Oxiduo

Leaflet accompanying the packaging: patient information

Oxyduo, 5 mg + 2.5 mg, prolonged-release tablets
Oxyduo, 10 mg + 5 mg, prolonged-release tablets
Oxyduo, 20 mg + 10 mg, prolonged-release tablets
Oxycodone hydrochloride + Naloxone 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, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Oxyduo and what is it used for
• 2. Important information before taking Oxyduo
• 3. How to take Oxyduo
• 4. Possible side effects
• 5. How to store Oxyduo
• 6. Package contents and other information

1. What is Oxyduo and what is it used for

Oxyduo is a prolonged-release tablet, which means that the active substances are released over a prolonged period. Their effect lasts for 12 hours.
These tablets can only be used in adults.

Pain relief

Oxyduo is indicated for the treatment of severe pain that can only be adequately controlled with opioid painkillers. Naloxone hydrochloride counteracts constipation.
How Oxyduo works to relieve pain
Oxyduo contains two active substances: oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone hydrochloride is responsible for the analgesic effect of Oxyduo and is a strong opioid painkiller.
The second active substance of Oxyduo, naloxone hydrochloride, prevents constipation.
Gastrointestinal disorders (e.g., constipation) are a typical side effect of opioid painkillers.

2. Important information before taking Oxyduo

When not to take Oxyduo

• if the patient is allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has breathing problems that prevent adequate oxygen supply to the blood and removal of carbon dioxide produced in the body (respiratory depression),
• if the patient has severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease, COPD),
• if the patient has a condition called cor pulmonale. In this case, the right side of the heart is enlarged due to increased pressure in the blood vessels in the lungs (e.g., as a result of COPD - see above), if the patient has severe asthma,
• if the patient has paralytic ileus (a type of intestinal obstruction) not caused by opioids,
• if the patient has moderate to severe liver function disorders.

Warnings and precautions

Before starting treatment with Oxyduo, the patient should consult a doctor or pharmacist:

• in the case of elderly patients and debilitated patients,
• if the patient has paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if the patient has kidney function disorders,
• if the patient has mild liver function disorders,
• if the patient has severe lung function disorders (i.e., reduced vital capacity),
• if the patient has a condition characterized by frequent pauses in breathing during the night, which can cause daytime sleepiness (sleep apnea),
• if the patient has myxedema (a thyroid disorder characterized by dryness, decreased temperature, and swelling of the skin ["moon face"], including the face and limbs),
• if the thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if the adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
• if the patient has a mental disorder with accompanying loss of touch with reality (psychosis) caused by alcohol or other substances (substances that cause psychosis),
• if the patient has complaints related to gallstones or any other bile duct disorders (bile duct disease, gallbladder, etc.)
• if the patient has an enlarged prostate gland,
• if the patient suffers from alcoholism or delirium tremens,
• if the patient has pancreatitis,
• if the patient has low blood pressure (hypotension),
• if the patient has high blood pressure (hypertension),
• if the patient has previously diagnosed cardiovascular disease,
• if the patient has a head injury (due to the risk of increased intracranial pressure),
• if the patient has epilepsy or a tendency to seizures,
• if the patient is taking or has taken MAO inhibitors (used to treat depression or Parkinson's disease) within the last two weeks, e.g., drugs containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if the patient experiences sleepiness or episodes of sudden sleepiness.

The patient should consult a 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 ducts.
Respiratory disorders during sleep
Oxyduo may cause respiratory disorders during 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 consult a doctor. The doctor may consider reducing the dose.
The patient should consult a doctor if the above information applied to them in the past.
The patient should also consult a doctor if any of the above disorders develop during treatment with Oxyduo. The most serious consequence of overdosing on opioid painkillers is respiratory depression(slow and shallow breathing). This can lead to, among other things, a decrease in oxygen levels in the blood, leading to fainting.
Diarrhea
If the patient experiences severe diarrhea at the beginning of treatment, it may be caused by the action of naloxone. This may indicate that bowel function is returning to normal. Such diarrhea may occur within the first 3-5 days of treatment. If the diarrhea persists after 3-5 days or bothers the patient, they should consult a doctor.
Switching to Oxyduo
In the case of switching to Oxyduo after previously taking another opioid painkiller for a long time, initial withdrawal symptoms may occur, such as restlessness, especially motor restlessness, increased sweating, and muscle pain. If the patient experiences such symptoms, special medical supervision may be necessary.
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 painkiller. Repeated use of opioid painkillers can lead to decreased efficacy of the medicine (the patient becomes accustomed to it, which is called tolerance). Repeated use of Oxyduo can lead to dependence and abuse, which can lead to life-threatening overdose. The risk of these side effects may increase with increasing dose and longer treatment duration.
Dependence or abuse can cause the patient to feel that they have lost control over the dose of the medicine 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 Oxyduo or addiction varies from person to person. The risk of Oxyduo dependence may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illicit drugs;
• the patient smokes;
• the patient has had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

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

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

If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment option, including when to stop taking the medicine and how to safely stop treatment (see section 3 "Stopping Oxyduo treatment").
Advanced cancer of the digestive tract or pelvis
The patient should inform their doctor if they have advanced cancer of the digestive tract or pelvis, where intestinal obstruction may be a problem.
Surgery
If the patient is to undergo surgery, they should inform their doctor about taking Oxyduo.
Effect on hormone production
Like other opioids, oxycodone can affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if the patient has taken high doses for a long time. If the patient experiences symptoms that persist, such as nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sex drive, they should talk to their doctor, who may order hormone level monitoring.
Hypersensitivity
This medicine may increase sensitivity to pain, especially at high doses. The patient should inform their doctor if this happens. It may be necessary to reduce the dose or change the medicine.
Residue in feces
The patient may notice a residue of the prolonged-release tablet in their feces. They should not be concerned, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestines and absorbed by the body.

Incorrect use of Oxyduo

Oxyduo is not suitable for the treatment of withdrawal symptoms.
Oxyduo 5 mg + 2.5 mg
Prolonged-release tablets should be swallowed whole, without dividing, breaking, chewing, or crushing. Taking a divided, broken, chewed, or crushed tablet can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher dose of Oxyduo than recommended").
Oxyduo 10 mg + 5 mg, 20 mg + 10 mg
Prolonged-release tablets can be divided into equal doses, but they should not be chewed or crushed. Taking chewed or crushed tablets can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher dose of Oxyduo than recommended").
Abuse
Never abuse Oxyduo, especially if you are addicted to drugs. In people addicted to substances such as heroin, morphine, or methadone, abusing Oxyduo can cause severe withdrawal symptoms, as Oxyduo contains naloxone. Previous withdrawal symptoms may worsen.
Incorrect use
Do not misuse Oxyduo prolonged-release tablets by dissolving and injecting the contents of the tablet (e.g., into blood vessels). The tablets contain, in particular, talc, which can cause local tissue breakdown (necrosis) and changes in lung tissue (pulmonary granulomas). Such abuse can also lead to other serious consequences, even death.
Doping
Taking Oxyduo can result in a positive test for stimulants (doping). Using Oxyduo as a stimulant can pose a risk to health.

Oxyduo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The risk of side effects increases if the patient is taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone, which may cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If the patient experiences any of these symptoms, they should consult a doctor.
Concomitant use of opioids, including oxycodone hydrochloride, and sedatives, such as benzodiazepines or other similar medicines, increases the risk of sleepiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Oxyduo with sedatives, they should limit the dose and duration of concomitant treatment.
The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should consult a doctor. Examples of these sedatives or similar medicines include:

• other strong painkillers (opioid painkillers),
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and sedatives (including benzodiazepines, anxiolytics),
• antidepressants,
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
• medicines used to treat psychiatric or mental disorders (antipsychotics, which include phenothiazines and neuroleptics).

If the patient is taking these tablets at the same time as other medicines, the effect of these tablets or the other medicine, as described below, may change. The patient should tell their doctor if they are taking:

• medicines that reduce blood clotting (coumarin derivatives), as the blood clotting time may be prolonged or shortened,
• macrolide antibiotics (e.g., clarithromycin, erythromycin, or telithromycin),
• azole antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, and posaconazole),
• specific medicines called protease inhibitors, used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, saquinavir),
• cimetidine (used to treat stomach ulcers, indigestion, or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat epilepsy, seizures, or certain types of pain),
• phenytoin (used to treat epilepsy, seizures, or certain types of pain),
• herbal preparations containing St. John's wort (also known as Hypericum perforatum),
• quinidine (used to treat heart rhythm disorders),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

No interaction is expected between Oxyduo and paracetamol, acetylsalicylic acid, or naltrexone.

Oxyduo with food, drink, and alcohol

Drinking alcohol while taking Oxyduo can cause sleepiness or increase the risk of severe side effects, such as shallow breathing with the risk of apnea and loss of consciousness. Drinking alcohol while taking Oxyduo is contraindicated.
The patient should avoid drinking grapefruit juice while taking Oxyduo.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Oxyduo should be avoided in pregnant women unless the doctor considers it necessary. Long-term use of Oxyduo during pregnancy may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is used during delivery, the newborn may experience respiratory depression (slow and shallow breathing).
Breastfeeding
The patient should stop breastfeeding while taking Oxyduo. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the breastfed infant cannot be excluded, especially with repeated use of Oxyduo.

Driving and using machines

Oxyduo can impair the ability to drive and use machines because it can cause sleepiness and dizziness. This effect is particularly expected at the beginning of treatment with Oxyduo, after each dose increase, or when switching to another medicine. However, when the patient has been taking a fixed dose of Oxyduo for a long time, these disorders may subside.
Oxyduo has been associated with sleepiness and sudden sleep episodes. If the patient experiences these side effects, they should not drive or operate machinery.
The patient should talk to their doctor if they experience such side effects.
The patient should ask their doctor if they can drive or operate machinery.

Oxyduo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Oxyduo

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Oxyduo, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxyduo treatment").
Oxyduo is a prolonged-release tablet, which means that the active substances are released over a prolonged period. Their effect lasts for 12 hours.
Oxyduo, 5 mg + 2.5 mg

Prolonged-release tablets should be swallowed whole, without dividing, breaking, chewing, or crushing. Taking a divided, broken, chewed, or crushed tablet can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher dose of Oxyduo than recommended").

Oxyduo, 10 mg + 5 mg, 20 mg + 10 mg

Prolonged-release tablets can be divided into equal doses, but they should not be chewed or crushed. Taking chewed or crushed tablets can lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher dose of Oxyduo than recommended").

Unless the doctor has prescribed otherwise, the usual dose of Oxyduo is:

Pain relief
Adults
Typically, the initial dose is 1 prolonged-release tablet of Oxyduo 10 mg oxycodone hydrochloride + 5 mg naloxone hydrochloride every 12 hours.
The doctor will decide what dose of Oxyduo the patient should take daily and how to divide the daily dose into morning and evening doses. The doctor will also decide on any necessary dose adjustments during treatment. The doctor will adjust the dose according to the severity of the pain and the patient's individual sensitivity. The patient should receive the smallest effective dose to control the pain. In the case of previous use of opioid painkillers, treatment with Oxyduo can be started with higher doses.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If the patient requires a higher dose, the doctor may prescribe additional doses of oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose should not exceed 400 mg of oxycodone hydrochloride. When additional doses of oxycodone hydrochloride are administered, the beneficial effect of naloxone hydrochloride on bowel function may be impaired.
If the doctor prescribes a change from Oxyduo to another opioid painkiller, bowel function may worsen.
If the patient experiences pain before the next dose of Oxyduo is due, they may need to take a fast-acting painkiller. Oxyduo is not intended for this purpose. In such cases, the patient should consult a doctor.
If the patient feels that the effect of Oxyduo is too strong or too weak, they should consult a doctor or pharmacist.
Pain relief
Elderly patients
Typically, no dose adjustment is necessary in elderly patients with normal liver and/or kidney function.
Liver or kidney function disorders
If the patient has kidney function disorders or mild liver failure, the doctor may prescribe Oxyduo with caution. If the patient has moderate to severe liver failure, Oxyduo should not be used (see also section 2 "When not to take Oxyduo" and "Warnings and precautions").

Children and adolescents under 18 years

Oxyduo has not been studied in children and adolescents under 18 years. The safety and efficacy of Oxyduo in children and adolescents have not been established. Therefore, Oxyduo is not recommended for children and adolescents under 18 years.

Method of administration

Oxyduo, 5 mg + 2.5 mg
Oral tablets. Oxyduo should be swallowed with a sufficient amount of liquid (half a glass of water). The tablet should be swallowed whole, without dividing, breaking, chewing, or crushing. The tablet can be taken with or without food.
Oxyduo, 10 mg + 5 mg, 20 mg + 10 mg
Oral tablets. Oxyduo should be swallowed with a sufficient amount of liquid (half a glass of water). The tablet can be divided into equal doses, but it should not be chewed or crushed. The tablet can be taken with or without food.
Oxyduo should be taken every 12 hours, according to the established treatment plan (e.g., in the morning at 8:00, in the evening at 20:00).

Duration of treatment

As a rule, Oxyduo should not be taken for longer than necessary. If the patient is being treated with Oxyduo for a long time, the treating doctor should regularly check if the patient still needs Oxyduo.

Taking a higher dose of Oxyduo than recommended

If the patient has taken a higher dose of Oxyduo than recommended, they should immediately consult a doctor.
Overdose may be characterized by:

• constricted pupils
• slow and shallow breathing (respiratory depression)
• sleepiness leading to loss of consciousness
• decreased muscle tone (hypotonia)
• slow heart rate
• decreased blood pressure
• brain disorders (toxic leukoencephalopathy). In severe cases, loss of consciousness (coma), pulmonary edema, and circulatory collapse may occur, which can lead to death in some cases.

The patient should avoid activities that require increased attention, such as driving.

Missing a dose of Oxyduo

If the patient misses a dose of Oxyduo or takes a lower dose than prescribed, they may not feel the effect of the medicine.
If the patient forgets to take a dose of Oxyduo, they should follow the instructions below:

• If there are 8 hours or more until the next dose: the patient should take the missed dose immediately and continue taking the medicine according to the established schedule.
• If there are less than 8 hours until the next dose: the patient should take the missed dose. Then, they should wait 8 hours before taking the next dose. The patient should try to return to the original dosing schedule (e.g., in the morning at 8:00, in the evening at 20:00).

The patient should not take more than one dose in 8 hours.
The patient should not take a double dose to make up for a missed dose.

Stopping Oxyduo treatment

The patient should not stop taking Oxyduo without consulting a doctor. If treatment is no longer necessary, the patient should gradually reduce the daily dose after consulting a doctor. This way, the patient can avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxyduo can cause side effects, although not everybody gets them.

Important information about side effects or their symptoms and what to do if they occur:

If the patient experiences any of the following serious side effects, they should immediately consult a doctor.
Slow and shallow breathing (respiratory depression) is the main risk associated with opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids can also cause a significant decrease in blood pressure in sensitive patients.

The following side effects have been observed in patients treated for pain:

Frequent(may occur in 1 in 10 people)

• abdominal pain
• constipation
• diarrhea
• dry mouth
• indigestion
• vomiting
• nausea
• flatulence
• decreased appetite to loss of appetite
• dizziness or "spinning" sensation
• headache
• hot flashes
• feeling of unusual weakness
• fatigue or exhaustion
• itching
• skin reactions/rash
• sweating
• vertigo of labyrinthine origin
• difficulty sleeping
• sleepiness

Uncommon(may occur in 1 in 100 people)

• bloating
• unusual thoughts
• restlessness
• confusion
• depression
• anxiety
• chest tightness, especially with existing coronary heart disease
• decreased blood pressure
• withdrawal symptoms, such as agitation
• fainting
• lack of energy
• thirst
• changes in taste
• palpitations
• biliary colic
• chest pain
• malaise
• pain
• edema of hands, ankles, or feet
• difficulty concentrating
• speech disorders
• tremors
• breathing difficulties
• restlessness
• chills
• increased liver enzyme activity
• increased blood pressure
• decreased sex drive
• runny nose
• cough
• hypersensitivity/allergic reactions
• weight loss
• injuries due to accidents
• frequent urination
• muscle spasms
• muscle tremors
• muscle pain
• vision disorders
• seizures (especially in people with seizure disorders or a predisposition to seizures)

Rare(may occur in 1 in 1,000 people)

• rapid heart rate
• dependence on the medicine
• dental disorders
• weight gain
• yawning

Frequency not known(frequency cannot be estimated from the available data)

• euphoria
• severe sleepiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• urinary retention
• aggression
• tingling sensation
• belching
• sleep apnea (pauses in breathing during sleep)

The active substance, oxycodone hydrochloride, if administered without naloxone hydrochloride, can cause the following side effects:

Oxycodone can cause breathing problems (respiratory depression), decreased pupil size, bronchial muscle spasms, and smooth muscle spasms, as well as decreased cough reflex.
Frequent(may occur in 1 in 10 people)

• mood changes and personality changes (e.g., depression, feeling extremely happy)
• decreased activity
• increased activity
• urinary retention
• hiccups

Uncommon(may occur in 1 in 100 people)

• concentration disorders
• migraines
• increased muscle tone
• involuntary muscle contractions
• gastrointestinal disorders (intestinal obstruction)
• dry skin
• tolerance to the medicine
• decreased sensitivity to pain and touch
• coordination disorders
• voice changes (hoarseness)
• edema due to fluid retention
• hearing disorders
• mouth ulcers
• difficulty swallowing
• irritated gums
• perception disorders (e.g., hallucinations, derealization)
• skin redness
• dehydration
• agitation
• decreased sex hormone levels, which can affect sperm production in men or menstrual cycle in women

Rare(may occur in 1 in 1,000 people)

• itchy rash (urticaria)
• infections, such as herpes (which can cause blisters in the mouth or genital area)
• increased appetite
• black (tarry) stools
• gum bleeding

Frequency not known(frequency cannot be estimated from the available data)

• severe allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• amenorrhea
• withdrawal symptoms in newborns
• gastrointestinal disorders that can cause severe abdominal pain (disorders of the Oddi sphincter)
• bile duct disorders
• tooth decay

The following side effects have been observed in patients treated for other conditions:

Very common(may occur in more than 1 in 10 people)

• headache
• sleepiness
• constipation
• nausea
• sweating
• fatigue or exhaustion

Frequent(may occur in 1 in 10 people)

• decreased appetite to loss of appetite
• difficulty sleeping
• depression
• dizziness or "spinning" sensation
• difficulty concentrating
• tremors
• tingling sensation in hands or feet
• vision disorders
• vertigo of labyrinthine origin
• hot flashes
• decreased blood pressure
• increased blood pressure
• abdominal pain
• dry mouth
• vomiting
• increased liver enzyme activity
• itching
• skin reactions/rash
• chest pain
• chills
• erectile dysfunction
• withdrawal symptoms, such as agitation
• edema of hands, ankles, or feet
• injuries due to accidents

Uncommon(may occur in 1 in 100 people)

• decreased sex drive
• episodes of sudden sleepiness
• changes in taste
• breathing difficulties
• flatulence
• erectile dysfunction
• withdrawal symptoms, such as agitation
• edema of hands, ankles, or feet
• injuries due to accidents

Frequency not known(frequency cannot be estimated from the available data)

• hypersensitivity/allergic reactions
• unusual thoughts
• anxiety
• confusion
• agitation, especially motor agitation
• euphoria
• hallucinations
• nightmares
• seizures (especially in people with seizure disorders or a predisposition to seizures)
• dependence on the medicine
• severe sleepiness
• speech disorders
• fainting
• chest tightness, especially with existing coronary heart disease
• palpitations
• rapid heart rate
• shallow breathing
• cough
• runny nose
• yawning
• bloating
• diarrhea
• aggression
• indigestion
• belching
• gastrointestinal disorders
• tooth decay
• biliary colic
• muscle spasms
• muscle tremors
• muscle pain
• urinary retention
• frequent urination
• general malaise
• weight loss
• weight gain
• feeling of unusual fatigue
• lack of energy

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxyduo

The medicine should be kept out of sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death in a person for whom it was not prescribed.
Do not use this medicine after the expiry date stated on the carton, label, and blister after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Blister: Store in a temperature below 25°C.
Bottles: Store in a temperature below 30°C.
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. Package contents and other information

What Oxyduo contains

The active substances of the medicinal product are oxycodone hydrochloride and naloxone hydrochloride.
Oxyduo 5 mg + 2.5 mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to
4.5 mg of oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg of naloxone hydrochloride
dihydrate, equivalent to 2.25 mg of naloxone).
Oxyduo 10 mg + 5 mg
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to
9 mg of oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg of naloxone hydrochloride
dihydrate, equivalent to 4.5 mg of naloxone).
Oxyduo 20 mg + 10 mg
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to
18 mg of oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg of naloxone hydrochloride
dihydrate, equivalent to 9 mg of naloxone).
The other ingredients are:
Tablet core
polyvinyl acetate, povidone, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose and magnesium stearate.
Tablet coating
Oxyduo 5 mg + 2.5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.
Oxyduo 10 mg + 5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and red iron oxide (E172).
Oxyduo 20 mg + 10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

What Oxyduo looks like and what the pack contains

Oxyduo 5 mg + 2.5 mg
White, round, biconvex prolonged-release tablet, with a diameter of 4.7 mm and a height of 2.9 – 3.9 mm.
Oxyduo 10 mg + 5 mg
Pink, oval, biconvex prolonged-release tablet, with a score line on both sides of the tablet, with a length of 10.2 mm, width of 4.7 mm and a height of 3.0 – 4.0 mm.
The tablet can be divided into equal doses.
Oxyduo 20 mg + 10 mg
White, oval, biconvex prolonged-release tablet, with a score line on both sides of the tablet, with a length of 11.2 mm, width of 5.2 mm and a height of 3.3 – 4.3 mm.
The tablet can be divided into equal doses.
Oxyduo is available in:
Child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 or 100 prolonged-release tablets; child-resistant perforated unit dose blisters containing 56 x 1 or 60 x 1 prolonged-release tablets or child-resistant bottles containing 50, 100, 200 or 250 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warszawa
tel.: (22) 345 93 00

Manufacturer

1/ Develco Pharma GmbH
Grienmatt 27, Schopfheim 79650, Germany
2/ PLIVA Hrvatska d.o.o. (Pliva Croatia Ltd.), Prilaz baruna Filipovića 25
10000 Zagreb, Croatia

Date of last revision of the leaflet: February 2025