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

It is very important that you read the contents of this leaflet before taking this medicine, as it contains important information for you.

• 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 give it 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.

Contents of the pack

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

Oxydolor Fast is a strong pain-relieving medicine 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 much carbon dioxide in your blood
• if you have chronic lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease)
• if you have certain heart disorders, such as cor pulmonale
• if you have asthma
• if you have a type of bowel obstruction called paralytic ileus
• if you have severe stomach pain or delayed stomach emptying

Warnings and precautions

Before starting treatment with 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 your 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 alcohol or other substance abuse
• 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 where 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 feeling weak 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 you or someone else observes these symptoms, you should contact your doctor. Your 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 elderly or frail patients. 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, the dose may need to be gradually increased. You should not change the dosage without consulting your doctor.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid analgesics can lead to decreased efficacy of the medicine (the 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 you or a family member have ever abused or been dependent on alcohol, prescription drugs, or illicit drugs ("addiction");
• if you are a smoker;
• if you have ever had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental disorders.

If you notice any of the following symptoms while taking Oxydolor Fast, it may indicate that you are developing dependence or addiction.

• need to take the medicine for longer than prescribed by your 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";
• repeatedly attempting to stop or reduce the use of the medicine without success;
• feeling unwell after stopping the use of the medicine and improving after resuming it ("withdrawal effect").

If you observe any of these symptoms, you should contact your doctor to discuss the best treatment plan for you, 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, runny nose, sneezing, goosebumps, sweating, anxiety, restlessness, seizures, insomnia, or muscle pain. If the use of the medicine is no longer necessary, your doctor will gradually reduce the dose.
Your doctor will assess the possible risk compared to the benefits of using this medicine.
You should consult your doctor if you have any further questions about this.

The active substance of this medicine, oxycodone hydrochloride, like other strong opioids (strong pain-relieving medicines), has the potential for abuse. Psychological dependence may also develop. Oxydolor Fast should be used with special caution in patients who have abused or are currently abusing alcohol, drugs, or medicines.
When using high doses, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to further dose increases of Oxydolor Fast. Your doctor will then decide whether to reduce the dose or use another strong pain-relieving medicine (opioid).
If you are to undergo surgery, you should inform your doctor about taking Oxydolor Fast.
You should consult your doctor if you experience severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disorders.
Like other opioids, oxycodone can affect hormone production in the body (such as cortisol and sex hormones). This is especially true when taking high doses for a long time.

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.
Using Oxydolor Fast as a doping agent can pose a risk to health.

Oxydolor Fast and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Oxydolor Fast and sedating medicines, such as benzodiazepines or related medicines, increases the risk of sedation, respiratory depression, coma, and death. Therefore, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Oxydolor Fast together with sedating medicines, the dose and duration of concomitant use should be limited by your doctor.
You should inform your doctor about all sedating medicines you are taking and strictly follow your doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the signs and symptoms listed above. In the event of such symptoms, you should contact your 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.

• sleep-inducing or 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 medicines, phenothiazines, or neuroleptics)
• medicines used to treat epilepsy, pain, or anxiety, such as gabapentin and pregabalin

The risk of side effects increases if you are taking antidepressant medicines (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). These medicines can interact with oxycodone, causing symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, shivering, increased reflexes, increased muscle tone, and elevated body temperature above 38°C. If you experience any of these symptoms, you should contact your 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-relieving medicines (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 drinks

You should not take Oxydolor Fast with alcohol. Consuming alcohol can increase the side effects of oxycodone, such as sedation, drowsiness, and slow and shallow breathing.
You should avoid using Oxydolor Fast in patients who currently or previously abused alcohol or medicines.
Grapefruit juice may increase the levels 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
Do not takeOxydolor Fast during pregnancy.
Use ofoxycodone in pregnancyfor a long time may causewithdrawal symptomsin the newborn. If oxycodone is given during delivery, the baby may experience respiratory depression (breathing difficulties).
Breastfeeding
Do not breastfeedwhile taking Oxydolor Fast. Oxycodone hydrochloride passes into breast milk and may cause sedation, shallow and slow breathing (respiratory depression) in the breastfed baby. Therefore, the risk to the breastfed baby cannot be excluded, especially after repeated 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 increase, 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.
Your treating doctor must assess your individual situation.

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 carmine red, aluminum lake

Oxydolor Fast, 5 mg, coated tablets contain the colorant carmine red, aluminum lake (E 124), which may cause allergic reactions.

3. How to take Oxydolor Fast

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Oxydolor Fast, when and how long to take it, when to contact your 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.
Your doctor will determinethe dose based on the severity of the pain and individual response to treatment.
Do not changethe dose without consulting your doctor.
You should take the smallest effective dose that provides adequate pain relief.
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 your doctor has not prescribed otherwise, the recommended dose is:

• adults and adolescents (12 years and older)The usual starting dose is 5 mg every 6 hours. The interval between doses of Oxydolor Fast can be reduced to 4 hours if necessary. Oxydolor Fast should not be taken more than 6 times a day. Your doctor will prescribe the dose needed to treat your pain. If you still experience pain while taking these tablets, you should talk to 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 start with half the recommended dose for adults. Your doctor may prescribe a lower starting dose.
• other risk groupsIn the case of patients with low body weight or patients whose bodies metabolize 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 established 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-relieving medicines (opioids) may be prescribed a higher starting dose by their doctor.
Your doctor will decide on the daily dose and how to divide it into individual doses in the morning and evening. Your 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 oxycodone hydrochloride formulation.

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 directed by your 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 allow for early treatment of any side effects that may occur 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 child-resistant packaging. 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 contact your doctor immediately.

Overdose may cause:

• narrowing of the 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 resulting 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 less 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.
Remember that this medicine should be taken every 4-6 hours.
Do 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, runny nose, sneezing, goosebumps, sweating, anxiety, restlessness, seizures, insomnia, or muscle pain). Therefore, it may be recommended that your doctor gradually reduce the dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxydolor Fast can cause side effects, although not everybody gets them.
Very common:occur in 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. Your doctor will prescribe appropriate medicines to treat these symptoms.
• itching

Common:occur in less than 1 in 10 people

• mood changes and personality changes (anxiety, confusion, depression, nervousness, sleep disorders, abnormal 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:occur in less than 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 antidiuretic hormone (ADH) levels in the blood
• insufficient fluid 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 (arms and legs),
• speech disorders, decreased sensitivity to pain or touch, coordination disorders, taste disorders
• vision disorders, narrowing of the pupils
• hearing disorders, feeling of spinning (vertigo)
• 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, constipation
• 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., hands, ankles, or feet, especially in the ankles), thirst

Rare:occur in less than 1 in 1000 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 on the lips or genital area, or herpes simplex or herpes zoster infection)
• 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 tooth decay
• bile duct obstruction, biliary colic (causing abdominal pain)
• absence of menstruation
• long-term use of Oxydolor Fast during pregnancy may cause life-threatening withdrawal syndrome in the newborn; symptoms to look out for in the baby include irritability, hyperactivity, and abnormal sleep pattern, high-pitched crying, shaking, vomiting, diarrhea, and failure to gain weight
• disorder affecting the intestine, 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, Poland, phone: +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 where others cannot access it. It can be very harmful and may cause death in a person it was not prescribed for.
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 substance is oxycodone hydrochloride.

Oxydolor Fast, 5 mg, coated tablets

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

Oxydolor Fast, 10 mg, coated tablets

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

Oxydolor Fast, 20 mg, coated tablets

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

Other ingredients are:

Tablet core:
Sodium carboxymethylcellulose (type A)
Lactose monohydrate
Microcrystalline cellulose
Colloidal anhydrous silica
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Talc
Titanium dioxide (E 171)
Macrogol 3350
Soybean lecithin (E 322)
Indigo carmine, aluminum lake (E 132)
Carmine red, aluminum lake (E 124) (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 further information on 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
biuro@gl-pharma.pl

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