OXICODONE/NALOXONE VIATRIS 40 mg/20 mg EXTENDED-RELEASE TABLETS

2. What you need to know before you take Oxicodona/Naloxona Viatris

Do not take Oxicodona/Naloxona 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 is not sufficient to provide enough oxygen to your blood or to remove the carbon dioxide produced by your body (respiratory depression),
• if you have a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD),
• if you have a condition known as cor pulmonale. This condition consists of the right side of the heart becoming enlarged due to increased pressure inside the blood vessels of the lungs, etc. (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

Consult your doctor or pharmacist before starting to take Oxicodona/Naloxona Viatris:

• if you are an elderly or debilitated patient,
• 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 condition characterized by frequent interruptions of breathing during sleep that make you feel 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 limbs),
• if your thyroid gland does not produce enough hormones (underactive thyroid or hypothyroidism),
• if your adrenal gland functions poorly, e.g. in Addison's disease,
• if you have a mental illness accompanied by a loss (partial) of contact with reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems with gallstones,
• if you have an abnormal increase in the size of the prostate (prostate hypertrophy),
• if you have a history of alcoholism or delirium tremens,
• if you have pancreatitis (inflammation of the pancreas),
• if you have low blood pressure (hypotension),
• if you have high blood pressure (hypertension),
• if you have any 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), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if you feel drowsy or if you fall asleep sometimes.

Contact your doctor if you have severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis or biliary tract disease.

Tolerance, dependence, and addiction

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

Repeated use of Oxicodona/Naloxona Viatris may cause dependence, abuse, and addiction, which can lead to a life-threatening overdose. The risk of these side effects may increase with higher doses and longer treatment duration.

Dependence or addiction can make you feel that you no longer have control over the amount of 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 to 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 Oxicodona/Naloxona Viatris:

• if you or a family member have a history of abuse or dependence on alcohol, prescription medicines, or illegal substances ("addiction"),
• if you smoke,
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental health disorders.

If you notice any of the following signs while taking Oxicodona/Naloxona Viatris, it could be a sign that you have become dependent or addicted.

• You need to take the medicine for a longer period than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medicine for reasons other than those prescribed, e.g. "to feel calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop or control the 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, talk to 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 Oxicodona/Naloxona Viatris).

Tell your doctor if you have had any of these illnesses in the past. Also, inform your doctor if you develop any of these illnesses during treatment with this medicine.

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

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

Therefore, the 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 been established.

How to take Oxicodona/Naloxona Viatris correctly

Diarrhea

If you experience severe diarrhea at the start of treatment, it may be due to the effect of naloxone. It may be a sign that your bowel function is returning to normal. This diarrhea may occur in the first 3 to 5 days of treatment. If it persists after this period or if you are concerned, contact your doctor.

Switching to Oxicodona/Naloxona Viatris

If you have been receiving high doses of another opioid, you may experience withdrawal symptoms soon after starting treatment with this medicine, e.g. restlessness, sweating, 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 symptoms.

Surgery

If you need to undergo surgery, tell the doctors that you are taking oxicodone/naloxone.

Long-term treatment

If you use this medicine for a long time, you may experience tolerance. This means that you will need a higher dose to achieve the desired pain relief. Long-term use of this medicine can also lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped suddenly (restlessness, sweating, muscle pain). If you no longer need treatment, you should gradually reduce the daily dose, consulting your doctor.

Psychological dependence

Oxycodone hydrochloride, the active substance in this medicine, has the same potential for abuse as other potent opioids (strong painkillers). It can create psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with a history of alcohol, drug, or medicine abuse.

Misuse

Never dissolve the prolonged-release tablets of Oxicodona/Naloxona Viatris to inject them (e.g. into a blood vessel). The reason is that they contain talc, which can cause local tissue destruction (necrosis) and changes in lung tissue (pulmonary granuloma). This abuse can also have other serious consequences and even cause death.

Incorrect use of Oxicodona/Naloxona Viatris

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

Taking chewed or crushed tablets can 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 Oxicodona/Naloxona Viatris than you should").

Abuse

Never abuse Oxicodona/Naloxona Viatris, especially if you have a history of substance abuse. If you are addicted to substances like heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse this medicine, as it contains the active substance naloxone. It can worsen pre-existing withdrawal symptoms.

Doping

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

Other medicines and Oxicodona/Naloxona Viatris

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

The risk of experiencing side effects increases if you take this medicine at the same time as medicines that affect brain function. In this case, the side effects of this medicine can be enhanced and life-threatening. For example, you may experience drowsiness or somnolence, or respiratory depression (slow and shallow breathing) or coma may worsen. Due to this, concomitant use should only be considered when other treatment options are not possible.

Examples of medicines that affect brain function:

• other strong painkillers (opioids),
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and sedatives (such as benzodiazepines, hypnotics, anxiolytics),
• antidepressants,
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• other medicines for treating psychiatric or mental disorders (antipsychotics, including phenothiazines or neuroleptics),
• muscle relaxants,
• medicines for treating 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 side effects increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone and may cause symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Tell your doctor about all sedative medicines you are taking and follow your doctor's recommendations closely. It may be useful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

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

• medicines that reduce the blood's ability to clot (coumarin derivatives), the clotting speed 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 for treating stomach ulcers, indigestion, or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures or certain painful conditions),
• phenytoin (used to treat seizures),
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum),
• quinidine (a medicine for treating arrhythmias).

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

Taking Oxicodona/Naloxona Viatris with food, drinks, and alcohol

Drinking alcohol while taking this medicine can make you feel more drowsy or increase the risk of serious side effects such as slow and shallow breathing, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Breastfeeding should be discontinued during treatment with this medicine. Oxycodone hydrochloride passes into breast milk. It is not known whether oxycodone hydrochloride is excreted in breast milk. Therefore, a risk to the breastfed child cannot be excluded, especially if the mother receives repeated doses of this medicine.

Driving and using machines

This medicine may affect your ability to drive or use machines. In particular, this is more likely at the start of treatment with this medicine, after a dose increase, or after switching to a different medicine. However, these side effects disappear once you have a stable dose of oxycodone/naloxone.

Medicines containing oxycodone/naloxone, such as Oxicodona/Naloxona Viatris, have been associated with somnolence and sudden sleep episodes. If you experience this side effect, do not drive or operate machinery. Tell your doctor if you experience these side effects.

Consult your doctor if you can drive or use machines.

Oxicodona/Naloxona Viatris contains sodium

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

3. How to Take Oxicodona/Naloxona Viatris

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using Oxicodona/Naloxona 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 treatment with Oxicodona/Naloxona Viatris").

Unless your doctor tells you otherwise, the usual dose is:

To treat 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 dose of oxycodone/naloxone you should take per day and how to divide it into morning and evening doses. They will also decide if the dose needs to be adjusted during treatment. Your dose will be adapted to your degree of pain and individual sensitivity. You should receive the minimum dose necessary to relieve pain. If you have already received treatment with opioids, the initial dose of this medication may be higher.

The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride should 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 replace this medication with another opioid analgesic, your intestinal function may worsen.

If you experience pain between two doses of this medication, you may need to take an additional fast-acting analgesic. This medication is not suitable for treatment in this case. Discuss this with your doctor.

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

Elderly patients

In general, no dose adjustment is necessary in elderly patients with normal kidney and/or liver function.

Liver or kidney problems

If you have liver or kidney disorders of any degree or mild liver disorders, your doctor will prescribe this medication with special caution. If you have moderate or severe liver disorders, you should not take Oxicodona/Naloxona Viatris (see also section 2 "Do not take Oxicodona/Naloxona Viatris" and "Warnings and precautions").

Children and adolescents under 18 years

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

Method of administration

Oral.

Take this medication every 12 hours, following a fixed schedule (e.g., 8 am and 8 pm).

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

Duration of use

In general, you should not take this medication for longer than necessary. If you receive this medication for a long time, your doctor should regularly check that you still need it.

If you take more Oxicodona/Naloxona Viatris than you should

If you have taken more oxycodone/naloxone than prescribed, inform your doctor immediately.

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the medication leaflet to the healthcare professional.

An overdose can cause:

• constricted pupils
• slow and shallow breathing (respiratory depression)
• a state similar to narcosis (somnolence that can lead to loss of consciousness)
• low muscle tone (hypotonia)
• reduced heart rate
• decreased blood pressure
• a brain disorder (known as toxic leukoencephalopathy)

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

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

If you forget to take Oxicodona/Naloxona Viatris

If you forget to take this medication or take a lower dose than prescribed, you may stop feeling the analgesic effect.

If you forget to take a dose, follow these instructions:

• If there are 8 hours or more until the next normal dose: take the missed prolonged-release tablet immediately, and continue with the normal schedule.
• If there are less than 8 hours until the next normal dose: take the missed prolonged-release tablet. Wait another 8 hours before taking the next prolonged-release tablet. Try to recover the original schedule (e.g., 8 am and 8 pm). Do not take more than one dose within an 8-hour period.

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

If you stop treatment with Oxicodona/Naloxona Viatris

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

If you no longer need to continue treatment, you should gradually reduce the daily dose after discussing it with your doctor. This will help you avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Important side effects to look for and what to do if you experience them:

If you already have any of the following important side effects, consult your doctor immediately.

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

Side effects are subdivided into two sections: pain treatment and treatment with oxycodone hydrochloride as the active substance only.

The following side effects have been observed in patients receiving pain treatment

Frequent (may affect up to 1 in 10 people)

• reduced or lost appetite
• difficulty sleeping, fatigue, or weakness
• feeling dizzy or like "everything is spinning," headache, somnolence
• vertigo
• flushing
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, nausea, flatulence
• itching, 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
• seizures (especially in people with epilepsy or a predisposition to seizures), difficulty concentrating, speech disorders, fainting, tremors
• taste disorders
• feeling somnolent or fatigued and lazy (lethargy)
• vision disorders
• feeling of chest tightness, especially if you already have coronary heart disease, palpitations
• decreased blood pressure, increased blood pressure
• breathing difficulties, runny nose, cough
• abdominal distension
• increased liver enzymes, biliary colic
• muscle cramps, muscle contractions, muscle pain
• increased need to urinate
• withdrawal symptoms such as restlessness, chest pain, chills, general malaise, pain, swelling of the hands, ankles, or feet
• thirst
• weight loss
• accidental injuries

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 somnolence
• shallow breathing
• belching
• urination difficulties
• erectile dysfunction

It is known that the active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, has the following side effects, which are different from those listed:

Oxycodone can cause respiratory problems (respiratory depression), reduced pupil size in the eye, muscle spasms in the bronchial muscles, and muscle spasms in the smooth muscles, as well as depression of the cough reflex.

Frequent (may affect up to 1 in 10 people)

• mood changes and personality changes (e.g., depression, feeling extremely happy), decreased activity, increased activity
• hypo
• urination difficulties

Uncommon (may affect up to 1 in 100 people)

• dehydration
• agitation, perception disorders (e.g., hallucinations, derealization)
• difficulty concentrating, migraines, increased muscle tension, involuntary muscle contractions, reduced pain or touch sensitivity, coordination disorders
• hearing difficulties
• vasodilation
• voice disorders (dysphonia)
• swallowing difficulties, ileus, oral ulcers, irritated gums
• dry skin
• fluid retention, drug tolerance
• decrease in sex hormone levels, which can affect sperm production in men or the menstrual cycle in women

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

• herpes simplex
• increased appetite
• black stools (with a tar-like appearance), gum bleeding
• 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
• bile flow problems
• a problem affecting a valve in the intestine, which can cause severe abdominal pain (sphincter of Oddi dysfunction)
• absence of menstrual periods
• prolonged use of oxycodone during pregnancy can cause life-threatening withdrawal symptoms in newborns. Symptoms to look for in the baby include irritability, hyperactivity, and abnormal sleep patterns, sharp crying, tremors, illness, diarrhea, and weight loss

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Oxicodona/Naloxona Viatris

Keep this medication out of sight and reach of children. Store this medication in a safe and closed place, where others cannot access it. It can cause serious harm and be fatal for people when not prescribed to them.

Do not use this medication after the expiration date shown on the box, bottle, or blister, after CAD or EXP. The expiration date is the last day of the month indicated.

Blister:

Do not store above 25°C.

Bottles:

Do not store above 30°C.

Validity period after first opening: 3 months.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Oxicodona/Naloxona Viatris

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 (21.8 mg as naloxone hydrochloride dihydrate, equivalent to 18 mg of naloxone).

The other ingredients are:

Tablet core

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

Tablet coating

Polyvinyl alcohol, titanium dioxide (E-171), red iron oxide (E-172), macrogol 3350, talc.

Appearance and package contents

Prolonged-release tablet, pink, oblong, biconvex with score lines on both sides, 14.2 mm long, 6.7 mm wide, and 3.6-4.6 mm high.

The tablet can be divided into equal doses.

Oxicodona/Naloxona Viatris is available in:

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

Child-resistant screw-capped bottles: 50, 100, 250 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization 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

You can request more information about this medication from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Germany Oxycodon-HCl/Naloxon-HCl Mylan 40 mg/20 mg Retardtabletten

Slovakia

Spain Oxicodona/Naloxona Viatris 40 mg/20 mg prolonged-release tablets EFG

Italy Elatrex

United Kingdom (Northern Ireland) Oxyargin 40 mg/20 mg prolonged-release tablets

Czech Republic Oxykodon/Naloxon Viatris 40 mg/20 mg prolonged-release tablets

Date of last revision of this leaflet:October 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/