OXYCODONE SANDOZ 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Oxicodona Sandoz 80 mg prolonged-release tablets EFG

oxycodone hydrochloride

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Oxicodona Sandoz contains the active substance oxycodone hydrochloride, which is a strong analgesic from the opioid group, acting centrally.

Oxicodona Sandoz is used in adults and adolescents over 12 years of age to treat severe pain, which can only be relieved with opioid analgesics.

2. What you need to know before you take Oxicodona Sandoz

Do not takeOxicodona Sandoz if:

• you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• you have breathing problems, such as severe respiratory depression (respiratory depression), severe chronic obstructive pulmonary disease, or severe bronchial asthma. Symptoms may include difficulty breathing, coughing, slower or weaker breathing than expected,
• you have high levels of carbon dioxide in the blood,
• you have a heart problem after a long lung disease (cor pulmonale),

• you have intestinal paralysis (paralytic ileus). Symptoms may include that your stomach empties more slowly than expected (delayed gastric emptying) or that you have severe abdominal pain.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take oxycodone if

• you are elderly or debilitated,
• you have severely impaired lung function,
• you have liver or kidney problems,
• you have a thyroid disorder, with dryness, coldness, and inflammation of the skin, affecting the face and extremities (myxedema),
• you have impaired thyroid function,
• you have adrenal insufficiency that can cause symptoms including weakness, weight loss, dizziness, and feeling sick (Addison's disease),
• you have prostate enlargement that causes difficulty urinating (in men), have previously experienced withdrawal symptoms such as agitation, anxiety, tremors, or sweating when stopping alcohol or drugs,
• you or a family member have a history of abuse or dependence on alcohol, prescription drugs, or illicit substances ("addiction"),
• you smoke,
• you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses,
• you have a mental disorder as a result of intoxication, e.g. with alcohol (toxic psychosis),
• you have pancreatitis that can cause severe abdominal and back pain,
• you have problems with your gallbladder or bile duct,
• you have an obstructive or inflammatory disease of the intestine,
• you have a head injury, severe headache, or feel unwell, as this may indicate that the pressure in your brain is increased,
• you have low blood pressure,
• you have low blood volume (hypovolemia), this can occur with severe bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting,

• you have epilepsy or are prone to seizures,
• you are taking monoamine oxidase inhibitor (MAOI) medicines for the treatment of depression or Parkinson's disease or if you have taken this type of medicine in the last 2 weeks,
• you are going to have surgery or have recently had abdominal surgery.

Tell your doctor if you have or have had any of the conditions mentioned above.

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 and biliary tract disease.

Sleep-related breathing disorders

Oxicodona Sandoz 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 staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, talk to your doctor. Your doctor may consider reducing the dose.

Respiratory depression

The main danger of an overdose with opioids is slow and shallow breathing (respiratory depression). This occurs especially in weak and elderly patients and can also cause a decrease in oxygen levels in the blood. This can cause, for example, fainting.

Chronic non-cancer pain

Opioids are not the first choice for treating non-cancer pain and are not recommended as the only treatment. In the treatment of chronic pain, other medications should be used in addition to opioids. Your doctor should closely monitor you and make the necessary adjustments to your dose while you are taking oxycodone to prevent addiction and abuse.

Oxycodone can cause dependence. When used for a long period, tolerance to the effects may occur, and higher doses may be needed to maintain pain control.

Chronic use of oxycodone can lead to physical dependence, and withdrawal symptoms may occur after sudden interruption (see section 3, "If you stop taking Oxicodona Sandoz"). Withdrawal symptoms may include yawning, pupil dilation, abnormal or excessive tearing, runny nose, tremors or agitation, increased sweating, anxiety, agitation, seizures, insomnia, and muscle pain. When therapy with oxycodone is no longer necessary, your doctor will gradually reduce your daily dose to avoid this.

Tolerance, dependence, and addiction

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

Repeated use of Oxicodona Sandoz 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 like 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 like you need to keep taking the medication, even when it no longer helps relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Oxicodona Sandoz if:

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

If you notice any of the following signs while taking Oxicodona Sandoz, 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 higher doses than recommended,
• you are using the medication 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 medication without success.
• 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 discuss the best treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, "If you stop taking Oxicodona Sandoz").

The prolonged-release tablets should be administered with special caution in patients with a history of drug and alcohol abuse.

Increased sensitivity to pain

An increase in pain sensitivity (hyperalgesia) may occur, which will not respond to an additional increase in the dose of oxycodone, especially at high doses. It may be necessary to reduce the dose of oxycodone or switch to an alternative opioid.

In the event of abusive injection (intravenous injection), the excipients of the tablet can cause destruction (necrosis) of local tissue, changes in lung tissue (granulomas in the lung), or other potentially fatal serious effects.

Like other opioids, oxycodone can affect the normal production of hormones in the body, such as cortisol or sex hormones, particularly if you are taking high doses for long periods.

You may see residues of the tablet in your stool. Do not worry, as the active substance oxycodone hydrochloride has been released before, while the tablet passed through your gastrointestinal system and has started to take effect in your body.

Athletes should be aware that this medication may produce a positive result in anti-doping tests.

The use of oxycodone as a doping agent can be a health hazard.

Other medicines and Oxicodona Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Taking oxycodone at the same time as certain medicines that affect brain function (see below) can increase the risk of stopping breathing, especially in cases of overdose in elderly patients, and/or increase the sedative effect of oxycodone (you may feel very drowsy).

The concomitant use of oxycodone and medicines that may affect brain function (e.g., sedatives such as benzodiazepines or related medicines, see below) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes oxycodone along with sedative medicines, your doctor should 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 helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor when you experience such symptoms.

Medicines that affect brain function:

• other strong analgesics (opioids),
• sleeping pills and tranquilizers (sedative medicines such as benzodiazepines),
• medicines for treating depression, such as paroxetine,
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• medicines for treating psychiatric or mental disorders (antipsychotics),
• medicines for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• medicines used to treat Parkinson's disease.

The risk of side effects increases if you are taking 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, including muscles that control eye movements, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C. Contact your doctor if you experience such symptoms.

Other interactions may occur with:

• certain medicines that prevent blood clotting (known as coumarin anticoagulants, e.g., warfarin or phenprocoumon). Oxycodone may affect the effects of these,
• muscle relaxants,
• other strong analgesics,
• certain antibiotics (e.g., clarithromycin, erythromycin, or telithromycin),
• rifampicin for treating tuberculosis,
• certain medicines for treating fungal infections (e.g., ketoconazole, voriconazole, itraconazole, or posaconazole),
• certain medicines for treating HIV infection (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
• cimetidine, a medicine for treating stomach ulcers,
• carbamazepine (a medicine for treating spasms or seizures/attacks and certain pain conditions),
• phenytoin, a medicine for treating seizures,
• St. John's Wort, a medicine for treating depression,
• quinidine (a medicine for treating rapid heartbeats),
• monoamine oxidase inhibitors, or if you have taken this type of medicine in the last two weeks (see section 2 "Warnings and precautions").

Taking Oxicodona Sandoz with food, drinks, and alcohol

Drinking alcohol during treatment with oxycodone can make you feel drowsy or increase the risk of serious side effects such as shallow breathing and loss of consciousness. It is recommended not to drink alcohol while taking oxycodone.

Drinking grapefruit juice while taking oxycodone can increase the risk of adverse reactions. You should avoid drinking grapefruit juice during treatment with oxycodone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

You should not take oxycodone during pregnancy. There are limited data on the use of Oxicodona Sandoz in pregnant women.

Oxycodone crosses the placenta into the baby's bloodstream.

Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn. The use of oxycodone during delivery may cause slow and shallow breathing (respiratory depression) in the newborn.

• Breastfeeding

You should not take Oxicodona Sandoz if you are breastfeeding, as the active substance oxycodone may pass into breast milk and cause drowsiness (sedation) or slow and shallow breathing (respiratory depression) in the infant.

Driving and using machines

Oxycodone can affect your ability to drive and use machines.

In patients who are stabilized on a specific dose, it may not affect driving restrictions. Your doctor will make this decision based on your individual case. Consult your doctor about when, or under what conditions, you can drive a vehicle.

Oxicodona Sandoz contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Oxicodona Sandoz

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, 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 Sandoz, 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 taking Oxicodona Sandoz").

Other concentrations of this medicine may be available for dose adjustment.

The recommended dose is:

Adults and adolescents (12 years and older)

The usual initial dose is 10 mg of oxycodone hydrochloride at 12-hour intervals. Your doctor will indicate the necessary dose to treat the pain.

Take the determined number of prolonged-release tablets twice a day, as directed by your doctor.

The subsequent determination of the daily dose, the division into individual doses, and any dose adjustment during the subsequent course of treatment should be carried out by the treating physician, taking into account previous doses.

Patients who have already taken opioids may start treatment with higher doses, considering their previous experience.

Some patients who receive oxycodone prolonged-release tablets on a fixed schedule need fast-acting analgesics as rescue medication to control breakthrough pain. Oxycodone prolonged-release tablets are not indicated for the treatment of breakthrough pain.

For the treatment of non-cancer pain, a daily dose of 40 mg of oxycodone hydrochloride is generally sufficient, but higher doses may be necessary.

Patients with cancer-related pain usually require daily doses of 80 to 120 mg of oxycodone hydrochloride, which in some cases can be increased up to 400 mg.

During treatment, pain relief and other effects should be regularly monitored to achieve the best possible pain treatment, as well as to treat any adverse effects that may occur as soon as possible, and to decide whether to continue treatment.

Children under 12 years

This medication has not been studied in children under 12 years of age. Therefore, its safety has not been demonstrated, and its use is not recommended in children.

Patients with renal and/or hepatic insufficiency

Your doctor may prescribe a lower initial dose.

Other patients at risk

Your doctor may prescribe a lower initial dose if you have a low body weight or if you metabolize medications more slowly.

Method of administration

Oral use only.

Swallow the prolonged-release tablets whole with a sufficient amount of liquid (half a glass of water), with or without food, in the morning and in the evening, following a fixed schedule (e.g., at 8 am and 8 pm).

The prolonged-release tablets should not be divided, broken, crushed, or chewed, as this can lead to rapid release of oxycodone due to alteration of the prolonged-release properties. Administration of broken, chewed, or crushed tablets can lead to rapid release and absorption of a potentially fatal dose of the active ingredient oxycodone (see the section "If you take more Oxicodona Sandoz than you should").

Oxycodone is for oral use only. In case of abusive injection (intravenous injection), the excipients of the tablet can cause destruction (necrosis) of local tissues, changes in lung tissue (granulomas in the lung), or other serious and potentially fatal effects.

If you take more Oxicodona Sandoz than you should

If you have taken more oxycodone than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose may be:

• constriction of the pupils,
• slower or weaker breathing (respiratory depression),
• drowsiness progressing to loss of consciousness,
• decreased muscle tone,
• decreased pulse,

• drop in 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.

Never expose yourself to situations that require a high degree of concentration, such as driving.

If you forget to take Oxicodona Sandoz

If you use a lower dose of oxycodone than prescribed, or forget to take the tablets, pain relief will be insufficient, or will cease completely.

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

• If there are 8 hours or more until the next normal dose: take the forgotten dose immediately and continue with your usual dosing schedule.
• If there are less than 8 hours until the next normal dose: take the forgotten dose and wait another 8 hours before taking the next dose. Try to return to your normal dosing schedule.

Do not take more than one dose in an 8-hour period.

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

If you interrupt treatment with Oxicodona Sandoz

Do not interrupt treatment without consulting your doctor first.

When a patient no longer needs treatment with oxycodone, it may be advisable to gradually decrease the dose to prevent withdrawal symptoms (e.g., yawning, pupil dilation, lacrimation, nasal discharge, tremors, sweating, anxiety, restlessness, convulsions, difficulty sleeping, or muscle pain).

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

The most common adverse effects are nausea (especially at the beginning of therapy) and constipation. Constipation as an adverse effect can be counteracted with preventive measures (such as drinking plenty of fluids, a fiber-rich diet). If you experience nausea or vomiting, your doctor may prescribe medication for you.

Important adverse effects or signs that you should be aware of and what to do if you are affected:

Stop taking oxycodone and consult your doctor or go to your nearest emergency center immediately if you experience any of the following symptoms:

• sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially those that cover the whole body. These can be signs of severe allergic reactions.
• slower or weaker breathing (respiratory depression). This is the most serious adverse effect with an overdose of strong analgesics like oxycodone and occurs mainly in elderly and weak patients,
• decrease in blood pressure (you may feel dizzy or faint),
• reduction in pupil size, muscle spasms in the airways (which can cause difficulty breathing), decreased ability to cough when needed.

Possible adverse effects

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

• sedation, drowsiness, dizziness, headache,
• constipation, feeling sick (nausea), vomiting,
• itching of the skin.

Common(may affect up to 1 in 10 people)

• anxiety, depression, decreased activity, restlessness, increased activity, nervousness, difficulty sleeping, strange thoughts, confusion, tremors,
• lack of energy, feeling of weakness, fatigue,
• difficulty breathing, wheezing,
• dry mouth, hiccups, indigestion, stomach pain, diarrhea,
• decreased appetite up to loss of appetite,
• rash, increased sweating,
• difficulty urinating, increased frequency of urination.

Uncommon(may affect up to 1 in 100 people)

• a condition where you breathe more slowly and weakly than expected (respiratory depression),
• allergic reactions,
• lack of water in the body (dehydration),
• restlessness, emotional lability, feeling of elation,
• hallucinations, alteration of reality,
• visual disturbances, reduction in pupil size,
• hearing problems, feeling of dizziness or "spinning" (vertigo),
• change in taste,
• increased muscle tone, involuntary muscle contractions, epileptic convulsions (seizures),
• tingling or numbness, decreased sensitivity to pain or touch,
• coordination or balance disorders,
• memory loss, concentration disorders, speech disorders,
• fainting,
• rapid heartbeat, heart palpitations (in the context of withdrawal syndrome),
• vasodilation causing a decrease in blood pressure,
• cough, voice alteration,
• mouth ulcers, gum inflammation,
• flatulence, difficulty swallowing, belching,
• intestinal obstruction (ileus),
• decreased sexual desire, impotence, low levels of sex hormones in the blood called hypogonadism (seen in blood tests),
• accidental injuries,
• general feeling of discomfort, pain (e.g., chest pain),
• swelling of hands, ankles, or feet (edema),
• migraine,
• tolerance to the medication,
• dry skin,
• thirst,
• urination problems,
• chills,
• physical dependence, including withdrawal symptoms (see the section "If you interrupt treatment with Oxicodona Sandoz"),
• increased liver enzymes (seen in a blood test).

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

• low blood pressure, dizziness, fainting, caused by a sudden drop in blood pressure when standing up,
• gum bleeding, increased appetite, dark-colored stools, alterations in teeth,
• blisters on the skin and mucous membranes (herpes or oral ulcers), hives (urticaria),
• changes in body weight (increase or decrease).

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

• absence of menstrual bleeding,
• severe allergic reactions that cause difficulty breathing or dizziness,
• aggression,
• increased sensitivity to pain (hyperalgesia),
• dental caries,
• biliary colic (causing stomach pain), biliary congestion,
• withdrawal syndrome in newborns,
• becoming addicted to or dependent on these tablets,
• smooth muscle spasms,
• depression of the cough reflex,
• sleep apnea (interruption of breathing during sleep),
• a problem that affects a valve in the intestine, which can cause severe abdominal pain (disfunction of the Oddi sphincter).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Oxicodona Sandoz

Keep this medication out of 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 who have not been prescribed it.

Do not use this medication after the expiration date that appears on the blister pack, bottle, and packaging after "CAD/EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Bottles: Expiration after the first opening:

6 months.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Oxicodona Sandoz 80 mg prolonged-release tablets:

• The active ingredient is oxycodone hydrochloride.

Each prolonged-release tablet contains 80 mg of oxycodone hydrochloride, equivalent to 71.7 mg of oxycodone.

• The other ingredients are:

Core of the tablet:hydrogenated ricin oil, copovidone, behenoyl polyoxylglycerides, lactose monohydrate, magnesium stearate, corn starch, anhydrous colloidal silica, medium-chain triglycerides.

Coating of the tablet:microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E171), black iron oxide (E172), carmine aluminum lake (E132), and quinoline yellow aluminum lake (E104).

Appearance of Oxicodona Sandoz and package contents

Prolonged-release tablets, film-coated, green, round, biconvex, 9.8-10.4 mm in diameter.

The prolonged-release tablets are packaged in child-resistant blister packs or closed bottles with a child-resistant Twist-off cap, with or without a desiccant capsule, containing silica gel as a desiccant.

Package sizes:

Blister pack: 10, 20, 28, 30, 40, 50, 56, 60, 100, and 112 prolonged-release tablets.

Bottles: 50 and 100 prolonged-release tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovskova 57,

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: Oxycodonhydrochlorid - 1 A Pharma 80 mg Retardtabletten

Belgium: Oxycodon Sandoz 80 mg tabletten met verlengde afgifte

Denmark: Oxycodone Depot Sandoz

Netherlands: Oxycodon HCl Sandoz retard 80mg, tabletten met verlengde afgifte

Sweden: Oxycodone Depot 1A Farma 80 mg depottabletter

Slovenia: Codilek 80 mg tablete s podaljšanim sprošcanjem

Slovakia: Contiroxil 80 mg tablety s predlženým uvolnovaním

United Kingdom

Northern Ireland: Carexil 80 Prolonged release tablets

Date of the last revision of this prospectus:April 2025.

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