Oxilaxon

Leaflet included in the packaging: patient information

Oxylaxon, 5 mg+2.5 mg, prolonged-release tablets

Oxylaxon, 10 mg+5 mg, prolonged-release tablets

Oxylaxon, 20 mg+10 mg, prolonged-release tablets

Oxylaxon, 30 mg+15 mg, prolonged-release tablets

Oxylaxon, 40 mg+20 mg, prolonged-release tablets

Oxycodone hydrochloride+Naloxone hydrochloride
You should carefully read the contents of the 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 a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Oxylaxon and what is it used for

Pain treatment

Oxylaxon has been prescribed to treat severe pain that can only be adequately controlled with opioid painkillers.

How Oxylaxon works on pain

Oxylaxon contains the active substances oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone is responsible for the pain-relieving effect of the medicine. It is a strong painkiller that belongs to a group of medicines called opioids.
Naloxone counteracts constipation, which is a typical side effect of strong painkillers (opioids).

2. Important information before taking Oxylaxon

When not to take Oxylaxon

• if the patient is allergic to oxycodone, naloxone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has breathing problems, such as slower or weaker breathing than usual (respiratory depression);
• if the patient has severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease);
• if the patient has a condition called cor pulmonale; in this case, the right side of the heart is enlarged due to increased pressure in the blood vessels of the lungs (e.g., as a result of chronic obstructive pulmonary disease);
• if the patient has severe asthma;
• if the patient has a condition called intestinal obstruction, not caused by opioids;
• if the patient has moderate to severe liver failure.

Warnings and precautions

Before starting treatment with Oxylaxon, the patient should discuss it with their doctor or pharmacist.

• in the case of elderly patients and weakened patients;
• if the patient has opioid-induced intestinal obstruction;
• in the case of kidney dysfunction;
• in the case of mild liver failure;
• if the patient has severe lung disorders (e.g., reduced breathing ability);
• if the patient has a condition characterized by frequent pauses in breathing during sleep, which can cause daytime sleepiness (sleep apnea);
• if the patient has a condition called hypothyroidism (a thyroid disorder characterized by feelings of dryness, coldness, and swelling of the skin, including the face and extremities);
• if the patient has a thyroid disorder (hypothyroidism);
• if the patient has adrenal gland disorders (adrenal glands do not function properly), such as Addison's disease;
• in the case of mental illness with accompanying loss of touch with reality (psychosis), caused by alcohol or other substance intoxication (substance-induced psychosis);
• if the patient has gallstones;
• in the case of abnormal prostate enlargement (prostate hypertrophy);
• in the case of pancreatitis;
• in the case of low blood pressure (hypotension);
• in the case of high blood pressure (hypertension);
• in the case of heart disorders;
• in the case of head injuries (due to the risk of increased intracranial pressure);
• if the patient has epilepsy or a tendency to seizures;
• if the patient is taking MAO inhibitor drugs (used to treat depression or Parkinson's disease), such as tranylcypromine, phenelzine, isocarboxazid, and moclobemide;
• if the patient experiences sleepiness or episodes of sudden sleepiness.

The patient should inform their doctor if they have had any of the above conditions in the past. The patient should also contact their doctor if they occur during treatment with Oxylaxon.
Respiratory disorders during sleep
Oxylaxon may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.
Tolerance, dependence, and addiction
This medicine contains oxycodone, which is an opioid. It may cause dependence and (or) addiction.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may lead to reduced efficacy of the medicine (the patient's body gets used to it, which is called tolerance).
Long-term use of Oxylaxon may lead to dependence, abuse, and addiction, which can lead to life-threatening overdose. The risk of these side effects may be higher when using a higher dose for a longer period.

• if the patient or a family member has ever abused or been dependent on alcohol, prescription drugs, or street drugs ("addiction");
• if the patient is a smoker;
• if the patient has 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 Oxylaxon, 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 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 Oxylaxon treatment").
Oxylaxon is not recommended for patients with advanced cancer of the digestive tract or pelvic area, where intestinal obstruction may occur.
If the patient experiences acute diarrhea at the beginning of treatment (within the first 3-5 days), it may be an effect of naloxone. This may be a sign that bowel function is returning to normal. If diarrhea persists after 3-5 days or bothers the patient, they should contact their doctor.
If the patient has previously taken high doses of other opioids, when switching to Oxylaxon, they may initially experience withdrawal symptoms (such as restlessness, sweating, and muscle pain). If such symptoms occur, the patient may require special medical supervision.
If the patient is to undergo surgery, they should inform their doctor about taking Oxylaxon.
The patient should consult their doctor if they 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.
Long-term use of Oxylaxon may lead to tolerance to the medicine. This means that the patient may require higher doses to achieve the desired effect. Long-term use of this medicine may lead to physical dependence. The patient should avoid taking medicines containing oxycodone if they have a history of alcohol, drug, or medicine abuse. If treatment is stopped suddenly, withdrawal symptoms may occur. If the patient no longer needs treatment, the daily dose should be gradually reduced, in consultation with their doctor.
Oxylaxon may cause positive results in doping tests.
Using Oxylaxon as a stimulant can be life-threatening.

Children and adolescents

Oxylaxon should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established.

Oxylaxon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The risk of side effects increases if Oxylaxon is taken with other medicines that affect brain function. In such cases, the patient may feel drowsy or experience breathing difficulties (respiratory depression).
Medicines that affect brain function:

• other strong painkillers (opioids),
• sedatives and tranquilizers,
• antidepressants (e.g., paroxetine, fluoxetine),
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
• other medicines that affect the nervous system (phenothiazines, neuroleptics).

The risk of side effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the patient to experience the following symptoms: involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, shivering, increased reflexes, muscle tension, and elevated body temperature above 38°C. If these symptoms occur, the patient should contact their doctor.
Concomitant use of Oxylaxon and sedatives, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), or sleepiness, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available.
If Oxylaxon is taken with sedatives, the doctor should limit the dose and duration of concomitant use.
The patient should tell their doctor about all sedatives they are taking and strictly follow the prescribed dose.
It may be helpful to inform a family member or close friend of the patient about the possibility of these symptoms. If they occur, the patient should consult their doctor.
The patient should inform their doctor about the following medicines:

• medicines that reduce blood clotting (coumarin derivatives), as clotting time may be accelerated or slowed down,
• macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin),
• azole antifungal medicines (e.g., ketoconazole, voriconazole, itraconazole, posaconazole),
• ritonavir or other protease inhibitors (used to treat HIV, such as indinavir, nelfinavir, saquinavir),
• cimetidine (a medicine used to treat stomach ulcers, indigestion, or heartburn),
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizure disorders, seizures, or certain types of pain),
• phenytoin (used to treat seizure disorders, seizures, or convulsions),
• St. John's Wort,
• quinidine (a medicine used to treat irregular heart rhythm),
• medicines used to treat depression,
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
• medicines used to treat mental disorders (antipsychotics or neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

Using Oxylaxon with food, drink, and alcohol

Consuming alcohol while taking Oxylaxon may cause drowsiness or increase the risk of serious side effects, such as shallow breathing with a risk of respiratory arrest and loss of consciousness. During treatment with Oxylaxon, it is recommended to avoid consuming alcohol.
The patient should avoid drinking grapefruit juice while taking Oxylaxon.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Whenever possible, Oxylaxon should be avoided during pregnancy. If the medicine is used during pregnancy for a long time, oxycodone may cause withdrawal symptoms in the newborn. If oxycodone is given during delivery, the newborn may experience respiratory depression (slow and shallow breathing).
Breastfeeding
Oxylaxon should not be used during breastfeeding. Oxycodone passes into breast milk. It is not known whether naloxone also passes into breast milk. For this reason, there is a risk to the breastfed child, especially if the mother takes multiple doses of Oxylaxon.

Driving and using machines

This medicine may affect the patient's ability to drive and use machines, as it may cause drowsiness or dizziness. This is most likely to happen at the start of treatment, when the dose is increased, or when switching from another medicine. These side effects should disappear when the patient has been taking the same dose for a long time.
Oxylaxon may cause drowsiness or episodes of sudden sleepiness. If these occur, the patient should not drive or operate machinery.
The patient should consult their doctor or pharmacist if they are unsure whether they can drive safely while taking this medicine.

Oxylaxon 5 mg+2.5 mg and 10 mg+5 mg contain lactose

Patients with intolerance to some sugars should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, which means it is "sodium-free".

3. How to take Oxylaxon

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
If it is difficult to take the required dose with the given strength of the medicine, another strength of the same medicinal product may be used.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from taking Oxylaxon, when and for how long they should take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxylaxon treatment").

If the doctor has not prescribed otherwise, the usual dose of Oxylaxon is:

In pain treatment

Adults
The usual starting dose is 10 mg of oxycodone hydrochloride and 5 mg of naloxone hydrochloride every 12 hours.
The doctor will decide what total daily dose should be taken and how it should be divided into morning and evening doses. The doctor will also decide on any necessary dose adjustments during treatment, depending on the severity of the pain and the patient's individual sensitivity.
The patient should take the lowest effective dose to relieve pain.
If the patient has previously taken opioids, treatment with Oxylaxon may be started with a higher initial dose.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If higher doses are necessary, the doctor may prescribe an additional dose of oxycodone without naloxone. However, the maximum daily dose of oxycodone hydrochloride should not exceed 400 mg. When additional doses of oxycodone hydrochloride are given, the beneficial effect of naloxone hydrochloride on bowel function may be reduced.
If the patient experiences pain between doses, another, faster-acting painkiller may be necessary. Oxylaxon is not intended for this purpose. The patient should consult their doctor in such cases.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.
Elderly patients
Usually, there is no need to adjust the dose in elderly patients with normal kidney and liver function.
Kidney or liver dysfunction
If the patient has kidney or mild liver dysfunction, the doctor will prescribe Oxylaxon with caution. Oxylaxon should not be taken if the patient has moderate to severe liver failure (see also section 2 "When not to take Oxylaxon" and "Warnings and precautions").

Administration

Oral use.
The tablets should be swallowed whole with a glass of water. They can be taken with or without food. The tablets should be taken every 12 hours, according to the established schedule. For example, if the patient takes a tablet at 8 am, the next one should be taken at 8 pm.
The prolonged-release tablets should not be divided, broken, chewed, or crushed.

Instructions for the blister pack:

This medicine is in a child-resistant packaging. The patient should press the blister firmly to release the tablet.

Duration of treatment

Oxylaxon should not be taken for longer than necessary. If the patient takes Oxylaxon for a long time, their doctor will regularly check if it is still necessary.

Taking a higher dose of Oxylaxon than recommended

If the patient takes a higher dose of Oxylaxon than recommended, they must contact their doctor immediately.
Overdose may cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness or loss of consciousness,
• reduced muscle tone (hypotonia),
• slow heart rate,
• low blood pressure,
• brain disorders (toxic leukoencephalopathy).

In severe cases, loss of consciousness (coma), water retention in the lungs, and circulatory collapse may occur, which can lead to death.
The patient should avoid situations that require increased attention (e.g., driving vehicles).

Missing a dose of Oxylaxon

If a dose of Oxylaxon is missed or a lower dose than prescribed is taken, the patient may not feel the effects of the medicine.
If a dose is missed, the patient should follow these instructions:

• if the next dose is to be taken in 8 hours or more: the missed dose should be taken immediately, and the treatment should continue according to the normal schedule;
• if the next dose is to be taken in less than 8 hours: the missed dose should be taken, and the patient should wait 8 hours before taking the next dose. The patient should try to return to their normal dosing schedule (e.g., at 8 am and 8 pm).

The patient should not take more than one dose in 8 hours.
The patient should not take a double dose to make up for a missed dose.

Stopping Oxylaxon treatment

The patient should not stop taking Oxylaxon without consulting their doctor.
If the patient no longer needs treatment, their doctor will recommend gradually reducing the daily dose. This way, the patient can avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxylaxon can cause side effects, although not everybody gets them.
Serious side effects or symptoms that require attention and action in case of their occurrence:

• slow and shallow breathing (respiratory depression). This is the most serious side effect of Oxylaxon, most commonly occurring in elderly and weakened patients;
• opioids may also cause a significant drop in blood pressure in sensitive patients;
• swelling of the face, lips, or throat; difficulty swallowing; hives; difficulty breathing; and low blood pressure (anaphylactic reactions).

Side effects observed in patients treated with painkillers:

Frequent(may occur in less than 1 in 10 patients):

• abdominal pain, nausea, constipation, diarrhea, gas
• dry mouth
• vomiting, feeling unwell
• decreased appetite, up to loss of appetite
• dizziness, dizziness
• headache
• hot flashes, sweating
• general weakness, fatigue, or exhaustion
• skin rash, skin reactions (rash)
• difficulty sleeping, drowsiness

Uncommon(may occur in less than 1 in 100 patients):

• abdominal distension
• abnormal thinking
• anxiety, confusion, depression, nervousness, difficulty concentrating
• chest tightness, especially in patients with coronary artery disease, chest pain
• low blood pressure, high blood pressure
• withdrawal symptoms, such as agitation
• fainting
• palpitations
• biliary colic
• general malaise
• pain
• swelling of hands, feet, and ankles
• speech disorders
• shivering
• breathing difficulties
• restlessness
• chills
• increased liver enzyme activity
• nasal congestion
• cough
• hypersensitivity (allergic reactions)
• weight loss
• accidents
• increased urination
• muscle spasms, muscle twitching, muscle pain
• vision disorders
• seizures (especially in patients with seizure disorders or a tendency to seizures)

Rare(may occur in less than 1 in 1000 patients)

• increased heart rate
• changes in urination
• weight gain
• yawning

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

• euphoria
• calmness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• sleep apnea (pauses in breathing during sleep)
• difficulty urinating
• tingling in hands or feet
• belching

The active substance oxycodone, not in combination with naloxone, may cause the following side effects:

Respiratory disorders, such as slow and shallow breathing (respiratory depression), constricted pupils, muscle spasms, and reduced cough reflex.
Frequent(may occur in less than 1 in 10 patients)

• mood and personality changes (e.g., depression, feeling extremely happy)
• decreased activity, increased activity
• difficulty urinating
• hiccups

Uncommon(may occur in less than 1 in 100 patients)

• concentration disorders, agitation
• migraine
• taste disorders
• increased muscle tone, involuntary muscle contractions
• dependence on the medicine, tolerance to the medicine
• intestinal obstruction
• dry skin, skin redness
• reduced sensitivity to pain and touch
• coordination disorders
• voice changes (hoarseness)
• fluid retention
• hearing disorders
• mouth ulcers, toothache
• difficulty swallowing
• perception disorders (e.g., hallucinations, depersonalization)
• reduced sexual desire
• dehydration, thirst

Rare(may occur in less than 1 in 1000 patients)

• pruritus (itching)
• urticaria (hives)
• increased appetite
• tarry stools
• gum bleeding

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

• acute generalized allergic reactions (anaphylactic reactions)
• amenorrhea (absence of menstruation)
• liver disorders
• long-term use of Oxylaxon 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 crying, shivering, vomiting, diarrhea, and failure to gain weight
• a disorder affecting the bowel, which can cause severe abdominal pain (dysfunction of the Oddi sphincter)

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Oxylaxon

The medicine should be stored out of 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 it was not prescribed for.
The medicine should not be used after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month stated.
The medicine should not be stored at a temperature above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oxylaxon contains

• The active substances of Oxylaxon are oxycodone hydrochloride and naloxone hydrochloride.

Oxylaxon, 5 mg+2.5 mg, prolonged-release tablets
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride, equivalent to 4.5 mg of oxycodone, and 2.5 mg of naloxone hydrochloride as 2.75 mg of naloxone hydrochloride dihydrate, equivalent to 2.25 mg of naloxone.
Oxylaxon, 10 mg+5 mg, prolonged-release tablets
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride, equivalent to 9 mg of oxycodone, and 5 mg of naloxone hydrochloride as 5.5 mg of naloxone hydrochloride dihydrate, equivalent to 4.5 mg of naloxone.
Oxylaxon, 20 mg+10 mg, prolonged-release tablets
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride, equivalent to 18 mg of oxycodone, and 10 mg of naloxone hydrochloride as 10.99 mg of naloxone hydrochloride dihydrate, equivalent to 9 mg of naloxone.
Oxylaxon, 30 mg+15 mg, prolonged-release tablets
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride, equivalent to 26.9 mg of oxycodone, and 15 mg of naloxone hydrochloride as 16.485 mg of naloxone hydrochloride dihydrate, equivalent to 13.5 mg of naloxone.
Oxylaxon, 40 mg+20 mg, prolonged-release tablets
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride, equivalent to 36 mg of oxycodone, and 20 mg of naloxone hydrochloride as 21.98 mg of naloxone hydrochloride dihydrate, equivalent to 18 mg of naloxone.

• Other ingredients are: Tablet core: polyvinyl acetate, povidone K30, sodium lauryl sulfate, silica, microcrystalline cellulose, lactose monohydrate (Oxylaxon 5 mg+2.5 mg and 10 mg+5 mg), colloidal silica, magnesium stearate. Tablet coating: polyvinyl alcohol, partially hydrolyzed, macrogol 3350, titanium dioxide (E171), talc, and brilliant blue FCF (E133), aluminum lake (Oxylaxon 5 mg+2.5 mg) iron oxide red (E172) (Oxylaxon 20 mg+10 mg and 30 mg+15 mg) iron oxide yellow (E172) (Oxylaxon 30 mg+15 mg and 40 mg+20 mg) iron oxide black (E172) (Oxylaxon 30 mg+15 mg)

What Oxylaxon looks like and contents of the pack

Oxylaxon is a prolonged-release tablet, which means that the active substances are released into the body over a longer period. Their effect lasts for 12 hours.
Oxylaxon, 5 mg+2.5 mg, prolonged-release tablets
Light blue, round, and biconvex prolonged-release tablets, with "5" embossed on one side.
Oxylaxon, 10 mg+5 mg, prolonged-release tablets
White or almost white, round, and biconvex prolonged-release tablets, with "10" embossed on one side.
Oxylaxon, 20 mg+10 mg, prolonged-release tablets
Light pink, round, and biconvex prolonged-release tablets, with "20" embossed on one side.
Oxylaxon, 30 mg+15 mg, prolonged-release tablets
Brown, round, and biconvex prolonged-release tablets, with "30" embossed on one side.
Oxylaxon, 40 mg+20 mg, prolonged-release tablets
Yellow, round, and biconvex prolonged-release tablets, with "40" embossed on one side.
Packaging containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, and 100 prolonged-release tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more information and information on the medicinal product name in other EU Member States, please contact 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]

Date of last revision of the leaflet: 28.05.2025