Prospect: information for the patient

Oxicodona Sandoz 80 mg prolonged-release tablets EFG

hydrochloride of oxicodona

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

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isOxicodona Sandozand for what it is used

2.What you need to know before starting to takeOxicodona Sandoz

3.How to takeOxicodona Sandoz

4.Possible adverse effects

5.Storage ofOxicodona Sandoz

6.Contents of the package and additional information

Oxicodona Sandoz contains the active ingredient hydrochloride of oxicodona which is a strong analgesic from the opioid group, that acts at central level.

Oxicodona Sandoz is used in adults and older adolescents over 12 years old to treat intense pain, which can only be alleviated with opioid analgesics.

Do not take Oxicodona Sandoz if:

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

-you have respiratory 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 elevated levels of carbon dioxide in the blood,
• you have a heart problem after a long pulmonary disease (cor pulmonale),

-you have intestinal paralysis (paralytic ileus). Symptoms may be that your stomach empties more slowly than usual (delayed gastric emptying) or that you have intense abdominal pain.

Warnings and precautions

Consult your doctor or pharmacist before starting to take oxicodona if

-you are elderly or debilitated,

-your lung function is severely impaired,

-you have liver or kidney problems,

-you have a thyroid disorder, with dryness, coldness, and inflammation of the skin, affecting the face and extremities (myxoedema),

-your thyroid function is impaired,

-you have adrenal insufficiencywhich may cause symptoms such as weakness, weight loss, dizziness, and feeling or being sick(Addison's disease),

-you have an enlarged prostatewhich causes difficulty urinating (in men), have previously experienced symptoms of withdrawal such as agitation, anxiety, tremors, or sweating when stopping taking alcohol or drugs,

-you or a family member has 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 a personality disorder), or have received treatment from a psychiatrist for other mental illnesses,

-you have a mental disorder as a result of intoxication, e.g. with alcohol (toxic psychosis),

-you have pancreatitiswhich may cause severe abdominal and back pain,

-you have problems with your gallbladder or bile duct,

-you have some obstructive or inflammatory intestinal disease,

• 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), which may occur with severe bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting,

-you have epilepsy or a tendency to seizures,

-you are taking monoamine oxidase inhibitors (MAOIs) for the treatment of depressionor for Parkinson's disease or if you have taken this type of medication in the last 2 weeks,

-you are to be operated on or have recently undergone abdominal surgery.

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

Consult your doctor if you have severe upper abdominal pain that may extend to your back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis and biliary tract disease.

Respiratory disorders related to sleep

Oxicodona Sandoz may cause respiratory disorders related to sleep 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, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or another person observes these symptoms, consult 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 mainly in weak and elderly patients and may also cause a decrease in oxygen levels in the blood. This may cause, for example, fainting.

Chronic non-cancer pain

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

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

The chronic use of oxicodona may lead to physical dependence, and withdrawal symptoms may occur after a sudden interruption (see section 3. “If you stop taking Oxicodona Sandoz”). Withdrawal symptoms may include yawning, dilated pupils, abnormal or excessive tear secretion, nasal discharge, tremors, agitation, increased sweating, anxiety, agitation, convulsions, insomnia, and muscle pain. When oxicodona therapy is no longer needed, your doctor will gradually reduce your daily dose to avoid this.

Tolerance, dependence, and addiction

This medication contains oxicodona, which is an opioid medication. The repeated use of opioid analgesics may make the drug less effective (you become accustomed to it, known as tolerance).

The repeated use of Oxicodona Sandoz may also cause dependence, abuse, and addiction, which may lead to a potentially life-threatening overdose. The risk of these side 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.

The risk of becoming dependent or addicted to Oxicodona Sandoz 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 has 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 a personality disorder) or have received treatment from a psychiatrist 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 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 stop taking Oxicodona Sandoz).

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

Increased sensitivity to pain

There may be an increase in sensitivity to pain (hyperalgesia) that does not respond to an additional increase in the dose of oxicodona, especially at high doses. You may need to reduce the dose of oxicodona or switch to an alternative opioid.

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

Like other opioids, oxicodona may affect the normal production of hormones in the body, such as cortisol or sex hormones, particularly if you are taking high doses for a long period.

You may see residues of the tablet in your feces. Do not worry, as the active principle hydrochloride of oxicodona has already been released before, while the tablet passed through your gastrointestinal tract and has begun to be effective in your body.

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

The use of oxicodona as a doping agent may be a health hazard.

Other medications and Oxicodona Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking oxicodona with certain medications that affect brain function (see below) may increase the risk of respiratory depression, especially in cases of overdose in elderly patients, and/or increase the sedative effect of oxicodona (you may feel very drowsy).

The concomitant use of oxicodona and medications that can affect brain function (e.g. sedatives such as benzodiazepines or related medications, see below) increases the risk of somnolence, respiratory depression, coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes oxicodona with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor of all sedatives you are taking and follow your doctor's recommended doses closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Medications that affect brain function:

• other strong analgesics (opioids),
• somnifacients and tranquilizers (sedatives such as benzodiazepines),
• medications for treating depression, such as paroxetine,
• medications used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• medications for treating psychiatric or mental disorders (antipsychotics),
• medications for treating epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
• medications 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, or venlafaxine). These medications may interact with oxicodona and cause symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and a body temperature above 38°C. Contact your doctor if you experience these symptoms.

Other interactions may occur with:

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

Taking Oxicodona Sandoz with food, drinks, and alcohol

Drinking alcohol during treatment with oxicodona may make you feel 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.

Drinking grapefruit juice while taking oxicodona may increase the risk of adverse reactions. You should avoid taking grapefruit juice during treatment with oxicodona.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

• Pregnancy

You should not takeoxicodonaduring pregnancy. There are limited data on the use ofOxicodona Sandozin pregnant women.

Oxicodona crosses the placenta into the fetal circulation.

Prolonged use of oxicodona during pregnancy may cause withdrawal symptoms in the newborn. Use of oxicodona 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 principle oxicodona may pass into breast milk and cause drowsiness (sedation) or slow and shallow breathing (respiratory depression) in the infant.

Driving and operating machinery

Oxicodona may affect your ability to drive and operate machinery.

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

Oxicodona Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication 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 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 interrupt treatment with Oxicodona Sandoz”).

Other concentrations of this medication may be available for dose adjustment.of this medication may be available for dose adjustment.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 hydrochloride of oxicodone at intervals of 12 hours. Your doctor will indicate the necessary dose to treat the pain.

Take two times a day the amount of prolonged-release tablets determined by your doctor.

The subsequent determination of the daily dose, division into individual doses, and any adjustment of the dose during the subsequent course of treatment, should be made by the doctor in charge of the treatment and taking into account previous doses.

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

Some patients to whom oxicodone prolonged-release tablets are administered according to a fixed schedule, need rapid-acting analgesics as rescue medication to control breakthrough pain. Oxicodona prolonged-release tablets are not indicated for the treatment of breakthrough pain.

For the treatment of pain not due to cancer, a daily dose of 40 mg of hydrochloride of oxicodone is usually sufficient, but higher doses may be necessary.

Patients with pain due to cancer usually need daily doses of 80 to 120 mg of hydrochloride of oxicodone, which in some cases can be increased to 400 mg.

During treatment, the relief of pain and other effects should be regularly monitored to achieve the best possible pain treatment, as well as to be able to treat any adverse effect that occurs 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 high-risk patients

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

Administration form

Only by oral route.

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 afternoon following a fixed schedule (e.g. at 8 am and at 8 pm).

Prolonged-release tablets should not be divided, broken, crushed, or chewed, as this would result in rapid release of oxicodone due to alteration of the prolonged-release properties. Administration of broken, crushed, or chewed tablets would result in rapid release and absorption of a potentially lethal dose of the active principle oxicodone (see the section “If you take more Oxicodona Sandoz than you should”).

Oxicodone is only for oral administration. In case of abusive injection (intravenous injection), the excipients of the tablet may cause local tissue destruction (necrosis), changes in lung tissue (pulmonary granulomas), or other severe and potentially fatal effects.

If you take more Oxicodona Sandoz than you should

If you have taken more oxicodone than you should, consult your doctor, pharmacist, or call the Toxicological 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),
• increasing drowsiness that progresses to loss of consciousness,
• decreased muscle tone,
• decreased pulse,

• fall in blood pressure,
• a cerebral disorder (known as toxic leukoencephalopathy).

In severe cases, loss of consciousness (coma), accumulation of fluid in the lungs, and circulatory collapse that can be fatal may occur.

You should never expose yourself to situations that require high concentration, such as driving.

If you forget to takeOxicodona Sandoz

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

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

• If 8 hours or more have elapsed since the next scheduled dose: take the missed dose immediately and continue with your usual dosing schedule.
• If less than 8 hours have elapsed since the next scheduled dose: take the missed dose and wait 8 hours before taking the next dose. Try to return to your usual dosing schedule

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

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

If you interrupt treatment with Oxicodona Sandoz

Do not interrupt treatment without consulting your doctor.

When a patient no longer needs treatment with oxicodone, it may be advisable to gradually reduce the dose to prevent withdrawal symptoms (e.g. yawning, dilation of the pupil of the eye, lacrimation disorder, nasal secretion, 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.

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

The most common side effects are nausea (especially at the beginning of therapy) and constipation. Constipation caused by side effects can be counteracted with preventive measures (such as drinking many liquids, a diet rich in fiber). If you experience nausea or vomiting, your doctor may prescribe a medication.

Side effects or important signs to be aware of and what to do if you are affected:

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

• Sudden hissing, difficulty breathing, swelling of the eyelids, face, or lips, hives, or itching, especially those that cover the entire body. These may be signs of severe allergic reactions.
• Slower or weaker breathing (respiratory depression). This is the most serious side effect with an overdose of strong analgesics such as oxicodone and occurs mainly in elderly and weak patients,
• Decreased blood pressure (you may feel dizzy or faint),
• Constriction of the pupils, muscle spasms in the bronchi (which cause difficulty breathing), reduced ability to cough when needed.

Possible side effects

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

• Drowsiness, drowsiness, dizziness, headache,
• Constipation, feeling sick (nausea), vomiting,
• Itching on 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 weak, fatigue,
• Difficulty breathing, wheezing,
• Dry mouth, hiccups, indigestion, stomach pain, diarrhea,
• Decreased appetite to loss of appetite,
• Hives, increased sweating,
• Painful urination, increased frequency of urination.

Rare(may affect up to 1 in 100 people)

• A condition where you breathe more slowly and weakly than expected (respiratory depression),
• Allergic reactions,
• Dehydration,
• Restlessness, emotional instability, feeling of euphoria,
• Hallucinations, alteration of reality,
• Visual disturbances, constriction of the pupils,
• Problems with hearing, feeling dizzy or "spinning" (vertigo),
• Change in taste,
• Increased muscle tone, involuntary muscle contractions, epileptic seizures (attacks),
• Tickling or numbness, decreased sensitivity to pain or touch,
• Coordination or balance disturbances,
• Memory loss, alteration of concentration, speech disorders,
• Fainting,
• Fast pulse, palpitations of the heart (in the context of withdrawal syndrome),
• Enlargement of blood vessels causing decreased blood pressure,
• Cough, alteration of voice,
• Oral ulcers, inflammation of the gums,
• Flatulence, difficulty swallowing, belching,
• Intestinal obstruction (ileus),
• Decreased libido, impotence, low levels of sex hormones in the blood called hypogonadism (seen in blood tests),
• Injuries due to accidents,
• General feeling of discomfort, pain (e.g. chest pain),
• Swelling of hands, ankles, or feet (edema),
• Migraine,
• Tolerance to the medication,
• Dry skin,
• Thirst,
• Difficulty urinating,
• Chills,
• Physical dependence, including withdrawal symptoms (see section 3 "If you stop taking 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,
• Swollen gums, increased appetite, dark-colored stools, and alterations in the teeth,
• Blisters on the skin and mucous membranes (herpes or oral ulcers), rashes (urticaria),
• Changes in body weight (increase or decrease).

Unknown frequency(cannot be estimated from 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 (which causes stomach pain), biliary congestion,
• Withdrawal syndrome in newborns,
• Becoming addicted or dependent on these tablets,
• Muscle cramps of smooth muscles,
• Depression of the cough reflex,
• Sleep apnea (interruption of breathing during sleep),
• A problem affecting a valve in the intestine, which can cause severe abdominal pain (Oddi sphincter dysfunction).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the 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 medicine.

Keep this medication out of the sight and reach of children.Conserve this medication in a safe and closed location, where other people cannot access it. It can cause severe harm and be fatal to individuals when not prescribed.

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

No special storage conditions are required.

Bottles: Expiration date after the first opening:

6 months.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at 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 of Oxicodona Sandoz 80 mg prolonged-release tablets:

• The active ingredient is hydrochloride of oxicodona.

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

• The other components are:

Tablet core:hydrogenated ricin oil, copovidone, polioxyglycerides of behenoyl, lactose monohydrate, magnesium stearate, cornstarch, anhydrous colloidal silica, medium-chain triglycerides.

Tablet coating:microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E171), iron oxide black (E172), aluminium lake of carminic acid (E132) and aluminium lake of quinoline yellow (E104).

Appearance of Oxicodona Sandoz and packaging contents:

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

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

Packaging sizes:

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

Containers: 50 and 100 prolonged-release tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Lek Pharmaceuticals d.d

Verovskova 57,

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicine 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:OxycodoneDepot 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

Last review date of thisleaflet:April 2025.

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.