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
Oxycodoni hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Oxydolor is and what it is used for

Oxydolor contains the active substance oxycodone hydrochloride, which is a strong opioid analgesic.
Oxydolor is used in adults and adolescents aged 12 years and older for the treatment of severe pain that requires long-term, continuous, and potent opioid analgesic therapy.

2. Important information before using Oxydolor

When not to use Oxydolor:

if the patient is allergic to oxycodone, soya, peanuts, or any of the other ingredients of this medicine (listed in section 6)
if the patient has breathing problems such as abnormally slow or shallow breathing (respiratory depression)
if there is too high a concentration of carbon dioxide in the blood
if the patient has severe, chronic lung diseases associated with airway obstruction (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 known as paralytic ileus
if the patient has acute and severe stomach pain or delayed gastric emptying

Warnings and precautions
Before starting to take Oxydolor, consult a doctor or pharmacist:

in elderly or debilitated patients
in case of severe impairment of lung, heart, or kidney function
in case of thyroid disorders causing facial and extremity swelling, cold and dry skin (myxoedema)
if the thyroid gland does not produce enough hormones (hypothyroidism)
if the patient has adrenal gland disorders (adrenal glands not functioning properly), for example Addison's disease
in case of enlarged prostate gland (prostate)
if the patient has a mental disorder caused by alcohol or substance addiction
if the patient is undergoing detoxification treatment
if the patient has gallbladder disorders
if the patient has pancreatitis, which may cause severe abdominal or back pain
in case of difficulty or pain during urination
if the doctor suspects paralytic ileus (a condition in which the intestines stop working)
in case of head injury with severe headache or discomfort – signs of increased intracranial pressure
in case of low blood pressure or feeling weak when standing up
in case of low blood volume (hypovolemia)
in case of epilepsy or a tendency to seizures
if the patient is taking medicines used to treat depression belonging to the group of MAO inhibitors (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid) or has taken them within the last two weeks
if the patient has constipation

Sleep-related breathing disorders
Oxydolor may cause breathing disorders during sleep such as sleep apnoea (pauses in breathing during sleep) and associated hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, medical advice should be sought. The doctor may consider reducing the dose.
The most serious risk associated with opioid overdose is shallow and slowed breathing (respiratory depression). It most commonly occurs in elderly or debilitated patients. This may also reduce blood oxygen levels, potentially leading to fainting.
This medicine has been specially designed to release the active substance into the body over a 12-hour period. Extended-release tablets must not be broken, split, chewed, or crushed. Doing so may result in the absorption of a potentially dangerous dose of the active substance, oxycodone hydrochloride (see section “Taking more Oxydolor than you should”).

Tolerance, dependence, and abuse
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or abuse.
This medicine contains oxycodone, an opioid medicine. Repeated use of opioid painkillers may reduce the medicine’s effectiveness (the patient’s body becomes accustomed to it, known as tolerance). Repeated use of Oxydolor may lead to dependence, misuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged use.
Dependence or addiction 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 does not relieve pain.
The risk of dependence or addiction varies among individuals. The risk of developing addiction or abuse of Oxydolor may be higher if:

the patient or someone in their family has ever misused or been addicted to alcohol, prescription medicines, or 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 the patient notices any of the following symptoms while taking Oxydolor, it may indicate developing dependence or addiction:

need to take the medicine longer than prescribed by the doctor;
need to take a higher dose than recommended;
taking 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 after restarting it (‘withdrawal effect’).

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate time and safe method of stopping treatment (see section 3 “Stopping Oxydolor”).
Oxydolor has addictive properties. If treatment is stopped abruptly, withdrawal symptoms such as yawning, pupil dilation, tearing, runny nose, tremors, nausea, sweating, anxiety, restlessness, seizures, insomnia, or muscle pain may occur. If Oxydolor is no longer needed, the doctor will gradually reduce the daily dose.
The doctor will assess possible risks versus benefits of using this medicine. Consult your doctor if you have further questions.
The active substance of this medicine, oxycodone hydrochloride, like other very strong opioids (strong painkillers), has potential for abuse. Psychological dependence may also develop. Oxydolor should be used with particular caution in patients who have previously misused or currently misuse alcohol, drugs, or medicines.
Especially with high-dose use, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to further increases in Oxydolor dose. The doctor will then decide whether to reduce the dose or switch to another strong painkiller (opioid).
Oxydolor is intended exclusively for oral use (extended-release tablets must be swallowed whole). Extended-release tablets must not be dissolved and injected, as this may have serious consequences, potentially leading to death.
If the patient is to undergo surgery, inform the doctor about taking Oxydolor.
Contact a doctor if the patient experiences severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile ducts.
Like other opioids, oxycodone may affect hormone production in the body (such as cortisol and sex hormones), especially with long-term use of high doses.

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

Doping warning
The use of medicinal product Oxydolor may result in positive findings during anti-doping controls.
Using medicinal product Oxydolor as a doping agent may pose a health risk.

Oxydolor and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Concurrent use of Oxydolor and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
If the doctor prescribes Oxydolor together with sedative medicines, the dose and duration of concurrent use should be limited by the doctor.
Inform the doctor about all sedative medicines being taken and strictly follow the doctor’s dosing instructions. It may be helpful to inform friends or relatives about the signs and symptoms listed above. If such symptoms occur, contact the doctor.
Adverse effects of Oxydolor may occur more frequently or be more severe if taken concurrently with medicines affecting brain function or medicines used to treat allergies, motion sickness, or vomiting. Adverse effects may include shallow and slowed breathing (respiratory depression), constipation, dry mouth, or difficulty urinating.
The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
These medicines may interact with oxycodone. Possible symptoms include involuntary rhythmic muscle contractions, including muscles controlling eye movement, restlessness, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. If these symptoms occur, contact the doctor.
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

sleeping or sedative medicines (including benzodiazepines)
medicines used to treat depression (e.g., paroxetine or amitriptyline), including those belonging to the group of MAO inhibitors (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid) (see also section 2 “Before starting to take Oxydolor, consult a doctor or pharmacist”)
medicines used to treat allergies, motion sickness, or vomiting (antihistamines, antiemetics)
medicines used for mental or psychological disorders (such as psychotropic medicines, phenothiazines, or neuroleptics)
medicines used to treat epilepsy, pain, and anxiety states, e.g., gabapentin and pregabalin
muscle relaxants used to treat muscle spasms (e.g., tizanidine)
medicines used to treat Parkinson’s disease
other strong painkillers (opioids)
cimetidine (a medicine used for stomach ulcers, indigestion, or heartburn)
medicines used for fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole)
medicines used for bacterial infections (such as clarithromycin, erythromycin, or telithromycin)
protease inhibitors used in HIV treatment (e.g., boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir)
rifampicin used to treat tuberculosis
carbamazepine (a medicine used to treat epilepsy, seizures, or certain types of pain)
phenytoin (a medicine used to treat epilepsy or seizures)
St John’s wort (Hypericum perforatum)
quinidine (a medicine used for irregular heartbeat)
certain medicines preventing blood clotting or thinning the blood (anticoagulants of the coumarin type)

Using Oxydolor with food, drink, and alcohol
Consuming alcohol while taking Oxydolor may cause drowsiness and increase the risk of serious adverse effects such as shallow breathing with risk of respiratory arrest and loss of consciousness. Alcohol consumption is not recommended during treatment with Oxydolor.
Avoid administering Oxydolor to patients with a history of alcohol or drug addiction.
Grapefruit juice may increase Oxydolor blood levels. Consult your doctor if the patient regularly drinks grapefruit juice.

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

Pregnancy
Oxydolor should not be used during pregnancy. There are insufficient data on oxycodone use in pregnant women.
Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn.
Infants born to mothers who received oxycodone during the last 3–4 weeks before delivery may experience significant breathing difficulties (respiratory depression).
Oxydolor may be used during pregnancy only if benefits outweigh potential risks to the fetus.

Breastfeeding
Oxycodone passes into human milk and may cause sedation, shallow and slowed breathing (respiratory depression) in the breastfed infant. Therefore, Oxydolor should not be used during breastfeeding.

Driving and operating machinery
Oxydolor may impair the ability to drive and operate machinery. This should be expected especially at the beginning of treatment, after dose increases, or after changes in therapy, as well as when Oxydolor interacts with alcohol or medicines that may impair brain function. Once therapy is stabilised, a general driving ban is not necessary. The treating doctor must assess the individual patient’s situation.
Discuss with the doctor whether and under what conditions the patient may drive or operate machinery.

Oxydolor contains soya lecithin
If the patient is allergic to peanuts or soya, this medicine should not be taken.

3. How to use Oxydolor

This medicine should always be taken according to the instructions provided by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during ongoing therapy, your doctor will discuss with you what to expect when using Oxydolor, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Discontinuing treatment with Oxydolor").

Dosage
Your doctor will determine the dose based on the intensity of pain and your individual response to treatment.
For doses that cannot be achieved with this strength, other strengths of this medicine are available.
Do not change the dosage without consulting your doctor.
The lowest effective dose sufficient to relieve pain should be administered.
If you have previously been treated with opioids, your doctor may start therapy with a higher dose.
Gradual dose escalation may be necessary if pain relief is inadequate or if pain worsens.

Unless otherwise directed by your doctor, the recommended dose is:

Adults and adolescents (aged 12 years and older)
The usual starting dose is 10 mg of oxycodone hydrochloride administered every 12 hours. In some cases, your doctor may prescribe an initial dose of 5 mg to reduce the risk of adverse effects. Your doctor will prescribe the dose required to treat your pain. If you continue to experience pain while taking these tablets, discuss this with your doctor. In the treatment of non-malignant pain, a daily dose of 40 mg of oxycodone hydrochloride (20 mg taken twice daily) is generally sufficient; however, higher doses may also be necessary. Patients with cancer-related pain typically require doses of 80 to 120 mg of oxycodone hydrochloride, which may be increased up to 400 mg in individual cases.

In some patients receiving Oxydolor on a regular schedule, there may be a need for a fast-acting painkiller as a "rescue" medication to manage breakthrough pain. Oxydolor prolonged-release tablets are not intended for the treatment of breakthrough pain.

Special patient groups

Elderly patients (65 years and older)
There is no need to adjust the dose in elderly patients with normal liver and/or kidney function.
Patients with impaired liver and/or kidney function
If the patient has impaired liver or kidney function and has not previously taken opioids, treatment should be initiated at half the recommended adult dose.
Other risk groups
For patients with low body weight or patients who metabolize drugs more slowly, the initial dose should be half the recommended adult dose.
Children under 12 years of age
The safety and efficacy of Oxydolor have not been sufficiently studied in children under 12 years of age. Therefore, Oxydolor is not recommended for use in children under 12 years of age.

Method of administration
Oxydolor is intended for oral use. Tablets should be swallowed whole with an adequate amount of liquid (e.g., ½ glass of water). Oxydolor can be taken with or without food. Prolonged-release tablets must be swallowed whole to maintain their characteristic prolonged release of the active substance over time. Prolonged-release tablets must not be broken, split, chewed, or crushed.

Duration of treatment
Your doctor will inform you how long you should take Oxydolor.
Do not discontinue Oxydolor without consulting your doctor (see section "Discontinuing treatment with Oxydolor").
If Oxydolor is taken long-term, you should monitor your treatment and discuss it regularly with your doctor. This is necessary to achieve optimal pain therapy, including timely management of any adverse effects, and to make decisions about dose adjustments and continuation of treatment.
Consult your doctor or pharmacist if you feel that the effect of Oxydolor is too strong or too weak.

Taking more Oxydolor than recommended
Seek immediate medical advice if you have taken more tablets than prescribed.
Overdose may cause:

Constricted pupils
Shallow and slowed breathing (respiratory depression)
Drowsiness progressing to loss of consciousness (narcosis-like state)
Reduced skeletal muscle tone
Slowed heart rate
Low blood pressure
Brain disorders (known as toxic leukoencephalopathy)

In more severe cases, unconsciousness (coma), pulmonary edema, circulatory failure, and potentially death may occur.
Under no circumstances should you expose yourself to situations requiring high concentration, such as driving.

Missing a dose of Oxydolor
If you take less Oxydolor than prescribed or miss a dose, adequate pain relief may not be achieved.
If you miss a dose, you may take it if the next scheduled dose is due in more than 8 hours. If the time until the next dose is shorter, take the missed dose and then take the next dose 8 hours later.
Then continue with your regular dosing schedule.
Generally, Oxydolor should not be taken more frequently than every 8 hours.
If in doubt, consult your doctor or pharmacist.
Do not take a double dose to make up for a missed dose.

Discontinuing treatment with Oxydolor:
Do not stop treatment without consulting your doctor.
Stopping Oxydolor may lead to withdrawal symptoms (e.g., yawning, dilated pupils, tearing, runny nose, tremors, sweating, anxiety, restlessness, muscle spasms, insomnia, or muscle pain). Therefore, your doctor may recommend gradually reducing the dose.
If treatment with Oxydolor is no longer needed, your doctor will advise you on how to gradually reduce the dose to prevent withdrawal symptoms.
If you have any questions regarding 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 experiences them.
You should contact your doctor immediately if any of the following symptoms occur:

Sudden difficulty breathing, swelling of the eyelids, face or lips, rash and skin itching, especially when affecting the entire body – these are symptoms of severe allergic reactions.
Slowed or weak breathing (respiratory depression). This is the most common risk associated with medicines such as Oxydolor (opioids), and when used in high doses, it may lead to death.
Low blood pressure. This may cause dizziness and fainting.
Constricted pupils, bronchial muscle spasms (leading to shortness of breath), suppression of the cough reflex.

OTHER ADVERSE REACTIONS
Very common (occur in more than 1 in 10 patients)

constipation – this adverse effect can be managed by preventive measures (such as drinking plenty of fluids and a high-fiber diet)
nausea, vomiting. Your doctor will prescribe appropriate medication to treat these symptoms
drowsiness, dizziness, headache
itching

Common (occur in fewer than 1 in 10 patients)

mood changes (anxiety, disorientation, depression, nervousness, sleep disturbances, abnormal thoughts)
uncontrolled tremors or shaking of one or more parts of the body, feeling of weakness
low blood pressure, rarely accompanied by symptoms such as palpitations or fainting
difficulty breathing or wheezing
dry mouth, rarely accompanied by thirst and difficulty swallowing, general gastrointestinal symptoms such as stomach pain, diarrhea, heartburn
reduced appetite
rash, excessive sweating
pain during urination, increased need to urinate
fatigue or weakness

Uncommon (occur in fewer than 1 in 100 patients)

need to take increasingly higher doses of Oxydolor to achieve the same level of pain relief (tolerance)
injuries resulting from accidents due to reduced alertness
allergic reactions
increased secretion of antidiuretic hormone (ADH), with symptoms such as headache, irritability, lethargy, nausea, vomiting, confusion and disturbances of consciousness
insufficient fluid in the body (dehydration)
restlessness, mood changes, euphoric mood
perceptual disturbances (e.g. hallucinations)
reduced libido
seizures (especially in patients with epilepsy or a predisposition to seizures)
memory loss, difficulty concentrating, migraines
increased or decreased muscle tone, tics, tingling or numbness (e.g. in hands or feet)
speech disturbances, reduced sensitivity to pain or touch, taste disturbances
visual disturbances, constricted pupils
dizziness (sensation of spinning surroundings)
unpleasant sensation of irregular and/or strong heartbeat, rapid pulse
dilation of blood vessels leading to low blood pressure
voice changes, increased coughing
difficulty swallowing, mouth ulcers, gum pain
bloating (excessive gas in the stomach or intestines), belching, intestinal obstruction
increased blood concentration of certain liver enzymes
dry skin
difficulty urinating (urinary retention)
reduced sexual desire and inability to achieve or maintain an erection during sexual intercourse
decreased levels of sex hormones, which may affect sperm production in men or menstrual cycle in women
chills
pain (e.g. chest pain), nausea
fluid retention (edema – e.g. in hands, ankles or feet, particularly in ankles), thirst

Rare (occur in fewer than 1 in 1000 patients)

lymph node disease
muscle cramps, seizures, particularly in patients suffering from epilepsy or with a predisposition to seizures
low blood pressure
increased appetite
increased sensitivity to light
haematuria (blood in urine)
skin inflammation
feeling of weakness, particularly when standing up
bleeding gums, black stools, tooth decay
itchy rash, skin and mucous membrane blisters (herpes simplex)
changes in body weight (increase or decrease in body weight)

Very rare (occur in fewer than 1 in 10,000 patients)

speech disorders
scaly rash
muscle atrophy

Frequency unknown (frequency cannot be estimated from available data)

aggression
increased sensitivity to pain
sleep apnoea (breathing pauses during sleep)
severe allergic reactions
tooth decay or dental caries
bile stasis, biliary colic (causing abdominal pain)
prolonged use of Oxydolor during pregnancy may cause a life-threatening withdrawal syndrome in the newborn; symptoms to watch for in the child include: irritability, hyperexcitability and abnormal sleep patterns, high-pitched crying, tremors, vomiting, diarrhea and failure to gain weight
a disorder affecting the valve in the intestines, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 may 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 Oxydolor

Keep this medicine out of 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 may cause death in a person for whom it has not been prescribed. Do not use Oxydolor after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Oxydolor Contains
Oxydolor 5 mg, prolonged-release tablets
The active substance is oxycodone hydrochloride.
Each 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
Anhydrous colloidal silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc (E 553b)
Titanium dioxide (E171)
Macrogol 3350
Soybean lecithin (E 322)
Iron oxide yellow (E 172)
Iron oxide black (E 172)
Indigo carmine (E 132), lac

Oxydolor 10 mg, prolonged-release tablets
The active substance is oxycodone hydrochloride.
Each 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
Anhydrous colloidal silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc (E 553b)
Titanium dioxide (E171)
Macrogol 3350
Soybean lecithin (E 322)

Oxydolor 20 mg, prolonged-release tablets
The active substance is oxycodone hydrochloride.
Each 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
Anhydrous colloidal silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc (E 553b)
Titanium dioxide (E171)
Macrogol 3350
Soybean lecithin (E 322)
Iron oxide yellow (E 172)
Iron oxide black (E 172)
Iron oxide red (E 172)

Oxydolor 40 mg, prolonged-release tablets
The active substance is oxycodone hydrochloride.
Each 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
Anhydrous colloidal silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc (E 553b)
Titanium dioxide (E171)
Macrogol 3350
Soybean lecithin (E 322)
Iron oxide yellow (E 172)
Iron oxide black (E 172)
Iron oxide red (E 172)

Oxydolor 80 mg, prolonged-release tablets
The active substance is oxycodone hydrochloride.
Each 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
Anhydrous colloidal silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc (E 553b)
Titanium dioxide (E171)
Macrogol 3350
Soybean lecithin (E 322)
Iron oxide yellow (E 172)
Iron oxide black (E 172)
Indigo carmine (E 132), lac

What Oxydolor Looks Like and Contents of the Pack:
Prolonged-release tablet

Oxydolor 5 mg, prolonged-release tablets
Oxydolor 5 mg prolonged-release tablets are light grey, round, biconvex coated tablets.

Oxydolor 10 mg, prolonged-release tablets
Oxydolor 10 mg prolonged-release tablets are white, round, biconvex coated tablets.

Oxydolor 20 mg, prolonged-release tablets
Oxydolor 20 mg prolonged-release tablets are pale red, round, biconvex coated tablets.

Oxydolor 40 mg, prolonged-release tablets
Oxydolor 40 mg prolonged-release tablets are beige, round, biconvex coated tablets.

Oxydolor 80 mg, prolonged-release tablets
Oxydolor 80 mg prolonged-release tablets are pale green, round, biconvex coated tablets.

Oxydolor is packaged in PVC/PVDC/Aluminum blisters in cardboard boxes containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 72, 98 and 100 prolonged-release tablets, or in perforated blisters (unit-dose) PVC/PVDC/Aluminum in cardboard boxes containing 30x1, 50x1, 56x1, 60x1, 72x1, 98x1 and 100x1 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
A-8502 Lannach
Austria

This medicinal product is authorised in the European Economic Area countries 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 prolonged-release tablets)
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

For further information about this medicinal product, please contact the representative of the Marketing Authorisation 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]