Reltebon

Leaflet accompanying the packaging: patient information

Reltebon, 5 mg, prolonged-release tablets

Reltebon, 10 mg, prolonged-release tablets

Reltebon, 20 mg, prolonged-release tablets

Reltebon, 40 mg, prolonged-release tablets

Reltebon, 80 mg, prolonged-release tablets

Oxycodone hydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Reltebon and what is it used for
• 2. Important information before taking Reltebon
• 3. How to take Reltebon
• 4. Possible side effects
• 5. How to store Reltebon
• 6. Contents of the packaging and other information

1. What is Reltebon and what is it used for

Reltebon contains the active substance oxycodone hydrochloride, which belongs to a group of strong painkillers called opioids.
Reltebon is used in adults and adolescents aged 12 years and older to treat severe pain that can only be controlled with opioid painkillers.

2. Important information before taking Reltebon

When not to take Reltebon

• if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing difficulties (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide in the blood (hypercapnia),
• if you have severe, chronic lung disease with airway obstruction (severe chronic obstructive pulmonary disease, also known as COPD);
• if you have been diagnosed with cor pulmonale (a change in the heart caused by long-term lung disease)
• if you have severe asthma
• if you have a condition where the intestines do not work properly (paralytic ileus)
• if you have a condition with severe abdominal pain, known as "acute abdomen" or delayed gastric emptying.

Warnings and precautions

Before starting to take Reltebon, you should discuss with your doctor or pharmacist:

• if you are elderly or weakened
• if you have severe lung disease
• if you have recurring pauses in breathing during sleep (sleep apnea), as this condition may worsen,
• if you have kidney or liver dysfunction,
• if you have mucous membrane swelling (some thyroid diseases) or thyroid dysfunction,
• if you have adrenal insufficiency (adrenal glands do not work properly), e.g. Addison's disease,
• if you have a mental disorder caused by alcohol or other substance toxicity (toxic psychosis),
• if you have alcoholism
• if you have symptoms of alcohol or other substance withdrawal, such as delirium tremens,
• if you have an enlarged prostate gland (prostatic hypertrophy),
• if you have pancreatitis, which can cause severe abdominal or back pain,
• if you have bile duct disease, biliary colic, and ureteral colic,
• if you have obstructive or inflammatory bowel disease,
• if you have constipation
• in case of increased intracranial pressure, e.g. due to head injury
• if you have epilepsy or are prone to seizures
• if you are taking monoamine oxidase inhibitors (MAOIs) (used to treat depression) or have taken MAOIs in the last 2 weeks (see "Warnings and precautions"),
• if you have recently undergone surgery in the abdominal cavity,
• if the doctor suspects that the intestines are not working properly,
• if you have low blood pressure or decreased blood volume

You should consult your doctor if any of the above conditions apply or have applied to you in the past.
Respiratory depression during sleep
Reltebon may cause sleep-related breathing difficulties, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices such symptoms, you should contact your doctor. Your doctor may consider reducing the dose.
Shallow and slow breathing (respiratory depression).
The main risk associated with opioid overdose is shallow and slow breathing (respiratory depression). This occurs most often in elderly or weakened patients.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. Repeated use of opioid painkillers can lead to reduced efficacy of the medicine (the patient's body gets used to it, which is called tolerance). Repeated use of Reltebon can lead to dependence, abuse, and addiction, which can lead to life-threatening overdose. The risk may be higher when using higher doses for longer periods.
Dependence or addiction can lead to the patient not being able to control how much medicine they take or how often they take it. The patient may feel the need to take the medicine even if it does not relieve the pain.
The risk of developing dependence or addiction varies from person to person. There may be a higher risk of developing addiction or dependence on Reltebon if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription drugs, or illicit drugs ("addiction");
• the patient is a smoker;
• the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental disorders.

If you notice any of the following symptoms while taking Reltebon, it may indicate that you are developing dependence or addiction.

• need to take the medicine for longer than prescribed by the doctor;
• need to take a higher dose than prescribed;
• taking the medicine for reasons other than prescribed, e.g. "to calm down" or "to fall asleep";
• making repeated, unsuccessful attempts to stop or reduce the use of the medicine;
• feeling unwell after stopping the medicine and improving after restarting it ("withdrawal effect").

If you have observed any of these symptoms, you should contact your doctor to discuss the best treatment plan for you, including the right time and safe way to stop treatment (see section 3 "Stopping Reltebon treatment").
Withdrawal symptoms
In case of sudden stopping of treatment, withdrawal symptoms may occur, which may include yawning, pupil dilation, tear disturbances, runny nose, tremors, sweating, anxiety, restlessness, seizures, difficulty sleeping, or muscle pain. When treatment with Reltebon is no longer necessary, your doctor will gradually reduce the daily dose to prevent this.
Chronic non-cancer pain treatment
Opioids are not the first-choice medicines for treating non-cancer pain and are not recommended as the only treatment. Opioids should be used as part of a comprehensive treatment program that includes other medicines and treatment methods. Your doctor should closely monitor your condition and make necessary dose adjustments while taking Reltebon to prevent dependence and abuse.
Pancreatitis and bile duct disease
You should contact your doctor if you experience severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disease.
Increased sensitivity to pain
Rarely, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to increased doses of oxycodone. If such a condition occurs, your doctor may reduce the dose of oxycodone or use a different opioid medicine.
Improper use (injection)
Reltebon is intended for oral use only. In case of improper, intravenous injection (injection into a blood vessel), the excipients of the tablet may cause local tissue breakdown (necrosis), changes in lung tissue (pulmonary granuloma), or other serious, potentially life-threatening events.
Incorrect administration
The tablets should not be broken, crushed, or chewed, as this can lead to rapid release of oxycodone due to destruction of the prolonged-release properties of the tablets. Taking broken, crushed, or chewed Reltebon tablets can lead to rapid release and absorption of a potentially fatal dose of oxycodone by the patient's body (see section 3 "Taking a higher dose of Reltebon than prescribed").
Surgery (operations)
It is not recommended to take Reltebon before surgery or within 24 hours after surgery. If you are going to have surgery, you should tell your doctors that you are taking Reltebon.
Hormonal changes
Like other opioids, Reltebon may affect the normal production of hormones in the body, such as cortisol or sex hormones, especially if you have taken high doses for a long time. Symptoms that may occur include nausea or vomiting, loss of appetite, fatigue, dizziness, sexual dysfunction, changes in menstrual cycle, or impotence. You should discuss this with your doctor.

Children

Reltebon should not be used in children under 12 years of age, as the safety and efficacy of this age group have not been established.

Reltebon and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of opioids, including Reltebon, with sedative medicines such as benzodiazepines or similar medicines, increases the risk of sedation, breathing difficulties (respiratory depression), coma, and life-threatening conditions. Therefore, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Reltebon to be taken with sedative medicines, the dose and duration of treatment should be limited by your doctor.
You should tell your doctor about all sedative medicines you are taking and follow your doctor's instructions regarding dosage. It is helpful to inform friends or relatives about the possibility of the above symptoms. You should contact your doctor if such symptoms occur.
Side effects caused by taking Reltebon may occur more frequently or be severe when Reltebon is taken in combination with medicines that affect brain function.
Examples of side effects that may occur in this case are: shallow and slow breathing (respiratory depression).
The risk of side effects increases if you are taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). These medicines may interact with oxycodone, causing symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, elevated body temperature above 38°C. If you experience any of these symptoms, you should contact your doctor.
If you take these tablets with other medicines, the effect of these tablets or other medicines may be altered, and the risk of side effects increases. You should tell your doctor or pharmacist if you are taking:

• a type of medicine called monoamine oxidase inhibitors (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid) or if you have taken this type of medicine in the last two weeks (see "Warnings and precautions"),
• medicines that help you sleep or sedate you (e.g. anxiolytics, hypnotics, or sedatives, including benzodiazepines)
• medicines used to treat depression (e.g. paroxetine or fluoxetine)
• medicines used to treat allergies, motion sickness, or vomiting (antihistamines, antiemetics)
• medicines used to treat psychiatric or mental disorders (such as antipsychotics, phenothiazines, or neuroleptics)
• medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin
• medicines called muscle relaxants, used to relieve muscle spasms
• medicines used to treat Parkinson's disease
• other strong painkillers (opioids)
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn)
• medicines used to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole)
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, or telithromycin)
• a specific type of medicine known as protease inhibitors used to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir)
• rifampicin used to treat tuberculosis
• carbamazepine (a medicine used to treat epilepsy, seizures, and certain types of pain)
• phenytoin (a medicine used to treat seizures)
• a herbal medicine called St. John's Wort (also known as Hypericum perforatum)
• quinidine (a medicine used to treat irregular heartbeat)
• blood-thinning medicines such as warfarin (used to reduce the risk of blood clots and thin the blood)

You should also tell your doctor if you have recently undergone anesthesia.

Reltebon with food, drink, and alcohol

You should not consume alcohol while taking Reltebon. Consuming alcohol while taking Reltebon may cause sedation or drowsiness or increase the risk of serious side effects, such as shallow and slow breathing with the risk of respiratory arrest and loss of consciousness.
Grapefruit juice may increase the effect of oxycodone. Therefore, you should avoid consuming grapefruit juice while taking Reltebon.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should avoid taking Reltebon during pregnancy. There are limited data on the use of oxycodone in pregnant women. Oxycodone crosses the placental barrier and enters the newborn's bloodstream.
Long-term use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Infants whose mothers have taken oxycodone in the last 3 to 4 weeks before delivery should be monitored for respiratory depression.
Breastfeeding
You should not take Reltebon while breastfeeding, as oxycodone may pass into breast milk and cause shallow and slow breathing (respiratory depression) in the breastfed child.

Driving and using machines

Oxycodone may affect your ability to drive or operate machines.
This is especially likely at the start of treatment with Reltebon, when the dose is increased, or when Reltebon is taken in combination with medicines that affect brain function.
If treatment is stabilized, restrictions on driving may not apply to you. The decision in each individual case is made by your doctor, taking into account the existing circumstances. You should consult your doctor about the possibility and any conditions for driving or operating machines.

Reltebon contains lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Reltebon

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Reltebon, when and how long you should take it, when to contact your doctor, and when to stop taking it (see also "Stopping Reltebon treatment").

Adults and adolescents (12 years and older)

The recommended initial dose is 5 mg or 10 mg of oxycodone hydrochloride, taken twice a day (every 12 hours). However, your doctor will prescribe the dose necessary to treat your pain and adjust the dosage based on the intensity of the pain and your response to treatment.
Further determination of the daily dose, division into single doses, and any dose adjustments during ongoing therapy will be made by your attending physician based on your previous dosage. Under no circumstances should you change the dose without consulting your doctor. You should always be given the smallest dose sufficient to relieve the pain.
Patients who have previously taken opioids may be prescribed higher doses by their doctor, taking into account their previous response to opioid treatment.
Some patients taking Reltebon according to the established treatment schedule may need a fast-acting painkiller to quickly relieve breakthrough pain.
Reltebon is not indicated for the treatment of breakthrough pain.
You should contact your doctor if you experience breakthrough pain despite pain treatment.
For the treatment of pain other than cancer pain, a daily dose of 40 mg of oxycodone hydrochloride (20 mg taken twice a day) is usually sufficient, but higher doses may be necessary.
Patients with cancer pain usually require doses ranging from 80 mg to 120 mg of oxycodone hydrochloride, which may be increased individually up to 400 mg.

Elderly patients

In elderly patients without liver or kidney dysfunction, dose adjustment is usually not necessary.

Patients with liver or kidney dysfunction or low body weight

Patients with liver or kidney dysfunction or low body weight may be prescribed a lower initial dose by their doctor.

Method of administration

The prolonged-release tablets should be swallowed whole, with a sufficient amount of liquid (half a glass of water), in the morning and evening according to the established schedule (e.g. at 8 am and 8 pm). Reltebon can be taken with or without food.
The prolonged-release tablets should not be broken, chewed, or crushed (see also section 2 "Important information before taking Reltebon").

• 2. Important information before taking Reltebon)

Duration of treatment

Your doctor will inform you how long you should take Reltebon. You should not stop taking Reltebon without consulting your doctor (see "Stopping Reltebon treatment")
If you think that the effect of Reltebon is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Reltebon than prescribed

In case of taking a higher dose of Reltebon than prescribed or accidental ingestion of tablets by another person, you should immediately inform your doctor or local toxicology center.
Overdose may result in:

• pupil constriction,
• shallow and slow breathing (respiratory depression),
• sedation
• muscle weakness,
• decreased blood pressure,
• brain dysfunction (toxic leukoencephalopathy)

In severe cases, it may lead to circulatory failure, lack of mental and physical activity, loss of consciousness, slow heart rate, fluid accumulation in the lungs, low blood pressure, and death; taking large doses of opioid painkillers, such as oxycodone, can lead to death.
You should absolutely avoid situations that require increased concentration, such as driving a vehicle.

Missing a dose of Reltebon

In case of taking a lower dose of Reltebon than prescribed or missing a dose, pain relief may be insufficient or the pain may not subside at all.
You can take the missed tablet if the time to the next scheduled dose of Reltebon is at least 8 hours. Then you can continue taking the medicine according to the previously established schedule.
You can also take the prolonged-release tablets if the next scheduled dose of Reltebon is to be taken in less than 8 hours, but in this case, you should postpone the next dose by 8 hours. In principle, you should not take Reltebon more often than every 8 hours.
You should not take a double dose to make up for a missed dose.

Stopping Reltebon treatment

You should not stop taking Reltebon without consulting your doctor.
In case of stopping Reltebon treatment, withdrawal symptoms may occur (e.g. yawning, pupil dilation, tear disturbances, runny nose, tremors, sweating, anxiety, restlessness, seizures, or difficulty sleeping). Therefore, it may be recommended that your doctor gradually reduce the dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should stop taking Reltebon and contact your doctor immediately:

• sudden breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially those that cover the whole body - these are symptoms of severe allergic reactions (frequency not known: cannot be estimated from the available data)
• shallow and slow breathing - occurs most often in elderly or weakened patients, and is also the main risk factor due to overdose of the medicine (uncommon side effects; may affect up to 1 in 100 people),
• low blood pressure - may cause dizziness and lead to fainting (rare side effect, may affect up to 1 in 1,000 people),
• pupil constriction (uncommon side effect, may affect up to 1 in 100 people),
• bronchial spasms (causing shortness of breath) and inhibition of the cough reflex when necessary (common side effect, may affect up to 1 in 10 people).

Other possible side effects

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

• sedation - is most likely to occur at the start of treatment or when the dose is increased, but usually subsides after a few days
• dizziness, headache
• constipation, nausea (nausea), vomiting
• itching.

Common side effects(may affect up to 1 in 10 people):

• decreased appetite,
• anxiety, confusion, depression, nervousness, difficulty sleeping, abnormal thinking,
• involuntary tremors or lethargy
• shortness of breath, difficulty breathing, or wheezing (dyspnea)
• abdominal pain, diarrhea, dry mouth, indigestion,
• skin reactions and/or rash, excessive sweating
• increased need to urinate
• feeling of weakness (asthenia), fatigue

Uncommon side effects(may affect up to 1 in 100 people):

• hypersensitivity
• abnormal secretion of antidiuretic hormone
• dehydration (dehydration)
• restlessness, mood swings, feeling of well-being, cognitive impairment (e.g. hallucinations, depersonalization)
• decreased sex drive
• physical dependence and withdrawal symptoms (see also section 2 "Warnings and precautions"))
• abnormal muscle stiffness, decreased muscle tone, involuntary muscle contractions
• seizures (especially in people with a history of seizure disorders and a tendency to seizures)
• decreased sensitivity to pain or touch (hypoesthesia), speech disorders, fainting, tingling (paresthesia), coordination disorders, taste changes
• memory loss, migraine
• changes in tear secretion, vision disorders
• increased sensitivity to sound (enhanced hearing), feeling of dizziness or spinning
• rapid heartbeat, feeling of irregular and strong heartbeat (in the context of withdrawal syndrome)
• vasodilation
• voice changes, cough, sore throat, runny nose
• mouth ulcers, gum inflammation, mouth inflammation, difficulty swallowing, gas, belching, intestinal obstruction
• increased liver enzyme activity
• dry skin
• difficulty urinating
• impotence, decreased sex hormone levels
• chills, pain (e.g. in the chest), general malaise, thirst
• excess fluid in the tissues (edema), swelling of the hands, ankles, or feet
• physical dependence with withdrawal symptoms
• need to take increasingly higher doses of Reltebon to achieve the same level of pain relief (tolerance to the medicine)
• injuries due to falls

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

• herpes simplex (skin and mucous membrane disease)
• lymph node enlargement (lymphadenopathy)
• increased appetite
• low blood pressure, dizziness when standing up from a sitting or lying position
• dark, tarry stools, tooth discoloration, gum bleeding
• hives, increased sensitivity to light (photosensitivity)
• blood in the urine
• weight changes (decrease or increase), inflammation of the subcutaneous connective tissue.

Very rare side effects(may affect up to 1 in 10,000 people):

• -peeling rash (exfoliative dermatitis)

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

• aggression
• increased sensitivity to pain, which cannot be relieved by increasing the dose of oxycodone
• sleep apnea (pauses in breathing during sleep)
• tooth decay
• abdominal pain, itching, or jaundice caused by gallbladder inflammation
• a bowel disorder that can cause severe abdominal pain (dysfunction of the Oddi sphincter)
• absence of menstruation (amenorrhea)
• long-term use of Reltebon during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to watch for in the child include irritability, hyperactivity, and abnormal sleep pattern, high-pitched cry, tremors, vomiting, diarrhea, and failure to gain weight.

If you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Measures to be taken

If you experience any side effects from the above list, your doctor will take appropriate action.
To prevent constipation, you should follow a diet rich in fiber and drink plenty of fluids.
If you experience nausea or vomiting, your doctor may prescribe appropriate medicines.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Reltebon

The medicine should be stored out of sight and reach of children .
This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death in a person it has not been prescribed for.
Do not use this medicine after the expiry date stated on the blister, box, and container after: EXP. The expiry date refers to the last day of the month stated.
Blisters:
Do not store above 25°C.
HDPE containers:
5 mg, 10 mg: Do not store above 30°C.
20 mg, 40 mg, 80 mg: No special storage precautions.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Reltebon contains

• The active substance of Reltebon is oxycodone hydrochloride. Each prolonged-release tablet contains 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of oxycodone hydrochloride.
• The other ingredients are: Tablet core:lactose monohydrate, hypromellose, povidone K 30, stearic acid, magnesium stearate, colloidal anhydrous silica. Tablet coating:5 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, indigo carmine, aluminum lake (E132), yellow iron oxide (E172) 10 mg: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80 20 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172)

40 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)
80 mg: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), indigo carmine, aluminum lake (E132), yellow iron oxide (E172)

What Reltebon looks like and contents of the pack

Reltebon,5 mg, prolonged-release tablets:
Blue, round, biconvex tablets, 7 mm in diameter with the inscription "OX 5" on one side.
Reltebon,10 mg, prolonged-release tablets:
White, round, biconvex tablets, 9 mm in diameter with the inscription "OX 10" on one side.
Reltebon,20 mg, prolonged-release tablets:
Pink, round, biconvex tablets, 7 mm in diameter with the inscription "OX 20" on one side.
Reltebon,40 mg, prolonged-release tablets:
Yellow, round, biconvex tablets, 7 mm in diameter with the inscription "OX 40" on one side.
Reltebon,80 mg, prolonged-release tablets:
Green, round, biconvex tablets, 9 mm in diameter with the inscription "OX 80" on one side.
Reltebon is available in blisters (PVC/Al) containing:
5 mg, 10 mg, 20 mg, 40 mg, 80 mg: 30 and 60 prolonged-release tablets
Reltebon is available in blisters (PVC/Al/PET/paper) with a child-resistant closure:
5 mg, 10 mg, 20 mg, 40 mg, 80 mg: 30 and 60 prolonged-release tablets
Reltebon is available in white, round, HDPE containers with a PP cap, with a child-resistant closure, containing 98 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður
Iceland

Manufacturer

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sweden:
Oxikodon Depot Actavis
Bulgaria:
Oxycodone Actavis
Denmark:
Reltebon Depot
Hungary:
Reltebon 10 mg, 20 mg, 40 mg, 80 mg retard tabletta
Iceland:
Oxikodon Depot Actavis
Norway:
Reltebon Depot
Poland:
Reltebon

For further information on this medicine, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00

Date of last revision of the leaflet: February 2025