Oxidolor

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Oxydolor, 5 mg, prolonged-release tablets

Oxydolor, 10 mg, prolonged-release tablets

Oxydolor, 20 mg, prolonged-release tablets

Oxydolor, 40 mg, prolonged-release tablets

Oxydolor, 80 mg, prolonged-release tablets

Oxycodone hydrochloride

It is essential to carefully read the contents of this leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed for a specific individual. It should not be given to others. The medication can harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Oxydolor and what is it used for

Oxydolor contains the active substance oxycodone hydrochloride, which is a strong pain-relieving medication from the opioid group. Oxydolor is used in adults and adolescents over 12 years of age for the treatment of severe pain that can only be adequately managed with opioid pain-relieving medications.

2. Important information before taking Oxydolor

When not to take Oxydolor:

• if the patient is allergic to oxycodone, soy, peanuts, or any other ingredients of this medication (listed in section 6)
• if the patient has breathing difficulties, such as slow or shallow breathing (respiratory depression)
• if the patient has high levels of carbon dioxide in the blood
• if the patient has severe, chronic lung diseases associated with narrowing of the airways (COPD - chronic obstructive pulmonary disease)
• if the patient has certain heart disorders known as cor pulmonale
• if the patient has asthma
• if the patient has a type of intestinal obstruction called paralytic ileus
• if the patient has acute or severe abdominal pain or delayed gastric emptying

Warnings and precautions

Before starting to take Oxydolor, the patient should consult a doctor or pharmacist:

• in the case of elderly or frail patients
• in the case of severe impairment of lung, liver, or kidney function
• in the case of thyroid disorders, where the skin on the face and extremities is swollen, cool, and dry (myxedema)
• if the thyroid gland does not produce enough hormones (hypothyroidism)
• if the patient has adrenal gland disorders (adrenal insufficiency), such as Addison's disease
• in the case of prostate enlargement
• if the patient has a history of mental illness caused by alcohol or substance abuse
• if the patient is undergoing withdrawal treatment
• if the patient has gallbladder disorders
• if the patient has pancreatitis, which can cause severe abdominal or back pain
• in the case of difficulty or pain when urinating
• if the doctor suspects that the patient has paralytic ileus (a condition where the intestines stop working)
• in the case of head injury with severe headache or discomfort - signs of increased intracranial pressure
• in the case of low blood pressure or feeling weak when standing up
• in the case of low blood volume (hypovolemia)
• in the case of epilepsy or a history of seizures
• if the patient is taking medications used to treat depression, such as MAO inhibitors (e.g., tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid), or if they have taken them in the last two weeks
• if the patient has constipation

Respiratory depression during sleep

Oxydolor may cause respiratory depression during sleep, such as sleep apnea (pauses in breathing during sleep) and associated hypoxemia (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 the patient or another person observes these symptoms, they should contact a doctor. The doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medication contains oxycodone, which is an opioid. It may cause dependence and (or) addiction.

This medication contains oxycodone, which is an opioid medication. Repeated use of opioid pain-relieving medications can lead to decreased effectiveness of the medication (the patient's body gets used to it, which is known as tolerance). Repeated use of Oxydolor may lead to dependence, abuse, and addiction, which can lead to life-threatening overdose. The risk of these side effects may increase with dose escalation and prolonged use.

Children

The safety and efficacy of Oxydolor have not been adequately studied in children under 12 years of age. Therefore, Oxydolor is not recommended for use in children under 12 years of age.

Doping warning

Using the medicinal product Oxydolor may result in positive doping test results. Using the medicinal product Oxydolor as a doping agent can be hazardous to health.

Oxydolor and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Concomitant use of Oxydolor and sedating medications, such as benzodiazepines or related medications, increases the risk of sedation, respiratory depression, hypotension, and death. Therefore, concomitant use should only be considered when other treatment options are not possible.

Using Oxydolor with food and drink and alcohol

Consuming alcohol while taking Oxydolor may cause drowsiness and increase the risk of serious side effects, such as respiratory depression, with the risk of respiratory arrest and loss of consciousness. It is not recommended to consume alcohol while taking Oxydolor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication. PregnancyOxydolor should not be used during pregnancy. There are insufficient data on the use of oxycodone in pregnant women.

3. How to take Oxydolor

This medication should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.

Dosage

The doctor will determine the dosebased on the intensity of the pain and individual response to treatment. For doses that cannot be achieved with this strength, other strengths of this medication are available.

Special patient groups

• elderly patients (65 years and older)There is no need to adjust the dose in elderly patients with normal liver and kidney function.
• patients with impaired renal and/or hepatic functionIf the patient has liver or kidney impairment and has not previously taken opioids, treatment should be started with half the recommended dose for adults.
• other risk groups

Method of administration

Oxydolor is intended for oral use. The tablets should be swallowed whole with a sufficient amount of liquid(e.g., ½ glass of water). Oxydolor can be taken with or without food.

Duration of treatment

The doctor will inform the patient how long they should take Oxydolor. The patient should not stop taking Oxydolor without consulting a doctor (see "Stopping Oxydolor").

Taking too much Oxydolor

In case of overdose, the patient should contact a doctor immediately. Overdose can cause:

• constricted pupils
• slow and shallow breathing (respiratory depression)
• drowsiness up to loss of consciousness (similar to narcosis)
• decreased muscle tone
• slow heart rate
• low blood pressure
• brain disorders (toxic leukoencephalopathy)

Missing a dose of Oxydolor

If the patient has taken less Oxydolor than prescribed or missed a dose, it is likely that they will not achieve adequate pain relief.If a dose is missed, it can be taken if the next dose is not due for more than 8 hours. If the time to the next dose is less than 8 hours, the missed dose should be taken, and the next dose should be taken 8 hours later.

Stopping Oxydolor

The patient should not stop taking Oxydolor without consulting a doctor. Stopping Oxydolor may cause withdrawal symptoms (e.g., yawning, dilated pupils, lacrimation, rhinorrhea, sneezing, gooseflesh, nausea, vomiting, diarrhea, muscle aches). The doctor may advise gradual dose reduction to prevent withdrawal symptoms.

4. Possible side effects

Like all medications, Oxydolor can cause side effects, although not everybody gets them.

The patient should contact a doctor immediately if they experience any of the following symptoms:

• Sudden breathing difficulties, swelling of the eyelids, face, or lips, rash, and itching of the skin, especially all over the body - these are symptoms of severe allergic reactions.
• Slow or weak breathing (respiratory depression). This is the most serious risk associated with medications like Oxydolor (opioids) and can be life-threatening, especially when taking high doses.
• Low blood pressure- this can cause dizziness and fainting.
• Constricted pupils, bronchospasm (leading to shortness of breath), suppression of the cough reflex.

OTHER SIDE EFFECTS

Very common(affects more than 1 in 10 people)

• constipation - this side effect can be prevented by taking preventive measures (such as drinking plenty of fluids and a high-fiber diet)
• nausea, vomiting. The doctor will prescribe appropriate medications to treat these symptoms
• drowsiness, dizziness, headache
• confusion

Common(affects up to 1 in 10 people)

• mood changes (anxiety, disorientation, depression, nervousness, sleep disturbances, abnormal thoughts)
• uncontrolled shaking or shaking of one or more parts of the body, feeling of weakness
• low blood pressure, sometimes with accompanying symptoms such as palpitations or fainting
• breathing difficulties or wheezing
• dry mouth, sometimes with accompanying thirst and difficulty swallowing, general gastrointestinal disorders such as stomach pain, diarrhea, heartburn,
• decreased appetite
• rash, excessive sweating
• pain when urinating, increased need to urinate
• fatigue or weakness

Uncommon(affects up to 1 in 100 people)

• need to take increasingly higher doses of Oxydolor to achieve the same level of pain relief (tolerance)
• injuries caused by accidents resulting from decreased alertness
• allergic reactions
• increased production of antidiuretic hormone (ADH) with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion, and disturbances of consciousness
• excessive loss of fluids (dehydration)
• agitation, mood changes, euphoric mood
• perceptual disturbances (e.g., hallucinations)
• decreased libido
• seizures, especially in patients with a history of epilepsy or seizure disorders
• memory impairment, concentration disturbances, migraines
• increased or decreased muscle tone, tics, tingling or numbness (e.g., in the hands or feet)
• speech disturbances, decreased sensitivity to pain or touch, taste disturbances
• vision disturbances, constricted pupils
• dizziness (feeling of spinning)
• unpleasant sensation of irregular or forceful heartbeat, rapid heartbeat
• vasodilation leading to low blood pressure
• voice changes, wheezing
• difficulty swallowing, mouth ulcers, toothache
• bloating (excessive gas in the stomach or intestines), belching, indigestion,
• increased levels of certain liver enzymes in the blood
• dry skin
• difficulty urinating (urinary retention)
• decreased sex drive and inability to achieve or maintain an erection during sexual intercourse
• decreased levels of sex hormones, which can affect sperm production in men or the menstrual cycle in women
• chills
• pain (e.g., chest pain), nausea
• fluid retention (edema - e.g., in the hands, ankles, or feet, especially in the ankles), thirst

Rare(affects up to 1 in 1,000 people)

• lymphatic system disorders
• muscle spasms, seizures, especially in patients with a history of epilepsy or seizure disorders
• low blood pressure
• increased appetite
• increased sensitivity to light
• hematuria
• skin inflammation
• feeling of weakness, especially when standing up
• gum bleeding, black stools, tooth decay
• itching rash, blisters on the skin and mucous membranes (urticaria),
• weight changes (weight gain or loss)

Very rare(affects up to 1 in 10,000 people)

• speech disturbances
• scaly rash
• amenorrhea

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

• aggression
• increased sensitivity to pain
• sleep apnea (pauses in breathing during sleep)
• severe allergic reactions
• tooth loss or tooth decay
• bile duct obstruction, biliary colic (causing abdominal pain)
• long-term use of Oxydolor during pregnancy may cause life-threatening withdrawal syndrome in the newborn; symptoms to watch for in the child include irritability, hyperactivity, and abnormal sleep pattern, high-pitched cry, shaking, vomiting, diarrhea, and failure to gain weight
• gastrointestinal disorder that can cause severe abdominal pain (dysfunction of the Oddi sphincter)

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder.

5. How to store Oxydolor

The medication should be kept out of sight and reach of children. This medication should be stored in a closed and secure location, inaccessible to others. It can be very harmful and may cause death if taken by someone it was not prescribed for.

6. Contents of the pack and other information

What Oxydolor contains

Oxydolor, 5 mg, prolonged-release tablets

The active substance is oxycodone hydrochloride.

One prolonged-release tablet contains 5 mg of oxycodone hydrochloride, equivalent to 4.48 mg of oxycodone.

Excipients:

Tablet core: Kollidon SR (polyvinyl acetate, povidone (K=27.0 – 32.4), sodium lauryl sulfate, silica) Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate

Oxydolor, 10 mg, prolonged-release tablets

The active substance is oxycodone hydrochloride.

One prolonged-release tablet contains 10 mg of oxycodone hydrochloride, equivalent to 8.97 mg of oxycodone.

Excipients:

Tablet core: Kollidon SR (polyvinyl acetate, povidone (K=27.0 – 32.4), sodium lauryl sulfate, silica) Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate

Oxydolor, 20 mg, prolonged-release tablets

The active substance is oxycodone hydrochloride.

One prolonged-release tablet contains 20 mg of oxycodone hydrochloride, equivalent to 17.93 mg of oxycodone.

Excipients:

Tablet core: Kollidon SR (polyvinyl acetate, povidone (K=27.0 – 32.4), sodium lauryl sulfate, silica) Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate

Oxydolor, 40 mg, prolonged-release tablets

The active substance is oxycodone hydrochloride.

One prolonged-release tablet contains 40 mg of oxycodone hydrochloride, equivalent to 35.86 mg of oxycodone.

Excipients:

Tablet core: Kollidon SR (polyvinyl acetate, povidone (K=27.0 – 32.4), sodium lauryl sulfate, silica) Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate

Oxydolor, 80 mg, prolonged-release tablets

The active substance is oxycodone hydrochloride.

One prolonged-release tablet contains 80 mg of oxycodone hydrochloride, equivalent to 71.72 mg of oxycodone.

Excipients:

Tablet core: Kollidon SR (polyvinyl acetate, povidone (K=27.0 – 32.4), sodium lauryl sulfate, silica) Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate

What Oxydolor looks like and contents of the pack

Prolonged-release tablet Oxydolor, 5 mg, prolonged-release tabletsOxydolor, 5 mg, prolonged-release tablets are light gray, round, biconvex, film-coated tablets.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH Schloßplatz 1 A-8502 Lannach Austria

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Austria: Oxygerolan 5/10/20/40/80 mg-Retardtabletten
Bulgaria: Oxylan 20/40/80 mg филмирани таблетки с удължено освобождаване
Czech Republic: Oxycodon Lannacher
Denmark: Oxylan Depot 5/10/20/40/80 mg depottabletter
Germany: Oxypro 5/10/20/40/80 mg Retardtabletten
Hungary: Codoxy 5/10/20/40/80 mg retard tabletta
Iceland: Oxycodon HCl Lannacher 5/10/20/40/80 mg forðatöflur
Luxembourg: Oxypro 5/10/20/40/80 mg Retardtabletten
Poland: Oxydolor (5/10/20/40/80 mg tablets with prolonged release)
Romania: Oxidolor 20/40/80 mg, comprimate cu eliberare prelungită
Slovakia: Oxypro 5/10/20/40/80 mg tablety s predĺženým uvoľňovaním
Sweden: Oxycodone Depot Lannacher 5/10/20/40/80 mg depottablett

To obtain more detailed information on this medicinal product, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of approval of the leaflet: 08.06.2025