Oxycodone/naloxone Sandoz 5 mg/2.5 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oxicodone/Naloxone Sandoz 5 mg/2.5 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 others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

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

Oxicodona/Naloxona Sandoz is a prolonged-release tablet, which means that its active substances are released over an extended period of time. Its effect lasts for 12 hours.

These tablets are for adult use only.

Pain relief

You have been prescribed oxicodone/naloxone for the treatment of severe pain that can only be adequately managed with opioid analgesics. Hydrochloride of naloxone is added to counteract constipation.

How these tablets work for pain relief

Oxicodona/Naloxona Sandoz contains as active substances hydrochloride of oxycodone and hydrochloride of naloxone. Hydrochloride of oxycodone is responsible for the analgesic effect of oxicodone/naloxone and is a potent analgesic belonging to the opioid group.

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

2. What you need to know before taking OxyCODONE/NALOXONE Sandoz

Do not take OxyCODONE/NALOXONE Sandoz:

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing problems, such as slower or weaker breathing than expected (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 disorder 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 problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with oxycodone/naloxone:

• if you are elderly or debilitated (weak),
• if you have paralytic ileus (a type of intestinal obstruction) caused by opioids,
• if you have kidney problems,
• if you have mild liver disorder,
• if you have severe lung disease (e.g., 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 dry, cold, and swollen skin, affecting the face and extremities),
• 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 illness accompanied by a (partial) loss of touch with reality (psychosis), due to alcoholism or intoxication by other substances (substance-induced psychosis),
• if you have problems related to gallstones,
• if you have an abnormally enlarged prostate (prostatic 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, Parkinson's disease, or bacterial infections), e.g., medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid,
• if you feel drowsy or if you sometimes fall asleep suddenly.

This medicine may cause breathing problems while you sleep. These problems may include pauses in breathing during sleep, waking up due to breathlessness, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Inform your doctor if you have previously had any of these conditions. Also inform your doctor if you develop any of them during treatment with oxycodone/naloxone.

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

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

Contact your doctor if you experience severe pain in the upper abdomen 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.

If you develop 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 returning to normal. This diarrhea may occur during the first 3 to 5 days of treatment. If it persists beyond this 3- to 5-day period or if you are concerned, contact your doctor.

If you have been taking another opioid, you may experience withdrawal symptoms shortly after starting treatment with oxycodone/naloxone, e.g., restlessness, sweating episodes, and muscle pain. If you experience any of these symptoms, you may require special monitoring by your doctor.

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, fertility issues, or decreased sexual desire, consult your doctor so that your hormone levels can be monitored.

Surgery

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

Long-term treatment

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

Tolerance, dependence, and addiction

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

Psychological dependence

The active ingredient oxycodone hydrochloride, when uncombined, has the same abuse characteristics as other strong opioids (strong analgesics). It may cause psychological dependence. Medicinal products containing oxycodone hydrochloride should be avoided in patients who currently have or have a history of alcohol, drug, or medication abuse.

Incorrect use of Oxicodona/Naloxona Sandoz

These tablets are not suitable for the treatment of withdrawal syndrome.

The tablet must be swallowed whole and must not be divided, broken, chewed, or crushed.

Dividing, breaking, chewing, or crushing the tablets may lead to the absorption of a lethal dose of oxycodone hydrochloride (see section 3 “If you take more Oxicodona/Naloxona Sandoz than you should”).

You must never misuse oxycodone/naloxone, especially if you suffer from drug addiction. If you are addicted to substances such as heroin, morphine, or methadone, you may experience severe withdrawal symptoms if you misuse oxycodone/naloxone, because it contains the active ingredient naloxone. Pre-existing withdrawal symptoms may worsen.

You must also never dissolve these tablets for injection (e.g., into a blood vessel). This is because they contain talc, which can cause local tissue destruction (necrosis) and lung tissue damage (pulmonary granuloma). This type of abuse may also have other serious consequences and can even lead to death.

You may notice remnants of the tablet in your faeces. Do not be alarmed, as the active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released as the tablet passed through the stomach and intestine and have begun to take effect in your body.

Doping

Use of this medicinal product may result in positive anti-doping test results. Using this medicinal product as a doping agent may endanger health.

Children and adolescents

Oxycodone/naloxone has not been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been established in children and adolescents. Therefore, its use is not recommended in children and adolescents under 18 years of age.

Other medicines and Oxicodona/Naloxona Sandoz

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

Concomitant use of oxycodone hydrochloride/naloxone hydrochloride and sedative medicines such as benzodiazepines or related medicines (medicines that may affect brain function, see below) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and follow your doctor’s recommended doses carefully. It may be helpful to inform friends or family members about the signs and symptoms described above. Contact your doctor if you experience such symptoms.

Some examples of medicines that may affect brain function include:

• other strong analgesics (opioids),
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• sleeping pills and tranquilizers (sedative medicines, 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 (phenothiazines, neuroleptics, antipsychotics),
• muscle relaxants,
• medicines used to treat Parkinson’s disease.

The risk of side effects increases if antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) are used. These medicines may interact with oxycodone, and symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience such symptoms.

• 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), which may cause blood clotting to increase or decrease,

• macrolide antibiotics (such as clarithromycin, erythromycin, or telithromycin),

• azole antifungal agents (such as ketoconazole, voriconazole, itraconazole, or posaconazole),

• a specific type of medicine used to treat HIV (protease inhibitors, such as 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).

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

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

You should avoid drinking grapefruit juice while taking oxycodone/naloxone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Breastfeeding must be discontinued during treatment with oxycodone/naloxone. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, the risk to the infant cannot be ruled out, especially if the mother receives multiple doses of this medicine.

Driving and using machines

Oxycodone/naloxone may affect your ability to drive and use machines. This is especially true at the beginning of treatment with this medicine, after a dose increase, or after switching from another medication. However, these adverse effects usually disappear once the dose of this medicine has been stabilised.

Oxycodone/naloxone has been associated with drowsiness and sudden sleep episodes. If you experience these adverse effects, you must not drive or operate machinery. If this occurs, inform your doctor.

Ask your doctor whether you can drive or use machines while being treated with this medicine.

Oxicodona/Naloxona Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; hence, it is essentially “sodium-free”.

3. How to take Oxycodone/Naloxone Sandoz

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

Oxycodone/naloxone is a prolonged-release tablet, which means that the active substances are released over an extended period of time. Its effect lasts for 12 hours.

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

For the treatment of pain

Adults

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

Your doctor will decide the dose of oxycodone/naloxone you should take each day and how to divide the total daily dose between the morning and evening doses. Your doctor will also decide whether it is necessary to adjust the dose during treatment. Your dose will be adapted to the severity of your pain and your individual sensitivity. You should receive the lowest dose necessary to relieve your pain. If you have previously been treated with opioids, the initial dose of oxycodone/naloxone 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 daily dose of oxycodone hydrochloride must not exceed 400 mg. The beneficial effect of naloxone hydrochloride on intestinal function may be reduced if the dose of oxycodone hydrochloride is increased without increasing the dose of naloxone hydrochloride.

If you switch from oxycodone/naloxone to another opioid analgesic, your bowel function may worsen.

If you experience pain between doses of oxycodone/naloxone, you may need a fast-acting analgesic. Oxycodone/naloxone is not suitable for this purpose. Consult your doctor.

If you feel that the effect of oxycodone/naloxone is too strong or too weak, consult your doctor or pharmacist.

Elderly patients

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

Liver or kidney impairment

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

Method of administration

Oral use.

• Take oxycodone/naloxone with a glass of water.

The tablet must be swallowed whole and must not be divided, broken, chewed, or crushed.

• You may take the prolonged-release tablets with or without food.

Take oxycodone/naloxone every 12 hours, following a fixed schedule (e.g., 8 a.m. and 8 p.m.).

[Child-resistant peelable blister:]

How to remove tablets from child-resistant blisters

The tablets are packaged in single-dose child-resistant blisters.

Do not push the tablets through the blister foil.

Remove the tablets as indicated below:

1. Fold the blister along the perforated line.

1. Separate one blister foil along the perforated lines.

1. Carefully peel back the foil from the corner.

Remove the tablet.

[Push-through blister:]

How to remove tablets from child-resistant blisters

The tablets are packaged in single-dose child-resistant blisters.

To remove the tablet, press the tablet through the reinforced blister foil.

Duration of treatment

In general, you should not take oxycodone/naloxone longer than necessary. If you are receiving oxycodone/naloxone for a prolonged period, your doctor should regularly check whether you still need it.

If you take more Oxycodone/Naloxone Sandoz than you should

If you have taken more oxycodone hydrochloride/naloxone hydrochloride than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken.

An overdose may cause:

• pupil constriction,
• slow and shallow breathing (respiratory depression),
• drowsiness up to loss of consciousness,
• low muscle tone (hypotonia),
• reduced heart rate, and
• drop in blood pressure.

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 Oxycodone/Naloxone Sandoz

If you forget to take oxycodone/naloxone or take a lower dose than prescribed, you may no longer feel the analgesic effect.

If you miss a dose, follow the instructions below:

• If 8 hours or more remain until your next scheduled dose: take the missed dose immediately, and continue with your regular dosing schedule.
• If less than 8 hours remain until your next scheduled dose: take the missed dose. Wait an additional 8 hours before taking the next dose. Try to return to your original schedule (e.g., 8 a.m. and 8 p.m.). Do not take oxycodone/naloxone more than once within an 8-hour period.

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

If you stop taking Oxycodone/Naloxone Sandoz

Do not stop treatment with oxycodone/naloxone without consulting your doctor.

If you no longer need treatment, the daily dose should be gradually reduced after discussion with your doctor. This will help you avoid withdrawal symptoms such as restlessness, episodes of sweating, and muscle pain.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

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

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

The following adverse effects have been observed in patients receiving pain treatment:

Frequent (may affect up to 1 in 10 people)

• reduced or loss of appetite,
• difficulty sleeping, tiredness or weakness,
• dizziness or sensation of spinning, headache, drowsiness,
• hot flushes,
• abdominal pain, constipation, diarrhoea, dry mouth, indigestion, nausea, malaise, flatulence,
• skin itching, skin reactions, increased sweating,
• unusual feeling of weakness.

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity/allergic reactions,
• decreased sexual desire,
• restlessness, strange thoughts, anxiety, confusion, depression, nervousness,
• epileptic seizures (especially in people with epilepsy or predisposition to seizures), difficulty concentrating, taste disturbances, speech disturbances, fainting, tremor, loss of energy,
• visual disturbances,
• chest tightness, especially if you already have coronary heart disease, palpitations,
• low blood pressure, high blood pressure,
• difficulty breathing, runny nose, cough,
• abdominal distension,
• increased liver enzymes, biliary colic,
• muscle cramps, muscle contractions, muscle pain,
• increased urgency to urinate,
• withdrawal symptoms such as agitation,
• chest pain,
• chills, general feeling of discomfort, pain, thirst,
• swelling of hands, ankles or feet,
• weight loss,
• accidental injuries.

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

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

Frequency not known (cannot be estimated from available data)

• euphoria, hallucinations, nightmares, aggression,
• tingling, intense drowsiness,
• shallow breathing,
• belching,
• difficulty urinating,
• erectile dysfunction,
• breathing problems during sleep (sleep apnoea syndrome).

It is known that the active substance oxycodone hydrochloride, when not combined with naloxone hydrochloride, has the following adverse effects, different from those listed above:

Oxycodone may cause breathing problems (respiratory depression), pupil constriction, bronchial smooth muscle cramps, and suppression of the cough reflex.

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• infections such as oral herpes or herpes (which may cause blisters around the mouth or genital area),
• increased appetite,
• black, tarry stools, bleeding gums,
• itchy rash (urticaria).

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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 Oxycodeone/Naloxone Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, bottle or blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

Blister:

Do not store above 25°C.

Bottles:

Do not store above 30°C.

Expiry after first opening: 3 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, please 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 Oxycode/Naloxone Sandoz

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg of oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg of naloxone hydrochloride dihydrate, equivalent to 2.25 mg of naloxone).

The other excipients are:

Tablet core:

Polyvinyl acetate
Povidone K30
Sodium lauryl sulfate
Colloidal anhydrous silica
Microcrystalline cellulose
Magnesium stearate

Tablet coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Nature of the product and pack size

White, round, biconvex prolonged-release tablet with a diameter of 4.7 mm and a thickness of 2.9 to 3.9 mm.

Oxycode/Naloxone Sandoz is available in child-resistant single-dose blister packs, perforated for push-through or peelable, made of aluminium/PVC/PE/PVDC, containing 10x1 (hospital pack), 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1 and 100x1 prolonged-release tablets, or

in child-resistant blisters, aluminium/PVC/PE/PVDC, containing 28, 56 and 84 prolonged-release tablets, or in HDPE bottles with child-resistant screw caps containing 50 and 100 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Develco Pharma GmbH
Grienmatt 27, Baden-Wuerttemberg
D-79650 Schopfheim
Germany

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Oxycodon-HCl/Naloxon-HCl HEXAL 5 mg/2.5 mg Retardtabletten
Slovakia: Oxycodone/Naloxone Sandoz 5 mg/2.5 mg
Slovenia: Oksikodon/nalokson Lek 5 mg/2.5 mg tablete s podaljšanim sproščanjem
United Kingdom: Doneloxon 5 mg/2.5 mg Prolonged-release tablets
Finland: Tanonalla 5 mg/2.5 mg depottabletti
Ireland: Dancex SR Plus 5 mg/2.5 mg Prolonged-release tablets
Italy: Ossicodone e Naloxone Sandoz
Czech Republic: Oxycodon/Naloxon Sandoz 5 mg/2.5 mg
Sweden: Oxycodone/Naloxone Sandoz 5 mg/2.5 mg depottabletter
Norway: Tanonalla 5 mg/2.5 mg depottablett
Iceland: Tanonalla 5 mg/2.5 mg forðaðar töflur
Poland: Xanconalon
Portugal: Oxicodona + Naloxona Sandoz 10mg/5mg comprimidos revestidos por película

Date of the most recent revision of this leaflet: June 2025.

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/