5 mg, 10 mg, 20 mg, 40 mg, 80 mg prolonged-release tablet is
What OxyContin is and what it is used for
OxyContin contains oxycodone hydrochloride which belongs to a group of medicines called opioids and has a strong analgesic effect.
OxyContin prolonged-release tablets are used for long-term severe pain such as cancer pain.
Oxycodone hydrochloride contained in OxyContin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking OxyContin
Do not take OxyContin:
- if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you have severely impaired breathing ( respiratory depression ) with too little oxygen in the blood ( hypoxia ) and/or too much carbon dioxide ( hypercapnia ) in the blood
- if you have severe chronic lung disease (COPD = chronic obstructive pulmonary disease ), heart disease due to chronic congestion of the pulmonary circulation (cor pulmonale), or acute, severe tracheal asthma
- if you have a certain type of intestinal obstruction (paralytic ileus )
Warnings and cautions
Talk to your doctor or pharmacist before taking OxyContin if you:
- is older
- has impaired lung function
- has impaired renal function
- has impaired liver function
- have repeated pauses in breathing while sleeping ( sleep apnea ), as this condition may worsen
- has impaired thyroid function ( hypothyroidism )
- has impaired adrenal function (eg Addison’s disease )
- have prostate enlargement ( prostate hypertrophy )
- is or has previously been addicted to alcohol
- is or has previously been addicted to strong painkillers ( opioids )
- suffers from mental illness due to an overdose of another drug (toxic psychosis )
- have pancreatitis ( pancreatitis )
- has a head injury or increased pressure in the brain
- have low blood pressure ( hypotension )
- have diseases of the bile duct
- have inflammatory bowel disease
- have or usually have constipation
- have hypovolemia (decreased blood volume)
- taking drugs that affect brain function, see section 2 “Other drugs and OxyContin”
- take, or have recently (within 2 weeks) taken, MAO inhibitors (for the treatment of depression).
If you are going to have an operation, tell your doctor that you are taking OxyContin.
When OxyContin is used for a long time, tolerance to the effects may mean that an increased dose is required to maintain pain control.
Prolonged use of OxyContin may lead to physical dependence and withdrawal symptoms may occur with abrupt discontinuation of treatment. When a patient no longer needs oxycodone treatment, it is advisable to reduce the dose gradually to prevent withdrawal symptoms (see section 3 “If you stop taking OxyContin”).
The risk of developing physical or psychological dependence is small when used as directed by patients suffering from long-term pain and this risk must be weighed against the potential benefit.
Discuss this with your doctor.
Opioids are not the first-line treatment for long-term pain that is not caused by cancer and are not recommended as the only treatment. If you are taking this medicine for this type of pain, your doctor will monitor you closely and make the necessary dose adjustments to prevent addiction and abuse.
An increased sensitivity to pain, which does not respond to a dose increase of oxycodone, may occur during treatment with OxyContin. This is unusual, but if it does, your doctor may reduce your dose or switch to another opioid.
OxyContin can cause sleep-related respiratory disorders such as sleep apnea (repeated pauses in breathing while sleeping) and hypoxemia (low oxygen content in the blood). Symptoms of this can be shortness of breath during sleep, waking up short of breath, difficulty sleeping, or excessive fatigue during the day. If you or anyone else observes these symptoms, consult a doctor. Your doctor may reduce your dose one.
The tablets should not be used with alcohol. Alcohol can increase the risk of serious side effects such as drowsiness/drowsiness, impaired and slow breathing, unconsciousness, coma and can even be life-threatening.
Children and young people
OxyContin should not be used in children and adolescents below 18 years of age due to a lack of experience in the treatment of these patient categories.
Other medicines and OxyContin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The risk of side effects increases if you take OxyContin at the same time as medicines that affect brain function. In such cases, the side effects may be exacerbated. For example, fatigue/drowsiness, impaired and slow breathing may worsen and may lead to unconsciousness, coma, and may even be life-threatening.
Examples of drugs that affect brain function are:
- Other strong painkillers ( opioids )
- Medicines for epilepsy, pain, and anxiety (gabapentin and pregabalin)
- Hypnotics and sedatives ( sedatives (including benzodiazepines ), hypnotics, anxiolytics )
- Drugs for mental or mental illness (antipsychotics such as phenothiazines and neuroleptics )
- Medicines used under anesthesia or anesthesia
- Muscle relaxants used to relieve muscle cramps
- Medicines used to treat allergies, motion sickness, or nausea ( antihistamines or antiemetics)
Concomitant use of opioids, including OxyContin, and sedatives such as benzodiazepines or similar drugs increase the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes OxyContin at the same time as sedatives, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
The risk of side effects is increased if you take antidepressant drugs (for example, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine ). These drugs can affect or be affected by oxycodone, and you may experience symptoms such as involuntary, rhythmic muscle contractions, including in the muscles that control eye movements, sudden movements, heavy sweating, tremors, excessive reflexive movements, increased muscle tension, body temperature above 38 ° C. Contact your doctor if you experience these symptoms.
If you take OxyContin at the same time as medicines (coumarin derivatives) that reduce the blood’s ability to coagulate (clot), the clotting time may increase or decrease. It may be necessary to adjust the OxyContindos one.
Some medicines may increase the effect of OxyContin and therefore a dose reduction may be necessary:
- Certain types of antibiotics (macrolide antibiotics)
- Protease inhibitors (used to treat HIV )
- Cimetidine (antacid used to treat stomach ulcers and heartburn)
Some medicines may reduce the effect of OxyContin and therefore an increase in dose may be necessary:
- Rifampicin (used to treat tuberculosis )
- Carbamazepine (used in epilepsy and certain pain conditions)
- Phenytoin (used in epilepsy )
- St. John’s wort
OxyContin with food, drink, and alcohol
You can take OxyContin with a meal, but it is not necessary.
If you drink alcohol while taking OxyContin, it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. You should not drink alcohol while taking OxyContin.
You should avoid drinking grapefruit juice while taking OxyContin as it may increase the effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of this product should be avoided if possible in pregnant women. Prolonged use of OxyContin during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms that should be noticed in the infant are irritability, hyperactivity, screaming, shaking, vomiting, and not gaining weight.
OxyContin should not be used if you are breastfeeding because oxycodone passes into breast milk and may cause breathing problems in the breast-fed baby.
Driving and using machines
OxyContin impairs the ability to concentrate and react. This should be taken into account when sharper attention is required, e.g. when driving and when handling machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
OxyContin contains lactose
OxyContin contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take OxyContin
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
The usual starting dose is 10-20 mg at 12-hour intervals. The doctor will adjust the dose individually for you and prescribe the dose needed to treat the pain.
The daily dose one and any dose adjustments during treatment are determined by the attending physician and depend on the previous dose one. Patients who have previously taken opioids can based on their experience with opioid treatment, start treatment with higher doses. The doctor may prescribe a lower starting dose for elderly patients and at-risk patients with renal and/or hepatic impairment.
The tablets should be swallowed whole with a glass of water. They must not be split, chewed, or crushed. Empty matrices (tablets) can be seen in the stool.
If you take more OxyContin than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The following symptoms may occur with overdose: decreased pupil size, impaired breathing ( respiratory depression, pulmonary edema ), muscle weakness, slow heart rate, and drop in blood pressure. In severe cases, drowsiness and unconsciousness ( coma ) may occur.
If you forget to take OxyContin
You can take the missed tablet as soon as you remember, but if there is a short time left until the next dose, you should skip the missed dose. You can then continue to take the tablets according to the instructions.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking OxyContin
Do not stop treatment without first discussing it with your doctor.
If use is stopped abruptly after a long period of treatment, withdrawal symptoms such as restlessness, anxiety, anxiety, insomnia, involuntary muscle contractions, tremors, and gastrointestinal problems may occur. Your doctor will tell you how to stop the treatment to reduce the risk of withdrawal symptoms, usually done by gradually reducing the dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency data are used to evaluate the side effects:
Very common: May affect more than 1 user in 10
Common: May affect up to 1 in 10 people
Uncommon: May affect up to 1 in 100 people
Rare: May affect up to 1 in 1,000 people
Very rare: May affect up to 1 in 10,000 people
Has been reported: Occurs in an unknown number of users
Contact a doctor immediately if any of the following symptoms occur:
Very slow or weak breathing ( respiratory depression ). This is the most serious risk with medicines such as OxyContin ( opioids ) and can even be life-threatening.
Drowsiness, dizziness, headache, constipation, nausea, vomiting, itching.
Decreased appetite, anxiety, confusion, depression, insomnia, nervousness, abnormal thinking, tremors, drowsiness ( lethargy ), impaired breathing, tracheal cramps, abdominal pain, diarrhea, dry mouth, indigestion, rash, sweating, feeling weak.
Allergic reactions, dehydration, restlessness, gloom, elation, mood swings, hallucinations, decreased sexual desire, drug dependence, memory loss, seizures, high blood pressure, loss of sensation, involuntary muscle movements, speech disorders, fainting, and crawling, dizziness, puffiness, puffiness dizziness), palpitations (associated with abstinence ), dilation of blood vessels, very slow or weak breathing, difficulty swallowing, gas in the stomach, belching, intestinal upset, elevated liver enzyme levels, urethral spasm, dry skin, difficulty urinating, impotence, decreased hormone production in testicles/ovaries ( hypogonadism ), increased ADH -release, chills, abstinence, malaise, accumulation of fluid in the tissues ( edema ), swelling in the arms and legs due to fluid accumulation, drug tolerance, thirst.
Low blood pressure, tendency to faint standing up, hives.
Has been reported (occurs in an unknown number of users)
Anaphylactic reactions, anaphylactoid reaction, aggression, increased sensitivity to pain (hyperalgesia), repeated pauses in breathing during sleep ( sleep apnea ) (see section 2 “Warnings and precautions”), dental problems, bile arrest (cholestasis), biliary spasm, missed menstruation, neonatal abstinence.
How to store OxyContin
Do not store above 30 ° C.
10 mg, 20 mg, 40 mg and 80 mg:
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
The active substance is oxycodone hydrochloride.
Other ingredients are:
- Lactose monohydrate (see section 2 “OxyContin contains lactose”)
- Magnesium stearate
- Ammonia methacrylate copolymer
- Stearyl alcohol
- Sorbic acid
Film coating, incl. dyes:
5 mg: Hypromellose, titanium dioxide (E171), macrogol, brilliant blue (E133).
10 mg: Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol.
20 mg: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, red iron oxide (E172).
40 mg: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172).
80 mg: Hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol, indigo carmine (E132), yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
5 mg: Light blue, round tablet, approximately 7 mm in diameter, marked OC on one side and 5 on the other side.
10 mg: White, round tablet, about 7 mm in diameter, marked OC on one side and 10 on the other side.
20 mg: Pink, round tablet, about 7 mm in diameter, marked OC on one side and 20 on the other side.
40 mg: Yellow, round tablet, about 7 mm in diameter, marked OC on one side and 40 on the other side.
80 mg: Green, round tablet, about 9 mm in diameter, marked OC on one side and 80 on the other side
5 mg: 14, 25, 28, 56, 98 or 100 pcs (pressure pack).
10 mg and 20 mg: 14, 25, 28, 50, 56, 98 or 100 pcs (pressure pack and plastic jar with child-resistant lid).
40 mg and 80 mg: 25, 28, 50, 56, 98 or 100 pcs (pressure pack and plastic jar with child-resistant lid).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mölndalsvägen 30 B
412 63 Gothenburg
Fidelio Healthcare Limburg GmbH
Mundipharma DC BV
3832 RC Leusden