Oxycodone/naloxone Teva 40 mg/20 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxycodone/Naloxone Teva 40 mg/20 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 other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Oxicodona/Naloxona Teva

3. How to take Oxicodona/Naloxona Teva

4. Possible side effects

   1. Storage of Oxicodona/Naloxona Teva

5. Contents of the container and other information

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

Oxicodona/Naloxona Teva 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 adult use only.

Pain relief

You have been prescribed Oxicodona/Naloxona Teva for the treatment of severe pain that can only be adequately managed with opioid analgesics.

Naloxone hydrochloride is added to counteract constipation.

How Oxicodona/Naloxona Teva works in pain relief

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

The second active substance in Oxicodona/Naloxona Teva, 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 Oxicodone/Naloxone Teva

Do not take Oxicodone/Naloxone Teva

• 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 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 condition 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, 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 disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxicodone/Naloxone Teva

• if you are elderly or debilitated (weak),
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney disorders,
• if you have mild liver disorders,
• if you have severe lung disorders (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 limbs),
• 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 with gallstones or have had any other disorder of the biliary tract (a disease affecting bile ducts, gallbladder, etc.),
• if you have an abnormally enlarged 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 this type of medicine 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.

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

Sleep-related breathing disorders

Oxicodone/naloxone 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, trouble staying asleep, 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 had any of these conditions in the past. Also inform your doctor if you develop any of them during treatment with Oxicodone/Naloxone Teva.

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

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 the diarrhea persists beyond this 3- to 5-day period, or if you are concerned, contact your doctor.

Switching to Oxicodone/Naloxone Teva

If you have been receiving high doses of another opioid, you may experience withdrawal symptoms shortly after starting treatment with Oxicodone/Naloxone Teva, such as restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor.

Tolerance, dependence, and addiction

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

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of oxycodone/naloxone may also lead to dependence, abuse, and addiction, which may 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 take it. You may feel that you need to continue taking the medicine, even when it no longer helps relieve your pain or severe restless legs syndrome.

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

• 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 oxycodone/naloxone, 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, e.g., “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop or control the 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 oxycodone/naloxone”).

Advanced gastrointestinal or pelvic cancer

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

Surgery

If you need to undergo surgery, inform your doctors that you are being treated with Oxicodone/Naloxone Teva.

Effect on hormone production

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. If you notice persistent symptoms such as malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased sexual desire, consult your doctor so that your hormone levels can be monitored.

Hyperalgesia

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 change the medicine.

Residues in feces

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

Incorrect use of Oxicodone/Naloxone Teva

Oxicodone/Naloxone Teva is not suitable for the treatment of withdrawal syndrome.

The prolonged-release tablet may be divided into equal doses but must not be chewed or crushed.

Taking chewed or crushed tablets may lead to the absorption of a potentially fatal dose of oxycodone hydrochloride (see section 3, “If you take more Oxicodone/Naloxone Teva than you should”).

Abuse

Oxicodone/Naloxone Teva must never be abused, 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 oxicodone/naloxone, because it contains naloxone. Pre-existing withdrawal symptoms may worsen.

Misuse

You must never dissolve prolonged-release tablets of Oxicodone/Naloxone Teva for injection (e.g., into a blood vessel). In particular, they contain talc, which can cause local tissue destruction (necrosis) and lung tissue damage (pulmonary granuloma). This misuse may also have other serious consequences and may even cause death.

Doping

The use of Oxicodone/Naloxone Teva may result in positive findings in anti-doping tests.

Using Oxicodone/Naloxone Teva as a doping agent may endanger health.

Taking Oxicodone/Naloxone Teva with other medicines

Tell 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 if you take antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including those controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C may occur. Contact your doctor if you experience these symptoms.

The concomitant use of opioids, including oxycodone hydrochloride, and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (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 Oxicodone/Naloxone Teva 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 follow carefully the doses recommended by your doctor. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms. Some examples of sedative or related medicines are:

• other strong analgesics (opioids);
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• 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);

If you take these tablets together with other medicines, the effects of the tablets or 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 time 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 medicine called St. John’s wort (also known as Hypericum perforatum);
• quinidine (a medicine used to treat arrhythmias);
• muscle relaxants;
• medicines used to treat Parkinson’s disease.

No interactions are expected between Oxicodone/Naloxone Teva and paracetamol, acetylsalicylic acid, or naltrexone.

Taking Oxicodone/Naloxone Teva with food, drink, and alcohol

Drinking alcohol while taking Oxicodone/Naloxone Teva may make you feel more drowsy or increase the risk of serious adverse reactions such as shallow breathing with risk of respiratory arrest, and loss of consciousness. It is recommended not to drink alcohol while taking Oxicodone/Naloxone Teva.

You should avoid drinking grapefruit juice while taking Oxicodone/Naloxone Teva.

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 taking this medicine.

Pregnancy

Oxicodone/Naloxone Teva should be avoided during pregnancy unless your doctor considers treatment with this medicine essential. 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 Oxicodone/Naloxone Teva. 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 Oxicodone/Naloxone Teva.

Driving and using machines

Oxicodone/Naloxone Teva may affect your ability to drive and use machines, as it may cause drowsiness or dizziness. This is especially likely at the beginning of treatment with Oxicodone/Naloxone Teva, after a dose increase, or after switching from another medication. However, these adverse effects disappear once the dose of Oxicodone/Naloxone Teva is stabilized.

This medicine has been associated with drowsiness and sudden episodes of falling asleep. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this occurs.

Ask your doctor whether you can drive or use machines.

Oxicodone/Naloxone Teva 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 Teva

Follow exactly the instructions for use of 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 oxycodone/naloxone, 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 Oxycodeone/Naloxone Teva”).

Oxycodeone/Naloxone Teva is a prolonged-release tablet, meaning that the active substances are released over an extended period of time. Its effect lasts for 12 hours.

The prolonged-release tablet may be divided into equal doses but must not be chewed or crushed.

Taking chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxycodeone/Naloxone Teva than you should”).

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 of Oxycodeone/Naloxone Teva you should take and how to divide it into morning and evening doses. Your doctor will also decide whether dose adjustments are needed during treatment. Your dose will be adjusted according to the intensity of your pain and your individual sensitivity. You should receive the lowest effective dose necessary to relieve pain. If you have previously been treated with opioids, the initial dose of Oxycodeone/Naloxone Teva 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 Oxycodeone/Naloxone Teva to another opioid analgesic, your intestinal function may worsen.

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

If you feel that the effect of Oxycodeone/Naloxone Teva 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 impairment

If you have kidney impairment or mild liver impairment, your doctor will prescribe Oxycodeone/Naloxone Teva with special caution. If you have moderate or severe liver impairment, you must not take Oxycodeone/Naloxone Teva (see also section 2 “Do not take Oxycodeone/Naloxone Teva” and “Warnings and Precautions”).

Children and adolescents under 18 years of age

Oxycodeone/Naloxone Teva 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. Therefore, the use of Oxycodeone/Naloxone Teva is not recommended in children and adolescents under 18 years of age.

Method of administration

The tablets are for oral use. You must take Oxycodeone/Naloxone Teva with sufficient liquid (half a glass of water). The tablet may be divided into equal doses but must not be chewed or crushed. You may take the tablet with or without food.

Take Oxycodeone/Naloxone Teva every 12 hours, following a fixed schedule (for example, at 8 a.m. and 8 p.m.).

Duration of use

In general, you should not take Oxycodeone/Naloxone Teva longer than necessary. If you are receiving Oxycodeone/Naloxone Teva for a long time, your doctor should regularly check whether you still need it.

If you take more Oxycodeone/Naloxone Teva than you should

If you have taken more Oxycodeone/Naloxone Teva 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’s packaging and leaflet to the healthcare professional.

An overdose may cause:

• pinpoint pupils
• slow and shallow breathing (respiratory depression)
• drowsiness progressing to loss of consciousness
• low muscle tone (hypotonia)
• reduced heart rate, and
• 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 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 Oxycodeone/Naloxone Teva

If you forget to take Oxycodeone/Naloxone Teva or take a lower dose than prescribed, you may no longer feel its effect.

If you miss a dose, follow the instructions below:

• If 8 hours or more remain until your next scheduled dose: take the missed prolonged-release tablet of Oxycodeone/Naloxone Teva immediately, and continue with your normal dosing schedule.
• If less than 8 hours remain until your next scheduled dose: take the missed prolonged-release tablet of Oxycodeone/Naloxone Teva. 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 Oxycodeone/Naloxone Teva more than once within an 8-hour period.

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

If you stop treatment with Oxycodeone/Naloxone Teva

Do not stop treatment with Oxycodeone/Naloxone Teva 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 which you should pay attention, and what to do if you experience them:

If you already have 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 particularly in elderly and debilitated patients. Opioids may also cause a marked decrease in blood pressure in susceptible patients.

The following adverse effects were observed in patients treated for pain:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• bloating

• abnormal thoughts

• anxiety

• confusion

• depression

• nervousness

• feeling of chest tightness, especially if you already have coronary heart disease

• low blood pressure

• withdrawal symptoms such as agitation

• fainting

• loss of energy

• thirst

• altered taste

• palpitations

• biliary colic

• chest pain

• general feeling of discomfort

• pain

• swelling of hands, ankles or feet

• difficulty concentrating

• speech disturbance

• tremor

• difficulty breathing

• restlessness

• chills

• increased liver enzymes

• increased blood pressure

• decreased sexual desire

• rhinorrhea

• cough

• hypersensitivity/allergic reactions

• weight loss

• accident-related injuries

• increased urgency to urinate

• muscle cramps

• muscle contractions

• muscle pain

• visual disturbance

• epileptic seizures (especially in people with epileptic disorders or predisposition to seizures)

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

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

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

• euphoria
• intense somnolence
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• difficulty urinating
• aggression
• tingling of the skin
• belching
• sleep apnoea (interruptions in breathing during sleep)

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), pinpoint pupils, bronchial and smooth muscle spasms, and suppression of the cough reflex.

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• difficulty concentrating
• migraine
• increased muscle tension
• involuntary muscle contractions
• condition in which the bowel stops functioning properly (ileus)
• dry skin
• drug tolerance
• reduced sensitivity to pain or touch
• coordination abnormalities
• voice disturbances (dysphonia)
• swelling due to fluid retention
• hearing difficulties
• mouth ulcers
• difficulty swallowing
• gingivitis
• perceptual disturbances (e.g. hallucinations, derealization)
• redness of the skin
• dehydration
• agitation
• 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)

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

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

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

The following adverse effects have been observed:

Very frequent (may affect more than 1 in 10 people)

• headache
• somnolence
• constipation
• malaise
• sweating
• tiredness or fatigue

Frequent (may affect up to 1 in 10 people)

• decreased or loss of appetite
• difficulty sleeping
• depression
• dizziness or sensation that “everything is spinning”
• difficulty concentrating
• tremor
• tingling in hands or feet
• visual disturbances
• vertigo
• hot flushes
• low blood pressure
• high blood pressure
• abdominal pain
• dry mouth
• vomiting
• increased liver enzymes (increased alanine aminotransferase, increased gamma-glutamyltransferase)
• itching of the skin
• skin reactions/rash
• chest pain
• chills
• pain
• thirst

Uncommon (may affect up to 1 in 100 people)

• decreased sexual desire
• episodes of falling asleep suddenly
• disturbances in taste sensation
• difficulty breathing
• flatulence
• erectile dysfunction
• withdrawal symptoms such as agitation
• swelling of hands, ankles or feet
• accident-related injuries

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

• hypersensitivity/allergic reactions
• abnormal thoughts
• anxiety
• confusion
• nervousness
• restlessness
• euphoria
• hallucinations
• nightmares
• epileptic seizures (especially in people with epileptic disorders or predisposition to seizures)
• drug dependence
• intense somnolence
• speech disturbance
• fainting
• feeling of chest tightness, especially if you already have coronary heart disease
• palpitations
• increased heart rate
• shallow breathing
• cough
• rhinorrhea
• yawning
• abdominal distension
• diarrhoea
• aggression
• indigestion
• belching
• dental disorders
• biliary colic
• muscle cramps
• muscle contractions
• muscle pain
• difficulty urinating
• increased urgency to urinate
• general malaise
• weight loss
• weight gain
• unusual feeling of weakness
• lack of energy

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxycode/Naloxone Teva

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 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, label, and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Blister pack: Do not store above 25°C.

Bottles: Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxicodona/Naloxona Teva

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

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

Tablet coating

Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and red iron oxide (E172).

Appearance of the product and contents of the pack

Prolonged-release pink, oblong, biconvex tablet, scored on both sides, with a length of 14.2 mm, a width of 6.7 mm and a height of 3.6 – 4.6 mm.

The tablet may be divided into equal doses.

Oxicodona/Naloxona Teva is available in: child-resistant blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 prolonged-release tablets; single-dose perforated child-resistant blisters of 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1 and 100x1 prolonged-release tablets; or child-resistant bottles containing 50, 100, 200 or 250 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura nº 11, Edificio Albatros B, 1st floor

Alcobendas 28108 (Madrid)

Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim 79650

Germany

Saneca Pharmaceuticals A.S.

Nitrianska 100, 920 27 Hlohovec

Slovakia

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

Bulgaria: ?????????/???????? ???? 10 mg/5 mg, 20 mg/10 mg ???????? ? ???????? ?????????????

Croatia: Oksikodon/nalokson Pliva 5 mg/2.5 mg; 10 mg/5 mg; 20 mg/10 mg; 40 mg/20 mg tablete s produljenim oslobadanjem

Finland: Oxycodone/Naloxone ratiopharm 5/2.5, 10/5, 20/10 mg depottabletti

Germany: Oxycodon comp.-AbZ 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg Retardtabletten

Italy: Noxidol 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg

Poland: Oxyduo

Spain: Oxicodona/Naloxona Teva 5/2.5, 10/5, 20/10, 30/15, 40/20 mg prolonged-release tablets EFG

Sweden: Oxycodone/Naloxone Teva

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

Other sources of information

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/81725/P_81725.html