OxyContin 5 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

OxyContin 5 mg prolonged-release tablets

Oxycodone hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What OxyContin is and what it is used for

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

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

2. What you need to know before taking OxyContin

Do not take OxyContin if:

• you are allergic (hypersensitive) to oxycodone or to any of the other ingredients of the tablets (listed in section 6), or have previously had an allergic reaction when taking other strong painkillers (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, cough, or slower and weaker breathing than expected;
• you have a head injury causing severe headache or dizziness. This is because the tablets may worsen these symptoms or mask the extent of the injury;
• you have a condition in which the small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have sudden severe abdominal pain (acute abdomen);
• you have heart problems resulting from long-standing lung disease (cor pulmonale).

Warnings and precautions

Talk to your doctor or pharmacist before starting OxyContin if:

• you are elderly or debilitated;
• you have reduced activity of the thyroid gland (hypothyroidism);
• you have severe headache or dizziness, as these may indicate increased pressure in your skull;
• you have myxedema (a thyroid disorder causing dryness, coldness, and swelling (edema) of the skin, affecting the face and limbs);
• you have low blood pressure (hypotension);
• you or a family member has a history of alcohol, prescription medication, 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 have inflammation of the pancreas (which may cause severe abdominal and back pain) or problems with your gallbladder or bile duct;
• you have intestinal obstruction or an inflammatory bowel disorder;
• you have abdominal colic or discomfort;
• you have an enlarged prostate gland causing difficulty passing urine (in men);
• you have poor adrenal gland function (your adrenal glands do not work properly), for example Addison’s disease;
• you have breathing problems such as severely impaired respiratory function, chronic obstructive airway disease, severe lung injury, or reduced respiratory capacity. Symptoms may include difficulty breathing and cough;
• you have liver or kidney problems;
• you experience withdrawal symptoms such as restlessness, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs;
• you suffer from spasms, attacks, or seizures;
• you feel lightheaded or faint;
• 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 monoamine oxidase inhibitors (for example, tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken such medicines within the last two weeks;
• you suffer from constipation.

Sleep-related breathing disorders

OxyContin may cause sleep-related breathing disorders 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, 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, tell your hospital doctor that you are taking these tablets.

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

The tablets must never be crushed or injected, as this may cause serious side effects, which 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 should monitor you closely and make necessary dose adjustments while you are taking OxyContin to prevent addiction and abuse.

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

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid, and may cause dependence and/or 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 OxyContin 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 OxyContin:

• if you or a family member have a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“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 illnesses.

If you notice any of the following signs while taking OxyContin, it could indicate 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 the 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 OxyContin).

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.

Taking OxyContin 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 life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform friends or family members about the signs and symptoms listed 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 medicine.

Taking these tablets with certain medicines may alter their effect or the effect of other medicines.

The risk of side effects increases if antidepressants are used (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 or have taken them within the last two weeks (see section “Warnings and precautions”);
• medicines that help you sleep or stay calm (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 neuroleptic medicines);
• 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 medicines known as protease inhibitors to treat HIV (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin to treat tuberculosis;
• carbamazepine (a medicine to treat spasms, seizures, or convulsions and certain pain conditions);
• phenytoin (a medicine to treat 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 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 adverse reactions such as shallow breathing with risk of respiratory arrest 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

OxyContin contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take OxyContin

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

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 taking OxyContin").

Different strengths of this medicine are available. Your doctor will decide which strength of OxyContin prolonged-release tablets is most suitable for you.

Do not exceed the 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 a.m., you should take the next one at 8 p.m. It is recommended to take this medicine consistently with regard to mealtimes.

The tablets must not be crushed or injected, as this may cause very serious adverse effects. These tablets are intended for oral use only.

OxyContin tablets are designed to work properly over 12 hours when swallowed whole. If the tablet is broken, crushed, dissolved, or chewed, the full 12-hour dose may be rapidly absorbed by your body. This can be dangerous and may lead to serious problems such as overdose, which can be fatal.

Adults and adolescents (12 years of age and older)

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

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 kidney and/or liver problems

Please inform your doctor if you have kidney or liver problems, so that he or she may prescribe an alternative medicine or adjust your dose according to your condition.

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

Contact your doctor immediately or go to the hospital.

An overdose may cause:

• constricted (small) 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 some cases, an overdose may lead to unconsciousness or even death. When seeking medical help, make sure to bring this leaflet and any tablets you have with you to show your doctor.

If you have taken too many tablets, under no circumstances should you engage in any activity requiring alertness, such as driving a car.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 one tablet immediately. Then take your next tablet at the usual time. If the delay is more than 4 hours, consult your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

If you stop taking OxyContin

Do not stop taking these tablets 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 your daily dose to avoid unpleasant withdrawal symptoms. If you stop taking these tablets suddenly, withdrawal symptoms such as yawning, abnormally dilated pupils, tearing, runny nose, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremors, or sweating may occur.

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

4. Possible adverse effects

Like all medicines, these tablets may have adverse effects, although not everyone experiences them.

This medicine may cause allergic reactions, although severe allergic reactions are reported only rarely. Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, 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 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, nausea, vomiting (these symptoms usually disappear within a few days; however, your doctor may prescribe medication to prevent nausea if the problem persists).
• Drowsiness (more common when starting this medicine or when the dose is increased, but this should resolve 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, tremors, lack of energy, fatigue, anxiety, restlessness, difficulty sleeping, abnormal dreams, abnormal thoughts.
• Wheezing (whistling breath sounds) or difficulty breathing, shortness of breath.
• Difficulty urinating.
• Rash.
• Sweating, high temperature.

Uncommon

(May affect up to 1 in 100 patients)

• A condition in which breathing is slower and weaker than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, flatulence, conditions in which the intestine does not function properly (ileus), stomach inflammation, gastrointestinal disorders (e.g. stomach discomfort), altered taste, mouth ulcers or sores.
• A disorder that may cause abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Dizziness or spinning sensation (vertigo), hallucinations, mood changes, 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 of detachment from oneself, unusually hyperactive behaviour, feeling faint, reduced level of consciousness, unusual muscle stiffness or lethargy, 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 change, thirst, swelling of the hands, ankles or feet.
• Dry skin.
• Disorders in 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 (tinnitus).
• Nasal congestion and irritation, nosebleeds, voice changes.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening of kidney function tests (observed in blood tests).
• Withdrawal symptoms (see section 3 “If you stop taking OxyContin”).

Rare

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

• Feeling faint, especially when standing.
• Low blood pressure.
• Urticaria (hives).

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.
• Sleep apnoea (interruptions in breathing during sleep).
• Dental caries.
• Abdominal colic or discomfort.
• A problem affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).
• Blockage of bile flow 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.
• Hostility.
• Prolonged use of OxyContin 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, appearance of illness, diarrhoea and failure to gain weight.

You may notice remnants of the tablets in your stools. This should not affect the effectiveness of the tablets.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 OxyContin

Keep this medicine out of the sight and reach of children. Accidental overdose in a child is dangerous and can be fatal. Store this medicine in a secure, locked place where others cannot access it. It can cause serious harm and may be fatal to people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the blister and carton, after EXP. The expiry date refers to the last day of the month indicated. EXP 08 2020 means you should not take the tablets after the last day of August 2020.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OxyContin

The active substance is oxycodone hydrochloride.

Each tablet contains 5 mg of oxycodone hydrochloride.

The other components are:

Monohydrate lactose

Povidone

Ammomethacrylate copolymer

Sorbic acid

Glyceryl triacetate

Stearyl alcohol

Talc

Magnesium stearate

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol

In addition, the tablet coating contains Brilliant Blue (E133).

Appearance of the product and contents of the pack

The tablets are marked with "OC" on one side and the dose (5) on the other. All tablets are round and biconvex. The 5 mg tablets are approximately 7 mm in diameter.

The tablets have a light blue film coating.

The tablets are packed in blisters within the cartons.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Telephone: 913 821 870

Manufacturer

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the name OxyContin:

Austria OxyContin retard 5 mg Filmtabletten

Republic of Ireland OxyContin 5 mg prolonged release tablets

Spain OxyContin 5 mg prolonged release tablets

Italy OxyContin 5 mg compresse a rilascio prolungato

Date of the most recent review of this leaflet: March 2025.

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