Oxiduo

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 are for use in adults only.

Pain relief

Oxyduo is indicated for the treatment of severe pain, which can only be adequately managed with opioid analgesics.
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 analgesic.

2. Important information before taking Oxyduo

When not to take Oxyduo

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing problems, which make it difficult to get enough oxygen into your blood and to remove carbon dioxide produced by your body (respiratory depression),
• if you have severe lung disease which makes it difficult to breathe (chronic obstructive pulmonary disease, COPD),
• if you have a condition where the right side of your heart is enlarged due to increased blood pressure in the pulmonary vessels (e.g. due to COPD), if you have severe asthma,
• if you have a bowel obstruction (a condition where it is difficult to pass stools or where the bowel is blocked), not caused by opioids,
• if you have moderate to severe liver problems.

Warnings and precautions

Before taking Oxyduo, tell your doctor or pharmacist:

• if you are elderly or debilitated,
• if you have a bowel obstruction (a condition where it is difficult to pass stools or where the bowel is blocked) caused by opioids,
• if you have kidney problems,
• if you have mild liver problems,
• if you have severe lung problems (e.g. reduced lung function),
• if you have a condition where you stop breathing for short periods during sleep (sleep apnoea),
• if you have a condition where your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if you have a condition where your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
• if you have a mental health condition with some loss of reality (psychosis) caused by alcohol or drug abuse,
• if you have problems with your gallbladder or bile duct.
• if you have an enlarged prostate gland,
• if you have a history of alcohol or drug abuse,
• if you have pancreatitis,
• if you have low blood pressure,
• if you have high blood pressure,
• if you have pre-existing heart disease,
• if you have a head injury (due to the risk of increased intracranial pressure),
• if you have epilepsy or are prone to seizures,
• if you are taking or have taken MAO inhibitors (used to treat depression or Parkinson's disease) in the last two weeks,
• if you experience excessive daytime sleepiness or sudden sleep attacks.

Tell your doctor if you experience severe abdominal pain which may radiate to your back, nausea, vomiting or fever, as these may be signs of pancreatitis or bile duct problems.
Sleep apnoea syndrome
Oxyduo may cause sleep apnoea syndrome (pauses in breathing during sleep) and hypoxia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up during the night due to shortness of breath, difficulty staying asleep or excessive daytime sleepiness. If you or someone else notices these symptoms, you should contact your doctor. Your doctor may consider reducing the dose.
Consult your doctor if you have experienced these symptoms in the past.
Also, consult your doctor if you develop any of these problems while taking Oxyduo. The most serious side effect of overdose of opioid analgesics is respiratory depression(slow and shallow breathing). This can lead to a reduction in the amount of oxygen in the blood, which can cause loss of consciousness.

• Diarrhoea may occur at the start of treatment due to the effect of naloxone. This may indicate that bowel function is returning to normal. This type of diarrhoea usually occurs within the first 3-5 days of treatment. If the diarrhoea persists or troubles you, you should contact your doctor.

Switching to Oxyduo
When switching to Oxyduo after long-term treatment with another opioid, you may initially experience withdrawal symptoms, such as restlessness, particularly agitation, sweating and muscle pain. If you experience these symptoms, you may need special medical supervision.
Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid. It can cause addiction and (or) dependence.
This medicine contains oxycodone, which is an opioid analgesic. Repeated use of opioid analgesics may lead to physical dependence and (or) addiction.
Repeated use of Oxyduo may lead to dependence and (or) addiction, which can be life-threatening. The risk of these side effects may increase with dose and duration of treatment.
Dependence and (or) addiction can happen in anyone taking this medicine. The risk of dependence and (or) addiction is higher for those who:

• have a history of, or are currently, abusing alcohol, prescription medicines or illegal drugs;
• are smokers;
• have a history of mental problems (depression, anxiety or personality disorders) or have been treated for mental problems.

If you experience any of the following symptoms while taking Oxyduo, it may mean that you are becoming dependent on or addicted to it:

• you need to take the medicine for longer than your doctor has prescribed;
• you need to take more of the medicine than your doctor has prescribed;
• you are taking the medicine for reasons other than those for which your doctor prescribed it, for example to feel good or to sleep;
• you have had to take more of the medicine than you were prescribed to get the same level of pain relief;
• you get a withdrawal syndrome when you stop taking the medicine (see section 3, "If you stop taking Oxyduo").

If you experience any of these symptoms, you should contact your doctor. Your doctor will be able to advise you on the best course of action to take.

Incorrect use of Oxyduo

Oxyduo is not intended for the treatment of withdrawal symptoms.
Prolonged-release tablets can be divided into equal doses but must not be chewed or crushed. Taking a 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 prescribed").
Abuse
Never abuse Oxyduo, especially if you are dependent on substances such as heroin, morphine or methadone. Abuse of Oxyduo in people who are dependent on substances can lead to severe withdrawal symptoms, as Oxyduo contains naloxone. Previous withdrawal symptoms may be intensified.
Incorrect use
Do not misuse Oxyduo prolonged-release tablets by dissolving and injecting the tablet contents (e.g. into a vein). The tablets contain talc, which can cause local tissue necrosis (death of tissue) and lung tissue changes (pulmonary granulomas). Such abuse can also lead to other serious consequences, including death.
Doping
Taking Oxyduo may result in a positive test for doping substances. Taking Oxyduo as a doping substance can be a risk to your health.

Oxyduo and other medicines

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 are taking medicines for depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone, which may cause symptoms such as involuntary, rhythmic muscle contractions, excitement, excessive sweating, tremors, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If you experience these symptoms, you should contact your doctor.
Concomitant use of opioids, including oxycodone hydrochloride, and sedatives, such as benzodiazepines or similar drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
If your doctor has prescribed Oxyduo together with sedatives, they will limit the dose and duration of concomitant treatment.
Tell your doctor about all sedatives you are taking and follow your doctor's advice on dose carefully. It may be helpful to inform friends or relatives about the sedative effects of these medicines. If you experience these symptoms, you should contact your doctor. Examples of these sedatives or similar medicines are:

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

If you are taking any of these medicines, the effects of Oxyduo or the other medicine may be altered. Tell your doctor if you 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, fits or certain types of pain),
• phenytoin (used to treat epilepsy, fits or seizures),
• herbal preparations containing St. John's Wort (also known as Hypericum perforatum),
• quinidine (used to treat irregular heart rhythms),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

No interaction with paracetamol, acetylsalicylic acid (aspirin) or naltrexone is expected.

Oxyduo with food, drink and alcohol

Drinking alcohol while taking Oxyduo may cause drowsiness or increase the risk of serious side effects, such as shallow breathing and loss of consciousness. Drinking alcohol while taking Oxyduo is not recommended.
Do not drink grapefruit juice while taking Oxyduo.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Oxyduo should not be used during pregnancy unless absolutely necessary. Long-term use of Oxyduo during pregnancy may cause withdrawal symptoms in the newborn baby. If oxycodone hydrochloride is used during delivery, it may cause respiratory depression (slow and shallow breathing) in the newborn baby.
Breast-feeding
You should not breast-feed while taking Oxyduo. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, a risk to the breast-fed child cannot be excluded, especially if Oxyduo is taken repeatedly.

Driving and using machines

Oxyduo may affect your ability to drive or use machines, as it may cause drowsiness and dizziness. This is especially likely at the start of treatment, after each dose increase or when switching to a different opioid. However, if you have been taking the same dose of Oxyduo for some time, these effects should be minimal.
Oxyduo has been associated with drowsiness and sudden sleep attacks. If you experience this side effect, you should not drive or operate machinery.
Discuss with your doctor whether you can drive or use machines.
Oxyduo contains sodium

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

3. How to take Oxyduo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you how you are feeling and what you can expect when taking Oxyduo, when and how to take it, when to contact your doctor and when to stop taking it (see also "Stopping Oxyduo").
Oxyduo is a prolonged-release tablet, which means that the active substances are released over a prolonged period. Their effect lasts for 12 hours.

Prolonged-release tablets can be divided into equal doses but must not be chewed or crushed. Taking a 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 prescribed").

Taking a higher dose of Oxyduo than prescribed

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

Pain relief
Adults
Usual starting dose is one 10 mg oxycodone hydrochloride + 5 mg naloxone hydrochloride prolonged-release tablet every 12 hours.
Your doctor will decide what dose of Oxyduo you should take each day and how to divide your daily dose into morning and evening doses. Your doctor will also decide on any necessary dose adjustments during treatment. Your doctor will adjust the dose according to the severity of your pain and your individual sensitivity.
You should be given the lowest effective dose for the relief of your pain.

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 should not be used in children and adolescents under 18 years.

Method of administration

Oral use. Oxyduo should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablet can be divided into equal doses but must not be chewed or crushed.
Oxyduo can be taken with or without food.
Oxyduo should be taken every 12 hours, according to the established treatment schedule (e.g. in the morning at 8:00, in the evening at 20:00).

• Oxyduo should be taken every 12 hours, according to the established treatment schedule (e.g. in the morning at 8:00, in the evening at 20:00).

Duration of treatment

Oxyduo should not be taken for longer than necessary. If you are taking Oxyduo for a long time, your doctor will regularly check whether you still need it.

Taking a higher dose of Oxyduo than prescribed

If you take more Oxyduo than you should, contact your doctor immediately.
Overdose may cause:

• pupil constriction
• slow and shallow breathing (respiratory depression)
• drowsiness leading to loss of consciousness
• reduced muscle tone (hypotonia)
• slow heart rate
• low blood pressure
• brain disorders (toxic leukoencephalopathy). In severe cases, this can lead to loss of consciousness (coma), fluid accumulation in the lungs and circulatory collapse, which can be fatal in some cases.

Avoid activities that require increased attention, such as driving.

Missing a dose of Oxyduo

If you miss a dose of Oxyduo or take a lower dose than prescribed, you may not feel any effect of the medicine.
If you forget to take a dose, follow the instructions below:

• If there are 8 hours or more until your next dose: take the missed dose as soon as possible and continue taking your medicine as scheduled.
• If there are less than 8 hours until your next dose: take the missed dose. Then wait 8 hours before taking the next dose. Try to get back to your original dosing schedule (e.g. 8:00 am and 8:00 pm).

Do not take more than one dose in 8 hours.
Do not take a double dose to make up for a forgotten dose.

Stopping Oxyduo

Do not stop taking Oxyduo without consulting your doctor. If treatment is no longer necessary, your doctor will tell you how to reduce your dose gradually. This will help prevent withdrawal symptoms, such as restlessness, sweating and muscle pain.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Important information about side effects or their symptoms and what to do if you experience them:

If you experience any of the following serious side effects, contact your doctor immediately.
Shallow breathing (respiratory depression) is the main risk of overdose of opioid analgesics. It usually occurs in elderly or debilitated patients. Opioids can also cause a significant drop in blood pressure in susceptible patients.

The following side effects have been observed in patients taking Oxyduo for pain relief:

Common(may affect up to 1 in 10 people)

• abdominal pain
• constipation
• diarrhoea
• dry mouth
• indigestion
• vomiting
• nausea
• wind
• reduced appetite to loss of appetite
• dizziness or "spinning" sensation
• headache
• hot flushes
• feeling of unusual weakness
• fatigue or exhaustion
• itching
• skin reactions/rash
• sweating
• vertigo
• difficulty sleeping
• drowsiness

Uncommon(may affect up to 1 in 100 people)

• bloating
• abnormal thoughts
• restlessness
• confusion
• depression
• anxiety
• chest tightness, especially in patients with pre-existing heart disease
• low blood pressure
• withdrawal symptoms, such as agitation
• fainting
• lack of energy
• thirst
• changes in taste
• palpitations
• biliary colic
• chest pain
• malaise
• pain
• swelling of hands, ankles or feet
• difficulty concentrating
• speech disorders
• tremors
• breathing difficulties
• restlessness
• chills
• increased liver enzyme activity
• increased blood pressure
• decreased sexual desire
• nasal congestion
• cough

Rare(may affect up to 1 in 1,000 people)

• rapid heart rate
• drug dependence
• dental problems
• weight gain
• yawning

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

• euphoria
• excessive drowsiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• urinary retention
• aggression
• tingling sensation
• belching
• sleep apnoea syndrome (pauses in breathing during sleep)

Oxycodone hydrochloride, when given alone, can cause the following side effects:

Oxycodone can cause breathing problems (respiratory depression), pinpoint pupils, bronchospasm and spasms of the smooth muscles and a reduction in the cough reflex.
Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 1,000 people)

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

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

• severe generalised allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• absence of menstruation
• withdrawal symptoms in newborns
• gastrointestinal disorders affecting the ileum, which can cause severe abdominal pain (ileus)
• bile flow problems
• tooth decay

The following side effects have been reported in patients taking Oxyduo for other conditions:

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

• -headache
• -drowsiness
• -constipation
• -nausea
• -sweating
• -fatigue or exhaustion

Common(may affect up to 1 in 10 people)

• -reduced appetite to loss of appetite
• -difficulty sleeping
• -depression
• -dizziness or "spinning" sensation
• -difficulty concentrating
• -tremors
• -tingling sensation in hands or feet
• -vision disorders
• -vertigo
• -hot flushes
• -low blood pressure
• -high blood pressure
• -abdominal pain
• -dry mouth
• -vomiting
• -increased liver enzyme activity
• -itching
• -skin reactions/rash
• -chest pain
• -chills
• -pain
• -thirst

Uncommon(may affect up to 1 in 100 people)

• -reduced sexual desire
• -sudden sleep attacks
• -changes in taste
• -breathing difficulties
• -wind
• -erectile dysfunction
• -withdrawal symptoms, such as agitation
• -swelling of hands, ankles or feet
• -injuries due to accidents

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

• -hypersensitivity/ allergic reactions
• -abnormal thoughts
• -anxiety
• -confusion
• -restlessness, especially agitation
• -euphoria
• -hallucinations
• -nightmares
• -seizures (especially in patients with a history of seizure disorders or predisposition to seizures)
• -excessive drowsiness
• -speech disorders
• -fainting
• -chest tightness, especially in patients with pre-existing heart disease
• -palpitations
• -rapid heart rate
• -shallow breathing
• -cough
• -yawning
• -bloating
• -diarrhoea
• -aggression
• -indigestion
• -belching
• -dental problems
• -biliary colic
• -muscle spasms
• -muscle tremors
• -muscle pain
• -difficulty urinating
• -frequent urination
• -general malaise
• -weight loss
• -weight gain
• -feeling of unusual fatigue
• -lack of energy.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section below.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Oxyduo

Keep this medicine out of the sight and reach of children. This medicine should be stored in a locked and secure location, out of the reach of others. It can be very harmful and may cause death if taken by someone for whom it has not been prescribed.
Do not use this medicine after the expiry date which is stated on the packaging, label and blister after EXP. The expiry date refers to the last day of that month.
Blister: Store in a temperature not exceeding 25°C.
Bottles: Store in a temperature not exceeding 30°C.
Medicines 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 protect the environment.

6. Contents of the pack and other information

What Oxyduo contains

The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Each prolonged-release tablet contains 40 mg oxycodone hydrochloride (equivalent to 36 mg oxycodone) and 20 mg naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).
The other ingredients are:

Tablet core

Polyvinyl acetate, povidone, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose and magnesium stearate.
Tablet coating

Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and iron oxide red (E172).

What Oxyduo looks like and contents of the pack

Pink, oval, biconvex prolonged-release tablet with a score line on both sides, 14.2 mm in length, 6.7 mm in width and 3.6-4.6 mm in height.
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 single-dose perforated 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