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
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific reason. 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 slow or shallow breathing (respiratory depression);
• if the patient has severe lung disease with narrowing of the airways (chronic obstructive pulmonary disease);
• if the patient has a condition called cor pulmonale, where the right side of the heart is enlarged due to increased blood pressure in the pulmonary vessels (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, where there is a blockage in the intestines, 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, especially:

• in elderly or frail patients;
• if the patient has opioid-induced bowel obstruction;
• in case of kidney problems;
• in case of mild liver failure;
• if the patient has severe lung problems (e.g., reduced breathing ability);
• if the patient has a condition called sleep apnea, which causes pauses in breathing during sleep;
• if the patient has a condition called hypothyroidism, where the thyroid gland does not produce enough hormones;
• if the patient has adrenal gland problems (adrenal insufficiency), such as Addison's disease;
• in case of mental illness with loss of contact with reality (psychosis), caused by alcohol or other substance abuse;
• if the patient has gallstones;
• in case of an enlarged prostate gland;
• in case of pancreatitis;
• in case of low blood pressure (hypotension);
• in case of high blood pressure (hypertension);
• in case of heart problems;
• in 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 medicines called MAO inhibitors (used to treat depression or Parkinson's disease), such as tranylcypromine, phenelzine, isocarboxazid, and moclobemide;
• if the patient experiences excessive sleepiness or sudden sleep attacks.

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. Breathing problems during sleep Oxylaxon may cause breathing problems during sleep, 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 someone else notices these 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 can cause dependence and (or) addiction.

This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers can lead to a decrease in their effectiveness (the patient's body gets used to it, which is called tolerance). Long-term use of this medicine can 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 agreement with the doctor.

Possible signs of dependence or addiction The risk of these side effects is different for different people. The risk of addiction or dependence on Oxylaxon may be higher if:

• the patient or a family member has a history of alcohol, prescription drug, or illegal drug abuse ("addiction");
• the patient is a smoker;
• 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;
• taking the medicine for reasons other than prescribed, such as "to calm down" or "to help fall asleep";
• repeated, unsuccessful attempts to stop or reduce the use of the medicine;
• feeling unwell after stopping the medicine and improving after taking it again ("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 should not be used in patients with advanced intestinal or abdominal cancer, where bowel obstruction may occur. If the patient experiences sudden diarrhea at the start of treatment (within the first 3-5 days), it 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, they may experience withdrawal symptoms when switching to Oxylaxon, such as restlessness, sweating, and muscle pain. If these symptoms occur, the patient may require special medical supervision. If the patient is scheduled to undergo surgery, they should inform their doctor that they are 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 problems.

Long-term use of Oxylaxon may lead to tolerance to the medicine. This means that the patient may need higher doses to achieve the desired effect. Long-term use of this medicine can 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 agreement with the doctor.

Incorrect use of Oxylaxon Never misuse Oxylaxon, especially if the patient is addicted to medicines. In the case of addiction to drugs such as heroin, morphine, or methadone, misusing Oxylaxon can cause severe withdrawal symptoms, as it contains the active substance naloxone. Previous withdrawal symptoms may worsen. The patient should not misuse Oxylaxon prolonged-release tablets by dissolving them and injecting them (e.g., into blood vessels) or by inhaling them. The tablets contain talc, which can cause local tissue damage (necrosis) and changes in lung tissue (pulmonary granulomas). Misusing the medicine can have other serious consequences, even death. The patient should swallow the prolonged-release tablets whole, without dividing, breaking, chewing, or crushing them. Taking divided, broken, chewed, or crushed tablets can release a potentially fatal dose of oxycodone into the body (see section 3 "Taking a higher dose of Oxylaxon than prescribed").

Taking Oxylaxon may result in positive doping test results. 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 its 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 have breathing problems (respiratory depression). Medicines that affect brain function include:

• 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 can interact with oxycodone, causing symptoms such as 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 medicines, increases the risk of drowsiness, breathing problems (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 bleeding time may be accelerated or prolonged;
• 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 seizures, fits, or certain types of pain);
• phenytoin (used to treat seizures, fits, 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.

Taking Oxylaxon with food, drink, and alcohol

Consuming alcohol while taking Oxylaxon can 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, the patient should avoid drinking alcohol. The patient should also avoid drinking grapefruit juice while taking Oxylaxon.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

This medicine can affect the patient's ability to drive and use machines, as it can cause drowsiness or dizziness. This is most likely to happen at the start of treatment, after a dose increase, or when switching to this medicine from another. These side effects should go away after the patient has been taking the same dose for a long time. Oxylaxon can cause drowsiness or sudden sleep attacks. 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 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

The patient should always take this medicine exactly as their doctor has told them. If they are unsure, they should ask their doctor or pharmacist. If it is difficult to take the required dose with the given strength of the medicine, the patient can take a different strength of the same medicine. 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 to take it, when to contact the doctor, and when to stop taking it (see also "Stopping Oxylaxon treatment").

Unless the doctor has prescribed otherwise, the usual dose is:

For 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 to take and how to divide it 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 can start 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 needed, 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 taking additional doses of oxycodone hydrochloride, the beneficial effect of naloxone hydrochloride on bowel function may be reduced. If the patient experiences pain between doses, they may need to take a different, fast-acting painkiller. 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 problems If the patient has kidney or mild liver problems, the doctor will prescribe Oxylaxon with caution. The patient should not take Oxylaxon if they have moderate to severe liver failure (see also section 2 "When not to take Oxylaxon" and "Warnings and precautions"). Children and adolescents under 18 years of age Oxylaxon has not been studied in children and adolescents. Therefore, it is not recommended for patients under 18 years of age.

Method of administration

Oral use. The patient should swallow the tablets whole with a glass of water. The tablets can be taken with or without food. The patient should take them every 12 hours, following the established schedule. For example, if the patient takes a tablet at 8 am, they should take the next one at 8 pm. The patient should not divide, break, chew, or crush the prolonged-release tablets.

Instructions for the blister pack:

This medicine is in a packaging that is not accessible to children. The patient should press the blister firmly to remove 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 prescribed

If the patient takes more Oxylaxon than prescribed, they must contact their doctor immediately. Overdose can 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 problems (toxic leukoencephalopathy).

In severe cases, overdose can cause loss of consciousness (coma), fluid accumulation in the lungs, and circulatory failure, which can be life-threatening. The patient should avoid situations that require increased attention (e.g., driving vehicles).

Missing a dose of Oxylaxon

If the patient misses a dose of Oxylaxon or takes a lower dose than prescribed, they may not feel the effects of the medicine. If the patient forgets to take a dose, they should follow these instructions:

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 advise them to gradually reduce the daily dose. This way, the patient can avoid withdrawal symptoms, such as restlessness, sweating, and muscle pain. If the patient has any further questions 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:

The patient should stop taking Oxylaxon and contact their doctor or go to the nearest hospital emergency department immediately if they experience any of the following symptoms:

• slow and shallow breathing (respiratory depression). This is the most serious side effect of Oxylaxon, which occurs most often in elderly or frail patients;
• opioids can also cause a severe drop in blood pressure in sensitive patients;
• swelling of the face, tongue, or throat; difficulty swallowing; hives; difficulty breathing; and low blood pressure (anaphylactic reactions).

Side effects observed in patients taking painkillers:

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

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

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

• abdominal distension;
• abnormal thinking;
• anxiety, confusion, depression, nervousness;
• 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;
• edema of the hands, feet, and ankles;
• speech disorders;
• tremors;
• 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 a history of seizure disorders or a tendency to seizures).

Rare(may occur in less than 1 in 1,000 patients)

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

Unknown frequency(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 the hands or feet;
• belching;

The active substance oxycodone, which is not combined with naloxone, may cause the following side effects:

Respiratory problems, 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 unusually happy);
• decreased activity, increased activity;
• difficulty urinating;
• hiccups;

Infrequent(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;
• decreased sensitivity to pain and touch;
• impaired coordination;
• voice changes (hoarseness);
• fluid retention;
• hearing disorders;
• mouth ulcers, toothache;
• difficulty swallowing;
• perception disorders (e.g., hallucinations, depersonalization);
• decreased sexual desire;
• dehydration, thirst;

Rare(may occur in less than 1 in 1,000 patients)

• itching rash (hives);
• herpes;
• increased appetite;
• tarry stools;
• gum bleeding;

Unknown frequency(cannot be estimated from the available data)

• severe generalized allergic reactions (anaphylactic reactions);
• amenorrhea;
• bile duct disorders;
• long-term use of Oxylaxon during pregnancy may cause a life-threatening withdrawal syndrome in the newborn; symptoms to look out for in the child include irritability, hyperactivity, and abnormal sleep patterns, high-pitched crying, vomiting, diarrhea, and failure to gain weight;
• a bowel disorder that can cause severe abdominal pain (dysfunction of the Oddi sphincter).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Oxylaxon

The medicine should be kept out of sight and reach of children. This medicine should be stored in a closed and secure location, inaccessible to others. It can be very harmful and may cause death if taken by someone it was not prescribed for. The patient should not use this medicine 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 patient should not store the medicine at temperatures 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 they no longer need. 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 anhydrous 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 the number "5" embossed on one side. Oxylaxon, 10 mg+5 mg, prolonged-release tablets White or almost white, round, and biconvex prolonged-release tablets with the number "10" embossed on one side. Oxylaxon, 20 mg+10 mg, prolonged-release tablets Light pink, round, and biconvex prolonged-release tablets with the number "20" embossed on one side. Oxylaxon, 30 mg+15 mg, prolonged-release tablets Brown, round, and biconvex prolonged-release tablets with the number "30" embossed on one side. Oxylaxon, 40 mg+20 mg, prolonged-release tablets Yellow, round, and biconvex prolonged-release tablets with the number "40" embossed on one side. The tablets are available in packs 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 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 Tel: 022/ 636 52 23; 636 53 02 biuro@gl-pharma.pl

Date of last revision of the leaflet: 28.05.2025