OXICODONE/NALOXONE TEVA 10 mg/5 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Oxicodona/Naloxona Teva 10 mg/5 mg prolonged-release tablets EFG

oxycodone hydrochloride/naloxone hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Oxicodona/Naloxona Teva is and what it is used for
2. What you need to know before you take Oxicodona/Naloxona Teva
3. How to take Oxicodona/Naloxona Teva
4. Possible side effects
1. Storing Oxicodona/Naloxona Teva

1. Contents of the pack and further information

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

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

These tablets are for use in adults only.

Pain relief

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

Naloxone hydrochloride is added to counteract constipation.

How Oxicodona/Naloxona Teva works for pain relief

Oxicodona/Naloxona Teva contains the 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 called opioids.

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

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

Do not take Oxicodona/Naloxona 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 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 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 disease.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Oxicodona/Naloxona Teva

• if you are an elderly or debilitated patient (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 disease characterized by frequent pauses in breathing during sleep, which can 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 any mental illness accompanied by a loss (partial) of the notion of reality (psychosis), due to alcoholism or intoxication with other substances (substance-induced psychosis),
• if you have problems with gallstones, or if you have had any other biliary tract disorder (disease affecting the bile ducts, gallbladder, etc.),
• 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 had 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 in the last two weeks, for example, medicines that contain tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid.
• if you experience drowsiness or episodes of sudden sleep.

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.

Sleep-related breathing disorders

Oxicodona/naloxona 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, difficulty maintaining sleep, or excessive daytime sleepiness. 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 serious consequence of opioid overdose is respiratory depression(slow and shallow breathing). This can also cause the oxygen concentration in the blood to decrease, which can lead to fainting, etc.

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 intestinal function is returning to normal. This diarrhea may occur in 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 Oxicodona/Naloxona Teva

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

Tolerance, dependence, and addiction

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

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

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 or 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 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 diseases.

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 a longer period than recommended by your doctor.
• You need to take more doses than prescribed.
• You are using the medicine for reasons other than those prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated attempts to stop or control the use of the medicine without success.
• 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 it safely (see section 3, "If you stop taking oxycodone/naloxone").

Advanced digestive or pelvic cancer

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

Surgery

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

Effect on hormone production

Like other opioids, oxycodone can 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 they can monitor your hormone levels.

Hypersensitivity to pain

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.

Remnants in feces

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

Incorrect use of Oxicodona/Naloxona Teva

Oxicodona/Naloxona Teva is not suitable for the treatment of withdrawal symptoms.

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

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

Abuse

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

Misuse

Never dissolve the prolonged-release tablets of Oxicodona/Naloxona Teva to inject them (e.g. into a blood vessel).

In particular, 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 be fatal.

Doping

The use of Oxicodona/Naloxona Teva may result in positive doping tests.

The use of Oxicodona/Naloxona Teva as a doping agent can endanger your health.

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.

Taking Oxicodona/Naloxona Teva with other medicines

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

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 can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Oxicodona/Naloxona Teva together with sedative medicines, your doctor must limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and follow your doctor's recommended doses carefully. It may be useful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms. Some examples of sedative medicines or related medicines are:

• other potent analgesics (opioids);
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin;
• sleeping pills and tranquilizers (sedatives, including benzodiazepines, hypnotics, anxiolytics);
• medicines for treating 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 at the same time as other medicines, the effects of the tablets or the other medicines described below may change. Tell your doctor if you are taking:

• medicines that reduce the blood's ability to clot (coumarin derivatives), the clotting speed may increase or decrease:
• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin);
• antifungal agents of the azole type (such as ketoconazol, voriconazol, itraconazol, or posaconazol)
• a specific type of medicine known as a protease inhibitor used to treat HIV (e.g. ritonavir, indinavir, nelfinavir, or saquinavir);
• cimetidine (a medicine for treating stomach ulcers, indigestion, or heartburn);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures or certain painful diseases);
• phenytoin (used to treat seizures or certain painful diseases);
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum);
• quinidine (a medicine for treating arrhythmias).
• muscle relaxants;
• medicines for treating Parkinson's disease;

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 can make you feel more drowsy or increase the risk of serious side effects 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Oxicodona/Naloxona Teva should be avoided during pregnancy unless your doctor thinks that treatment with this medicine is essential. 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 Oxicodona/Naloxona Teva. Oxycodone hydrochloride passes into breast milk. It is not known if 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 Oxicodona/Naloxona Teva.

Driving and using machines

Oxicodona/Naloxona Teva can affect your ability to drive and use machines, as it can cause drowsiness or dizziness. This occurs especially at the start of treatment with Oxicodona/Naloxona Teva, after a dose increase, or after switching from another medicine. However, these side effects disappear once the dose of Oxicodona/Naloxona Teva is established.

This medicine has been associated with drowsiness and episodes of sudden sleep. If you experience these side effects, you should not drive or operate machinery. You should inform your doctor if this happens.

Ask your doctor if you can drive or use machines.

Oxicodona/Naloxona Teva 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 Teva

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

Before starting treatment and periodically during treatment, your doctor will discuss with you 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 (see also "If you stop 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. Its action lasts 12 hours.

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

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

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

To treat pain

Adults

The usual initial dose is 10 mg of oxicodona hydrochloride/5 mg of naloxona hydrochloride 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 it is necessary to adjust the dose 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 Oxicodona/Naloxona Teva may be higher.

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

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

If you replace Oxicodona/Naloxona Teva with 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 suitable for treatment in this case. Discuss this with your doctor.

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

To treat pain

Elderly patients

In general, it is not necessary to adjust the dose in elderly patients with normal kidney and/or liver function.

Liver or kidney disorder

If you have kidney or mild liver disorder, your doctor will prescribe Oxicodona/Naloxona Teva with special caution. If you have moderate or severe liver disorder, you should not take Oxicodona/Naloxona Teva (see also 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 in children and adolescents have not been demonstrated. For this reason, the use of Oxicodona/Naloxona Teva is not recommended in children and adolescents under 18 years.

Method of administration

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 it 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

In general, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

An overdose can cause:

• constricted pupils
• slow and shallow breathing (respiratory depression)
• drowsiness 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 may occur, which can be fatal in some cases.

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

If you forget to take Oxicodona/Naloxona Teva

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

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

• If there are 8 hours or more left until the next normal dose: take the missed prolonged-release tablet of Oxicodona/Naloxona Teva immediately, and continue with the normal schedule.
• If there are less than 8 hours left until the next normal dose: take the missed prolonged-release tablet of Oxicodona/Naloxona Teva. 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 Oxicodona/Naloxona Teva more than once in an 8-hour period.

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

If you stop treatment with Oxicodona/Naloxona Teva

Do not stop 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.

4. Possible side effects

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

Important side effects to which you should pay attention, 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 main danger of opioid overdose. It occurs mainly in elderly and debilitated patients. Opioids can also cause a significant decrease in blood pressure in susceptible patients.

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

Common(may affect up to 1 in 10 people)

• abdominal pain
• constipation
• diarrhea
• dry mouth
• indigestion
• vomiting
• discomfort
• flatulence (gas)
• reduced or lost appetite
• feeling of dizziness or spinning
• headache
• flushing
• unusual feeling of weakness
• fatigue or exhaustion
• itching of the skin
• skin reactions/rash
• sweating
• vertigo
• insomnia
• drowsiness

Uncommon(may affect up to 1 in 100 people)

• bloating
• abnormal thoughts
• anxiety
• confusion
• depression
• nervousness
• feeling of chest pressure, especially if you already have coronary heart disease
• decreased blood pressure
• withdrawal symptoms such as agitation
• fainting
• loss of energy
• thirst
• alteration of taste
• palpitations
• biliary colic
• chest pain
• feeling of general discomfort
• pain
• swelling of hands, ankles, or feet
• difficulty concentrating
• speech disorders
• tremors
• breathing difficulties
• restlessness
• chills
• increased liver enzymes
• increased blood pressure
• decreased sexual desire
• runny nose
• cough
• allergic reactions
• weight loss
• accidental injuries
• increased need to urinate
• muscle cramps
• muscle contractions
• muscle pain
• vision disorders

• 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 available data)

• euphoria
• intense drowsiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• urination difficulties
• aggression
• skin tingling
• belching
• sleep apnea (breathing interruptions during sleep)

It is known that the active ingredient oxicodona hydrochloride, if not combined with naloxona hydrochloride, has the following side effects, different from those listed:

Oxicodona may cause respiratory problems (respiratory depression), decreased pupil size, bronchial and smooth muscle spasms, and depression of the cough reflex.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• difficulty concentrating
• migraines
• increased muscle tension
• involuntary muscle contractions
• intestinal dysfunction (ileus)
• dry skin
• drug tolerance
• reduced pain sensitivity or touch
• coordination disorders
• voice disorders (dysphonia)
• water retention
• hearing difficulties
• mouth ulcers
• swallowing difficulties
• gingivitis
• perception disorders (e.g., hallucinations, derealization)
• skin redness
• dehydration
• agitation
• decreased 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)

• urticaria (hives)
• infections such as herpes labialis or herpes (which can cause blisters around the mouth or genital area)
• increased appetite
• black stools (with a tar-like appearance)
• gum bleeding

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

• acute generalized allergic reactions (anaphylactic reactions)
• increased pain sensitivity
• absence of menstrual periods
• withdrawal syndrome in newborns
• bile flow problems, a problem that affects a valve in the intestine, which can cause severe abdominal pain (sphincter of Oddi dysfunction)
• bile flow problems
• dental caries

The following side effects have been observed:

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

• headache
• drowsiness
• constipation
• discomfort
• sweating
• fatigue or exhaustion

Common(may affect up to 1 in 10 people)

• decreased or lost appetite
• sleeping difficulties
• depression
• feeling of dizziness or spinning
• difficulty concentrating
• tremors
• tingling in hands or feet
• vision disorders
• vertigo
• flushing
• decreased blood pressure
• increased blood pressure
• abdominal pain
• dry mouth
• vomiting
• increased liver enzymes (increased alanine aminotransferase, increased gamma-glutamyltransferase)
• skin itching
• skin reactions/rash
• chest pain
• chills
• pain
• thirst

Uncommon(may affect up to 1 in 100 people)

• decreased sexual desire
• sudden sleep episodes
• taste disorders
• breathing difficulties
• flatulence
• erectile dysfunction
• withdrawal symptoms such as agitation
• swelling of hands, ankles, or feet
• accidental injuries

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

• allergic reactions
• abnormal thoughts
• anxiety
• confusion
• nervousness
• restlessness
• euphoria
• hallucinations
• nightmares
• seizures (especially in people with epileptic disorders or predisposition to seizures)
• drug dependence
• intense drowsiness
• speech disorders
• fainting
• feeling of chest pressure, especially if you already have coronary heart disease
• palpitations
• increased heart rate
• shallow breathing
• cough
• runny nose
• yawning
• abdominal distension
• diarrhea
• aggression
• indigestion
• belching
• dental disorders
• biliary colic
• muscle cramps
• muscle contractions
• muscle pain
• urination difficulties
• increased need to urinate
• general discomfort
• weight loss
• weight gain
• unusual feeling of weakness
• lack of energy

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Oxicodona/Naloxona Teva

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, label, and blister pack after "CAD". The expiration date is the last day of the month indicated.

Blister pack: Do not store above 25°C.

Bottles: Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition ofOxycodone/Naloxone Teva

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg of naloxone hydrochloride dihydrate equivalent to 4.5 mg of naloxone).

The other components are:

Tablet core

Polyvinyl acetate, povidone, sodium lauryl sulfate, anhydrous colloidal 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 Container Content

Prolonged-release tablet, pink, oblong, biconvex, scored on both sides, with a length of 10.2 mm, a width of 4.7 mm, and a height of 3.0 – 4.0 mm.

The tablet can be divided into equal doses.

Oxycodone/Naloxone Teva is available in: child-resistant blisters of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 prolonged-release tablets; child-resistant unit-dose perforated blisters of 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, and 100x1 prolonged-release tablets or a bottle with a child-resistant closure 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, 1ª planta

Alcobendas 28108 (Madrid)

Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27, Schopfheim 79650

Germany

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 g 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

Date of the Last 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 for Medicines and Health Products (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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81723/P_81723.html