Package leaflet: Information for the patient

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
Oxyduo, 40 mg + 20 mg, prolonged-release tablets
Oxycodone hydrochloride + Naloxone hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Oxyduo is and what it is used for
What you need to know before taking Oxyduo
How to take Oxyduo
Possible side effects
How to store Oxyduo
Contents of the pack and other information

1. What Oxyduo is and what it is used for

Oxyduo is a prolonged-release tablet, meaning that the active substances are released over an extended period. Its effect lasts for 12 hours.
These tablets may only be used in adults.

Pain relief
Oxyduo is indicated for the treatment of severe pain that can only be adequately managed with opioid analgesics. Naloxone hydrochloride counteracts constipation.

How Oxyduo works in pain relief
Oxyduo contains two active substances: oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone hydrochloride is responsible for the analgesic effect of Oxyduo and is a potent opioid analgesic.
The second active substance in Oxyduo, naloxone hydrochloride, helps prevent constipation.
Gastrointestinal disturbances (e.g. constipation) are typical side effects of opioid analgesic therapy.

Restless legs syndrome
Oxyduo has been prescribed for the symptomatic second-line treatment of moderate to very severe restless legs syndrome in patients who cannot be treated with dopaminergic medicinal products.
Patients with restless legs syndrome experience unpleasant sensations in the limbs. These sensations may occur when sitting or lying down and are relieved only by an irresistible urge to move the legs, sometimes the arms or other parts of the body. This makes sitting still and falling asleep very difficult. Naloxone hydrochloride counteracts constipation.

How Oxyduo works in restless legs syndrome
These tablets help to alleviate the unpleasant sensations, thereby reducing the need to move the limbs. The second active substance in Oxyduo, naloxone hydrochloride, is intended to counteract constipation. Gastrointestinal disturbances (e.g. constipation) are typical side effects of opioid therapy.

2. Important information before using Oxyduo

When not to use 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 sufficient oxygen from entering the blood and carbon dioxide from being removed from the body (respiratory depression),
if the patient has severe lung disease associated with airway obstruction (chronic obstructive pulmonary disease, COPD),
if the patient has been diagnosed with cor pulmonale. In this condition, the right side of the heart is enlarged due to increased pressure in the blood vessels of the lungs (e.g. as a result of COPD - see above),
if the patient has been diagnosed with severe bronchial 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 impairment.

Additionally, in restless legs syndrome

if the patient has a history of opioid drug dependence.

Warnings and precautions
Before starting Oxyduo, consult a doctor or pharmacist:

in elderly and debilitated patients,
if the patient has opioid-induced paralytic ileus (a type of intestinal obstruction),
if the patient has kidney function disorders,
if the patient has mild liver function impairment,
if the patient has severe lung function disorders (i.e. reduced vital capacity),
if the patient has a condition characterised by frequent breathing pauses during the night, which may cause daytime sleepiness (sleep apnoea),
if the patient has myxoedema (a thyroid disorder presenting with dryness, lowered body temperature, and skin swelling ["puffy face"], affecting the face and limbs),
if the thyroid gland does not produce sufficient hormones (underactive thyroid or hypothyroidism),
if the adrenal glands do not produce sufficient hormones (adrenal insufficiency or Addison's disease),
if the patient has a mental disorder with accompanying (partial) loss of reality perception (psychosis) caused by alcohol or other substances (substances causing psychosis),
if the patient has symptoms related to gallstones or any other disorders of the biliary tract (biliary tract disease, gallbladder disease, etc.),
if the patient has been diagnosed with abnormal enlargement of the prostate gland (prostate enlargement),
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 a 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 currently taking or has taken monoamine oxidase inhibitors (MAOIs) within the past two weeks (used to treat depression or Parkinson's disease), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
if the patient experiences drowsiness or episodes of sudden sleep.

Contact a doctor if the patient develops severe upper abdominal pain, possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and biliary tract disorders.
Sleep-related breathing disorders
Oxyduo may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, contact a doctor. The doctor may consider reducing the dose.
Consult a doctor if any of the above conditions applied to the patient in the past.
Consult a doctor also if any of the above disorders develop during treatment with Oxyduo. The most serious consequence of opioid painkiller overdose is respiratory depression (slow and shallow breathing). This may lead, among other things, to reduced oxygen levels in the blood, resulting in fainting.
Diarrhoea
If severe diarrhoea occurs at the beginning of treatment, it may be due to the action of naloxone. This may indicate that intestinal function is returning to normal. Such diarrhoea may occur within the first 3–5 days of treatment. If diarrhoea persists beyond 3–5 days or is bothersome to the patient, the patient should contact a doctor.
Switching to Oxyduo
When switching to Oxyduo after long-term use of another opioid medicine, withdrawal symptoms such as restlessness, especially motor restlessness, excessive sweating, and muscle pain may initially occur. If the patient experiences such symptoms, special medical supervision may be necessary.
Tolerance, drug dependence, and addiction
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or addiction.
This medicine contains oxycodone, an opioid painkiller. Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (the patient becomes accustomed, known as tolerance). Repeated use of Oxyduo may lead to dependence and abuse, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or abuse may cause the patient to feel they have lost control over the dose or frequency of medicine intake. The patient may feel they must continue taking the medicine, even if it does not help relieve pain.
The risk of drug dependence or addiction varies between patients. The risk of dependence on Oxyduo may be higher if:

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

If, while taking Oxyduo, the patient notices any of the following symptoms, it may indicate developing tolerance to the medicine or addiction:

the patient needs to take the medicine longer than prescribed by the doctor;
the patient must take a higher dose than recommended;
the patient uses the medicine for reasons other than those prescribed by the doctor, e.g. "to stay calm" or "to help sleep";
the patient has made repeated, unsuccessful attempts to discontinue or control medicine use;
the patient feels unwell after stopping the medicine and feels better after resuming it ("withdrawal effects").

If any of these symptoms are observed, contact a doctor to discuss the best treatment path for the patient, including when to stop taking the medicine and how to discontinue treatment safely (see section 3 "Stopping Oxyduo treatment").
Advanced gastrointestinal or pelvic cancer
Inform the doctor if the patient has advanced gastrointestinal or pelvic cancer, where intestinal obstruction may be a problem.
Surgery
If the patient is to undergo surgery, they should inform the doctors about taking Oxyduo.
Effect on hormone production
Like other opioids, oxycodone may affect normal hormone production in the body, such as cortisol or sex hormones, especially if the patient has taken high doses for a prolonged period. If the patient develops persistent symptoms such as nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or reduced sex drive, discuss with a doctor, who may order hormone level monitoring.
Hyperalgesia
This medicine may increase sensitivity to pain, particularly at high doses. Inform the doctor if this occurs. Dose reduction or a change in medicine may be necessary.
Residue in stool
The patient may notice remnants of the prolonged-release tablet in the stool. Do not be alarmed, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestines and absorbed by the body.
Improper use of Oxyduo
Oxyduo is not suitable for treating withdrawal symptoms.
Oxyduo 5 mg + 2.5 mg
Prolonged-release tablets must be swallowed whole; they must not be divided, broken, chewed, or crushed. Taking a divided, broken, chewed, or crushed tablet may lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher than recommended dose of Oxyduo").
Oxyduo 10 mg + 5 mg, 20 mg + 10 mg, 40 mg + 20 mg
Prolonged-release tablets may be divided into equal doses but must not be chewed or crushed. Taking chewed or crushed tablets may lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking a higher than recommended dose of Oxyduo").
Abuse
Never abuse Oxyduo, especially in cases of drug dependence. In individuals dependent on substances such as heroin, morphine, or methadone, abusing Oxyduo may cause severe withdrawal symptoms, as Oxyduo contains naloxone as an ingredient. Existing withdrawal symptoms may worsen.
Improper use
Do not misuse Oxyduo by dissolving and injecting the tablet contents (e.g. into blood vessels). The tablets contain, in particular, talc, which may cause local tissue necrosis and lung tissue changes (pulmonary granulomas). Such abuse may also lead to other serious consequences, even death.
Doping
Using Oxyduo may result in a positive doping test. Using Oxyduo as a stimulant may pose a health risk.
Oxyduo and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C. If these symptoms occur, contact a doctor.
Concurrent use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or other similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered if other treatment options are not possible.
If the doctor prescribes Oxyduo together with sedative medicines, they should limit the dose and duration of combined treatment.
Inform the doctor about all sedative medicines taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or relatives so they are aware of the above symptoms. If such symptoms occur, contact 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 and calming medicines (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, including phenothiazines and neuroleptics).

When taking these tablets at the same time as other medicines, the effect of these tablets or the other medicine, as described below, may change. Inform the doctor if the patient is taking:

medicines that reduce blood clotting (coumarin derivatives), which may prolong or shorten blood clotting time,
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 convulsions),
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 between Oxyduo and paracetamol, acetylsalicylic acid, or naltrexone is expected.
Oxyduo with food, drink, and alcohol
Drinking alcohol while taking Oxyduo may cause drowsiness or increase the risk of severe adverse effects such as shallow breathing with risk of apnoea and loss of consciousness. Drinking alcohol while taking Oxyduo is contraindicated.
Avoid drinking grapefruit juice while taking Oxyduo.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Avoid using Oxyduo in pregnant women if possible, unless the doctor considers treatment with this medicine necessary. Long-term use of Oxyduo during pregnancy may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is used during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn.
Breastfeeding
Breastfeeding must be discontinued during treatment with Oxyduo. Oxycodone hydrochloride passes into breast milk. It is unknown 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 operating machinery
Oxyduo may impair the ability to drive and operate machinery as it may cause drowsiness and dizziness. This is particularly expected at the beginning of treatment with Oxyduo, after each dose increase, or after switching to another medicine. However, once the patient has been on a stable dose of Oxyduo for a prolonged period, these disturbances may subside.
This medicine has been associated with drowsiness and episodes of sudden sleep. If the patient experiences these adverse effects, they should not drive or operate machinery.
Discuss with the doctor if such adverse symptoms occur.
The patient should ask the doctor whether they can drive or operate machinery.
Oxyduo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially sodium-free.

3. How to take Oxyduo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Oxyduo, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Stopping Oxyduo").
Oxyduo comes in the form of prolonged-release tablets, which means that the active substances are released over an extended period. Their effect lasts for 12 hours.

Oxyduo, 5 mg + 2.5 mg
Prolonged-release tablets must be swallowed whole. Do not divide, break, chew, or crush them.
Ingesting a divided, broken, chewed, or crushed tablet may result in the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking more Oxyduo than prescribed").

Oxyduo, 10 mg + 5 mg, 20 mg + 10 mg, 40 mg + 20 mg
Prolonged-release tablets may be divided into equal doses, but must not be chewed or crushed. Ingesting chewed or crushed tablets may lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3 "Taking more Oxyduo than prescribed").

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

Pain treatment
Adults
The usual starting dose is one prolonged-release tablet of Oxyduo containing 10 mg oxycodone hydrochloride + 5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide the daily dose of Oxyduo you should take and how to divide the total daily dose into morning and evening doses. Your doctor will also determine any necessary dose adjustments during treatment. The dose will be adjusted according to the intensity of pain and your individual sensitivity. You should receive the lowest effective dose needed to control your pain. If you have previously been treated with opioid painkillers, treatment with Oxyduo may be started at higher doses.

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you require a higher dose, your doctor may prescribe additional doses of oxycodone hydrochloride without naloxone hydrochloride. However, the total daily dose of oxycodone hydrochloride should not exceed 400 mg. When additional doses of oxycodone hydrochloride are administered, the beneficial effect of naloxone hydrochloride on bowel function may be reduced.

If your doctor switches you from Oxyduo to another opioid painkiller, bowel function may worsen.

If you experience pain before the next scheduled dose of Oxyduo, you may need to take a fast-acting painkiller as needed. Oxyduo is not intended for this purpose. In such cases, consult your doctor.

If you feel the effect of Oxyduo is too strong or too weak, consult your doctor or pharmacist.

Restless legs syndrome treatment
Adults
The starting dose is 5 mg oxycodone hydrochloride + 2.5 mg naloxone hydrochloride every 12 hours.
Your doctor will decide the daily dose of Oxyduo you should take and how to divide the total daily dose into morning and evening doses. Your doctor will also determine any necessary dose adjustments during treatment. The dose will be adjusted according to your individual sensitivity. You should receive the lowest effective dose needed to relieve symptoms of restless legs syndrome.

If you feel the effect of the tablets is too strong or too weak, consult your doctor or pharmacist.

The maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride.
If achieving the required dose with a specific strength is difficult or impractical, another strength of the same medicinal product may be prescribed.

Pain or restless legs syndrome treatment
Elderly patients
Dose adjustment is usually not necessary in elderly patients with normal liver and/or kidney function.

Impaired liver or kidney function
If you have impaired kidney function or mild liver impairment, your doctor may prescribe Oxyduo with special caution. Oxyduo must not be used if you have moderate to severe liver impairment (see also section 2 "When not to take Oxyduo" and "Warnings and precautions").

Children and adolescents under 18 years of age
Oxyduo has not been studied in children and adolescents under 18 years of age. Safety and efficacy have not been established in this population. Therefore, Oxyduo is not recommended for use in children and adolescents under 18 years of age.

Method of administration
Oxyduo, 5 mg + 2.5 mg
Tablets for oral use. Oxyduo should be swallowed with an adequate amount of liquid (half a glass of water). The tablet must be swallowed whole; do not divide, break, chew, or crush it. The tablet may be taken with or without food.

Oxyduo, 10 mg + 5 mg, 20 mg + 10 mg, 40 mg + 20 mg
Tablets for oral use. Oxyduo should be swallowed with an adequate amount of liquid (half a glass of water). The tablet may be divided into equal doses but must not be chewed or crushed. The tablet may be taken with or without food.

Oxyduo should be taken every 12 hours according to the prescribed treatment schedule (e.g., 8:00 a.m. and 8:00 p.m.).

Duration of treatment
Oxyduo should not be taken longer than necessary. If you are on long-term treatment with Oxyduo, your doctor should regularly assess whether you still need this medicine.

Taking more Oxyduo than prescribed
If you have taken more Oxyduo than prescribed, contact your doctor immediately.
Overdose symptoms may include:

Constricted pupils
Slow and shallow breathing (respiratory depression)
Drowsiness up to loss of consciousness
Reduced muscle tone (hypotonia)
Slowed heart rate
Low blood pressure
Brain dysfunction (known as toxic leukoencephalopathy). In severe cases, loss of consciousness (coma), pulmonary edema, and circulatory collapse may occur, which can lead to death in some cases.

Avoid activities requiring increased attention, such as driving.

Missed dose of Oxyduo
If you miss a dose of Oxyduo or take a lower dose than prescribed, you may not experience the medicine's effect.
If you forget to take a dose, follow these instructions:

If 8 hours or more remain until the next scheduled dose: take the missed dose immediately and continue taking the medicine according to the prescribed schedule.
If less than 8 hours remain until the next scheduled dose: take the missed dose, then wait 8 hours before taking the next dose. Try to return to your original dosing schedule (e.g., 8:00 a.m. and 8:00 p.m.).

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

Stopping Oxyduo
Do not stop taking Oxyduo without consulting your doctor. If treatment is no longer needed, the daily dose should be gradually reduced under medical supervision. This helps prevent withdrawal symptoms such as restlessness, sweating, and muscle pain.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important information about side effects or their symptoms and actions to take if they occur:
If any of the following serious side effects occur, contact your doctor immediately.

Slow and shallow breathing (respiratory depression) is the main risk associated with opioid overdose. It occurs most commonly in elderly and debilitated patients. Opioids may also cause a significant drop in blood pressure in susceptible patients.

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

Common (may occur in 1 out of 10 people)

abdominal pain
constipation
diarrhoea
dry mouth
indigestion
vomiting
nausea
flatulence
decreased appetite up to loss of appetite
dizziness or spinning sensation
headache
hot flushes
feeling unusually weak
fatigue or exhaustion
itching of the skin
skin reactions/rash
sweating
vertigo of labyrinthine origin
difficulty falling asleep
drowsiness

Uncommon (may occur in 1 out of 100 people)

bloating
unusual thoughts
anxiety
confusion
depression
nervousness
chest tightness, especially in patients with existing ischaemic heart disease
low blood pressure
withdrawal symptoms such as restlessness
fainting
lack of energy
thirst
changes in taste perception
palpitations
hepatic colic
chest pain
malaise
pain
swelling of hands, ankles or feet
difficulty concentrating
speech disorders
tremor
breathing difficulties
motor restlessness
chills
increased activity of liver enzymes
high blood pressure
reduced sexual drive
catarrh
cough
hypersensitivity/allergic reactions
weight loss
injuries due to accidents
frequent urge to urinate
muscle cramps
muscle twitching
muscle pain
visual disturbances
seizures (especially in people with seizure disorders or predisposition to seizures)

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

increased heart rate
drug dependence
dental disorders
weight gain
yawning

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

euphoria
strong feeling of sleepiness
erectile dysfunction
nightmares
hallucinations
shallow breathing
difficulty passing urine
aggression
tingling sensation
belching
sleep apnoea (pauses in breathing during sleep)

The active substance, oxycodone hydrochloride, when administered without naloxone hydrochloride, causes the following side effects:

Oxycodone may cause breathing problems (respiratory depression), pupil constriction, bronchial muscle contraction and smooth muscle contraction, as well as reduced cough reflex.

Common (may occur in 1 out of 10 people)

mood swings and personality changes (e.g. depression, feeling of extreme happiness)
decreased activity
increased activity
difficulty passing urine
hiccups

Uncommon (may occur in 1 out of 100 people)

concentration difficulties
migraines
increased muscle tension
involuntary muscle contractions
intestinal dysfunction (intestinal obstruction)
dry skin
drug tolerance
reduced sensitivity to pain and touch
coordination disorders
voice changes (hoarseness)
oedema due to fluid retention
hearing disturbances
oral ulceration
difficulty swallowing
irritated gums
perceptual disturbances (e.g. hallucinations, derealisation)
skin redness
dehydration
restlessness
reduced levels of sex hormones, which may affect sperm production in men or menstrual cycle in women

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

itchy rash (urticaria)
infections such as herpes (which may cause blisters around the mouth or genital organs)
increased appetite
black (tarry) stools
bleeding gums

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

acute generalized allergic reactions (anaphylactic reactions)
increased sensitivity to pain
absence of menstruation
withdrawal symptoms in newborns
disorders affecting the valve in the intestine, potentially causing severe upper abdominal pain (dysfunction of the sphincter of Oddi)
problems with bile flow
dental caries

The following side effects have been observed in patients treated for restless legs syndrome:

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

headache
drowsiness
constipation
nausea
sweating
fatigue or exhaustion

Common (may occur in 1 out of 10 people)

decreased appetite to loss of appetite
difficulty falling asleep
depression
dizziness or spinning sensation
difficulty concentrating
tremors
tingling in hands or feet
visual disturbances
vertigo of labyrinthine origin
hot flushes
low blood pressure
high blood pressure
abdominal pain
dry mouth
vomiting
increased activity of liver enzymes (increased activity of alanine aminotransferase, gamma-glutamyl transferase)
itching of the skin
skin reactions and/or rash
chest pain
chills
pain
thirst

Uncommon (may occur in 1 out of 100 people)

reduced sexual drive
episodes of sudden sleep
changes in taste perception
breathing difficulties
flatulence
erectile dysfunction
withdrawal symptoms such as restlessness
swelling of hands, ankles or feet
injuries due to accidents

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

hypersensitivity and/or allergic reactions
unusual thoughts
anxiety
confusion
nervousness
restlessness, especially motor restlessness
euphoria
hallucinations
nightmares
seizures (especially in people with seizure disorders or predisposition to seizures)
drug dependence
strong feeling of sleepiness
speech disorders
fainting
chest tightness, especially in patients with existing ischaemic heart disease
palpitations
increased heart rate
shallow breathing
cough
catarrh
yawning
bloating
diarrhoea
aggression
indigestion
belching
dental disorders
hepatic colic
muscle cramps
muscle twitching
muscle pain
difficulty passing urine
frequent urge to urinate
general malaise
weight loss
weight gain
feeling of unusual tiredness
lack of energy

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 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 authorisation holder.

Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Oxyduo

Keep this medicine out of sight and reach of children. This medicine must be stored in a closed and secure place inaccessible to others. It may be highly harmful and can cause death in a person for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton, label, and blister after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Blister: Store below 25°C.
Bottles: Store below 30°C.
Medicines must 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 packaging and other information

What the medicine Oxyduo contains
The active substances 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).

Oxyduo 40 mg + 20 mg
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg of oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg of naloxone hydrochloride dihydrate, equivalent to 18 mg of naloxone).

Other ingredients are:
Tablet core
polyvinyl acetate, povidone, sodium lauryl sulfate, anhydrous colloidal 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.

Oxyduo 40 mg + 20 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and red iron oxide (E172).

What Oxyduo looks like and contents of the pack
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, oblong, biconvex prolonged-release tablet with a division line on both sides of the tablet, measuring 10.2 mm in length, 4.7 mm in width, and 3.0 – 4.0 mm in height.
The tablet can be divided into equal doses.

Oxyduo 20 mg + 10 mg
White, oblong, biconvex prolonged-release tablet with a division line on both sides of the tablet, measuring 11.2 mm in length, 5.2 mm in width, and 3.3 – 4.3 mm in height.
The tablet can be divided into equal doses.

Oxyduo 40 mg + 20 mg
Pink, oblong, biconvex prolonged-release tablet with a division line on both sides of the tablet, measuring 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:
Blister packs with child-resistant packaging containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 or 100 prolonged-release tablets; single-dose perforated blisters with child-resistant packaging containing 56 x 1 or 60 x 1 prolonged-release tablets; or bottles with child-resistant closure 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 Warsaw
tel.: (22) 345 93 00

Manufacturer
1/ Develco Pharma GmbH
Grienmatt 27, Schopfheim 79650, Germany
2/ Saneca Pharmaceuticals A.S.,
Nitrianska 100,
920 27 Hlohovec, Slovakia