Oxylaxon: detailed information

Package leaflet: Information for the patient

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 this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Oxylaxon is and what it is used for
What you need to know before taking Oxylaxon
How to take Oxylaxon
Possible side effects
How to store Oxylaxon
Contents of the pack and other information

1. What Oxylaxon is and what it is used for

Pain treatment
Oxylaxon has been prescribed to treat severe pain that can only be adequately managed with opioid analgesics.

How Oxylaxon works against pain
Oxylaxon contains the active substances oxycodone hydrochloride and naloxone hydrochloride.
Oxycodone is responsible for the analgesic effect of the medicine. It is a strong pain-relieving agent belonging to a group of medicines called opioids.
Naloxone counteracts constipation, which is a common side effect of strong painkillers (opioids).

2. Important information before using Oxylaxon

When not to use 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 weaker or slower breathing than usual (respiratory depression);
if the patient has severe lung disease associated with airway obstruction (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 bronchial asthma;
if the patient has opioid-independent intestinal obstruction;
if the patient has moderate to severe liver impairment.

Warnings and precautions
Before starting treatment with Oxylaxon, discuss this with your doctor or pharmacist:

in elderly or weakened patients;
if the patient has opioid-induced intestinal obstruction;
in case of kidney function disorders;
in case of mild liver impairment;
if the patient has severe lung disorders (e.g. reduced respiratory capacity);
if the patient suffers from a condition characterized by frequent pauses in breathing during sleep, which may cause daytime sleepiness (sleep apnoea);
if the patient has myxoedema (a thyroid disorder characterized by dryness, coldness, and swelling of the skin affecting the face and limbs);
if the patient’s thyroid gland does not produce sufficient amounts of hormones (hypothyroidism);
if the patient has adrenal gland disorders (adrenal glands not functioning properly), e.g. Addison’s disease;
in case of a mental disorder with associated (partial) loss of reality perception (psychosis), caused by alcohol or other substance intoxication (substance-induced psychosis);
if the patient has gallstones;
in case of abnormal enlargement of the prostate gland (prostate hyperplasia);
in case of pancreatitis;
in case of low blood pressure (hypotension);
in case of high blood pressure (hypertension);
in case of heart disorders;
in case of head injury (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 in the treatment of depression or Parkinson’s disease), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, or moclobemide;
if the patient experiences drowsiness or episodes of sudden sleep.

Inform your doctor if the patient has previously experienced any of the conditions listed above. You should also contact your doctor if any of these conditions occur during treatment with Oxylaxon.

Sleep-related breathing disorders
Oxylaxon may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood during sleep). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes such symptoms, contact a doctor. The doctor may consider reducing the dose.

Tolerance, dependence, and abuse
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or abuse.
This medicine contains oxycodone, which is an opioid analgesic. Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (the patient’s body becomes accustomed to it, known as tolerance).
Repeated use of Oxylaxon may lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may be higher when higher doses are used for prolonged periods.
Dependence or addiction may lead to the patient being unable to control how much medicine to take or how often to take it. The patient may feel a need to take the medicine even if it is no longer relieving pain.
The risk of developing dependence or addiction varies between individuals. The risk may be higher if:

the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or drugs ("addiction");
the patient is a smoker;
the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental disorders.

If the patient notices any of the following symptoms while taking Oxylaxon, this may indicate that dependence or addiction is developing:

need to take the medicine longer than prescribed by the doctor;
need to take a higher dose than recommended;
use of the medicine for reasons other than prescribed, e.g. "to calm down" or "to help fall asleep";
repeated unsuccessful attempts to stop or reduce use of the medicine;
feeling unwell after stopping the medicine and improvement after restarting (withdrawal effect).

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate time and safe way to discontinue treatment (see section 3 "Stopping treatment with Oxylaxon").

Oxylaxon is not recommended for use in patients with advanced gastrointestinal or pelvic tumours where intestinal obstruction may occur.
If acute diarrhoea occurs at the beginning of treatment (within the first 3–5 days), this may be a naloxone effect. It may indicate that intestinal function is returning to normal. If diarrhoea persists beyond 3–5 days or is concerning to the patient, contact a doctor.
If the patient has previously taken high doses of other opioids, withdrawal symptoms (such as restlessness, sweating episodes, and muscle pain) may initially occur when switching to Oxylaxon. If such symptoms occur, the patient may require special medical monitoring.
If the patient is scheduled for surgery, inform the doctor about the use of Oxylaxon.
Contact a doctor if the patient experiences severe upper abdominal pain, possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis or biliary tract inflammation.
With long-term use of Oxylaxon, tolerance to the medicine may develop. This means the patient may require higher doses to achieve the desired effect. Long-term use of this medicine may lead to physical dependence. Avoid using medicines containing oxycodone in patients with current or past alcohol, drug, or medicine abuse. If treatment is stopped abruptly, withdrawal symptoms may occur. If the patient no longer needs treatment, the daily dose should be gradually reduced in consultation with a doctor.
Undissolved tablet residues may be present in the stool. This is not a cause for concern, as the active substance has already been released in the stomach and intestines and absorbed by the body.

Misuse of Oxylaxon
Never misuse Oxylaxon, especially if the patient is drug-dependent. In patients dependent on drugs such as heroin, morphine, or methadone, misuse of Oxylaxon may cause severe withdrawal symptoms due to the presence of naloxone. Existing withdrawal symptoms may intensify.
Do not misuse Oxylaxon extended-release tablets by dissolving and injecting them (e.g. intravenously) or by inhaling them. The tablets contain talc, which may cause local tissue necrosis and lung tissue changes (pulmonary granulomas). Misuse may also lead to other serious consequences, including death.
Extended-release tablets must be swallowed whole to preserve the slow-release property of oxycodone. Tablets must not be divided, broken, chewed, or crushed. Taking divided, broken, chewed, or crushed tablets may result in the release of a potentially fatal dose of oxycodone (see section 3 "Taking a higher than recommended dose of Oxylaxon").
Use of Oxylaxon may lead to positive results in anti-doping tests.
Using Oxylaxon as a stimulant may pose a life-threatening risk.

Children and adolescents
This medicine 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
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
The risk of adverse effects increases if Oxylaxon is used together with other medicines that affect brain function. In such cases, the patient may experience drowsiness or worsening breathing problems (slow, shallow breathing).
Medicines that affect brain function include:

other strong painkillers (opioids);
sleeping pills and sedatives;
antidepressants (e.g. paroxetine, fluoxetine);
medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics);
other medicines affecting the nervous system (phenothiazines, neuroleptics).

The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the following symptoms in the patient: involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremors, increased reflexes, increased muscle tone, and body temperature rising above 38°C. If these symptoms occur, contact a doctor.
Concomitant use of Oxylaxon and sedatives, e.g. benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which may be life-threatening. Therefore, combination therapy should only be considered when no other treatment options are available.
If Oxylaxon is used together with sedatives, the doctor should limit the dose and duration of concomitant use.
The patient should inform the doctor about all sedative medicines being taken and strictly follow the prescribed dose. It may be helpful to inform a relative or close friend about the possibility of these symptoms occurring. If the described symptoms occur, consult a doctor.
Inform your doctor if the patient is taking any of the following medicines:

medicines that affect blood clotting (coumarin derivatives), as clotting time may be accelerated or slowed;
macrolide antibiotics (e.g. clarithromycin, erythromycin, telithromycin);
azole antifungal medicines (e.g. ketoconazole, voriconazole, itraconazole, posaconazole);
ritonavir or other protease inhibitors (used in HIV treatment, 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 convulsions and certain types of pain);
phenytoin (used to treat seizures, fits, or convulsions);
St John’s wort (Hypericum perforatum);
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 severe adverse effects such as shallow breathing, risk of respiratory arrest, and loss of consciousness. Avoid alcohol consumption during treatment with Oxylaxon.
Avoid drinking grapefruit juice while taking Oxylaxon.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
If possible, avoid using Oxylaxon during pregnancy. If the medicine is used for prolonged periods during pregnancy, oxycodone may cause withdrawal symptoms in the newborn. If oxycodone is administered during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn.
Breastfeeding
Breastfeeding must be discontinued during treatment with Oxylaxon. Oxycodone passes into breast milk. It is unknown whether naloxone also passes into breast milk. For this reason, the risk to the breastfed infant cannot be excluded, particularly if the mother is taking multiple doses of Oxylaxon.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery, as it may cause drowsiness or dizziness. This is most likely at the beginning of treatment, after dose increase, or after switching to this medicine from another. These adverse effects should subside when the patient has been on a stable dose for a longer period.
Oxylaxon may cause drowsiness or episodes of sudden sleep. If these occur, the patient should not drive or operate machinery. Inform the doctor about these effects.
Consult your doctor or pharmacist if you are unsure whether it is safe to drive while taking this medicine.

Oxylaxon 5 mg + 2.5 mg and 10 mg + 5 mg contains lactose.
Patients with intolerance to certain sugars should consult their doctor before using this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, which means it is "sodium-free".

3. How to use Oxylaxon

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

If the prescribed dose cannot be achieved or is impractical with the available strengths of this medicine, other strengths of the same medicinal product may be used.

Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Oxylaxon, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Stopping treatment with Oxylaxon").

Unless otherwise prescribed by your doctor, 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.

Your doctor will decide the total daily dose and how to divide it into morning and evening doses. Your doctor will also determine any necessary dose adjustments during treatment, depending on the intensity of pain and your individual sensitivity. You should take the lowest effective dose needed to relieve your pain. If you have previously taken opioids, treatment with Oxylaxon may be started at a higher initial dose.

The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone hydrochloride. If higher doses are required, your doctor may prescribe additional doses of oxycodone without naloxone. However, the maximum daily dose of oxycodone hydrochloride must not exceed 400 mg. When additional doses of oxycodone hydrochloride are administered, the beneficial effect of naloxone hydrochloride on bowel function may be reduced.

If you experience pain between doses, another fast-acting painkiller may be needed. Oxylaxon is not intended for this purpose. Consult your doctor in such cases.

If you feel the medicine’s effect is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Usually, no dose adjustment is necessary in elderly patients with normal kidney and/or liver function.

Impaired liver or kidney function
If you have kidney problems or mild liver impairment, your doctor will prescribe Oxylaxon with special caution. Do not take Oxylaxon if you have moderate to severe hepatic impairment (see also section 2. "When not to use Oxylaxon" and "Warnings and precautions").

Children and adolescents under 18 years
Studies on the efficacy and safety of Oxylaxon in children and adolescents have not been conducted. Therefore, this medicine is not recommended for patients under 18 years of age.

Method of administration

For oral use.

Swallow the tablets whole with a glass of water. Tablets may be taken with or without food. Take them every 12 hours as directed. For example, if you take a tablet at 8 a.m., the next should be taken at 8 p.m.

Do not split, break, chew, or crush prolonged-release tablets.

Instructions for use of the blister pack:
This medicine is packaged in child-resistant packaging. Press firmly on the blister to push the tablet out.

Duration of treatment

Do not use Oxylaxon longer than necessary. If you are taking Oxylaxon for an extended period, your doctor should regularly assess whether continued treatment is still required.

Taking more Oxylaxon than prescribed

If you take more Oxylaxon than prescribed, you must contact your doctor immediately.

Overdose may cause:

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

In severe cases, unconsciousness (coma), pulmonary edema, and circulatory collapse may occur, which can lead to death.

Avoid situations requiring increased attention (e.g., driving).

Missed dose of Oxylaxon

If you miss a dose of Oxylaxon or take a lower dose than prescribed, you may not experience the medicine’s effect.

If you forget to take a dose, follow these instructions:

If the next dose is due in 8 hours or more: take the missed dose immediately and continue treatment as usual.
If the next dose is due in less than 8 hours: take the missed dose, then wait 8 hours before taking the next dose. Try to return to the normal dosing schedule (e.g., at 8 a.m. and 8 p.m.).

Do not take more than one dose within 8 hours.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Oxylaxon

Do not stop taking Oxylaxon without consulting your doctor.

If you no longer need further treatment, your doctor will recommend gradually reducing the daily dose. This way, you can avoid withdrawal symptoms such as restlessness, sweating, and muscle pain.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects or symptoms requiring attention and actions to take if they occur:

Discontinue use of Oxylaxon and contact your doctor or go immediately to the nearest hospital emergency department if any of the following symptoms occur:

Slowed and shallow breathing (respiratory depression). This is the most serious adverse effect of Oxylaxon, occurring most frequently in elderly and debilitated patients;
Opioids may also cause a severe drop in blood pressure in sensitive patients;
Swelling of the face, tongue or throat; difficulty swallowing; hives, breathing difficulties and low blood pressure (anaphylactic reactions).

The following adverse effects have been observed in patients treated with analgesics:

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

Abdominal pain, indigestion, constipation, diarrhoea, flatulence
Dry mouth
Vomiting, nausea
Decreased appetite, up to loss of appetite
Sensation of spinning, dizziness
Headache
Hot flushes, sweating
General weakness, fatigue or exhaustion
Itching, skin reactions (rash)
Difficulty falling asleep, drowsiness

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

Abdominal distension
Impaired thinking
Anxiety, confusion, depression, nervousness, difficulty concentrating
Chest tightness, particularly in patients with coronary artery disease, chest pain
Low blood pressure, high blood pressure
Withdrawal symptoms such as restlessness
Fainting
Palpitations
Biliary colic
General malaise
Pain
Swelling of hands, ankles and feet
Speech disorders
Tremor
Breathing difficulties
Motor restlessness
Chills
Increased hepatic enzyme activity
Nasal irritation (allergic reactions)
Weight loss
Accidental injuries
Increased bladder pressure
Muscle cramps, muscle twitching, muscle pain
Visual disturbances
Seizures (particularly in patients with epilepsy or predisposition to seizures)

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

Increased heart rate
Dental changes
Weight gain
Yawning

Frequency unknown (cannot be estimated from available data):

Euphoria
Calmness
Erectile dysfunction
Nightmares
Hallucinations
Shallow breathing
Sleep apnoea (breathing pauses during sleep)
Difficulty urinating
Tingling in hands or feet
Hiccups

Active substance oxycodone, not combined with naloxone, may cause the following adverse effects:

Respiratory disturbances such as slowed and shallow breathing (respiratory depression), pinpoint pupils, muscle spasms, reduced cough reflex.

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

Mood and personality changes (e.g. depression, feeling of exceptional well-being)
Reduced activity, increased activity
Difficulty urinating
Hiccups

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

Concentration disorders, restlessness
Migraine
Taste disturbances
Increased muscle tension, involuntary muscle contractions
Drug dependence, drug tolerance
Intestinal obstruction
Dry skin, skin redness
Reduced sensitivity to pain and touch
Lack of coordination
Voice changes (hoarseness)
Fluid retention
Hearing disturbances
Oral ulceration, gum pain
Difficulty swallowing
Perception disorders (e.g. hallucinations, derealization)
Decreased libido
Dehydration, thirst

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

Itchy rash (urticaria)
Herpes
Increased appetite
Tarry stools
Bleeding gums

Frequency unknown (cannot be estimated from available data):

Severe generalized allergic reactions (anaphylactic reactions)
Amenorrhoea
Biliary drainage disorders
Prolonged use of Oxylaxon during pregnancy may cause life-threatening withdrawal syndrome in the newborn; symptoms to watch for in the infant include: irritability, hyperexcitability and abnormal sleep patterns, high-pitched crying, tremors, vomiting, diarrhoea and failure to gain weight
A disorder affecting the valve in the intestine, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:

Department of Monitoring Adverse Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].

Adverse effects may also be reported to the marketing authorisation holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Oxylaxon

Keep Oxylaxon out of sight and reach of children. This medicine must be stored in a closed and secure place to which others do not have access. It may be highly harmful and can cause death in a person for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Oxylaxon contains

The active substances 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 K 30, sodium lauryl sulfate, silica, microcrystalline cellulose, monohydrate lactose (Oxylaxon 5 mg + 2.5 mg and 10 mg + 5 mg), anhydrous colloidal silicon dioxide, magnesium stearate.
Tablet coating: polyvinyl alcohol, partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, and brilliant blue FCF (E133), aluminium lake (Oxylaxon 5 mg + 2.5 mg), red iron oxide (E172) (Oxylaxon 20 mg + 10 mg and 30 mg + 15 mg), yellow iron oxide (E172) (Oxylaxon 30 mg + 15 mg and 40 mg + 20 mg), black iron oxide (E172) (Oxylaxon 30 mg + 15 mg).

What Oxylaxon looks like and contents of the pack
Oxylaxon is a prolonged-release tablet, meaning the active substances are released into the body over an extended period. Its effect lasts for 12 hours.

Oxylaxon 5 mg + 2.5 mg prolonged-release tablets
Light blue, round, biconvex coated tablets with the number "5" embossed on one side.

Oxylaxon 10 mg + 5 mg prolonged-release tablets
White or almost white, round, biconvex coated tablets with the number "10" embossed on one side.

Oxylaxon 20 mg + 10 mg prolonged-release tablets
Light pink, round, biconvex coated tablets with the number "20" embossed on one side.

Oxylaxon 30 mg + 15 mg prolonged-release tablets
Brown, round, biconvex coated tablets with the number "30" embossed on one side.

Oxylaxon 40 mg + 20 mg prolonged-release tablets
Yellow, round, biconvex coated tablets with the number "40" embossed on one side.

Packs contain 7, 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 prolonged-release tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For further information and information on the names of the medicinal product in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]