxants;

• medications to treat high blood pressure;

• quinidina (a medication for rapid heart rhythm);

• cimetidina (a medication for stomach ulcers, indigestion or heartburn);

• medications to treat fungal infections (such as ketoconazol, voriconazol, itraconazol or posaconazol);

• medications used to treat bacterial infections (such as claritromicina, eritromicina, or telitromicina);

• a specific type of medication known as protease inhibitors to treat HIV (such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);

• rifampicina to treat tuberculosis;

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

• phenitoína (a medication to treat muscle spasms, seizures);

• a medicinal herb called “St. John's Wort” (also known as Hypericum perforatum);

• antihistamines;

• medications to treat Parkinson's disease.

You should also inform your doctor if you have recently received an anesthetic.

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 severe adverse reactions 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, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use these tablets during pregnancy and childbirth, unless your doctor specifically indicates that you should. Depending on the dose and duration of oxycodone treatment, 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 operating machinery

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

OxyContin contains lactose

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for these tablets as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. The labeling of your medication will tell you how to take the tablets and how often.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of oxicodone, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also “If you interrupt treatment with OxyContin”).

There are different doses available for this medication. Your doctor will decide which dose ofOxyContin prolonged-release tablets,is most suitable for you.

Do not exceed the recommended dose prescribed 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 am, you should take the next one at 8 pm. It is recommended to take this medication consistently in relation to meal times.

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

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 necessary dose 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 oxicodone have not been sufficiently proven in children under 12 years of age. Therefore, treatment with oxicodone is not recommended in children under 12 years of age.

Patients with 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 according to your situation.

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

Inform your doctor immediately or go to the 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

• decreased muscle tone (hypotonia)

• decreased pulse

• decreased 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 available to show to your doctor.

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, Teléfono 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 is more than 4 hours, consult your doctor or pharmacist. Do not take a double dose to compensate for the missed doses.

If you interrupt 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 and thus you will not experience unpleasant effects. If you stop taking these tablets suddenly, you may experience withdrawal symptoms such as yawning, abnormal pupil dilation, lacrimation, nasal secretion, agitation, anxiety, convulsions, difficulty sleeping, palpitations, tremors, or sweating.

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

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

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

The most 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).

• Dizziness, vomiting (these symptoms usually disappear in a few days, however, your doctor may prescribe medication to prevent nausea if the problem persists).

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

• Dizziness.

• Headache.

• Itching on the skin.

Common

(May affect 1 in 10 patients)

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

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

• Wheezing (popping sounds while breathing) or difficulty breathing, shortness of breath.

• Difficulty urinating.

• Rash.

• Sweating, high temperature.

Uncommon

(May affect 1 in 100 patients)

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

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

• A condition that may cause an abnormal production of the 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 discomfort, memory loss, difficulty speaking, decreased sensitivity to pain or touch, tingling or numbness, seizures, convulsions, abnormal gait, feeling of detachment from oneself, being exceptionally hyperactive, feeling of fainting, reduction of consciousness level, unusual muscle stiffness or lethargy, involuntary muscle contractions.

• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, seen in blood tests).

• Skin redness.

• Dehydration, weight change, thirst, swelling of the hands, ankles, or feet.

• Dry skin.

• Disorders in tear production, blurred vision, reduction of pupil size.

• Need to increase the dose to achieve the same level of pain relief (tolerance).

• Ringing or buzzing in the ears.

• Swelling and irritation inside the nose, nasal bleeding, voice alteration.

• Chills.

• Chest pain.

• Inability to completely empty the bladder.

• Worsening of kidney function tests (seen in blood tests).

• Symptoms of withdrawal (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.

• Urticaria.

Unknown

(Cannot be estimated from available data)

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

• Sleep apnea (interruptions of breathing during sleep).

• Tooth decay.

• Abdominal colic pain or discomfort.

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

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

• Absence of menstrual periods.

• Increased sensitivity to pain.

• Hostility.

• Prolonged treatment of OxyContin during pregnancy may cause withdrawal syndrome in newborns with a risk to their life. Symptoms seen in babies included irritability, hyperactivity, and abnormal sleep pattern, loud crying, tremors, appearance of being unwell, diarrhea, and failure to gain weight.

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

Reporting of side effects

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

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children. Accidental overdose in a child is dangerous and can be fatal.Store this medication in a safe and closed location where other people cannot access it. It can cause serious harm and be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date that appears on the blister and carton, after CAD. The expiration date is the last day of the month indicated. CAD 08 2020 means do 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 it may be hazardous and can cause serious problems such as an overdose.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

OxyContin Composition

The active ingredient is oxycodone hydrochloride.

Each tablet contains 40 mg of oxycodone hydrochloride.

The other components are:

Lactose monohydrate

Povidone

Acrylamide polymer

Sorbic acid

Glycerol triacetate

Stearic alcohol

Talc

Magnesium stearate

Hydroxypropyl methylcellulose (E464)

Titanium dioxide (E171)

Macrogol

Additionally, the coating of the tablets contains polysorbate 80 (E433) and yellow iron oxide (E172).

Product Appearance and Packaging Contents

The tablets are marked with OC on one side and the dose (40) on the other. All tablets are round and biconvex. The 40 mg tablets are approximately 7 mm in diameter.

The tablets have a yellow coating.

The tablets are packaged in blisters within boxes.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Phone: 913 821 870

Responsible 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:

AustriaOxyContin retard 40 mg Filmtabletten

Republic of IrelandOxyContin 40 mg prolonged release tablets

SpainOxyContin 40 mg prolonged release tablets

ItalyOxyContin 40 mg compresse a rilascio prolungato

Last review date of this leaflet: March 2025.

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