Oxicontin

Leaflet attached to the packaging: information for the user

OxyContin, 5 mg, prolonged-release tablets

OxyContin, 10 mg, prolonged-release tablets

OxyContin, 20 mg, prolonged-release tablets

OxyContin, 40 mg, prolonged-release tablets

OxyContin, 80 mg, prolonged-release tablets

Oxycodone hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, they should tell their doctor or pharmacist. This applies to any side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet:

• 1. What OxyContin is and what it is used for
• 2. Important information 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 pain-relieving medicine belonging to the opioid group.
OxyContin is used in adults and adolescents aged 12 years and older for the treatment of
severe pain that can only be adequately managed with opioid pain-relieving medicines.

2. Important information before taking OxyContin

When not to take OxyContin

• if the patient has been diagnosed with an allergy (hypersensitivity) to oxycodone hydrochloride or any of the other ingredients of OxyContin (full list see section 6);
• if the patient has severe, chronic lung disease with airway obstruction (severe, chronic obstructive pulmonary disease, also known as COPD);
• if the patient has been diagnosed with cor pulmonale (a change in the heart caused by chronic lung inflammation);
• if the patient has severe asthma;
• if the patient has serious respiratory problems, such as shallow and slow breathing (severe respiratory depression);
• if the patient has intestinal obstruction (paralytic ileus).

The patient should tell their doctor or pharmacist before taking OxyContin if they:

• have pancreatitis (which can cause severe abdominal and back pain), gallbladder problems, or bile duct problems;
• have abdominal pain or discomfort similar to colic.

Warnings and precautions

Before starting treatment with OxyContin, the patient should discuss it with their doctor or pharmacist.

When to exercise special caution when taking OxyContin

• in elderly and frail patients;
• in patients with severe lung disease;
• in patients with kidney or liver disease;
• in patients with thyroid disease characterized by dry, cold, swollen, and thickened skin of the face (so-called "moon face"), hands, and feet;
• in patients with insufficient production of thyroid hormones;
• in patients with Addison's disease;
• in patients having difficulty urinating due to prostate enlargement;
• in patients with a history of mental illness caused by alcohol or other substances;
• in patients who abuse or are addicted to alcohol;
• in patients with withdrawal symptoms related to alcohol or drugs;
• in patients who are addicted to opioids currently or in the past;
• in patients with gallbladder problems, gallstones, or bile duct problems;
• in patients with pancreatitis, which causes severe abdominal and back pain;
• in patients with obstructive or inflammatory bowel disease;
• in patients with suspected bowel obstruction;
• in patients with severe headaches or nausea, which may indicate increased intracranial pressure;
• in patients with blood pressure problems;
• in patients with epilepsy or a tendency to seizures;
• when taking MAO inhibitors used to treat depression or if the patient has taken an MAO inhibitor within the last 2 weeks (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid);
• in patients suffering from constipation.

Respiratory depression associated with sleep
OxyContin may cause respiratory depression associated with sleep, such as sleep apnea
(pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath,
difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms,
they should contact their doctor. The doctor may consider reducing the dose.
The patient should inform their doctor if the above information applies to them.
The main risk associated with opioid overdose is shallow and slow breathing (respiratory depression).
This occurs most frequently in elderly and frail patients. It can also cause a decrease in oxygen levels in the blood.
This can be life-threatening, e.g., cause fainting.
OxyContin 80 mg prolonged-release tablets
OxyContin 80 mg prolonged-release tablets must not be used by patients who have not previously taken opioids.
Such a high dose may cause shallow and slow breathing (respiratory depression) in them.
OxyContin has been formulated to release the active substance slowly from the tablets over 12 hours.
If the tablet is broken, divided, crushed, or chewed, a larger amount of the medicine will be released,
which can be life-threatening or dangerous to health.
During long-term use of OxyContin, the patient may develop tolerance to the medicine and may require
increasingly higher doses of OxyContin to maintain adequate pain control. The patient must not increase
the dose on their own without consulting their doctor.
Opioids are not the first-choice treatment for non-cancer pain and are not recommended as the only treatment.
In the treatment of chronic pain, other medicines should be used in addition to opioids. The doctor should closely
monitor the patient's condition and adjust the dose as needed while taking OxyContin to prevent addiction and abuse.
Prolonged use of OxyContin may lead to physical dependence. If treatment is stopped suddenly, withdrawal symptoms
may occur, such as yawning, abnormal dilation of the pupils, tearing, runny nose, shivering (chills), sweating,
anxiety, seizures, difficulty sleeping, and muscle pain. Therefore, it is recommended that the dose be gradually reduced
to prevent these symptoms.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It can cause dependence and
(or) addiction.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid pain-relieving medicines
can lead to decreased effectiveness of the medicine (the patient's body gets used to it, which is called tolerance).
Repeated use of OxyContin may lead to dependence, abuse, and addiction, which can be life-threatening.
The risk of these side effects may be higher when using higher doses for longer periods.
Dependence or abuse can cause the patient to feel that they have no control over the dose they take or how often they should take it.
The patient may feel that they need to continue taking the medicine, even if it no longer helps to relieve pain.
The risk of dependence on the medicine or addiction varies from person to person. The risk of dependence on OxyContin may be higher if:

• the patient or a family member has ever abused or been addicted to alcohol, prescription medicines, or illegal substances (so-called "addiction");
• the patient smokes;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental disorders.

If the patient experiences any of the following symptoms while taking OxyContin, it may indicate that they are developing tolerance to the medicine or are becoming dependent:

• The patient needs to take the medicine for longer than the doctor recommended.
• The patient must take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those recommended by the doctor, such as "to feel calm" or "to help sleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has failed.
• The patient feels unwell after stopping the medicine and feels better after taking it again ("withdrawal symptoms").

If the patient has observed any of these symptoms, they should contact their doctor to discuss the best treatment plan for them, including the right time and safe way to stop treatment (see section 3 " Stopping OxyContin").
The active substance in the medicine, oxycodone hydrochloride, can be abused and lead to dependence, like other strong opioids used to treat pain. Special caution is required when treating patients who currently or in the past have abused alcohol or medicines.
The patient should contact their doctor if they experience severe abdominal pain that radiates to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct problems.
The patient may experience increased sensitivity to pain despite taking higher doses of the medicine (hyperalgesia). Only the doctor can decide whether to change the dose or switch to a stronger pain-relieving medicine.
OxyContin should only be taken orally (by swallowing whole tablets). The tablets must not be dissolved or injected. This can have serious, life-threatening consequences.
If the patient is to undergo surgery, they should inform their doctor about taking OxyContin.
Like other opioids, oxycodone can affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if high doses are taken for a long time.
Tablet residues can be seen in the stool. The patient should not be concerned if the active substance oxycodone hydrochloride has been released during the passage of the tablet through the stomach and intestines and has already started to work in the body.
Taking OxyContin may result in positive doping control tests. Using OxyContin as a doping agent can be hazardous to health.

OxyContin and other medicines

Concomitant use of opioids (including oxycodone) and sedating medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If the doctor has prescribed OxyContin together with sedating medicines, they should limit the dose and duration of concomitant treatment.
The patient should tell their doctor about all sedating medicines they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of the above symptoms.
If any symptoms occur, the patient should contact their doctor.
The patient should tell their doctor about all medicines they are currently taking or plan to take.
Side effects caused by OxyContin may be more frequent and severe when OxyContin is used in combination with medicines that affect brain function, used to treat allergy symptoms, motion sickness, or nausea. Examples of side effects that may occur in this case are shallow and slow breathing (respiratory depression), constipation, dry mouth, or difficulty urinating.
The risk of side effects increases if the patient is taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone, causing the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, shivering, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If the above symptoms occur, the patient should contact their doctor.
The patient should tell their doctor, pharmacist, or nurse if they are taking:

• medicines that help with sleep or sedating medicines or sleeping medicines (including benzodiazepines),
• antidepressant medicines (e.g., paroxetine, amitriptyline), including medicines from the group of so-called monoamine oxidase inhibitors (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid),
• medicines for allergies, motion sickness, or nausea (antihistamines, antiemetics),
• medicines used to treat mental or psychiatric disorders (such as antipsychotics, phenothiazine derivatives, neuroleptics),
• muscle relaxants used to relieve muscle spasms (such as tizanidine),
• medicines used to treat Parkinson's disease,
• other strong pain-relieving medicines,
• cimetidine (a medicine used to treat stomach ulcers, indigestion, and heartburn),
• medicines used to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole),
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin),
• specific groups of medicines known as protease inhibitors used to treat HIV infections (including boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
• rifampicin used to treat tuberculosis,
• carbamazepine (a medicine used to treat seizures, epilepsy, and some types of pain),
• phenytoin (a medicine used to treat seizures or epilepsy),
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum),
• quinidine (a medicine used to treat irregular heartbeat),
• medicines known as coumarins, which prevent blood clotting or help with blood clotting (such as phenprocoumon).

OxyContin and alcohol

Drinking alcohol while taking OxyContin may increase the risk of serious oxycodone side effects, such as drowsiness and increased risk of side effects such as shallow breathing, with the risk of complete breathing stop and loss of consciousness. The patient should not drink alcohol while taking OxyContin.
The patient should avoid drinking grapefruit juice while taking OxyContin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
OxyContin should not be used during pregnancy.
There is limited data on the use of oxycodone hydrochloride in pregnant women.
Long-term use of OxyContin during pregnancy may cause withdrawal symptoms in newborns. The use of oxycodone hydrochloride during delivery may cause shallow breathing and slow breathing (respiratory depression) in the newborn.
Breastfeeding
OxyContin should not be used during breastfeeding, as oxycodone may pass into breast milk and may cause sedation and shallow breathing (respiratory depression) in the breastfed child.

Driving and using machines

Taking OxyContin may impair the patient's ability to drive and use machines. This is especially true during the initial treatment phase, when the dose is increased, or when OxyContin is taken in combination with medicines that affect brain function.
A general ban on driving does not necessarily apply to patients during stabilized treatment. The decision in each individual case is made by the doctor, taking into account the circumstances. The patient should consult their doctor about the possibility and any conditions for driving or operating machines.
OxyContin should not be taken more frequently than every 8 hours.
In case of doubts, the patient should consult their doctor or pharmacist.
The patient should never take a double dose to make up for a missed dose.

Missed dose of OxyContin

If the patient misses a dose, they should take it as soon as possible, unless the next scheduled dose is due in less than 8 hours.
In this case, the patient should take the missed dose and delay the next dose by 8 hours.
Then, the patient should continue taking the medicine according to the usual dosage schedule.
In case of doubts, the patient should consult their doctor or pharmacist.

Stopping OxyContin

The patient should not stop taking OxyContin without consulting their doctor.
Stopping OxyContin may cause withdrawal symptoms (such as yawning, dilation of the pupils, tearing, runny nose, shivering, sweating, anxiety, seizures, difficulty sleeping, and muscle pain). Therefore, it is recommended that the doctor gradually reduce the dose.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

3. How to take OxyContin

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist again.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from OxyContin, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping OxyContin").

Dosage

The doctor will determine how much OxyContin the patient should take and decide how to divide the total daily dose. The dose should be adjusted according to the intensity of the pain and the patient's sensitivity. Under no circumstances should the dose be changed without consulting the doctor.
The patient should be given the smallest dose necessary to relieve the pain.
If the patient has previously been treated with opioids, the doctor may start treatment with higher doses.
Gradual dose increase may be necessary if pain relief is insufficient or if the pain intensity increases.
The patient should contact their doctor if they experience breakthrough pain (pain that occurs despite adequate treatment of chronic pain). The doctor may prescribe additional pain-relieving medicines to relieve breakthrough pain (a pain-relieving medicine with immediate release) or adjust the dose of OxyContin prolonged-release tablets.
OxyContin prolonged-release tablets are not intended for the treatment of breakthrough pain.

Adults and adolescents (12 years and older)

OxyContin is available in strengths of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg.
The usual starting dose is 10 mg of oxycodone hydrochloride every 12 hours.
In some cases, the doctor may prescribe a starting dose of 5 mg to reduce side effects that may occur. The doctor will prescribe the dose required to treat the pain.
If the patient still experiences pain while taking these tablets, they should discuss this with their doctor.
For the treatment of non-cancer pain, a daily dose of 40 mg of oxycodone hydrochloride is usually sufficient (4 tablets of 10 mg OxyContin prolonged-release tablets or 2 tablets of 20 mg OxyContin prolonged-release tablets, divided into two single doses); however, higher doses may be necessary. Patients with cancer pain usually require doses ranging from 80 to 120 mg of oxycodone hydrochloride; in exceptional cases, this dose can be increased up to a maximum of 400 mg.

Children under 12 years

The safety and efficacy of OxyContin have not been sufficiently studied in children under 12 years. Therefore, it is not recommended to treat children under 12 years with OxyContin.

Elderly patients

In elderly patients without liver or kidney function disorders, dose adjustment is usually not necessary.

Patients with liver or kidney function disorders

Patients with liver and/or kidney function disorders who have not previously received opioids should initially take half the recommended starting dose for adults.

Other patients at increased risk

Patients with low body weight and those who metabolize medicines more slowly should initially take half the recommended starting dose for adults.

Method of administration

For oral use
The prolonged-release tablets should be swallowed wholewith enough liquid (half a glass of water) in the morning and evening, always at the same times (e.g., 8:00 a.m. and 8:00 p.m.). OxyContin can be taken with or without food.

• OxyContin can be taken with or without food.

The prolonged-release tablets should be swallowed whole to avoid damaging the system responsible for the prolonged release of the active substance. The prolonged-release tablets should be swallowed whole and not broken, divided, chewed, or crushed.

Duration of treatment

The duration of treatment with OxyContin is determined by the doctor.
The patient should not stop taking OxyContin without consulting their doctor (see:
Stopping OxyContin).
When taking OxyContin for a longer period, the patient should be closely monitored for any reactions and discuss them with their doctor. This is necessary to ensure the best possible pain-relieving therapy, to quickly treat any side effects that may occur, and to determine whether to change the dose or continue treatment.
The patient should contact their doctor or pharmacist if they think the effect of OxyContin is too strong or too weak.

Taking a higher dose of OxyContin than recommended or accidental ingestion

In case of ingestion of a higher number of prolonged-release tablets than recommended, or if someone else has accidentally taken OxyContin, the patient should immediately inform their doctor.
Overdose may result in the following symptoms:

• constricted pupils,
• shallow and slow breathing (respiratory depression),
• drowsiness, progressing to unconsciousness,
• decreased muscle tone,
• slow heart rate,
• low blood pressure,
• brain disorders (toxic leukoencephalopathy).

Loss of consciousness (coma), fluid accumulation in the lungs, and cardiac arrest may occur in severe cases and can be fatal.
The patient should absolutely avoid situations that require a high level of concentration, such as driving a car.

Missed dose of OxyContin

Taking a lower dose of OxyContin than recommended or missing a dose may result in inadequate pain relief.
In case of a single missed dose, the patient can take it later if the next scheduled dose is due in more than 8 hours.
If the next scheduled dose is due sooner, the patient should take the missed dose and delay the next dose by 8 hours.
Then, the patient should continue taking the medicine according to the usual dosage schedule.
As a rule, OxyContin should not be taken more frequently than every 8 hours.
In case of doubts, the patient should consult their doctor or pharmacist.
The patient should never take a double dose to make up for a missed dose.

Stopping OxyContin

The patient should not stop taking OxyContin without consulting their doctor.
Stopping OxyContin may cause withdrawal symptoms (such as yawning, dilation of the pupils, tearing, runny nose, shivering, sweating, anxiety, seizures, difficulty sleeping, and muscle pain). Therefore, it is recommended that the doctor gradually reduce the dose.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, OxyContin can cause side effects, although not everybody gets them.
As with other strong opioid analgesics, there is a risk of physical or psychological dependence on the medicine.

Important side effects or symptoms to know about and actions to take if they occur:

If the patient experiences any of the important side effects, they should immediately contact the nearest available doctor.

• Sudden breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially those affecting the whole body - are symptoms of allergic reactions,
• Shallow and slow breathing occurs most frequently in elderly and frail patients and is also a result of taking too high a dose of the medicine,
• Low blood pressure - can cause dizziness and lead to fainting,
• Constricted pupils, muscle spasms in the airways (causing shortness of breath), and inhibition of the cough reflex.

Other possible side effects

Very common (affects more than 1 in 10 people):

• Constipation - can be prevented by a diet rich in fiber and drinking plenty of fluids
• Nausea, vomiting - especially at the beginning of therapy; the doctor may prescribe medicines to prevent such symptoms
• Drowsiness more than usual (up to excessive sedation), dizziness, headache

Common (affects 1 in 10 people):

• Abdominal pain, diarrhea, dry mouth, hiccups, indigestion
• Decreased appetite to complete loss of appetite
• Anxiety, confusion, depression), decreased activity, restlessness, agitation, insomnia, abnormal thinking
• Tremors (seizures), lethargy
• Skin reactions and/or rash, sweating
• Painful urination, increased urge to urinate
• Feeling of weakness, fatigue

Uncommon (affects 1 in 100 people):

• Withdrawal symptoms, feeling that there is a need to take increasingly higher doses of OxyContin to achieve the same level of pain control (tolerance)
• Injuries due to accidents
• Allergic reactions
• Dehydration
• Agitation, mood swings, feeling of well-being, cognitive disorders (e.g., hallucinations, changed perception, unreality, detachment from the world)
• Decreased sex drive
• Seizures (especially in people with a history of seizures or a tendency to seizures)
• Memory loss, concentration disorders, migraine
• Increased muscle tone, involuntary muscle contractions, decreased sensitivity to pain and touch, coordination disorders
• Speech disorders, feeling of tingling or numbness, taste changes
• Blurred vision
• Hearing disorders, feeling of dizziness or "spinning"
• Fast heartbeat, palpitations
• Redness of the skin
• Voice changes (hoarseness), cough
• Mouth ulcers, mouth inflammation
• Gas, belching, bowel obstruction (intestinal obstruction)
• Worsening of liver function test results (visible in blood test results)
• Dry skin
• Inability to fully empty the bladder
• Impotence, decreased sex hormone levels
• Chills
• Pain (e.g., in the chest), feeling of general discomfort
• Swelling of the hands, ankles, and feet, thirst

Rare (affects 1 in 1,000 people):

• Feeling of weakness, especially when standing up
• Dark, tar-like stools, changes in teeth, gum bleeding
• Infections such as ulcers or herpes (which can cause blisters around the mouth or genital areas)
• Increased appetite
• Itchy rash (hives)
• Weight gain, weight loss

Unknown (frequency cannot be estimated from available data):

• Aggressive behavior
• Increased sensitivity to pain
• Sleep apnea (pauses in breathing during sleep)
• Tooth decay
• Abdominal pain due to colic, bile duct problems
• Amenorrhea
• Neonatal withdrawal syndrome in newborns whose mothers used OxyContin during pregnancy
• A problem affecting the bowel valve, which can cause severe abdominal pain (dysfunction of the Oddi sphincter).

Reporting side effects
If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store OxyContin

The medicine should be kept out of sight and reach of children. This medicine should be stored in a closed and secure location, to which other people do not have access. It can be very harmful and may cause death if taken by someone it was not prescribed for.
The medicine should not be used after the expiry date stated on the blister pack and carton after the words "EXP". The expiry date refers to the last day of the month stated.
OxyContin 5 mg prolonged-release tablets
Do not store above 30°C.
OxyContin 10 mg prolonged-release tablets
OxyContin 20 mg prolonged-release tablets
OxyContin 40 mg prolonged-release tablets
OxyContin 80 mg prolonged-release tablets
No special storage precautions are necessary.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What OxyContin contains

OxyContin 5 mg prolonged-release tablets
The active substance is oxycodone hydrochloride. One prolonged-release tablet contains 5 mg of oxycodone hydrochloride, which corresponds to 4.5 mg of oxycodone.
OxyContin 10 mg prolonged-release tablets
The active substance is oxycodone hydrochloride. One prolonged-release tablet contains 10 mg of oxycodone hydrochloride, which corresponds to 9 mg of oxycodone.
OxyContin 20 mg prolonged-release tablets
The active substance is oxycodone hydrochloride. One prolonged-release tablet contains 20 mg of oxycodone hydrochloride, which corresponds to 17.9 mg of oxycodone.
OxyContin 40 mg prolonged-release tablets
The active substance is oxycodone hydrochloride. One prolonged-release tablet contains 40 mg of oxycodone hydrochloride, which corresponds to 35.9 mg of oxycodone.
OxyContin 80 mg prolonged-release tablets
The active substance is oxycodone hydrochloride. One prolonged-release tablet contains 80 mg of oxycodone hydrochloride, which corresponds to 71.7 mg of oxycodone.
Other ingredients are:
Core:
Lactose monohydrate, Povidone K30, ammonio methacrylate copolymer (type B) (Eudragit RS30D),
triacetin, stearyl alcohol, talc, magnesium stearate
OxyContin 5 mg prolonged-release tablets
Coating:
Hypromellose (E464), macrogol 400, titanium dioxide (E171), brilliant blue (E 133).
OxyContin 10 mg prolonged-release tablets
Coating:
Hypromellose (E464), hydroxypropylcellulose, macrogol 400, titanium dioxide (E171).
OxyContin 20 mg prolonged-release tablets
Coating:
Hypromellose (E464), macrogol 400, polysorbate 80, titanium dioxide (E171), iron oxide red (E172).
OxyContin 40 mg prolonged-release tablets
Coating:
Hypromellose (E464), macrogol 400, polysorbate 80, titanium dioxide (E171), iron oxide yellow (E172).
OxyContin 80 mg prolonged-release tablets
Coating:
Hypromellose (E464), hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), indigo carmine (E132).

What OxyContin looks like and contents of the pack

OxyContin5 mg prolonged-release tablets

What OxyContin 5 mg looks like and contents of the pack

OxyContin 5 mg prolonged-release tablets are round, without a dividing line, light blue, approximately 7 mm in diameter, convex prolonged-release tablets, with the inscription "OC" and "5".
OxyContin5 mg is available in packs of 30 and 60 prolonged-release tablets.
OxyContin10 mg prolonged-release tablets

What OxyContin 10 mg looks like and contents of the pack

OxyContin 10 mg prolonged-release tablets are round, without a dividing line, white, approximately 7 mm in diameter, convex prolonged-release tablets, with the inscription "OC" and "10".
OxyContin10 mg is available in packs of 30 and 60 prolonged-release tablets.
OxyContin20 mg prolonged-release tablets

What OxyContin 20 mg looks like and contents of the pack

OxyContin 20 mg prolonged-release tablets are round, without a dividing line, pink, approximately 7 mm in diameter, convex prolonged-release tablets, with the inscription "OC" and "20".
OxyContin20 mg is available in packs of 30 and 60 prolonged-release tablets.
OxyContin40 mg prolonged-release tablets

What OxyContin 40 mg looks like and contents of the pack

OxyContin 40 mg prolonged-release tablets are round, without a dividing line, yellow, approximately 7 mm in diameter, convex prolonged-release tablets, with the inscription "OC" and "40".
OxyContin40 mg is available in packs of 30 and 60 prolonged-release tablets.
OxyContin80 mg prolonged-release tablets

What OxyContin looks like and contents of the pack

OxyContin80 mg prolonged-release tablets are round, without a dividing line, green, approximately 9 mm in diameter, convex prolonged-release tablets, with the inscription "OC" and "80".
OxyContin80 mg is available in packs of 30 and 60 prolonged-release tablets.

Marketing authorization holder

Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Manufacturer

Fidelio Healthcare Limburg GmbH
Mundipharma Strasse 2
65549 Limburg, Germany
Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden, Netherlands
Synergy Health Utrecht B.V.
Reactorweg 47 A
Utrecht 3542AD, Netherlands
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder: Mundipharma Polska Sp. z o.o., ul. Międzyborska 11B, lok.104, 04-041 Warsaw, tel. +48 22 3824850.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Oxycodon-HCl Krugmann
Poland OxyContin
Croatia OxyContin 10/20/40/80 mg
Date of last revision of the leaflet 02/2025.