Reltebon: detailed information

Package leaflet: Information for the patient

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
oxycodoni hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Reltebon is and what it is used for
Important information before taking Reltebon
How to take Reltebon
Possible side effects
How to store Reltebon
Contents of the pack and other information

1. What Reltebon is and what it is used for

Reltebon contains oxycodone hydrochloride as the active substance.
It is a strong painkiller belonging to a group of medicines called opioids.
Reltebon is used in adults and adolescents (aged over 12 years and older) for the treatment of severe pain that can only be managed with opioid painkillers.

2. Important Information Before Taking Reltebon

When not to take Reltebon

if the patient is allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6),
if the patient has severe respiratory disorders (respiratory depression) with too little oxygen in the blood (hypoxia) and/or excessive carbon dioxide in the blood (hypercapnia),
if the patient suffers from severe chronic lung disease associated with airway obstruction (severe chronic obstructive pulmonary disease, also known as COPD),
if the patient has been diagnosed with cor pulmonale (a heart condition caused by long-term lung disease),
if the patient suffers from severe asthma,
if the patient has intestinal paralysis (paralytic ileus),
if the patient has acute, severe abdominal pain syndrome (so-called "acute abdomen") or delayed gastric emptying.

Warnings and precautions
Before starting treatment with Reltebon, discuss with your doctor or pharmacist if:

the patient is elderly or debilitated,
the patient has severe lung disorders,
the patient experiences repeated breathing interruptions during sleep (sleep apnoea), as this condition may worsen,
the patient has impaired kidney or liver function,
the patient has myxoedema (a condition related to thyroid disease) or thyroid dysfunction,
the patient has adrenal insufficiency (adrenal glands not functioning properly), e.g. Addison’s disease,
the patient has a mental disorder caused by alcohol or other substance toxicity (toxic psychosis),
the patient suffers from alcoholism,
the patient experiences symptoms of alcohol or other substance withdrawal (e.g. drugs, narcotics), such as delirium tremens,
the patient has benign prostatic hyperplasia (enlarged prostate gland),
the patient has pancreatitis, which may cause severe abdominal or back pain,
the patient has biliary or urinary tract disorders, including biliary or ureteric colic,
the patient has obstructive or inflammatory bowel disease,
the patient suffers from constipation,
the patient has increased intracranial pressure, e.g. due to head injury,
the patient suffers from epilepsy or has a tendency to seizures,
the patient is taking monoamine oxidase inhibitors (MAO inhibitors) (used to treat depression) or has taken MAO inhibitors within the last 2 weeks (see section 2 "Reltebon and other medicines"),
the patient recently underwent surgery involving the intestines or abdominal cavity,
the doctor suspects intestinal dysfunction,
the patient has low blood pressure or reduced blood volume.

Consult your doctor if any of the above conditions apply or have applied in the past.

Breathing disorders during sleep
Reltebon may cause sleep-related breathing disorders such as sleep apnoea (breathing interruptions during sleep) and nocturnal hypoxaemia (low blood oxygen levels during sleep).
Symptoms may include breathing interruptions during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. The doctor may consider reducing the dose.

Shallow and slowed breathing (respiratory depression)
The main risk associated with opioid overdose is shallow and slowed breathing (respiratory depression). This occurs most frequently in elderly or debilitated patients.

Tolerance, dependence, and abuse
This medicine contains oxycodone, an opioid, which may cause dependence and/or abuse.
Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Reltebon may lead to dependence, misuse, and abuse, which may result in life-threatening overdose. The risk may be greater when higher doses are used for prolonged periods.
Dependence or abuse may cause the patient to lose control over how much medicine to take or how often to take it. The patient may feel a need to take the medicine even if it no longer relieves pain.

The risk of dependence or abuse varies among individuals. The risk may be higher if:

the patient or a family member has ever misused or been dependent on alcohol, prescription medicines, or narcotics ("addiction"),
the patient is a smoker,
the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental disorders.

If the patient notices any of the following symptoms while taking Reltebon, this may indicate developing dependence or abuse:

need to take the medicine longer than prescribed by the doctor,
need to take a higher dose than recommended,
using the medicine for reasons other than prescribed, e.g. "to calm down" or "to help fall asleep",
repeated unsuccessful attempts to stop or reduce medicine use,
feeling unwell after stopping the medicine and improvement upon restarting (withdrawal effect).

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate timing and safe method of discontinuing treatment (see section 3 "Stopping treatment with Reltebon").

Withdrawal symptoms
If treatment is stopped abruptly, withdrawal symptoms may occur, including yawning, dilated pupils, tearing, runny nose, tremor, sweating, restlessness, motor agitation, seizures, difficulty falling asleep, or muscle pain. When treatment with Reltebon is no longer necessary, the doctor will gradually reduce the daily dose to prevent this.

Treatment of chronic non-cancer pain
Opioids are not first-line medicines for treating non-cancer pain and are not recommended as sole therapy. Opioids should be used as part of a comprehensive treatment programme including other medicines and treatment methods. The doctor should closely monitor the patient and make necessary dosage adjustments during Reltebon treatment to prevent dependence and misuse.

Pancreatitis and biliary tract disorders
Contact your doctor if the patient experiences severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract disorders.

Increased pain sensitivity
Rarely, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to further increases in oxycodone dose. If this occurs, the doctor may reduce the oxycodone dose or switch to another opioid medicine.

Improper use (injection)
Reltebon is intended for oral use only. Intravenous injection (injection into a blood vessel) may cause tissue necrosis (tissue death), pulmonary granulomas (lung tissue changes), or other serious, potentially fatal events due to the excipients in the tablet.

Improper administration
Tablets must not be broken, crushed, or chewed, as this destroys the extended-release properties of the tablet, leading to rapid release of oxycodone. Administering broken, crushed, or chewed Reltebon tablets results in rapid release and absorption of a potentially fatal dose of oxycodone (see section 3 "Taking more than the recommended dose of Reltebon").

Surgery
Reltebon is not recommended before or within 24 hours after surgery. If the patient is scheduled for surgery, inform the doctors that they are taking Reltebon.

Hormonal changes
Like other opioids, Reltebon may affect normal hormone production in the body, such as cortisol or sex hormones, especially if high doses have been taken for a prolonged period. Symptoms may include nausea or vomiting, loss of appetite, fatigue, dizziness, sexual dysfunction, menstrual cycle changes, or impotence. Discuss this with your doctor.

Children under 12 years of age
The safety and efficacy of Reltebon have not been sufficiently established in children under 12 years of age. Therefore, Reltebon is not recommended for use in children under 12 years of age.

Reltebon and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Concurrent use of opioids, including Reltebon, with sedative medicines such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing problems (respiratory depression), coma, and potentially life-threatening outcomes. Therefore, concurrent use should only be considered if other treatment options are not possible.

If your doctor prescribes Reltebon together with sedative medicines, the dose and duration of treatment should be limited by the doctor.

Inform your doctor about all sedative medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the possibility of experiencing the symptoms described above. Contact your doctor if such symptoms occur.

Adverse effects caused by Reltebon may occur more frequently or be more severe when Reltebon is used together with medicines affecting brain function. Examples of such adverse effects include shallow and slowed breathing (respiratory depression).

The risk of adverse effects increases if the patient is taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing symptoms such as involuntary rhythmic muscle contractions (including eye movement muscles), agitation, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. Contact your doctor if these symptoms occur.

If the patient takes these tablets with other medicines, the effect of these tablets or other medicines may be altered, and the risk of adverse effects increases. Inform your doctor or pharmacist if the patient is taking:

monoamine oxidase inhibitors (MAO inhibitors) (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid) or has taken such medicines within the last two weeks (see "Warnings and precautions"),
medicines that help sleep or have a calming effect (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 nausea (antihistamines, antiemetics),
medicines used in psychiatric treatment or mental disorders (such as antipsychotics, phenothiazines, or neuroleptics),
medicines used to treat epilepsy, pain, and anxiety, such as gabapentin and pregabalin,
medicines known as muscle relaxants, used to relieve muscle spasms,
medicines used to treat Parkinson’s disease,
other strong painkillers (opioid medicines),
cimetidine (used for 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 in HIV treatment (e.g. boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
rifampicin (used to treat tuberculosis),
carbamazepine (used to treat seizures, epileptic fits, and certain types of pain),
phenytoin (used to treat seizures),
the herbal remedy St. John’s wort (also known as Hypericum perforatum),
quinidine (used to treat irregular heartbeat),
anticoagulant medicines of the coumarin type used to reduce the risk of blood clots and thin the blood (blood-thinning medicines).

Also inform your doctor if the patient has recently undergone anaesthesia.

Reltebon with food, drink, and alcohol
Do not consume alcohol while taking Reltebon. Drinking alcohol while taking Reltebon may cause drowsiness or drowsiness and increase the risk of serious adverse effects such as shallow and slowed breathing, with risk of respiratory arrest and loss of consciousness.

Grapefruit juice may increase the effect of oxycodone. Therefore, avoid drinking grapefruit juice while taking Reltebon.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
Reltebon should be avoided during pregnancy as far as possible. Data on the use of oxycodone in pregnant women are limited. Oxycodone crosses the placental barrier and enters the newborn's circulation.

Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Infants whose mothers used oxycodone during the last 3 to 4 weeks before delivery should be monitored for respiratory depression.

Breastfeeding
Do not take Reltebon while breastfeeding, as oxycodone may pass into breast milk and may cause shallow and slowed breathing (respiratory depression) in the breastfed infant.

Driving and operating machinery
Oxycodone may affect the ability to drive or operate machinery. This is particularly likely at the beginning of Reltebon treatment, when the dose is increased, when switching to another similar medicine, or when Reltebon is taken together with medicines affecting brain function.

Once treatment is stabilised, driving restrictions may not apply. The decision in each individual case is made by the doctor, considering the circumstances. Consult your doctor regarding the possibility and any conditions for driving or operating machinery.

Reltebon contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Reltebon

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Before starting treatment and regularly during ongoing treatment, your doctor will discuss with
you what to expect from taking Reltebon, when and for how long you should take it, when to contact
your doctor, and when to stop taking it (see also "Stopping treatment with Reltebon").
Adults and adolescents (aged over 12 years and older)
The recommended starting dose is 10 mg of oxycodone hydrochloride twice daily (every
12 hours). In some cases, your doctor may prescribe a starting dose of 5 mg to reduce the risk of
adverse effects that may occur.
Your doctor will prescribe the dose necessary to treat your pain. If you continue to experience pain
while taking these tablets, discuss this with your doctor. Your doctor will adjust the dosage according
to the intensity of your pain and your response to treatment.
Further determination of the daily dose, division into individual doses, and any subsequent dose
modifications will be decided by your treating doctor based on your previous dosing regimen. Under
no circumstances should you change the dose without consulting your doctor. The lowest effective
dose sufficient to relieve pain should always be used.
For patients who have previously taken opioids, your doctor may prescribe higher doses, taking
into account your prior response to opioid treatment.
Some patients taking Reltebon according to the prescribed regimen may require a fast-acting
painkiller to manage breakthrough pain.
Reltebon is not indicated for the treatment of breakthrough pain.
Contact your doctor if you experience breakthrough pain (transient pain) despite ongoing pain
treatment.
For the treatment of non-cancer pain, a daily dose of 40 mg oxycodone hydrochloride (20 mg taken
twice daily) is usually sufficient, although higher doses may be required.
Patients with cancer-related pain usually require doses of 80 mg to 120 mg of oxycodone
hydrochloride, which may be increased up to 400 mg in individual cases.
Elderly patients
In elderly patients without impaired liver or kidney function, dose adjustment is usually not
necessary.
Patients with impaired liver or kidney function or low body weight
Your doctor may prescribe a lower starting dose for patients with impaired kidney or liver function
or for patients with low body weight.
Method of administration
Extended-release tablets must be swallowed whole with an adequate amount of liquid (half a glass
of water), in the morning and evening according to the prescribed schedule (e.g., at 8 a.m. and 8
p.m.). Reltebon may be taken with or without food.
Extended-release tablets must not be broken, chewed, or crushed (see also section
2. Important information before taking Reltebon).
Duration of treatment
Your doctor will inform you how long you should take Reltebon. Do not stop taking Reltebon without
consulting your doctor (see "Stopping treatment with Reltebon").
If you feel that the effect of Reltebon is too strong or too weak, consult your doctor or pharmacist.
Taking more than the recommended dose of Reltebon
If you take more than the recommended dose of Reltebon or if someone else accidentally takes the
tablets, contact your doctor or local poison control center immediately.
Overdose may result in:

constricted pupils,
shallow and slowed breathing (respiratory depression),
drowsiness,
flaccidity of skeletal muscles,
reduced blood pressure,
brain dysfunction (known as toxic leukoencephalopathy).

In severe cases, circulatory failure, lack of mental and physical activity, loss of consciousness,
slowed heart rate, fluid accumulation in the lungs, low blood pressure, and death may occur.
Overdose with high doses of opioid painkillers such as oxycodone may lead to death.
Situations requiring high concentration (e.g., driving) must be strictly avoided.
Missed dose of Reltebon
If you take less than the recommended dose of Reltebon or miss a dose, pain relief may be
inadequate or pain may not subside at all.
You may take the missed tablet if at least 8 hours remain before the next scheduled dose. Then,
continue taking the medicine according to the previously prescribed schedule.
Alternatively, if the next scheduled dose is due in less than 8 hours, you may take the extended- release tablet, but the next dose should then be delayed by 8 hours. As a general rule, Reltebon
should not be taken more frequently than every 8 hours.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Reltebon
Do not stop taking Reltebon without consulting your doctor.
If treatment with Reltebon is discontinued, withdrawal symptoms may occur
(e.g., yawning, dilated pupils, tearing, runny nose, tremor, sweating, restlessness, motor agitation,
seizures, or difficulty sleeping). Therefore, it may be advisable for your doctor to gradually reduce
the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse symptoms occur, stop taking
Reltebon immediately and contact your doctor without delay:

sudden breathing difficulties, eyelid, facial or lip swelling, rash or itching, especially if affecting the whole body – these are signs of severe allergic reactions (frequency unknown: cannot be estimated based on available data)
shallow and slowed breathing – most commonly occurs in elderly or weakened patients, and is a major risk factor following overdose (uncommon adverse reaction; may affect up to 1 in 100 people)
low blood pressure – may cause dizziness and may lead to fainting (rare adverse reaction; may affect up to 1 in 1,000 people)
constricted pupils (uncommon adverse reaction; may affect up to 1 in 100 people)
bronchial muscle spasms (causing shortness of breath) and suppression of the cough reflex when needed (common adverse reaction; may affect up to 1 in 10 people)

Other possible adverse reactions
Very common adverse reactions (may affect more than 1 in 10 people):

drowsiness greater than usual – most likely at the beginning of treatment or when the dose is increased, but usually resolves after a few days
dizziness, headache
constipation, nausea, vomiting
itching

Common adverse reactions (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, breathing difficulties or wheezing (dyspnoea)
abdominal pain, diarrhoea, dry mouth, indigestion
skin reactions and/or rashes, excessive sweating
increased need to urinate
feeling of weakness (asthenia), fatigue

Uncommon adverse reactions (may affect up to 1 in 100 people):

hypersensitivity
abnormal secretion of antidiuretic hormone
lack of body water (dehydration)
psychomotor agitation, mood swings, feeling of euphoria, cognitive disturbances (e.g. hallucinations, depersonalization)
reduced sexual drive
drug and other substance dependence, see also section 2 "Warnings and precautions")
unusual muscle stiffness, decreased muscle tone, involuntary muscle contractions
seizures (especially in patients with epilepsy or seizure tendency)
reduced sensitivity to pain or touch (hypoesthesia), speech disturbances, fainting, tingling (paresthesia), coordination disturbances, taste changes
memory loss, migraine
changes in tear secretion, visual disturbances
increased sensitivity to sound (hyperacusis), sensation of dizziness or spinning
rapid pulse, sensation of irregular and forceful heartbeat (in the context of withdrawal syndrome)
dilation of blood vessels
voice changes, cough, sore throat, catarrh
oral ulceration, gingivitis, stomatitis, swallowing difficulties, flatulence, belching, intestinal obstruction
increased liver enzyme activity
dry skin
difficulty in passing urine
impotence, decreased levels of sex hormones
chills, pain (e.g. in the chest), general malaise, thirst
fluid accumulation in tissues (oedema), swelling of 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)
injuries due to falls

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

herpes simplex (a skin and mucous membrane disease)
enlarged lymph nodes (lymphadenopathy)
increased appetite
low blood pressure, dizziness upon standing from sitting or lying positions
dark, tarry stools, tooth discoloration, bleeding gums
urticaria, increased sensitivity to light (photosensitivity)
blood in urine
changes in body weight (decrease or increase), inflammation of subcutaneous connective tissue

Very rare adverse reactions (may affect up to 1 in 10,000 people):

exfoliative rash (exfoliative dermatitis)

Frequency not known (cannot be estimated based on available data):

aggression
increased sensitivity to pain that cannot be relieved by increasing the dose
sleep apnoea (pauses in breathing during sleep)
dental caries
pain in the right upper abdomen, itching or jaundice due to gallbladder inflammation
disorder affecting the intestinal valve, potentially causing severe upper abdominal pain (Oddi sphincter dysfunction)
absence of menstruation (amenorrhoea)
prolonged use of Reltebon during pregnancy may cause life-threatening withdrawal symptoms in newborns. Symptoms to watch for in the infant include irritability, hyperactivity and abnormal sleep patterns, high-pitched crying, tremors, vomiting, diarrhoea and failure to gain weight.

Remedial measures
If the patient observes any of the adverse reactions listed above, the doctor will take appropriate actions.
To prevent adverse reactions such as constipation, follow a high-fibre diet and drink more fluids.
If the patient experiences nausea or vomiting, the doctor may prescribe appropriate medication.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Reltebon

Keep this medicine out of the sight and reach of children.
This medicine should be stored in a closed and secure place, inaccessible to others. It may be highly harmful and could cause death in individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the blister, carton, and container after: EXP. The expiry date refers to the last day of the stated month.
Blister packs:
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 conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Reltebon contains

The active substance 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, indigotine, aluminium 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), indigotine, aluminium 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 imprint "OX 5" on one side.

Reltebon 10 mg, prolonged-release tablets:
White, round, biconvex tablets, 9 mm in diameter, with the imprint "OX 10" on one side.

Reltebon 20 mg, prolonged-release tablets:
Pink, round, biconvex tablets, 7 mm in diameter, with the imprint "OX 20" on one side.

Reltebon 40 mg, prolonged-release tablets:
Yellow, round, biconvex tablets, 7 mm in diameter, with the imprint "OX 40" on one side.

Reltebon 80 mg, prolonged-release tablets:
Green, round, biconvex tablets, 9 mm in diameter, with the imprint "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 child-resistant packaging:
5 mg, 10 mg, 20 mg, 40 mg, 80 mg: 30 and 60 prolonged-release tablets

Reltebon is also available in white, round HDPE containers with PP caps, with child-resistant closure, containing 98 or 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the following names in the Member States of the European Economic Area:

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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel. (22) 345 93 00