Oxidolor Fast

Patient Information Leaflet: Information for the User

Oxydolor Fast, 5 mg, coated tablets

Oxydolor Fast, 10 mg, coated tablets

Oxydolor Fast, 20 mg, coated tablets

Oxycodone hydrochloride

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed 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 experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Oxydolor Fast and what is it used for

Oxydolor Fast is a strong pain reliever belonging to the opioid group.
Oxydolor Fast is used in adults and adolescents aged 12 years and older for the treatment of
severe pain that can only be adequately managed with opioid analgesics.

2. Important information before taking Oxydolor Fast

When not to take Oxydolor Fast:

• if you are allergic to oxycodone hydrochloride, soy, peanuts, or any of the other ingredients of this medicine listed in section 6
• if you have breathing difficulties, such as slow or shallow breathing (respiratory depression)
• if you have too high a level of carbon dioxide in your blood
• if you have chronic pulmonary disease associated with narrowing of the airways (chronic obstructive pulmonary disease)
• if you have certain heart disorders, known as cor pulmonale
• if you have asthma
• if you have a type of intestinal obstruction called paralytic ileus
• if you have severe stomach pain or delayed stomach emptying

Warnings and precautions

Before starting to take Oxydolor Fast, you should discuss it with your 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 certain thyroid disorders (hypothyroidism) or if the thyroid gland does not produce enough hormones (hypothyroidism)
• if you have adrenal gland disorders (adrenal insufficiency), such as Addison's disease
• in the case of prostate enlargement
• in the case of mental illness caused by addiction to alcohol or other substances
• in the case of gallbladder disorders
• in the case of pancreatitis, which can cause severe abdominal or back pain
• in the case of difficulty or pain when urinating
• if your doctor suspects that you have paralytic ileus (a condition in which the intestines stop working)
• in the case of inflammatory bowel disease
• in the case of head injury with severe headache or discomfort - signs of increased intracranial pressure
• in the case of low blood pressure or a feeling of weakness when standing up
• in the case of low blood volume (hypovolemia)
• in the case of epilepsy or a history of seizures
• in the case of taking MAO inhibitors (used to treat depression or Parkinson's disease) or if they have been taken in the last two weeks

Respiratory depression during sleep

Oxydolor Fast may cause respiratory depression during sleep, such as sleep apnea (pauses in breathing during sleep) and associated hypoxemia (low oxygen level 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.
The most serious risk associated with opioid overdose is shallow and slow breathing (respiratory depression). This most often occurs in the elderly and frail. It can also cause a decrease in oxygen levels in the blood, which can lead to fainting.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It can cause dependence and (or) addiction.
If Oxydolor Fast is used for long-term treatment, tolerance to the medicine may develop. This means that in order to control the pain, there may be a need for gradual dose escalation. The dose should not be changed without consulting a doctor.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics can lead to a decrease in their effectiveness (the patient's body gets used to it, which is called tolerance). Repeated use of Oxydolor Fast can lead to dependence, abuse, and addiction, which can lead to life-threatening overdose. The risk of these side effects may be higher when using higher doses for a longer period.

• if the patient or their family member has ever abused or been dependent on alcohol, prescription drugs, or drugs ("addiction");
• if the patient is a smoker;
• if 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 Fast, it may indicate that they are developing dependence or addiction.

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

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the right time and safe way to stop treatment (see section 3 "Stopping Oxydolor Fast").
Oxydolor Fast has addictive properties. If treatment is stopped suddenly, withdrawal symptoms may occur, such as yawning, dilated pupils, lacrimation, rhinorrhea, sneezing, gooseflesh, sweating, anxiety, agitation, tremors, insomnia, or muscle pain. If the use of the medicine is no longer necessary, the doctor will gradually reduce the dose.
The doctor will assess the possible risk compared to the benefits of using this medicine.
You should consult your doctor if you have any additional questions about this.

Children

The safety and efficacy of Oxydolor Fast in children under 12 years of age have not been established. Therefore, the use of Oxydolor Fast in this age group is not recommended.

Doping Warning

Athletes should be aware that this medicine can cause a positive result in doping tests.
Taking Oxydolor Fast as a doping agent can be a risk to health.

Oxydolor Fast and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant use of Oxydolor Fast and sedating medicines, such as benzodiazepines or related drugs, increases the risk of sedation, respiratory depression, coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Oxydolor Fast with sedating medicines, the dose and duration of concomitant use should be limited by the doctor.
You should inform your doctor about all sedating medicines and strictly follow the doctor's instructions regarding dosage. It may be helpful to inform friends or relatives to be aware of the signs and symptoms listed above. In case of such symptoms, you should contact a doctor.
The side effects of Oxydolor Fast may occur more frequently or be more severe if it is used concomitantly with medicines that affect brain activity or with medicines used to treat allergies, motion sickness, or vomiting. Side effects may include shallow and slow breathing (respiratory depression), constipation, dry mouth, or urinary retention.

• sedating medicines (including benzodiazepines)
• medicines used to treat depression (such as paroxetine or amitriptyline), including those belonging to the MAO inhibitor group (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid)
• medicines used to treat allergies, motion sickness, or vomiting (antihistamines, antiemetics)
• medicines used to treat mental or psychiatric disorders (such as psychotropic drugs, phenothiazines, or neuroleptics)
• medicines used to treat epilepsy, pain, or anxiety, such as gabapentin and pregabalin

The risk of side effects increases if you take antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, which can cause the patient to experience the following symptoms: involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, tremors, increased reflexes, muscle stiffness, and elevated body temperature above 38°C. In case of these symptoms, you should contact a doctor.
You should inform your doctor or pharmacist if you are taking any of the following medicines:

• muscle relaxants used to treat muscle spasms (such as tizanidine)
• medicines used to treat Parkinson's disease
• other strong pain relievers (opioids)
• cimetidine (a medicine 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)
• protease inhibitors used to treat HIV infection (such as 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 that prevent blood clotting or thin the blood (such as phenprocoumon)

Oxydolor Fast with alcohol and grapefruit juice

You should not take Oxydolor Fast with alcohol. Consuming alcohol may increase the side effects of oxycodone, such as sedation, drowsiness, and slow and shallow breathing.
You should avoid taking Oxydolor Fast if you currently or have previously abused alcohol or drugs.
Grapefruit juice may increase the level of oxycodone in the blood. You should discuss this with your doctor if you regularly drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is recommended to avoidtaking Oxydolor Fast during pregnancy.
Use ofoxycodone during pregnancyfor a prolonged period may causewithdrawal symptomsin the newborn. If oxycodone is given during delivery, the baby may experience respiratory depression (shallow breathing).
Breastfeeding
You should stopbreastfeeding while taking Oxydolor Fast. Oxycodone hydrochloride passes into breast milk and may cause sedation, shallow and slow breathing (respiratory depression) in the breastfed child. Therefore, it cannot be ruled out that there is a risk to the breastfed child, especially after taking multiple doses of Oxydolor Fast.

Driving and using machines

Oxydolor Fast may impair your ability to drive and use machines.
You should expect this, especially when starting treatment with Oxydolor Fast, after dose escalation, or when switching treatment, as well as when Oxydolor Fast interacts with alcohol or medicines that affect brain activity. In the case of stabilized therapy, it is not necessary to introduce a general ban on driving. The treating doctor must assess the individual situation of the patient.

Oxydolor Fast contains lactose

Oxydolor Fast contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Oxydolor Fast contains soy

Oxydolor Fast contains soy. If you are allergic to peanuts or soy, you should not take this medicine.

Oxydolor Fast, 5 mg, contains Sunset Yellow FCF (E 110), aluminum lake

Oxydolor Fast, 5 mg, coated tablets contain the colorant Sunset Yellow FCF (E 110), aluminum lake, which may cause allergic reactions.

3. How to take Oxydolor Fast

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, you should consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from the use of Oxydolor Fast, when and how long to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxydolor Fast").

Recommended dose

For doses that cannot be achieved with this strength, other strengths of this medicine are available.
The doctor will determinethe dose based on the intensity of the pain and individual response to treatment.
Do not changethe dosage without consulting your doctor.
You should take the smallest effective dose necessary to relieve the pain.
If you have previously been treated with opioids, your doctor may start treatment with a higher dose.
It may be necessary to gradually increase the dose if pain relief is inadequate or if the pain worsens.
You should inform your doctor if the effect of Oxydolor Fast is too strong or too weak.

If the doctor does not prescribe otherwise, the recommended dose is:

• adults and adolescents (12 years and older)The usual starting dose is 5 mg every 6 hours. If necessary, the interval between doses of Oxydolor Fast can be shortened to 4 hours. Oxydolor Fast should not be taken more than 6 times a day. The doctor will prescribe the dose required for pain treatment. If you still experience pain while taking these tablets, you should discuss this with your doctor.
• elderly patients (65 years and older):Elderly patients with normal liver and/or kidney function may take the same doses as adults.
• patients with kidney and/or liver impairment:If you have liver or kidney impairment and have not previously taken opioids, treatment should be started with half the recommended dose for adults. The doctor may prescribe a lower starting dose.
• other risk groupsIn the case of patients with low body weight or patients whose body metabolizes medicines more slowly, the starting dose should be half the recommended dose for adults.
• children under 12 years:The safety and efficacy of Oxydolor Fast have not been sufficiently investigated in children under 12 years of age. Therefore, the use of Oxydolor Fast in this age group is not recommended.

Patients who have previously taken other strong pain relievers(opioids) may be prescribed a higher starting dose by their doctor.
The doctor will decide on the daily dose and how to divide it into individual doses.
The doctor will also decide on any dose changes during treatment.
If you experience pain between doses of Oxydolor Fast, it may mean that you need higher doses of the medicine. In this case, you should consult your doctor.
If you require long-term treatment for severe pain, you should switch to a prolonged-release formulation of oxycodone hydrochloride.

Method of administration

Oral use
The medicine should be taken with a sufficient amount of liquid(e.g., ½ glass of water) every 4-6 hours, as prescribed by the doctor. The medicine can be taken with or without food.

Duration of treatment

Your doctor will inform you how long to take Oxydolor Fast.
You should not stop taking Oxydolor Fast without consulting your doctor (see "Stopping Oxydolor Fast").
In the case of long-term use of Oxydolor Fast, you should regularly review your treatment with your doctor. This is necessary to achieve the best possible pain relief, i.e., to enable early treatment of any side effects and to decide on dose adjustment and continuation of treatment.
You should consult your doctor or pharmacist if you feel that the effect of Oxydolor Fast is too strong or too weak.

Instructions for opening the blister pack:

This medicine is in a pack that is protected against opening by children. You should press the tablet firmly to remove it from the blister pack.

Taking a higher dose of Oxydolor Fast than prescribed

In case of overdose, you should immediately contact a doctor.
Overdose may cause:

• constricted pupils
• shallow and slow breathing (respiratory depression)
• sedation up to a state of unconsciousness (a state similar to anesthesia)
• decreased muscle tone
• slow heart rate
• low blood pressure
• brain disorders (described as toxic leukoencephalopathy)

In severe cases, it may lead to loss of consciousness (coma), fluid accumulation in the lungs, and circulatory failure, potentially ending in death.
Under no circumstances should you expose yourself to situations that require increased concentration, such as driving a vehicle.

Missing a dose of Oxydolor Fast

If you take a lower dose of Oxydolor Fast than prescribed or miss a dose,
pain relief may not be achieved.
If you forget to take a dose, you can take it as soon as you remember.
You should remember that this medicine should be taken at intervals of 4-6 hours.
You should not take a double dose to make up for a missed dose.

Stopping Oxydolor Fast

You should not stop taking Oxydolor Fast without consulting your doctor.
Stopping Oxydolor Fast may cause withdrawal symptoms (such as yawning, dilated pupils, lacrimation, rhinorrhea, sneezing, gooseflesh, sweating, anxiety, agitation, tremors, insomnia, or muscle pain). Therefore, it may be recommended that the doctor gradually reduce the dose.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people

• drowsiness to somnolence, dizziness, headache
• 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 medicines to treat these symptoms.
• itching

Common:may affect up to 1 in 10 people

• mood changes and personality changes (anxiety, confusion, depression, nervousness, sleep disorders, unusual thoughts), decreased activity, restlessness, increased activity
• uncontrolled shaking of one or more parts of the body, feeling of weakness
• breathing difficulties or wheezing
• dry mouth, hiccups, general symptoms of indigestion such as stomach pain, diarrhea, heartburn
• skin reactions, rash, sweating
• weakness
• decreased appetite up to complete loss of appetite
• painful urination, increased need to urinate

Uncommon:may affect up to 1 in 100 people

• need to take increasingly higher doses of Oxydolor Fast to achieve the same level of pain relief (tolerance)
• injuries caused by accidents resulting from decreased alertness
• allergic reactions
• increased levels of antidiuretic hormone (ADH) in the blood
• insufficient fluids in the body (dehydration)
• agitation, mood changes, euphoric mood
• perception disorders (such as hallucinations)
• seizures (especially in people with epilepsy or a history of seizures)
• decreased libido
• memory loss, concentration disorders, migraine
• increased or decreased muscle tone, tics, tingling and numbness (hands and feet),
• speech disorders, decreased sensitivity to pain or touch, coordination disorders, taste disorders
• vision disorders, constricted pupils
• hearing disorders, feeling of spinning (dizziness)
• unpleasant feeling of irregular and/or forceful heartbeat, rapid pulse
• vasodilation leading to low blood pressure
• increased cough, sore throat, runny nose, voice changes
• 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,
• decreased sexual desire and inability to achieve or maintain an erection during sexual intercourse
• decreased levels of sex hormones that affect sperm production in men or menstrual cycle in women
• chills
• pain (e.g., chest pain), nausea
• fluid retention (edema - e.g., swelling of the hands, ankles, or feet, especially in the ankles), thirst

Rare:may affect up to 1 in 1,000 people

• feeling of weakness, especially when standing up
• lymphatic system disorders
• muscle spasms
• low blood pressure
• gastrointestinal bleeding, dark stools, tooth decay
• itching, rash, blisters on the skin and mucous membranes (hives or herpes simplex)
• weight changes (weight gain or loss)

Frequency not known: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 decay
• bile duct obstruction, biliary colic (causing abdominal pain)
• amenorrhea
• prolonged use of Oxydolor Fast 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, tremors, vomiting, diarrhea, and failure to gain weight
• disorder affecting the valve in the intestines, which can cause severe abdominal pain (dysfunction of the Oddi sphincter)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxydolor Fast

The medicine should be kept out of the sight and reach of children. This medicine should be stored in a closed and secure place, to which other people do not have access. It can be very harmful and may cause death in a person for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oxydolor Fast contains

The active substanceis oxycodone hydrochloride.

Oxydolor Fast, 5 mg, coated tablets

Each coated tablet contains 5 mg of oxycodone hydrochloride, which corresponds to 4.48 mg of oxycodone.

Oxydolor Fast, 10 mg, coated tablets

Each coated tablet contains 10 mg of oxycodone hydrochloride, which corresponds to 8.97 mg of oxycodone.

Oxydolor Fast, 20 mg, coated tablets

Each coated tablet contains 20 mg of oxycodone hydrochloride, which corresponds to 17.93 mg of oxycodone.

Other ingredients are:

Tablet core:
Sodium carboxymethylcellulose (type A)
Lactose monohydrate
Microcrystalline cellulose
Silica, colloidal, anhydrous
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc
Titanium dioxide (E 171)
Macrogol 3350
Soybean lecithin (E 322)
Indigo carmine, aluminum lake (E 132)
Sunset Yellow FCF, aluminum lake (E 110) (for 5 mg coated tablets)
Yellow iron oxide (E 172) (for 20 mg coated tablets)

What Oxydolor Fast looks like and contents of the pack

Oxydolor Fast, 5 mg, coated tablets

Dark blue, round, biconvex coated tablets.

Oxydolor Fast, 10 mg, coated tablets

Blue, convex, oblong coated tablets with a dividing line on both sides.
The tablet can be divided into two equal doses.

Oxydolor Fast, 20 mg, coated tablets

Light blue, convex, oblong coated tablets with a dividing line on both sides.
Length: 12.1 mm, thickness: 3.5 mm, width: 5.2 mm.
The tablet can be divided into two equal doses.
Oxydolor Fast is available in blister packs of 10, 20, 30, 56, or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
8502 Lannach
Austria

For more information about this medicine, you should 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
Phone: 022/636 52 23; 636 53 02
[email protected]

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

Germany: Oxycodon G.L. 5/10/20 mg Filmtabletten
Hungary: Codoxy Rapid 10mg filmtabletta
Poland: Oxydolor Fast

Date of last revision of the leaflet: 08.06.2025