Prospecto: information for the user

Oxicodona/Naloxona Teva 20 mg/10 mg prolonged-release tablets EFG

hydrochloride of oxicodone/hydrochloride of naloxone

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What is Oxicodona/Naloxona Teva and how it is used

2.What you need to knowbefore starting to takeOxicodona/Naloxona Teva

3.How to take Oxicodona/Naloxona Teva

4.Adverse effects

1. Storage ofOxicodona/Naloxona Teva

6. Contents of the pack and additional information

Oxicodona/Naloxona Teva is a prolonged-release tablet, meaning that its active ingredients are released over a prolonged period of time. Its action lasts 12 hours.

These tablets are only for use in adults.

Pain relief

You have been prescribed Oxicodona/Naloxona Teva for the treatment of intense pain, which can only be adequately treated with opioid analgesics.

Naloxone hydrochloride is added to counteract constipation.

How Oxicodona/Naloxona Teva works in pain relief

Oxicodona/Naloxona Teva contains as active ingredients oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the analgesic effect of Oxicodona/Naloxona Teva and is a potent analgesic that belongs to the group of medications called opioids.Oxycodone hydrochloride is a potent analgesic that belongs to the group of medications called opioids.

The second active ingredient of Oxicodona/Naloxona Teva, naloxone hydrochloride has the function of counteracting constipation. Intestinal dysfunction (e.g. constipation) is a common adverse effect of treatment with opioid analgesics.

Do not take Oxicodona/Naloxona Teva

-if you are allergic to hydrochloride of oxicodona, hydrochloride of naloxona or to any of the other components of this medication (listed in section 6),

-if you are unable to breathe in enough oxygen into your blood or eliminate the carbon dioxide produced in 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 called cor pulmonale. This condition consists of the right side of the heart increasing in size due to the increase in pressure inside the blood vessels of the lung, etc. (for example, 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

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

- 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 disorders,

- if you have mild liver disorders,

- if you have severe lung disorders (i.e., reduced ability to breathe),

- if you have a disease characterized by frequent pauses in breathing during sleep, which may make you feel very drowsy during the day (sleep apnea),

- if you have myxedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin, affecting the face and extremities),

- if your thyroid gland does not produce enough hormones (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 loss (partial) of the notion of reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),

- if you have gallstone problems, or if you have had any other disorder of the biliary tract (disease affecting the bile ducts, gallbladder, etc.),

- if you have an abnormal enlargement of the prostate (prostatic hypertrophy),

- if you have alcoholism or delirium tremens,

- if you have 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 and neck trauma (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), or have taken this type of medication in the past two weeks, for example, medications containing tranilcipromina, phenelzine, isocarboxazide, moclobemide, and linezolid.

- if you experience drowsiness or sudden episodes of sleep.

Respiratory disorders related to sleep

Oxicodona/naloxona may cause respiratory disorders related to sleep such as sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).

The symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor if you have had any of these diseases in the past. Also, inform your doctor if you develop any of them during treatment with Oxicodona/Naloxona Teva.

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

Diarrea

If you experience intense diarrhea at the beginning of treatment, it may be due to the effect of naloxona. It may be a sign that intestinal function is normalizing. This diarrhea may occur in the first 3 to 5 days of treatment. If diarrhea persists after that period of 3 to 5 days, or if you are concerned, contact your doctor.

Change to Oxicodona/Naloxona Teva

If you have been receiving another opioid, you may experience withdrawal symptoms shortly after starting treatment with Oxicodona/Naloxona Teva, for example, restlessness, sweating, and muscle pain. If you experience any of these symptoms, you may need special monitoring by your doctor.

Tolerancia, dependencia y adicción

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

This medication contains oxicodona, which is an opioid medication. Repeated use of opioid analgesics may make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of oxicodona/naloxona may also cause dependence, abuse, and addiction, which may lead to an overdose that puts your life at risk. The risk of these adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to take or how often you need to take it. You may feel that you need to continue taking the medication, even when it no longer helps to 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 oxicodona/naloxona:

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

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

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medication for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep”.
• You have made repeated and unsuccessful attempts to stop or control the use of the medication.
• You do not feel well when you stop taking the medication and feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to analyze the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with oxicodona/naloxona)

Cancer of the digestive or pelvic tract in advanced stages

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

Surgery

If you need to undergo surgery, tell the doctors that you are receiving treatment with Oxicodona/Naloxona Teva.

Effect on hormone production

Like other opioids, oxicodona may affect normal hormone production in the body, such as cortisol or sex hormones, especially if you have to take high doses for long periods of time. If you notice persistent symptoms such as discomfort (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in menstrual cycle, impotence, infertility, or decreased libido, consult your doctor to monitor your hormone levels.

Hypersensitivity

This medication may increase your sensitivity to pain, especially at high doses. Inform your doctor if this occurs. You may need to reduce the dose or change the medication.

Residuals in feces

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

Incorrect use of Oxicodona/Naloxona Teva

Oxicodona/Naloxona Teva is not a treatment for withdrawal syndrome.

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

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

Abuse

You should never abuse Oxicodona/Naloxona Teva, especially if you have a history of addiction. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse oxicodona/naloxona, as it contains naloxona. These symptoms may worsen pre-existing withdrawal symptoms.

Improper use

You should never dissolve the prolonged-release tablets of Oxicodona/Naloxona Teva to inject them (for example, into a blood vessel). In particular, they contain talc, which may cause local tissue destruction (necrosis) and alterations in lung tissue (pulmonary granuloma). This misuse may also have other serious consequences and even cause death.

Doping

The use of Oxicodona/Naloxona Teva may give positive results in antidoping controls.

The use of Oxicodona/Naloxona Teva as a doping agent may put your health at risk.

Taking Oxicodona/Naloxona Teva with other medications

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

The risk of adverse effects increases if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). These medications may interact with oxicodona and you may experience 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.

The concomitant use of opioids, including hydrochloride of oxicodona and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Oxicodona/Naloxona Teva along with sedative medications, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medications you are taking and follow the recommended doses closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms. Some examples of sedative medications or related medications are:

• other potent analgesics (opioids);
• medications to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• somnifacients and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);
• medications to treat depression;
• medications used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
• medications to treat psychiatric or mental disorders (antipsychotics that include phenothiazines and neuroleptics);

If you take these tablets at the same time as other medications, the effects of the tablets or the other medications described below may change. Inform your doctor if you are taking:

• medications that reduce the ability of the blood to coagulate (cumarinic derivatives), the speed of coagulation may increase or decrease:
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• azole antifungals (such as ketoconazole, voriconazole, itraconazole, or posaconazole)
• a specific type of medication known as a protease inhibitor used to treat HIV (for example, ritonavir, indinavir, nelfinavir, or saquinavir);
• cimetidine (a medication to treat stomach ulcers, indigestion, or acid reflux);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures or convulsions and certain painful diseases);
• phenytoin (used to treat seizures or convulsions);
• a medicinal plant called St. John's Wort (also known asHypericum perforatum);
• quinidine (a medication to treat arrhythmias).

No interactions are expected between Oxicodona/Naloxona Teva and paracetamol, acetylsalicylic acid, or naltrexone.

Taking Oxicodona/Naloxona Teva with food, drink, and alcohol

Drinking alcohol while taking Oxicodona/Naloxona Teva may make you feel more drowsy or increase the risk of severe adverse reactions such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking Oxicodona/Naloxona Teva.

You should avoid drinking grapefruit juice while taking Oxicodona/Naloxona Teva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

During pregnancy, Oxicodona/Naloxona Teva will be avoided unless your doctor thinks that treatment with this medication is essential. If you use Oxicodona/Naloxona Teva for prolonged periods during pregnancy, hydrochloride of oxicodona may cause withdrawal symptoms in the newborn. If hydrochloride of oxicodona is administered during delivery, the newborn may experience respiratory depression (slow and shallow breathing).

Breastfeeding

Stop breastfeeding during treatment with Oxicodona/Naloxona Teva. Hydrochloride of oxicodona passes into breast milk. It is not known if hydrochloride of naloxona also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives several doses of Oxicodona/Naloxona Teva.

Driving and operating machinery

Oxicodona/Naloxona Teva may affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness. This occurs especially at the beginning of treatment with Oxicodona/Naloxona Teva, after an increase in dose, or after a change from another medication. However, these adverse effects disappear once the dose of Oxicodona/Naloxona Teva is established.

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

Ask your doctor if you can drive or operate machinery.

Oxicodona/Naloxona Teva contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of oxicodona/naloxona, when and for how long you should take it, when to contact your doctor and when to stop taking it (also see “If you interrupt treatment with Oxicodona/Naloxona Teva”)

Oxicodona/Naloxona Teva is a prolonged-release tablet, which means that the active ingredients are released over a prolonged period of time. Its effect lasts 12 hours.

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

Taking chewed or crushed tablets can lead to the absorption of a potentially fatal dose of hydrochloride oxicodona (see section 3 “If you take more Oxicodona/Naloxona Teva than you should”).

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

For pain treatment

Adults

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

Your doctor will decide the dose of Oxicodona/Naloxona Teva you should take per day and how to divide it into morning and evening doses. They will also decide if you need to adjust the dose during treatment. Your dose will be adjusted to your level 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 Oxicodona/Naloxona Teva may be higher.

The maximum daily dose is 160 mg of hydrochloride oxicodona and 80 mg of hydrochloride naloxona. If you need a higher dose, your doctor may prescribe you more hydrochloride oxicodona without hydrochloride naloxona. However, the maximum daily dose of hydrochloride oxicodona should not exceed 400 mg.

The beneficial effect of hydrochloride naloxona on intestinal activity may be affected if the dose of hydrochloride oxicodona is increased without increasing the dose of hydrochloride naloxona.

If you substitute Oxicodona/Naloxona Teva for another opioid analgesic, it is likely that your intestinal function will worsen.

If you experience pain between two doses of Oxicodona/Naloxona Teva, you may need to take an additional rapid-acting analgesic. Oxicodona/Naloxona Teva is not a treatment for this.

If you think the effect of Oxicodona/Naloxona Teva is too strong or too weak, consult your doctor or pharmacist.

For pain treatment

Older patients

Generally, no dose adjustment is necessary in older patients with normal kidney and/or liver function.

Liver or kidney disorder

If you have a kidney disorder or mild liver disorder, your doctor will prescribe Oxicodona/Naloxona Teva with special caution. If you have a moderate or severe liver disorder, you should not take Oxicodona/Naloxona Teva (also see section 2 “Do not take Oxicodona/Naloxona Teva” and “Warnings and Precautions”).

Children and adolescents under 18 years

Oxicodona/Naloxona Teva has not been studied in children and adolescents under 18 years. Its safety and efficacy have not been demonstrated in children and adolescents. Therefore, the use of Oxicodona/Naloxona Teva in children and adolescents under 18 years is not recommended.

Administration form

The tablets are for oral use. You should take Oxicodona Naloxona Teva with sufficient liquid (half a glass of water). The tablet can be divided into equal doses but should not be chewed or crushed. You can take the tablet with or without food.

Take Oxicodona/Naloxona Teva every 12 hours, following a fixed schedule (e.g., at 8 am and 8 pm).

Duration of use

Generally, you should not take Oxicodona/Naloxona Teva for longer than necessary. If you receive Oxicodona/Naloxona Teva for a long time, your doctor should regularly check that you still need Oxicodona/Naloxona Teva.

If you take more Oxicodona/Naloxona Teva than you should

If you have taken more Oxicodona/Naloxona Teva than prescribed, you should inform your doctor immediately. Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

A overdose can cause:

• pupil constriction

• slow and shallow breathing (respiratory depression)

• drowsiness that can lead 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, it can cause loss of consciousness (coma), fluid accumulation in the lungs, and circulatory collapse, which can be fatal in some cases.

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

If you forgot to take Oxicodona/Naloxona Teva

If you forget to take Oxicodona/Naloxona Teva or if you take a dose lower than prescribed, you may not feel the effect.

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

• If 8 hours or more have passed since the next scheduled dose: take the missed prolonged-release tablet of Oxicodona/Naloxona Teva immediately, and continue with the regular schedule.

• If less than 8 hours have passed since the next scheduled dose: take the missed prolonged-release tablet of Oxicodona/Naloxona Teva. Wait 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 Oxicodona/Naloxona Teva more than once in an 8-hour period.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Oxicodona/Naloxona Teva

Do not interrupt treatment with Oxicodona/Naloxona Teva 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 the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important side effects to be aware of, and what to do if you experience them:

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

The slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids can also cause a severe decrease in blood pressure in susceptible patients.

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

Frequent(may affect up to 1 in 10 people)

• Abdominal pain
• Constipation
• Diarrea
• Dry mouth
• Indigestion
• Vomiting
• Uncomfortable feeling
• Flatulence (gas)
• Loss or decrease of appetite
• Sensation of dizziness or feeling like "everything is spinning"
• Headache
• Seizures
• Unusual feeling of weakness
• Tiredness or fatigue
• Itching skin
• Reactions/skin eruptions
• Sweating
• Dizziness
• Insomnia
• Drowsiness

Less frequent(may affect up to 1 in 100 people)

• Flatulence
• Abnormal thoughts
• Anxiety
• Confusion
• Depression
• Nervousness
• Sensation of chest oppression, especially if you already have coronary heart disease
• Decrease in blood pressure
• Symptoms of withdrawal such as agitation
• Fainting
• Loss of energy
• Thirst
• Alteration of taste
• Palpitations
• Biliary colic
• Chest pain
• General feeling of discomfort
• Pain
• Swelling of hands, ankles, or feet
• Difficulty concentrating
• Alteration of speech
• Trembling
• Difficulty breathing
• Restlessness
• Chills
• Increased liver enzymes
• Increased blood pressure
• Decrease in sexual desire
• Rhinorrhea
• Cough
• Reactions of hypersensitivity/allergic reactions
• Weight loss
• Accidental injuries
• Urgent need to urinate
• Muscle cramps
• Muscle contractions
• Muscle pain
• Vision disturbances

- Seizures (especially in people with epilepsy or predisposition to seizures)

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

• Increased heart rate
• Dependence on the medication
• Dental alterations
• Weight gain
• Yawns

Frequency unknown(frequency cannot be estimated from available data)

• Euphoria
• Intense drowsiness
• Impotence
• Nightmares
• Alucinations
• Shallow breathing
• Difficulty urinating
• Aggression
• Prickling sensation on the skin
• Belching
• Apnea during sleep (interruptions of breathing during sleep)

The active ingredient hydrochloride of oxicodone, if not combined with hydrochloride of naloxone, has the following side effects, different from those mentioned:

Oxicodone can cause respiratory problems (respiratory depression), decrease in pupil size, muscle cramps of the bronchial and smooth muscles, and depression of the cough reflex.

Frequent(may affect up to 1 in 10 people)

• Alteration of mood and changes in personality (e.g. depression, feeling extremely happy)
• Decrease in activity
• Increased activity
• Difficulty urinating
• Constipation

Poorly frequent(may affect up to 1 in 100 people)

• Difficulty concentrating
• Migraines
• Increased muscle tension
• Unintentional muscle contractions
• State in which the intestine stops functioning properly (ileus)
• Dry skin
• Tolerance to the medication
• Reduction of sensitivity to pain or touch
• Coordination anomalies
• Voice alterations (dysphonia)
• Swelling due to water retention
• Auditory difficulties
• Oral ulcers
• Difficulty swallowing
• Gingivitis
• Perception disturbances (e.g. hallucinations, derealization)
• Redness of the skin
• Dehydration
• Agitation
• Decrease in hormone levels that can affect sperm production in men or menstrual cycle in women

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

• Urticaria (hives)
• Infections such as herpes labial or herpes (which can cause blisters around the mouth or genital area)
• Increased appetite
• Black stools (with a tar-like appearance)
• Encrustation of the gums

Frequency unknown(frequency cannot be estimated from available data)

• Reactions to anaphylactic shock
• Increased sensitivity to pain
• Absence of menstrual periods
• Withdrawal syndrome in newborns
• Disfunction of the Oddi sphincter (a condition that affects the normal functioning of the bile duct)
• Problems with bile flow
• Dental caries

The following side effects have been observed:

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

• Headache
• Drowsiness
• Constipation
• Uncomfortable feeling
• Sweat
• Tiredness or fatigue

Frequent(may affect up to 1 in 10 people)

• Decrease or loss of appetite
• Difficulty sleeping
• Depression
• Sensation of dizziness or feeling like "everything is spinning"
• Difficulty concentrating
• Trembling
• Prickling sensation in hands or feet
• Vision disturbances
• Dizziness
• Seizures
• Decrease in blood pressure
• Increased blood pressure
• Abdominal pain
• Dry mouth
• Vomiting
• Increased liver enzymes (increase in alanine aminotransferase, increase in gamma glutamiltransferase)
• Itching skin
• Reactions/skin eruptions
• Chest pain
• Chills
• Pain
• Thirst

Poorly frequent(may affect up to 1 in 100 people)

• Decrease in sexual desire
• Episodes of sudden sleep
• Alteration of taste
• Difficulty breathing
• Flatulence
• Impotence
• Symptoms of withdrawal such as agitation
• Inflammation of hands, ankles, or feet
• Accidental injuries

Frequency unknown(frequency cannot be estimated from available data)

• Reactions of hypersensitivity/allergic reactions
• Abnormal thoughts
• Anxiety
• Confusion
• Nervousness
• Restlessness
• Euphoria
• Alucinations
• Nightmares
• Seizures (especially in people with epilepsy or predisposition to seizures)
• Dependence on the medication
• Intense drowsiness
• Alteration of speech
• Fainting
• Sensation of chest oppression, especially if you already have coronary heart disease
• Palpitations
• Increased heart rate
• Shallow breathing
• Cough
• Rhinorrhea
• Yawns
• Abdominal distension
• Diarrea
• Aggression
• Indigestion
• Belching
• Dental alterations
• Biliary colic
• Muscle cramps
• Muscle contractions
• Muscle pain
• Difficulty urinating
• Urgent need to urinate
• General feeling of discomfort
• Weight loss
• Weight gain
• Unusual feeling of weakness
• Lack of energy

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box, label, and blister after “CAD”.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.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofOxicodona/Naloxona Teva

The active ingredients are hydrochloride of oxicodona and hydrochloride of naloxona.

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

The other components are:

Tablet core

Acrylic acid ester, povidone, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, and magnesium stearate.

Tablet coating

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

Appearance of the product and contents of the package

Prolonged-release tablet, white, oblong, biconvex, scored on both sides, with a length of 11.2 mm, a width of 5.2 mm, and a height of 3.3 – 4.3 mm.

The tablet can be divided into equal doses.

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

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 (Madrid)

Spain

Responsible manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim 79650

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25,

10000Zagreb

Croatia

This medicinal product is authorized in the member states of the European Economic Area with 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, 30/15, 40/20mg 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 5mg/2,5mg, 10mg/5mg, 20mg/10mg, 30mg/15mg, 40mg/20mg

Poland: Oxyduo

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

Sweden: Oxycodone/Naloxone Teva

Last review date of this leaflet:April 2025

Other sources of information

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81724/P_81724.html