Oxicontin

Leaflet accompanying 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 taking 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.
• If you have 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 packaging 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 respiratory 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's intestines do not work properly (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 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 (myxedema), hands, and feet;
• in patients with insufficient hormone secretion by the thyroid gland;
• in patients with Addison's disease;
• in patients having difficulty urinating due to an enlarged prostate;
• in patients who have a history of mental illness caused by alcohol or other substances;
• in patients who abuse or are addicted to alcohol;
• in patients with symptoms of withdrawal 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;
• while 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 a 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 commonly 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 without consulting their doctor.
Opioids are not the first-choice medicine 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 addition to opioids. The doctor should closely monitor the patient's condition and adjust the dose as needed during OxyContin treatment 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 doctor gradually reduce the dose to prevent these symptoms from occurring.
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 a decrease in their effectiveness (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 may cause the patient to feel that they have no control over the dose they take or how often they 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 previously abused or been addicted to alcohol, prescription medicines, or illegal substances (addiction);
• the patient smokes;
• the patient has previously 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 observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, 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 cause dependence, like other strong opioids used to treat pain. Special care should be taken when treating patients who currently or previously had a history of alcohol or drug abuse.
The patient should contact their doctor if they experience severe abdominal pain that may radiate 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, potentially fatal consequences.
If the patient is to undergo surgery, they should inform their doctor about taking OxyContin.
Like other opioids, oxycodone may 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 may be visible in the stool. The patient should not be concerned if the 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 inform 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 have recently taken, as well as any medicines they 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 include 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 these 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 pills (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 psychological disorders (such as antipsychotics, phenothiazine derivatives, neuroleptics),
• medicines known as 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 pain conditions),
• 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 taking 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 phase of treatment with OxyContin, 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 existing circumstances. The patient should consult their doctor about the possibility and any conditions for driving or operating machines.
The patient should not take OxyContin more frequently than at 8-hour intervals.
In case of doubt, 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, provided that the next scheduled dose is more than 8 hours away.
If the next scheduled dose is 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.
In case of doubt, the patient should consult their doctor or pharmacist.

Stopping OxyContin treatment

The patient should not stop taking OxyContin without consulting their doctor.
Stopping OxyContin treatment may cause withdrawal symptoms (such as yawning, pupil dilation, 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 doubt 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 pain-relieving medicines, 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 commonly in elderly and frail patients and is also a result of taking too high a dose of the medicine,
• Low blood pressure may cause dizziness and lead to fainting,
• Pupil constriction, bronchial muscle spasms (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
• Vomiting, nausea - especially at the beginning of therapy; the doctor may prescribe measures 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, excessive movement, nervousness, difficulty sleeping, 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
• Restlessness, mood swings, feeling of well-being, cognitive impairment (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, difficulty concentrating, migraine
• Increased muscle tone, involuntary muscle contractions, decreased sensitivity to pain and touch, coordination disorders
• Speech disorders, feeling of tingling or prickling, taste changes
• Blurred vision
• Hearing disorders, feeling of dizziness or "spinning"
• Fast heartbeat, palpitations
• Redness of the skin
• Voice changes (hoarseness), cough
• Oral ulcers, mouth inflammation
• Gas, bloating, bowel obstruction (intestinal obstruction)
• Worsening of liver function tests (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 the 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 took OxyContin during pregnancy
• A problem affecting the valve in the intestines, which can cause severe abdominal pain (Oddi's sphincter dysfunction).

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 for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 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

Keep the medicine out of the 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.
Do not use this medicine 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 required.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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 of the medicine are:
Tablet core:
Lactose monohydrate, Povidone K30, ammonio methacrylate copolymer (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., 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.