Duoxona 5 mg/2.5 mg prolonged-release tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duoxona 5 mg/2.5 mg prolonged-release tablets EFG

Oxycodone hydrochloride / naloxone hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Duoxona is and what it is used for

Duoxona is a prolonged-release tablet, meaning that its active substances are released over an extended period of time. Its effect lasts for 12 hours.

These tablets are intended for use in adults only.

Pain relief

You have been prescribed Duoxona for the treatment of severe pain that can only be adequately managed with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work for pain relief

These tablets contain as active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride provides the analgesic effect of Duoxona; it is a potent analgesic belonging to the opioid group.

The second active substance in Duoxona, naloxone hydrochloride, serves to counteract constipation. Gastrointestinal dysfunction (for example, constipation) is a common adverse effect of treatment with opioid analgesics.

2. What you need to know before taking Duoxona

Do not take Duoxona

if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
if your breathing does not provide enough oxygen to the blood or remove the carbon dioxide produced in the body (respiratory depression),
if you have severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
if you have a disorder called cor pulmonale. This condition involves enlargement of the right side of the heart due to increased pressure in the blood vessels of the lungs (e.g., as a result of COPD, see above),
if you have severe bronchial asthma,
if you have paralytic ileus (a type of intestinal obstruction) not caused by opioids,
if you have moderate to severe liver disease.

Contact your doctor if you experience severe pain in the upper abdomen that may spread to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

in elderly or debilitated (weak) patients,
if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
if you have kidney disorder,
if you have mild liver disorder,
if you have severe lung disorder (i.e., reduced breathing capacity),
if you have a condition characterized by frequent breathing pauses during sleep, which may make you feel very sleepy during the day (sleep apnea),
if you have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and extremities),
if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
if your adrenal glands do not produce enough hormones (adrenal insufficiency or Addison's disease),
if you have a mental disorder accompanied by partial or complete loss of touch with reality (psychosis) due to alcoholism or intoxication with other substances (substance-induced psychosis),
if you have problems related to gallstones,
if you have an abnormal enlargement of the prostate (prostate hypertrophy),
if you have alcoholism or delirium tremens,
if you have inflammation of the pancreas (pancreatitis),
if you have low blood pressure (hypotension),
if you have high blood pressure (hypertension),
if you have a previous cardiovascular disease,
if you have a head injury (due to the risk of increased pressure in the brain),
if you have epilepsy or are prone to seizures,
if you are also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease), or have taken such medicines within the last two weeks, for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
if you experience drowsiness or sudden episodes of falling asleep.
Sleep-related breathing disorders

Duoxona may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have ever had any of these conditions in the past. Also inform your doctor if you develop any of them while taking this medicine.

The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This may also lead to decreased oxygen concentration in the blood, which can cause fainting, etc.

Swallow the prolonged-release tablet whole, to ensure the slow release of oxycodone hydrochloride from the prolonged-release tablet is not affected. Do not split, chew, or crush the tablets. Taking them split, chewed, or crushed may lead to potentially fatal absorption of oxycodone hydrochloride (see section 3 “If you take more Duoxona than you should”).

Diarrhea

If you experience severe diarrhea at the beginning of treatment, it may be due to the effect of naloxone. It may be a sign that intestinal function is normalizing. This diarrhea may occur during the first 3 to 5 days of treatment. If it persists beyond this 3- to 5-day period, or if you are concerned, contact your doctor.

Switching to Duoxona

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with oxycodone/naloxone, for example, restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor. This medicine is not suitable for the treatment of withdrawal syndrome.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid, and may cause dependence and/or addiction.

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Duoxona may also lead to dependence, abuse, and addiction, which can result in a life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it. You may feel that you need to keep taking the medicine, even when it no longer helps relieve your pain.

The risk of becoming dependent or addicted to Duoxona varies from person to person. You may have a higher risk of becoming dependent or addicted to Duoxona:

if you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”).
if you smoke.
if you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Duoxona, it could be a sign that you have become dependent or addicted:

You need to take the medicine for longer than recommended by your doctor.
You need to take higher doses than recommended.
You are using the medicine for reasons other than prescribed, for example, “to stay calm” or “to help you sleep.”
You have made repeated unsuccessful attempts to stop or control your use of the medicine.
You feel unwell when you stop taking the medicine and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, speak with your doctor to discuss the best treatment for you, including when it is appropriate to stop taking Duoxona and how to do so safely (see section 3, If you stop taking Duoxona).

Inform your doctor if you have cancer with peritoneal metastases or initial intestinal obstruction in advanced stages of gastrointestinal or pelvic cancers.

Surgery

If you need to undergo surgery, tell the medical staff that you are taking Duoxona.

Like other opioids, oxycodone may affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if high doses are taken for long periods of time. If you experience persistent symptoms such as malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased libido, consult your doctor so they can monitor your hormone levels.

This medicine may increase your sensitivity to pain, especially at high doses. Inform your doctor if this occurs. It may be necessary to reduce the dose or switch to another medicine.

You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the stomach and intestine and absorbed into your body.

How to take Duoxona correctly

These tablets are not suitable for the treatment of withdrawal syndrome.

Abuse

Oxycodone/naloxone should never be used if you have a substance use disorder. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse Duoxona, because it contains naloxone. Pre-existing withdrawal symptoms may worsen.

Misuse

You should never dissolve Duoxona for injection (for example, into a blood vessel). The reason is that they contain talc, which may cause local tissue destruction (necrosis) and lung tissue damage (pulmonary granuloma). This type of abuse may also lead to other serious consequences and even result in death.

Long-term treatment

If administered over a long period, you may develop tolerance to oxycodone/naloxone. This means that higher doses may be needed to relieve pain. Long-term use of oxycodone/naloxone may lead to physical dependence. If treatment is stopped abruptly, withdrawal symptoms may occur (such as restlessness, episodes of sweating, and menstrual pain). If treatment is no longer needed, it is advisable to gradually reduce the daily dose under the supervision of your doctor.

Psychological dependence

The abuse potential of oxycodone hydrochloride is similar to that of other potent opioids (strong analgesics). There is a possibility of developing psychological dependence. Medicinal products containing oxycodone hydrochloride should be used with particular caution in patients with a history of alcohol, drug, or medication abuse.

Taking Duoxona with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The risk of side effects increases when antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) are used. These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

Concomitant use of opioids, including oxycodone/naloxone, and sedative medicines such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes oxycodone/naloxone together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members so they can be aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Some examples of sedative or related medicines include:

other strong painkillers (opioids);
sleeping pills and tranquilizers (sedatives, hypnotics);
medicines used to treat depression (antidepressants);
medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
medicines used to treat psychiatric or mental disorders (antipsychotics including phenothiazines and neuroleptics).

If you take these tablets together with other medicines, the effects of the tablets or of the other medicines listed below may change. Inform your doctor if you are taking:

medicines that reduce blood clotting ability (coumarin derivatives), as blood clotting speed may increase or decrease;
macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
antifungal agents of the -azole type (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
a specific type of medicine known as a protease inhibitor used to treat HIV (e.g., ritonavir, indinavir, nelfinavir, or saquinavir);
cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn);
rifampicin (used to treat tuberculosis);
carbamazepine (used to treat seizures or convulsions and certain painful conditions);
phenytoin (used to treat seizures or convulsions);
a herbal remedy called St. John’s wort (also known as Hypericum perforatum);
quinidine (a medicine used to treat arrhythmias).

No interactions between oxycodone/naloxone and paracetamol, acetylsalicylic acid, or naltrexone are expected.

Taking Duoxona with food, drinks, and alcohol

Drinking alcohol while taking this medicine may make you feel more drowsy or increase the risk of serious adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness. It is recommended not to drink alcohol while taking oxycodone/naloxone.

You should avoid drinking grapefruit juice while taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

These tablets should be avoided during pregnancy as much as possible. If used over prolonged periods during pregnancy, oxycodone hydrochloride may cause withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during labor, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Breastfeeding must be discontinued during treatment with these tablets. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives multiple doses of oxycodone/naloxone.

Driving and using machines

Duoxona may affect your ability to drive and use machinery. This is especially true at the beginning of treatment with oxycodone/naloxone, after a dose increase, or after switching from another medication. However, these adverse effects usually disappear once the dose of this medicine is stabilized.

Oxycodone/naloxone has been associated with drowsiness and episodes of sudden sleep. If you experience these adverse effects, you should not drive or operate machinery. If this occurs, you must inform your doctor.

Ask your doctor whether you can drive or use machines during treatment with Duoxona.

Duoxona contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Duoxona

Follow exactly the administration instructions for this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Duoxona is a prolonged-release tablet, which means that the active substances are released over an extended period of time. Its action lasts for 12 hours.

The tablet must be swallowed whole and must not be divided, broken, chewed, or crushed.

To avoid impairing the prolonged-release properties of the tablet, it must not be crushed or chewed, as this may cause the absorption of a potentially lethal dose of oxycodone hydrochloride (see “If you take more Duoxona than you should”).

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using Duoxona, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking Duoxona”).

Unless otherwise directed by your doctor, the usual dose is:

For the treatment of pain

Adults

The usual initial dose is 10 mg of oxycodone hydrochloride / 5 mg of naloxone hydrochloride in prolonged-release tablets every 12 hours.

Your doctor will decide the daily dose you should take and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide whether the dose needs to be adjusted during treatment. Your dose will be adapted according to the severity of your pain and your individual sensitivity. You should receive the lowest dose necessary to relieve pain. If you have previously received opioid treatment, the initial dose of Duoxona may be higher.

The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you require a higher dose, your doctor may prescribe additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal activity may be affected if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.

If you switch from these tablets to another opioid analgesic, your intestinal function may worsen.

If you experience pain between doses of Duoxona, you may need a fast-acting analgesic. Duoxona is not suitable for treatment in this case. Discuss this with your doctor.

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

For the treatment of pain

Elderly patients

In general, dose adjustment is not necessary in elderly patients with normal kidney and/or liver function.

Liver or kidney impairment

If you have any degree of kidney impairment or mild liver impairment, your doctor will prescribe these tablets with special caution. If you have moderate or severe liver impairment, you must not take these tablets (see also section 2 “Do not take Duoxona” and “Warnings and precautions”).

Children and adolescents under 18 years of age

Duoxona has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in these patients. For this reason, the use of Duoxona is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral use.

Take Duoxona every 12 hours, following a fixed schedule (for example, at 8 a.m. and 8 p.m.).

Swallow these tablets with sufficient liquid (half a glass of water). The tablet must be swallowed whole and must not be divided, broken, chewed, or crushed. You may take the tablets with or without food.

Duration of use

In general, you should not take these tablets longer than necessary. If you are taking these tablets for a prolonged period, your doctor should regularly check whether you still need them.

If you take more Duoxona than you should

If you have taken more tablets than prescribed, you must inform your doctor immediately. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

An overdose may cause:

Constriction of the pupils
Slow and shallow breathing (respiratory depression)
- A brain disorder (known as toxic leukoencephalopathy)
Drowsiness up to loss of consciousness
Low muscle tone (hypotonia)
Reduced heart rate, and
Drop in blood pressure.

In severe cases, loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse may occur, which can be fatal in some instances.

You should avoid situations requiring a high level of alertness, such as driving.

If you forget to take Duoxona

If you forget to take Duoxona or take a lower dose than prescribed, you may no longer feel the analgesic effect.

If you miss a dose, follow the instructions below:

If there are 8 hours or more until your next scheduled dose: Take the missed prolonged-release Duoxona tablet immediately, and continue with your regular dosing schedule.
If there are less than 8 hours until your next scheduled dose: Take the missed prolonged-release Duoxona tablet. Wait another 8 hours before taking the next prolonged-release tablet. Try to return to your original schedule (for example, 8 a.m. and 8 p.m.). Do not take Duoxona more than once within an 8-hour period.

Do not take a double dose to make up for a missed dose.

If you stop taking Duoxona

Do not stop treatment without consulting your doctor. If you no longer need treatment, you should gradually reduce the daily dose after discussing it with your doctor. This will help you avoid withdrawal symptoms such as restlessness, episodes of sweating, and muscle pain.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Important adverse effects to watch for, and what to do if they occur:

If you are already experiencing any of the following important adverse effects, consult your nearest doctor immediately.

Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. This occurs mainly in elderly and weakened patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

The side effects are subdivided below into two sections: treatment for pain and treatment with oxicodone hydrochloride as the sole active substance.

The following adverse effects have been observed in patients receiving treatment for pain

Frequent (may affect up to 1 in 10 patients)

reduced or loss of appetite
insomnia, tiredness or exhaustion
dizziness or sensation that “everything is spinning”
drowsiness
vertigo
hot flushes
abdominal pain, constipation, diarrhoea, dry mouth, indigestion, vomiting (nausea), malaise, flatulence (gas)
headache
itching of the skin, skin reactions/rashes, sweating
feeling of weakness

Uncommon (may affect up to 1 in 100 patients)

hypersensitivity/allergic reactions
restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness
epileptic seizures (especially in people with epileptic disorders or predisposition to seizures), difficulty concentrating
speech disturbance, fainting, tremors
visual disturbances
sensation of chest tightness, especially if you already have coronary heart disease, palpitations
decrease in blood pressure, increase in blood pressure
difficulty breathing, runny nose (rhinorrhea), cough
bloating
increase in liver enzymes, biliary colic
muscle cramps, muscle contractions, muscle pain
increased urgency to urinate
withdrawal symptoms such as agitation, chest pain, chills, general malaise, pain, swelling of hands, ankles and feet
weight loss
injury due to accidents
decreased sexual desire
lack of energy
thirst
taste disturbances

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

increased heart rate
yawning
dental disorders
weight gain
drug dependence

Frequency not known (cannot be estimated from available data)

euphoria, hallucinations, nightmares
skin tingling, severe sedation
breathing problems during sleep (sleep apnoea syndrome); for further information see section 2 “Warnings and precautions”.
respiratory depression
belching
difficulty urinating
erectile dysfunction

It is known that the active substance oxicodone hydrochloride, when not combined with naloxone hydrochloride, has the following adverse effects, different from those listed above:

Oxicodone may cause breathing problems (respiratory depression), pupil constriction, bronchial and smooth muscle cramps, and suppression of the cough reflex.

Frequent (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

dehydration
restlessness, perceptual disturbances (e.g., hallucinations, derealization), drug dependence
difficulty concentrating, migraine, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination abnormalities
hearing difficulties
voice alterations (dysphonia)
difficulty swallowing, condition in which the intestine stops functioning properly (ileus), mouth ulcers, gingivitis
dry skin
fluid retention (oedema), drug tolerance
skin redness
increased concentration of sex hormones which may affect sperm production in men or menstrual cycle in women (menstruation)

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

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

Frequency not known (cannot be estimated from available data)

acute generalized allergic reactions (anaphylactic reactions)
problems with bile flow
absence of menstrual periods
withdrawal syndrome in newborns
dental caries
aggression
increased sensitivity to pain
a condition affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duoxona

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe, closed place, where others cannot access it.

It may cause serious harm and be fatal to people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton or blister, following "EXP". The expiry date refers to the last day of the month indicated.

Blister:

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duoxona

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

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).

The other components are:

Tablet core: Povidone K30, polyvinyl acetate, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of Duoxona and pack contents

Duoxona 5 mg/2.5 mg are prolonged-release, white, round, biconvex tablets with a diameter of 4.7 mm and a height of 4.0 mm.

These tablets are available in child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 or 100 tablets, or in screw-cap child-resistant bottles containing 50, 100 or 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

NEURAXPHARM SPAIN, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 42

79650 Schopfheim

Germany

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Saneca Pharmaceuticals A.S.

Nitrianska 100, Slovakia-920 27 Hlohovec

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic	Duoxona
Germany	Oxycodon-HCl/Naloxon-HCl neuraxpharm 5 mg/2.5 mg; 10 mg/5 mg; 20 mg/10 mg; 30 mg/15 mg; 40 mg/20 mg Retard tablets
Italy	Duoxona
Finland	Duoxona 5 mg/2.5 mg prolonged-release tablets; Duoxona 10 mg/5 mg prolonged-release tablets; Duoxona 30 mg/15 mg prolonged-release tablets; Duoxona 40 mg/20 mg prolonged-release tablets
Slovakia	Duoxona 5 mg/2.5 mg; 10 mg/5 mg; 20 mg/10 mg; 30 mg/15 mg; 40 mg/20 mg prolonged-release tablets
Spain	Duoxona 5 mg/2.5 mg prolonged-release tablets EFG Duoxona 10 mg/5 mg prolonged-release tablets EFG Duoxona 20 mg/10 mg prolonged-release tablets EFG Duoxona 30 mg/15 mg prolonged-release tablets EFG Duoxona 40 mg/20 mg prolonged-release tablets EFG
Iceland	Duoxona 5 + 2.5 mg prolonged-release tablet; Duoxona 10 + 5 mg prolonged-release tablet; Duoxona 20 + 10 mg prolonged-release tablet; Duoxona 30 + 15 mg prolonged-release tablet; Duoxona 40 + 20 mg prolonged-release tablet
Sweden	Duoxona 5 mg/2.5 mg prolonged-release tablet; Duoxona 10 mg/5 mg prolonged-release tablet; Duoxona 20 mg/10 mg prolonged-release tablet; Duoxona 30 mg/15 mg prolonged-release tablet; Duoxona 40 mg/20 mg prolonged-release tablet
Norway	Duoxona 5 mg/2.5 mg prolonged-release tablet; Duoxona 10 mg/5 mg prolonged-release tablet; Duoxona 20 mg/10 mg prolonged-release tablet; Duoxona 30 mg/15 mg prolonged-release tablet; Duoxona 40 mg/20 mg prolonged-release tablet

Date of the most recent review of this leaflet: April 2025

"Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"