RELTEBON 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Reltebon, 5 mg, prolonged-release tablets
3. Reltebon, 10 mg, prolonged-release tablets
4. Reltebon, 20 mg, prolonged-release tablets
5. Reltebon, 40 mg, prolonged-release tablets
6. Reltebon, 80 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
7. What Reltebon is and what it is used for
8. Important information before taking Reltebon
   1. When not to take Reltebon
   2. Warnings and precautions
   3. Respiratory depression during sleep
   4. Shallow and slow breathing (respiratory depression)
   5. Tolerance, dependence, and addiction
   6. Withdrawal symptoms
   7. Chronic non-cancer pain
   8. Pancreatitis and bile duct problems
   9. Increased sensitivity to pain
   10. Incorrect use (injection)
   11. Incorrect administration
   12. Surgery (operations)
   13. Hormonal changes
   14. Children
   15. Reltebon with other medicines
   16. Reltebon with food, drink, and alcohol
   17. Pregnancy and breastfeeding
   18. Pregnancy
   19. Breastfeeding
   20. Driving and using machines
   21. Reltebon contains lactose
9. How to take Reltebon
   1. Adults and children (12 years and older)
   2. Elderly patients
   3. Patients with liver or kidney problems or low body weight
   4. Method of administration
   5. Duration of treatment
   6. If you take more Reltebon than you should
   7. If you forget to take Reltebon
   8. Stopping Reltebon
10. Possible side effects
    1. If you experience any of the following side effects, stop taking Reltebon and contact your doctor immediately:
    2. Other possible side effects
    3. What to do if you experience side effects
    4. Reporting side effects
11. How to store Reltebon
    1. Blister packs:
    2. HDPE containers:
12. Contents of the pack and other information
    1. What Reltebon contains
    2. What Reltebon looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. For further information on this medicine, contact the representative of the marketing authorization holder:
    8. Date of last revision of the package leaflet: February 2025

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

Oxycodone hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, as 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Reltebon is and what it is 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 pack and other information

1. What Reltebon is and what it is used for

Reltebon contains the active substance oxycodone hydrochloride, which belongs to a group of strong pain-relieving medicines called opioids. Reltebon is used to treat moderate to severe pain in adults and children aged 12 years and older, when other pain-relieving medicines have not worked or are not suitable.

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 your blood (hypoxia) and/or too much carbon dioxide in your blood (hypercapnia),
• if you have severe, chronic lung disease that causes narrowing of the airways (severe chronic obstructive pulmonary disease, COPD),
• if you have heart failure due to long-term lung disease,
• if you have severe asthma,
• if you have a condition where the intestines are paralyzed (paralytic ileus),
• if you have a condition where the intestines are partially or completely blocked (intestinal obstruction),

Warnings and precautions

Before taking Reltebon, tell your doctor or pharmacist if:

• you are elderly or frail,
• you have severe lung disease,
• you have recurring episodes of stopped breathing during sleep (sleep apnea), as this condition may worsen,
• you have kidney or liver problems,
• you have thyroid problems or adrenal gland problems (e.g., Addison's disease),
• you have a mental health disorder caused by alcohol or other substance toxicity (toxic psychosis),
• you have a history of alcohol or substance abuse,
• you have symptoms of alcohol or substance withdrawal,
• you have an enlarged prostate gland,
• you have pancreatitis, which can cause severe abdominal or back pain,
• you have bile duct problems or gallstones,
• you have inflammatory bowel disease,
• you have constipation,
• you have increased pressure in the brain (e.g., due to head injury),
• you have epilepsy or are prone to seizures,
• you are taking monoamine oxidase inhibitors (MAOIs) (used to treat depression) or have taken MAOIs in the last 2 weeks (see section 2 "Reltebon with other medicines"),
• you have recently had surgery on your intestines or abdomen,
• your doctor suspects that your intestines are not working properly,
• you have low blood pressure or decreased blood volume.

Tell your doctor if any of these conditions apply to you or have applied in the past.

Respiratory depression during sleep

Reltebon may cause respiratory depression during sleep, 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, waking up at night due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, 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 frail patients.

Tolerance, dependence, and addiction

This medicine contains oxycodone, which is an opioid. Repeated use of opioid pain-relieving medicines can lead to tolerance, dependence, and addiction. The risk may be greater if you have a history of substance abuse or addiction, or if you are taking higher doses or using the medicine for longer periods.

Withdrawal symptoms

If you stop taking Reltebon suddenly, you may experience withdrawal symptoms, which can include yawning, dilated pupils, tearing, runny nose, sweating, restlessness, and anxiety. To avoid this, your doctor will gradually reduce the dose when it is no longer needed.

Chronic non-cancer pain

Opioids are not the first choice for treating chronic 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 therapies. Your doctor will closely monitor your condition and adjust the dose as needed to prevent dependence and abuse.

Pancreatitis and bile duct problems

Tell your doctor if you experience severe abdominal pain that radiates to your back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or bile duct problems.

Increased sensitivity to pain

Rarely, you may experience increased sensitivity to pain (hyperalgesia), which does not respond to increased doses of oxycodone. If this occurs, your doctor may reduce the dose or switch to a different opioid medicine.

Incorrect use (injection)

Reltebon is for oral use only. If the tablets are injected into a vein, the inactive ingredients can cause local tissue damage (necrosis), lung tissue changes (pulmonary granuloma), or other serious, potentially life-threatening events.

Incorrect administration

Do not break, crush, or chew the prolonged-release tablets, as this can lead to rapid release of oxycodone and potentially fatal doses (see section 3 "If you take more Reltebon than you should").

Surgery (operations)

Do not take Reltebon before surgery or within 24 hours after surgery. If you are going to have surgery, tell your doctor that you 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 you take high doses for a long time. Symptoms may include nausea, vomiting, loss of appetite, fatigue, dizziness, sexual dysfunction, changes in menstrual cycle, or impotence. Discuss this with your doctor.

Children

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

Reltebon with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• monoamine oxidase inhibitors (MAOIs) (e.g., tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid) or if you have taken MAOIs in the last 2 weeks (see "Warnings and precautions"),
• sedatives, such as benzodiazepines or similar medicines,
• antidepressants (e.g., paroxetine or fluoxetine),
• antihistamines or anti-emetics (for allergies or nausea and vomiting),
• psychiatric or anti-psychotic medicines (e.g., phenothiazines or neuroleptics),
• anti-epileptic medicines (e.g., gabapentin or pregabalin),
• muscle relaxants,
• Parkinson's disease medicines,
• other strong pain-relieving medicines (opioids),
• cimetidine (for stomach ulcers, heartburn, or acid reflux),
• antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, or posaconazole),
• antibacterial medicines (e.g., clarithromycin, erythromycin, or telithromycin),
• a specific type of medicine known as protease inhibitors for HIV treatment (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir),
• rifampicin (for tuberculosis),
• carbamazepine (for epilepsy, seizures, or certain types of pain),
• phenytoin (for seizures),
• the herbal medicine St. John's Wort (Hypericum perforatum),
• quinidine (for irregular heartbeat),
• blood-thinning medicines (e.g., warfarin),

Tell your doctor if you have recently had anesthesia.

Reltebon with food, drink, and alcohol

Do not drink alcohol while taking Reltebon, as this can cause drowsiness or sedation or increase the risk of serious side effects, such as shallow and slow breathing with risk of respiratory arrest and loss of consciousness.

Pregnancy and breastfeeding

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

Pregnancy

Reltebon should be avoided during pregnancy, as there is limited information on its use in pregnant women. Oxycodone crosses the placental barrier and may be present in the baby's bloodstream.

Breastfeeding

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

Driving and using machines

Oxycodone may affect your ability to drive or use machines. This is especially likely at the start of treatment, when you switch to a different medicine, or when you take Reltebon with other medicines that affect the brain.

Reltebon contains lactose

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking Reltebon.

3. How to take Reltebon

Always take Reltebon exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults and children (12 years and older)

The recommended starting dose is 5 mg or 10 mg of oxycodone hydrochloride, twice daily (every 12 hours). However, your doctor will prescribe the dose needed to treat your pain and adjust the dosage based on your response to treatment.

Elderly patients

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

Patients with liver or kidney problems or low body weight

Patients with liver or kidney problems or low body weight may require a lower starting dose.

Method of administration

Swallow the prolonged-release tablets whole with a sufficient amount of liquid (half a glass of water), in the morning and evening, as directed. Reltebon can be taken with or without food.

Duration of treatment

Your doctor will tell you how long to take Reltebon. Do not stop taking Reltebon without consulting your doctor (see "If you stop taking Reltebon").

If you take more Reltebon than you should

If you take more Reltebon than you should, contact your doctor or local poison control center immediately.

If you forget to take Reltebon

If you miss a dose, you can take the missed dose if the time to the next scheduled dose is at least 8 hours. Then, continue taking Reltebon as directed. If the next scheduled dose is less than 8 hours away, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping Reltebon

Do not stop taking Reltebon without consulting your doctor. If you stop taking Reltebon, you may experience withdrawal symptoms (e.g., yawning, dilated pupils, tearing, runny nose, sweating, restlessness, and anxiety). To avoid this, your doctor may gradually reduce the dose.

4. Possible side effects

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

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

• sudden difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially if these symptoms are severe and spread over the whole body - these are symptoms of a severe allergic reaction (frequency not known: cannot be estimated from the available data),
• shallow and slow breathing - occurs most often in elderly or frail patients, and is the main risk factor for overdose (uncommon side effects; may affect up to 1 in 100 people),
• low blood pressure - can cause dizziness and fainting (rare side effects; may affect up to 1 in 1,000 people),
• constricted pupils (uncommon side effects; may affect up to 1 in 100 people),
• muscle spasms of the airways (causing shortness of breath) and suppression of the cough reflex (common side effects; may affect up to 1 in 10 people).

Other possible side effects

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

• drowsiness - most likely at the start of treatment or when the dose is increased, but usually resolves after a few days,
• dizziness, headache,
• constipation, 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 muscle tremors or lethargy,
• shortness of breath, difficulty breathing, wheezing,
• abdominal pain, diarrhea, dry mouth, indigestion,
• skin reactions or rashes, excessive sweating,
• increased need to urinate,
• feeling weak, tiredness.

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

• allergic reactions,
• abnormal production of antidiuretic hormone,
• dehydration,
• restlessness, mood swings, feeling of well-being, cognitive impairment (e.g., hallucinations, depersonalization),
• reduced sex drive,
• dependence on the medicine and other substances (see also section 2 "Warnings and precautions"),
• abnormal muscle stiffness, reduced muscle tone, involuntary muscle contractions,
• seizures (especially in people with a history of seizure disorders or a tendency to have seizures),
• reduced sensitivity to pain or touch (hypoesthesia), speech disorders, fainting, tingling, coordination problems, taste changes,
• memory loss, migraine,
• changes in tear production, vision problems,
• increased sensitivity to sound (hyperacusis), feeling of dizziness or spinning,
• rapid heartbeat, feeling of irregular or forceful heartbeat,
• vasodilation,
• voice changes, cough, sore throat, runny nose,
• mouth ulcers, gum inflammation, mouth inflammation, difficulty swallowing, gas, belching,
• increased liver enzyme activity,
• dry skin,
• difficulty urinating,
• impotence, reduced sex hormone levels,
• chills, pain (e.g., chest pain), general feeling of being unwell, thirst,
• excess fluid in the tissues (edema), swelling of the hands, feet, or ankles,
• physical dependence with withdrawal symptoms,
• need for 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 (a skin and mucous membrane disease),
• enlarged lymph nodes (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,
• changes in body weight (weight loss or gain), inflammation of the connective tissue under the skin.

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

• peeling skin 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,
• sleep apnea (pauses in breathing during sleep),
• tooth decay,
• abdominal pain, itching, or jaundice due to gallbladder problems,
• intestinal valve dysfunction, which 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 look out for in the baby include irritability, hyperactivity, and abnormal sleep pattern, high-pitched crying, trembling, vomiting, diarrhea, and failure to gain weight.

What to do if you experience side effects

If you experience any side effects, your doctor will take appropriate action.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Reltebon

Keep Reltebon out of the sight and reach of children.

Store Reltebon in a locked and secure location, where others cannot access it. It can be very harmful and may cause death if taken by someone it was not prescribed for.

Do not use Reltebon after the expiry date stated on the blister, carton, or container after EXP. The expiry date refers to the last day of the month stated.

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 precautions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will 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 K30, stearic acid, magnesium stearate, silica colloidal anhydrous. 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 "OX 5" embossed on one side.
Reltebon,10 mg, prolonged-release tablets:
White, round, biconvex tablets, 9 mm in diameter, with "OX 10" embossed on one side.
Reltebon,20 mg, prolonged-release tablets:
Pink, round, biconvex tablets, 7 mm in diameter, with "OX 20" embossed on one side.
Reltebon,40 mg, prolonged-release tablets:
Yellow, round, biconvex tablets, 7 mm in diameter, with "OX 40" embossed on one side.
Reltebon,80 mg, prolonged-release tablets:
Green, round, biconvex tablets, 9 mm in diameter, with "OX 80" embossed on one side.
Reltebon is available in blister packs (PVC/Al) containing:
5 mg, 10 mg, 20 mg, 40 mg, 80 mg: 30 and 60 prolonged-release tablets
Reltebon is available in child-resistant blister packs (PVC/Al/PET/paper):
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 child-resistant PP cap, 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, 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 package leaflet: February 2025