Oxycodone/naloxone Viatris 20 mg/10 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxycodone/Naloxone Viatris 20 mg/10 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Oxicodona/Naloxona Viatris is and what it is used for

You have been prescribed Oxicodona/Naloxona Viatris for the treatment of severe pain, which can only be appropriately managed with opioid analgesics.

How Oxicodona/Naloxona Viatris relieves pain

Oxicodona/Naloxona Viatris contains as active substances oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of Oxicodona/Naloxona Viatris; it is a potent analgesic belonging to the group of medicines known as opioids.

The second active substance in Oxicodona/Naloxona Viatris, naloxone hydrochloride, functions to counteract constipation. Gastrointestinal dysfunction (e.g., constipation) is a typical side effect of treatment with opioid analgesics.

Oxicodona/Naloxona Viatris is a prolonged-release tablet, meaning that its active substances are released over an extended period. Its effect lasts for 12 hours.

2. What you need to know before taking Oxicodone/Naloxone Viatris

Do not take Oxicodone/Naloxone Viatris

• 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 sufficient oxygen to the blood or remove carbon dioxide produced in the body (respiratory depression),
• if you suffer from 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 problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxicodone/Naloxone Viatris:

• if you are elderly or debilitated (weak),
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver problems,
• if you have severe lung problems (i.e., reduced ability to breathe),
• if you have a disorder characterized by frequent breathing interruptions causing daytime sleepiness (sleep apnea),
• if you have myxedema (a thyroid disorder characterized by dry, cold, and swollen skin affecting the face and limbs),
• if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if your adrenal glands function poorly, for example, in 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 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), for example, medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if you feel drowsy or fall asleep unexpectedly.

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

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics may make the drug less effective (you become accustomed to it, known as tolerance).

Repeated use of Oxicodone/Naloxone Viatris may cause dependence, abuse, and addiction, which may lead to a life-threatening overdose. The risk of these side 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 varies from person to person. You may have a higher risk of becoming dependent or addicted to Oxicodone/Naloxone Viatris:

• 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 Oxicodone/Naloxone Viatris, it could be a sign that you have become dependent or addicted:

• You need to take the medicine 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 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 it and how to do so safely (see section 3, If you stop taking Oxicodone/Naloxone Viatris).

Talk to your doctor if you have had any of these conditions in the past. Also inform your doctor if you develop any of them during treatment with this medicine.

The most serious consequence of opioid overdose is respiratory depression (slow and shallow breathing). This can also cause blood oxygen levels to drop, potentially leading to fainting, etc.

There is no clinical experience with this medicine in patients with cancer associated with peritoneal metastases or in patients with advanced stages of gastrointestinal or pelvic cancers with initial intestinal obstruction.

Therefore, use of this medicine is not recommended in these patients.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age, as its benefits and safety have not yet been established.

How to take Oxicodone/Naloxone Viatris 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 Oxicodone/Naloxone Viatris

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

Surgery

If you need to undergo surgery, inform the medical staff that you are being treated with oxycodone/naloxone.

Long-term treatment

If you use this medicine for a long time, you may develop tolerance. This means you may need a higher dose to achieve the desired pain relief. Prolonged use of this medicine may also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped abruptly (restlessness, sweating episodes, muscle pain). If you no longer need treatment, the daily dose should be reduced gradually, in consultation with your doctor.

Psychological dependence

The active ingredient oxycodone hydrochloride, when not combined, has the same abuse potential as other strong opioids (potent analgesics). It may lead to psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients who have or have had a history of alcohol, drug, or medication abuse.

Misuse

You must never dissolve the prolonged-release tablets of Oxicodone/Naloxone Viatris for injection (e.g., into a blood vessel). This is because they contain talc, which may cause local tissue destruction (necrosis) and lung tissue abnormalities (pulmonary granuloma). This type of abuse may also have other serious consequences and may even cause death.

Incorrect use of Oxicodone/Naloxone Viatris

Please note that although the tablets can be divided, they must not be broken, chewed, or crushed.

Taking chewed or crushed tablets may affect the slow-release properties of the tablet and lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see "If you take more Oxicodone/Naloxone Viatris than you should").

Abuse

You must never abuse Oxicodone/Naloxone Viatris, especially if you have a substance use disorder. If you are addicted to substances such as heroin, morphine, or methadone, you are likely to experience severe withdrawal symptoms if you misuse this medicine, because it contains the active substance naloxone. Pre-existing withdrawal symptoms may worsen.

Doping

Athletes should be aware that this medicine may cause a positive result in anti-doping tests. The use of oxycodone/naloxone as a doping agent may endanger health.

Other medicines and Oxicodone/Naloxone Viatris

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

The risk of experiencing adverse effects increases if you take this medicine at the same time as medicines that affect brain function. In such cases, the adverse effects of this medicine may be intensified and may become life-threatening. For example, you may experience fatigue/drowsiness, worsening of respiratory depression (slow and shallow breathing), or coma. Therefore, concomitant use should only be considered when no other treatment options are available.

Examples of medicines that affect brain function:

• other strong analgesics (opioids),
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and tranquilizers (sedatives such as benzodiazepines, hypnotics, anxiolytics),
• antidepressants,
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• other medicines used to treat psychiatric or mental disorders (antipsychotics including phenothiazines or neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

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

The risk of adverse effects increases if 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.

Inform your doctor about all sedative medicines you are taking and closely follow your doctor's recommendations. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

Inform your doctor if you are taking any of the following medicines:

• medicines that reduce blood clotting ability (coumarin derivatives), as clotting time may increase or decrease,
• macrolide antibiotics (such as clarithromycin),
• antifungal agents of the -azole type (e.g., ketoconazole),
• ritonavir or other protease inhibitors (used to treat HIV),
• 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).

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

Taking Oxicodone/Naloxone Viatris 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 this medicine.

You should avoid drinking grapefruit juice while taking this medicine.

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

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

Breastfeeding

Breastfeeding must be discontinued during treatment with this medicine. 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 this medicine.

Driving and using machines

This medicine may affect your ability to drive or operate machinery. This is particularly likely at the beginning of treatment, after a dose increase, or after switching to a different medicine. However, these adverse effects usually disappear once you are on a stable dose of oxycodone/naloxone.

Medicines containing oxycodone/naloxone such as Oxicodone/Naloxone Viatris have been associated with drowsiness and episodes of sudden sleep. If you experience this adverse effect, you must not drive or operate machinery. Inform your doctor if you experience these adverse effects.

Consult your doctor to determine whether you can drive or operate machinery.

Oxicodone/Naloxone Viatris contains sodium

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

3. How to take Oxycodeone/Naloxone Viatris

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using Oxycodeone/Naloxone Viatris, 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 Oxycodeone/Naloxone Viatris”).

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 of oxycodone/naloxone you should take and how to divide it into 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 your pain. If you have previously received opioid treatment, the initial dose of this medicine 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 this medicine to another opioid analgesic, your bowel function may worsen.

If you experience pain between doses of this medicine, you may need to take an additional fast-acting analgesic. This medicine is not suitable for treating such episodes. Discuss this with your doctor.

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

Elderly patients

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

Liver or kidney problems

If you have any degree of liver or kidney disorder, or mild liver problems, your doctor will prescribe this medicine with special caution. If you have moderate or severe liver problems, you must not take Oxycodeone/Naloxone Viatris (see also section 2 “Do not take Oxycodeone/Naloxone Viatris” and “Warnings and precautions”).

Children and adolescents under 18 years of age

Oxycodeone/naloxone has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in children and adolescents. For this reason, the use of this medicine is not recommended in children and adolescents under 18 years of age.

Method of administration

Oral use.

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

This medicine should be taken with sufficient fluid (half a glass of water). The tablet may be divided into equal doses. However, it must not be broken, chewed, or crushed. The tablet may be taken with or without food.

Duration of use

In general, you should not take this medicine for longer than necessary. If you are taking this medicine for a long time, your doctor should regularly check whether you still need it.

If you take more Oxycodeone/Naloxone Viatris than you should

If you have taken more oxycodone/naloxone 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, stating 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 narcosis-like state (drowsiness that may progress to loss of consciousness)
• Low muscle tone (hypotonia)
• Reduced heart rate
• Drop in blood pressure
• A brain disorder (known as toxic leukoencephalopathy)

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

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

If you forget to take Oxycodeone/Naloxone Viatris

If you forget to take this medicine or take a smaller 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 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 tablet. Wait another 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 more than one dose within an 8-hour period.

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

If you stop taking Oxycodeone/Naloxone Viatris

Do not stop treatment with this medicine without consulting your doctor.

If you no longer need treatment, you should gradually reduce your 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 will experience them.

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

If you already have any of the following serious adverse effects, consult your nearest doctor immediately.

Slow and shallow breathing (respiratory depression) is the most serious adverse effect of opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

The adverse effects are divided below into two sections: treatment for pain and treatment with oxycodone 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 people)

• reduced or loss of appetite
• difficulty sleeping, tiredness or weakness
• dizziness or sensation of spinning, headache, drowsiness
• vertigo
• flushing
• abdominal pain, constipation, diarrhoea, dry mouth, indigestion, vomiting, nausea, flatulence
• itchy skin, skin reactions, sweating
• general malaise

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity/allergic reactions
• restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness
• decreased sexual desire
• epileptic seizures (especially in people with epilepsy disorders or predisposition to seizures), difficulty concentrating, speech disturbance, fainting, tremor
• disturbances in taste sensation
• feeling drowsy, fatigued, and sluggish (lethargy)
• visual disturbances
• sensation of chest tightness, especially if you already have coronary heart disease, palpitations
• low blood pressure, high blood pressure
• difficulty breathing, runny nose, cough
• abdominal distension
• 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 the hands, ankles or feet
• thirst
• weight loss
• injury from accidents

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

• increased heart rate
• yawning
• dental disorders
• weight gain
• drug dependence

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

• euphoria, hallucinations, nightmares, aggression
• tingling, intense drowsiness
• shallow breathing
• 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 breathing problems (respiratory depression), reduction in pupil size in the eye, bronchial muscle cramps, and cramps in smooth muscles, as well as suppression of the cough reflex.

Frequent (may affect up to 1 in 10 people)

• 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 people)

• dehydration
• agitation, perceptual disturbances (e.g., hallucinations, derealization)
• difficulty concentrating, migraine, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, coordination abnormalities
• hearing difficulties
• blood vessel dilation
• voice changes (dysphonia)
• difficulty swallowing, ileus, mouth ulcers, irritated gums
• dry skin
• swelling due to fluid retention, drug tolerance
• decreased levels of sex hormones which may affect sperm production in men or menstrual cycle in women

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

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

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

• acute generalized allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• dental caries
• problems with bile flow
• a condition affecting a valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)
• absence of menstrual periods
• prolonged use of oxycodone during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to watch for in the baby include irritability, hyperactivity and abnormal sleep patterns, high-pitched crying, tremors, illness, diarrhoea and poor weight gain

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxicodona/Naloxona Viatris

Keep this medicine out of sight and reach of children. Store this medicine in a safe, closed 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 packaging, bottle, or blister pack, after CAD or EXP. The expiry date refers to the last day of the month indicated.

Blister packs:

Do not store above 25°C.

Bottles:

Do not store above 30°C.

Period of validity after first opening: 3 months.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to a SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Oxycodeone/Naloxone Viatris

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone) and 10 mg of naloxone hydrochloride (10.9 mg as naloxone hydrochloride dihydrate, equivalent to 9 mg of naloxone).

The other components are:

Tablet core

Polyvinyl acetate, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.

Tablet coating

Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the pack

White, oblong, biconvex prolonged-release tablet with score lines on both sides, 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.

Oxycodeone/Naloxone Viatris is available in:

Child-resistant blisters: 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets.

Bottles with child-resistant closures: 50, 100, 250 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Develco Pharma GmbH
Grienmatt 27
D-79650 Schopfheim
Germany

Or

Mylan Hungary Kft.
Mylan utca 1
Komárom 2900
Hungary

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Germany: Oxycodon-HCl/Naloxon-HCl Mylan 20 mg/10 mg Retardtabletten
Spain: Oxycodeone/Naloxone Viatris 20 mg/10 mg prolonged-release tablets EFG
Italy: Elatrex
United Kingdom (Northern Ireland): Oxyargin 20 mg/10 mg prolonged-release tablets
Czech Republic: Oxykodon/Naloxon Viatris 20 mg/10 mg tablety s prodlouženým uvolnováním

Date of the most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/