Duoxona 40 mg/20 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Duoxona 40 mg/20 mg prolonged-release tablets EFG

Oxycodone hydrochloride / naloxone hydrochloride

Read the entire leaflet carefully before you start 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 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

1. What Duoxona is and what it is used for
2. What you need to know before taking Duoxona
3. How to take Duoxona
4. Possible side effects
5. How to store Duoxona
6. Contents of the pack and other information

1. What Duoxona is and what it is used for

Duoxona is a prolonged-release tablet, which means 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

Duoxona has been prescribed to you 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 is responsible for the analgesic effect of Duoxona; it is a potent analgesic belonging to the opioid group.

The second active substance in Duoxona, naloxone hydrochloride, functions to counteract constipation. Gastrointestinal dysfunction (e.g., 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 is unable to supply sufficient 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 known as 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you are an elderly or debilitated (weak) patient,
• 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 cause excessive daytime sleepiness (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 a partial or complete loss of contact 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 abnormally enlarged prostate (prostatic 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 pre-existing cardiovascular 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 also receiving treatment with MAO inhibitors (used to treat depression or Parkinson's disease), for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid,
• if you experience drowsiness or sudden episodes of falling asleep.

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

Inform your doctor if you have previously had any of these conditions. Also notify your doctor if any of these conditions develop during treatment with these tablets.

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.

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

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 continue 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 medication, 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 do not feel well 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 it and how to do so safely (see section 3, If you stop treatment with Duoxona).

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 levels of oxygen 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.

Children and adolescents under 18 years of age

The safety and benefits of oxycodone/naloxone in children and adolescents under 18 years of age have not been established.

How to take Duoxona correctly

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, such as 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.

Surgery

If you need to undergo surgery, inform your doctors that you are taking oxycodone/naloxone.

Long-term treatment

If used long-term, you may develop tolerance to oxycodone/naloxone. This means you may require higher doses to relieve pain. Long-term use of oxycodone/naloxone may lead to physical dependence. If treatment is stopped abruptly, withdrawal symptoms (restlessness, sweating episodes, and menstrual pain) may occur. If treatment is no longer needed, it is advisable to gradually reduce the daily dose with the help of your doctor.

Psychological dependence

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

Incorrect use of Duoxona

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

The tablet may be divided, but must not be broken, chewed, or crushed.

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

Abuse

Oxycodone/naloxone must never be used if you have substance addiction. If you are addicted to substances such as heroin, morphine, or methadone, you are likely to 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 (e.g., into a blood vessel). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and lung tissue abnormalities (pulmonary granuloma). This abuse may also lead to other serious consequences and even result in death.

Doping

Athletes should be aware that the use of this medication may result in positive outcomes in anti-doping controls. The use of oxycodone/naloxone as a doping agent may endanger health.

Taking Duoxona with other medicines

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

The concomitant use of oxycodone/naloxone and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Because of this, 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 must limit the dose and duration of concomitant treatment.

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

With the concomitant use of these tablets and other medicines, the effect of oxycodone/naloxone and of the other medicines may be altered. Inform your doctor if you are taking:

• other strong painkillers (opioids);
• sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);
• medicines used to treat depression;
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
• medicines used to treat psychiatric or mental disorders (antipsychotics including phenothiazines and neuroleptics);
• medicines that reduce blood clotting ability (coumarin derivatives), which may cause blood clotting time to 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 medicine called St. John's Wort (also known as Hypericum perforatum);
• quinidine (a medicine used to treat arrhythmias).

Interactions between oxycodone/naloxone and paracetamol, acetylsalicylic acid, or naltrexone are not 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 the 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 might 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 machines. 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 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 must not drive or operate machinery. If this occurs, you should inform your doctor.

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

3. How to take Duoxona

Follow exactly the instructions for use of this medicine as prescribed by your doctor. If in doubt, 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 effect lasts for 12 hours.

The tablet may be divided, but must not be broken, chewed, or crushed.

To avoid impairing the prolonged-release properties of the tablet, it must not be crushed or chewed, as this could lead to 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 instructed by your doctor, the usual dose is:

For pain treatment

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 determine whether dose adjustments are needed during treatment. Your dose will be adjusted according to the severity of your pain and your individual sensitivity. You should receive the lowest effective dose necessary to relieve your pain. If you have previously been treated with opioids, 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 total daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal function may be reduced if the dose of oxycodone hydrochloride is increased without a corresponding increase in 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 this purpose. 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 pain treatment

Elderly patients

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

Liver or kidney disorders

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

Children and adolescents under 18 years

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. Therefore, the use of Duoxona is not recommended in children and adolescents under 18 years.

Method of administration

Oral use.

Take Duoxona every 12 hours, following a fixed schedule (e.g., 8 a.m. and 8 p.m.).

Swallow these tablets with sufficient liquid (half a glass of water). Do not break, crush, or chew the tablets. The tablets may be taken 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, 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 progressing to loss of consciousness

• Low muscle tone (hypotonia)

• Reduced heart rate, and

• Decreased 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 lose 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 an additional 8 hours before taking the next prolonged-release tablet. Try to return to your original schedule (e.g., 8 a.m. and 8 p.m.). Do not take Duoxona more than once within an 8-hour interval.

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

If you stop taking Duoxona

Do not stop treatment without consulting your doctor. If you no longer need treatment, your daily dose should be gradually reduced after discussion 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 debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

Side effects are subdivided below into two sections: treatment for pain and treatment with the active substance oxycodone hydrochloride alone.

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

Common (may affect up to 1 in 10 patients)

• reduced or loss of appetite
• insomnia, tiredness or exhaustion
• dizziness or sensation of spinning, headache
• drowsiness
• vertigo
• hot flushes
• abdominal pain, constipation, diarrhoea, dry mouth, indigestion, vomiting (nausea), discomfort, flatulence (gas)
• 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 epilepsy or predisposition to seizures), difficulty concentrating
• speech disturbance, fainting, tremors
• visual disturbances
• chest tightness, especially if you already have coronary heart disease, palpitations
• decrease in blood pressure, increase in blood pressure
• difficulty breathing, runny nose, cough
• bloating
• increased 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
• accident-related injuries
• 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

Frequency not known (cannot be estimated from available data)

• euphoria
• skin tingling, severe sedation
• respiratory depression
• belching
• difficulty urinating
• erectile dysfunction

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

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

Common (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
• agitation, perceptual disturbances (e.g. hallucinations, derealization), drug dependence
• difficulty concentrating, migraines, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination abnormalities
• hearing difficulties
• voice disorders (dysphonia)
• difficulty swallowing, condition in which the intestine stops functioning properly (ileus), mouth ulcers, gingivitis
• dry skin
• fluid retention (edema), 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)

• herpes simplex
• increased appetite
• black, tarry stools, bleeding gums
• itchy rash (urticaria)

Frequency not known (cannot be estimated from available data)

• severe generalized allergic reactions (anaphylactic reactions)
• problems with bile flow
• absence of menstrual periods
• withdrawal syndrome in newborns
• dental caries
• aggression
• increased sensitivity to pain
• sleep apnoea (interruptions in breathing during sleep)
• 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 it is a possible adverse effect 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, locked place where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

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

Blister pack:

Do not store above 25 °C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. 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 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).

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), iron oxide red (E172), macrogol 3350, talc.

Appearance of Duoxona and contents of the pack

Duoxona 40 mg/20 mg are prolonged-release, pink, oblong, biconvex tablets with break lines on both sides, measuring 14.2 mm in length, 6.7 mm in width, and 5.0 mm in height. The tablet can be divided into equal doses.

These tablets are available in child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, and 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

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

or

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	Oxycodone HCl/Naloxone HCl neuraxpharm 5 mg/2.5 mg; 10 mg/5 mg; 20 mg/10 mg; 30 mg/15 mg; 40 mg/20 mg prolonged-release 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 tablets; Duoxona 10 + 5 mg prolonged-release tablets; Duoxona 20 + 10 mg prolonged-release tablets; Duoxona 30 + 15 mg prolonged-release tablets; Duoxona 40 + 20 mg prolonged-release tablets
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 and detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"