Mst Continus

Leaflet attached to the packaging: patient information

MST Continus 10, 30, 60, 100, 200 mg,
prolonged-release tablets
Morphine sulfate

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 specifically for you. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is MST Continus and what is it used for

MST Continus contains the active substance morphine sulfate, which is a strong painkiller belonging to the group of opioid medicines.
MST Continus is used:

• to treat moderate to severe pain that does not respond to weaker painkillers;
• to treat severe post-operative pain from the second day after surgery.

2. Important information before taking MST Continus

When not to take MST Continus

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6), if the patient has acute abdominal syndrome;
• if the patient has paralytic ileus or suspected ileus;
• if the patient has severe respiratory depression with hypoxia and/or hypercapnia (reduced breathing rate or respiratory arrest);
• if the patient has delayed gastric emptying;
• if the patient has acute liver disease;
• if the patient has severe chronic obstructive pulmonary disease;
• if the patient has severe asthma.

Tolerance, dependence, and addictive use
This medicine contains morphine, which is an opioid medicine. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient gets used to it, which is called tolerance).
Repeated use of MST Continus can lead to dependence and abuse, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and longer treatment duration.
Dependence or abuse can cause the patient to feel that they have lost control over the dose of the medicine they take or how often they take it.
The risk of dependence on the medicine or addiction varies from patient to patient. The risk of dependence on MST Continus may be higher if:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription drugs, or illicit drugs;
• the patient smokes; the patient has had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

Warnings and precautions

It is not recommended to administer the medicine:

• to patients before surgery and for 24 hours after surgery (as there is an increased risk of reduced intestinal motility or respiratory depression),
• to children under 12 years of age,
• to children and adolescents over 12 years of age for post-operative pain treatment.

Particular caution should be exercised when taking MST Continus:

• if the patient has been or is dependent on opioids,
• if the patient has been or is psychologically dependent on drugs and psychotropic substances and/or alcohol in their history,
• if the patient has delirium tremens,
• if the patient has impaired consciousness,
• if the patient has severe disturbances of the respiratory center (part of the nervous system responsible for the frequency and depth of breathing) or lung function. The patient should also be cautious if they have any other condition that may lead to breathing difficulties,
• if the patient has respiratory depression,
• if the patient has severe right ventricular hypertrophy (enlargement of one of the heart's elements)
• if the patient has sleep apnea,
• if the patient has a head injury, intracranial changes, or increased intracranial pressure, when mechanical ventilation is not performed,
• if the patient has low blood pressure, also related to low circulating blood volume (hypotension with hypovolemia),
• if the patient has prostatic hypertrophy causing urinary retention in the bladder (risk of bladder rupture due to urinary retention),
• if the patient has urethral stricture,
• if the patient has renal colic,
• if the patient has severe renal impairment,
• if the patient has severe hepatic impairment,
• if the patient has biliary tract disorders,
• if the patient has pancreatitis or problems with the gallbladder caused by the presence of gallstones,
• if the patient has non-specific intestinal inflammation,
• if the patient has hypothyroidism,
• if the patient has adrenal insufficiency,
• if the patient has a pheochromocytoma,
• if the patient has epilepsy or increased seizure susceptibility,
• if the patient is elderly,
• if the patient is taking MAO inhibitors and the period of 2 weeks after discontinuing MAO inhibitors,
• if the patient is taking medicines that affect the central nervous system, including other opioid medicines, sedatives, anxiolytics (including phenothiazines), general anesthetics, and muscle relaxants, gabapentin (an antiepileptic drug), certain antihypertensive drugs, antiemetic drugs, and alcohol, as morphine enhances their effects: excessive sedation, low blood pressure, and particularly respiratory depression (manifested by reduced breathing rate or respiratory arrest, which can lead to coma and even death).

Patients 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 biliary tract disorders.
In case of any of the following symptoms during treatment with MST Continus, patients should consult their doctor, pharmacist, or nurse:

• Increased sensitivity to pain, despite increased doses of the medicine (hyperalgesia). The doctor will decide whether a change in dosage or the use of a stronger painkiller is necessary (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms that the adrenal glands are not producing enough cortisol and hormone supplements may be necessary.
• Loss of sexual desire, impotence, amenorrhea. This may be due to reduced production of sex hormones.
• If the patient has a history of drug or alcohol dependence. Patients should also tell their doctor if they notice that they are becoming dependent on MST Continus during treatment. For example, when they start thinking about taking the next dose frequently, even if they don't need it to relieve pain.
• Withdrawal symptoms or dependence. The most common withdrawal symptoms are listed in section 3. In such cases, the doctor may change the medicine or the time between doses.

When to exercise particular caution when taking MST Continus

In connection with treatment with MST Continus, there have been reports of acute generalized exanthematous pustulosis (AGEP). Symptoms usually occur within the first 10 days of treatment. Patients should tell their doctor if they have ever experienced severe skin rash or exfoliation, blisters, and/or ulcers in the mouth after taking MST Continus or other opioids. Patients should discontinue MST Continus and seek medical attention immediately if they notice any of the following symptoms: blisters, widespread exfoliation, or pustular eruptions with fever.
Respiratory depression
If the patient has breathing problems, shortness of breath, or apnea, they should contact their doctor. Inhibition of the respiratory center in the central nervous system is a significant hazard in case of opioid overdose.
Sleep-related breathing disorders
MST Continus may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood) or worsening of existing sleep disorders. These symptoms may include moments of apnea during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. Patients should consult their doctor if they or someone else notices these symptoms. The doctor may consider reducing the dose.
Children and the elderly are more sensitive to morphine, so these patients should be given MST Continus with particular caution.
If the patient has breathing problems, shortness of breath, or apnea, they should contact their doctor. Inhibition of the respiratory center in the central nervous system is a significant hazard in case of opioid overdose.
Opioids may cause sleep-related breathing disorders, including central sleep apnea and sleep-related hypoxemia, as well as worsening of existing sleep apnea. If the patient has central sleep apnea, the doctor should consider reducing the total daily dose of the painkiller.
The medicine, due to its ability to cause spasm of the sphincters, may lead to the occurrence of biliary or renal colic. It should be used with caution after surgical procedures, especially in the biliary tract, and in patients with secondary acute pancreatitis.
If the patient is to undergo chordotomy (cutting of certain nerves to eliminate pain) or another pain relief procedure, they should tell their doctor that they are taking MST Continus.
If the patient experiences symptoms such as abdominal pain that is difficult to localize, vomiting, abdominal distension, and gas and stool retention, with or without a drop in blood pressure (paralytic ileus), they should contact their doctor.
Morphine may increase the risk of seizures in patients with epilepsy (epilepsy).
If the patient has been treated with high doses of morphine sulfate and develops hyperalgesia that does not respond to increased doses of MST Continus, it may be necessary to reduce the dose of morphine sulfate or switch to another opioid.
Taking MST Continus may lead to habituation (development of tolerance to the medicine) and the patient may need to take higher doses to achieve the desired pain-relieving effect.
Morphine has an addictive potential similar to that of other strong opioid medicines. In patients who are dependent on drugs, alcohol, currently or in the past, or have a tendency to addiction, MST Continus should be used with particular caution.
Taking opioid painkillers may lead to the development of physical and/or psychological dependence or tolerance. The risk associated with this increases with the duration of treatment and with higher doses. Symptoms can be limited by adjusting the dose or form of the medicine and gradual withdrawal of morphine.
Sudden discontinuation of treatment may lead to the occurrence of a withdrawal syndrome, which is characterized by, among other things, diarrhea, pain, and circulatory disorders. If treatment with morphine is no longer necessary, the doctor will gradually reduce the dose of the medicine to prevent the occurrence of withdrawal symptoms (see "Discontinuing MST Continus" in section 3).
High doses of morphine should not be taken at the beginning of treatment without gradual administration of small doses.
Morphine should be used with particular caution in patients who are also taking MAO inhibitors or within 2 weeks of discontinuing MAO inhibitors.
If the patient has adrenal insufficiency (e.g., Addison's disease), the doctor will recommend testing the level of adrenal cortex hormone (cortisol level in blood serum) and, if necessary, may prescribe the patient appropriate hormone replacement therapy.
Constipation is a typical side effect associated with morphine treatment. Patients should discuss this with their doctor. The doctor may recommend taking laxatives from the start of morphine treatment, especially if the patient has had problems with intestinal motility before taking morphine.
It is not recommended to administer MST Continus during the perioperative period or within 24 hours after surgery.
Intravenous administration of an oral dose can cause severe side effects. Abuse of morphine taken orally or parenterally can lead to serious side effects that can be fatal.
Taking alcohol while using MST Continus may enhance the side effects of MST Continus; patients should avoid concurrent use.

Children

MST Continus should not be used in children under 12 years of age.

MST Continus and other medicines

Patients should tell their doctor about all medicines they are currently taking or have taken recently, as well as any medicines they plan to take, including those available without a prescription.
This is especially important when taking MST Continus and:

• rifampicin, used to treat tuberculosis.
• certain medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken with morphine.
• sedatives, such as benzodiazepines or derivatives, increase the risk of sedation, breathing difficulties (respiratory depression), or life-threatening coma. Therefore, combined treatment should only be considered when other treatment options are not available. If MST Continus is taken with sedatives, the doctor should limit the dose and duration of concurrent use. Patients should tell their doctor about all sedatives they are taking and strictly follow the prescribed dose. It may be helpful to inform a relative or close friend of the patient about the possibility of these symptoms. If these symptoms occur, patients should consult their doctor.
• monoamine oxidase inhibitors (MAOIs), as they can cause inhibition or stimulation of the central nervous system with accompanying hypertension or hypotension, so morphine should not be taken concurrently or within 2 weeks of discontinuing MAOIs.
• other medicines that affect the central nervous system, including other opioid medicines, sedatives, anxiolytics (including phenothiazines), general anesthetics, and muscle relaxants, gabapentin (an antiepileptic drug), certain antihypertensive drugs, antiemetic drugs, and alcohol, as morphine enhances their effects: excessive sedation, low blood pressure, and particularly respiratory depression (manifested by reduced breathing rate or respiratory arrest, which can lead to coma and even death).
• medicines with anticholinergic effects, such as antihistamines (anti-allergic), antiemetics, and anti-Parkinson's disease medicines, as they can enhance some of the side effects of opioids: constipation, dry mouth, or urinary retention.
• other painkillers with agonist-antagonist effects on opioid receptors, such as pentazocine, nalbuphine, butorphanol, buprenorphine, as they may cause withdrawal symptoms (see section 3, Discontinuing MST Continus).
• Cimetidine (a medicine used to treat stomach ulcers) and other medicines that hinder the metabolic process in the liver, as they can inhibit the breakdown of morphine and thus increase morphine levels in the blood.
• Ritonavir (used to treat HIV infections), as it may reduce morphine levels in the blood.
• Gabapentin or pregabalin in the treatment of epilepsy and pain caused by nervous system disorders (neuropathic pain).
• Medicines that act as selective antagonists of opioid receptors (e.g., naloxone), as they can counteract the effects of morphine.

If, while taking MST Continus, the patient notices any of the following symptoms, it may indicate that they are developing tolerance to the medicine or are becoming dependent:

• the patient needs to take the medicine for a longer period than prescribed by the doctor;
• the patient needs to take a higher dose than prescribed;
• the patient takes the medicine for reasons other than those prescribed by the doctor, for example, "to feel calm" or "to help with sleep";
• the patient has made repeated, unsuccessful attempts to stop or control the use of the medicine;
• the patient feels unwell after stopping the medicine and feels better after taking it again ("withdrawal symptoms").

If any of these symptoms are noticed, patients should discuss the best treatment strategy with their doctor, including when it is appropriate to stop treatment and how to do so safely (see "Discontinuing MST Continus" in section 3).

MST Continus with food, drink, and alcohol

Taking the tablets is independent of meal times, and the medicine can be taken with or without food.
Tablet residues can be seen in the stool. Patients should not be concerned, as the active substance (morphine) has been released during the passage of the tablet through the digestive system.
Drinking alcohol while taking MST Continus may cause drowsiness or increase the risk of serious side effects, such as shallow breathing and loss of consciousness. Drinking alcohol while taking MST Continus is contraindicated.

Pregnancy, breastfeeding, and fertility

Animal studies have shown that morphine has a harmful effect on reproduction and fetal development.
MST Continus should not be used during pregnancy, unless the doctor considers morphine treatment to be absolutely necessary. If MST Continus was taken during pregnancy for a longer period, there is a risk of withdrawal symptoms in the newborn (abstinence syndrome), which should be treated by a doctor. Morphine may prolong or shorten the duration of labor.
Morphine passes into breast milk, so breastfeeding is not recommended during treatment with MST Continus.
Due to the mutagenic properties of morphine, effective contraception should be used during treatment with MST Continus.

Driving and using machines

MST Continus affects reaction time, causing the patient to react insufficiently or too slowly to unexpected or sudden events.
Patients should consult their doctor about the possibility and conditions of driving a vehicle.

MST Continus contains lactose and orange yellow S

MST Continus 10 mg, 30 mg, and 60 mg tablets contain 90 mg, 70 mg, and 40 mg of lactose as an excipient, respectively. If the doctor has informed the patient that they do not tolerate some sugars, they should consult their doctor before starting treatment with MST Continus.
MST Continus 30 mg and 60 mg tablets contain the dye orange yellow S (E110), which may cause allergic reactions.

3. How to take MST Continus

This medicine should always be taken as directed by the doctor. In case of doubts, patients should consult their doctor or pharmacist.
Before starting and regularly during treatment, the doctor will discuss with the patient what to expect from MST Continus, when and for how long to take it, when to consult a doctor, and when to stop taking the medicine (see also "Discontinuing MST Continus" in this section).
The dose of MST Continus should be determined based on the severity of the pain, the patient's age, and their response to previously taken painkillers. The doctor may start treatment with morphine with unmodified release (tablets or solution) to determine the necessary dose to achieve adequate pain control and then prescribe MST Continus.
Modified-release tablets should be swallowed whole, without breaking, chewing, or crushing.
Administration of a broken, chewed, or crushed modified-release tablet can cause rapid release and absorption of a potentially fatal dose of morphine (see "Taking a higher dose of MST Continus than recommended" in section 3).
Adults
The most commonly used initial dose in patients with low body weight is 10 mg every 12 hours, and in other patients, it is 30 mg every 12 hours. It is recommended to take the tablets in the morning and evening, always maintaining a 12-hour interval.
The initial dose is then increased until adequate pain control is achieved.
If pain recurs before the next dose is taken, the interval between doses should not be shortened. In case of doubts about the dosage, patients should consult their doctor. The doctor will increase the dose of MST Continus or prescribe an additional morphine-containing medicine in the form of fast-acting tablets or injections.
In the treatment of post-operative pain, but not earlier than the day after surgery: in patients with a body weight of less than 70 kg, 2 tablets of 10 mg are taken every 12 hours; in patients with a body weight of more than 70 kg, 1 tablet of 30 mg is taken every 12 hours.
Use in adolescents over 12 years of age:
Dosage is strictly dependent on the doctor's decision, and the recommended initial dose is 0.2-0.8 mg of morphine per kilogram of body weight every 12 hours.
MST Continus should not be used to treat post-operative pain in adolescents.
MST Continus should not be used in children under 12 years of age.
Elderly patients and those in poor general health
Elderly patients (75 years of age and older) and those in poor general health may be more sensitive to morphine. In these patients, the doctor may recommend longer intervals between doses or a lower dose of the medicine.
Method of administration
Modified-release tablets should be swallowed whole, without chewing, crushing, or dividing. Patients should take the medicine with a sufficient amount of liquid. The medicine can be taken independently of meals, either during or between meals.
Duration of treatment
The duration of treatment will be decided by the doctor based on the severity of the pain experienced by the patient.
If the patient feels that the effect of MST Continus is too strong or too weak, they should consult their doctor.

Taking a higher dose of MST Continus than recommended

In case of taking a higher dose of MST Continus than recommended, patients should immediately consult their doctor, as overdose of strong opioids can be fatal.
The patient may experience one of the following symptoms: breathing difficulties leading to loss of consciousness and even death, drowsiness deepening to coma, pinpoint pupils, muscle flaccidity, low blood pressure, slowed heart rate. Pneumonia caused by inhalation of vomit or foreign bodies may also occur. Symptoms may include shortness of breath, cough, and fever.
Morphine overdose can lead to brain damage (toxic leukoencephalopathy).
In case of overdose, the following actions may be helpful while waiting for the doctor to arrive: keeping the patient awake, giving breathing commands, and supporting breathing by placing the patient in a sitting position. It may be necessary to transport the patient to the hospital and provide constant medical care.

Missing a dose of MST Continus

Taking a lower dose of MST Continus than recommended or missing a dose may lead to insufficient pain relief.
Patients should not take MST Continus more frequently than every 12 hours.
Patients should not take a double dose to make up for a missed dose.

Discontinuing MST Continus

Patients should not stop taking MST Continus unless their doctor advises them to do so. To discontinue MST Continus, patients should consult their doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Sudden discontinuation of treatment may lead to the occurrence of withdrawal symptoms. These may include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mood changes, hallucinations, seizures, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils.
The risk of withdrawal symptoms is higher if treatment is stopped suddenly. If treatment is to be discontinued, the dose should be gradually reduced.

4. Possible side effects

Like all medicines, MST Continus can cause side effects, although not everybody gets them.
In case of any of the following symptoms, patients should stop taking MST Continus and seek medical attention immediately:

• constipation is a characteristic side effect of long-term treatment.
• intestinal obstruction
• morphine causes dose-dependent respiratory depression and sedation of varying degrees, ranging from mild fatigue to somnolence.
• bronchospasm,
• morphine can cause various psychological side effects, the severity and nature of which vary from person to person (depending on personality and treatment duration).
• morphine can cause severe allergic reactions causing breathing difficulties or dizziness, fainting (loss of consciousness).
• clinically significant hypotension or hypertension, heart failure
• pancreatitis,
• renal colic
• Severe skin reaction with blisters, widespread exfoliation, and pustular eruptions with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).

When evaluating side effects, the following frequency is taken into account:
Very common (more than 1 in 10 people): nausea, constipation.
Common (less than 1 in 10 people): changes in activity level (usually decreased, but also increased), insomnia, changes in cognitive and sensory function (e.g., perception disorders, confusion), dizziness, headache, involuntary muscle contractions, somnolence, abdominal pain, anorexia, dry mouth, vomiting (especially at the start of treatment), loss of appetite, excessive sweating, rash, urinary retention, weakness, asthenia, fatigue, malaise, pruritus.
Uncommon (less than 1 in 100 people): allergic reactions (hypersensitivity), agitation, euphoria, hallucinations, mood changes, seizures, increased muscle tone, paresthesia, fainting (loss of consciousness), visual impairment, dizziness, flushing, clinically significant hypotension or hypertension, pulmonary edema, respiratory depression, bronchospasm, intestinal obstruction, taste disorders, dyspepsia, increased liver enzyme activity, urticaria, urinary retention, peripheral edema (transient, resolving after discontinuation of morphine), tachycardia (rapid heartbeat).
Rare (less than 1 in 1000 people): increased pancreatic enzyme levels or pancreatitis, renal colic.
Very rare (less than 1 in 10,000 people): dependence on the medicine, decreased libido, tremor, increased sensitivity to pain (feeling pain in situations that do not normally cause pain in healthy people), blurred vision, double vision, and nystagmus, dyspnea, other rashes such as exanthema, muscle spasms, muscle stiffness, syndrome of inappropriate antidiuretic hormone secretion (SIADH) - the main symptom of which is hyponatremia.

• Frequency not known (cannot be estimated from the available data): sleep apnea (moments of apnea during sleep),
• severe skin reaction with blisters, widespread exfoliation, and pustular eruptions with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP), anaphylactic reactions, pseudo-anaphylactic reactions, thinking disorders, depression, pinpoint pupils, excessive sweating, reduced cough reflex,
• symptoms related to pancreatitis and biliary tract disorders, such as severe abdominal pain that may radiate to the back, nausea, vomiting, or fever. amenorrhea, decreased libido, erectile dysfunction, withdrawal symptoms or dependence (information on symptoms - see "Discontinuing MST Continus" in section 3).

Changes in dental status have been observed, but a direct link with morphine treatment has not been established.
Palpitations, reduced heart rate, and heart failure may occur.

Reporting side effects

If side effects occur, including any not listed in this leaflet, patients should tell their doctor or pharmacist. Side effects can be reported directly to: Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store MST Continus

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their 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 MST Continus contains

The active substance of the medicine is morphine.
One modified-release tablet contains 10, 30, 60, 100, or 200 mg of morphine sulfate (Morphini sulphas).
The other ingredients are:
MST Continus 10 mg
Lactose anhydrous, hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry 85F270017 (gold-bronze) with the composition: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
MST Continus 30 mg
Lactose anhydrous, hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-6708 (purple).
MST Continus 60 mg
Lactose anhydrous, hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-3508 (orange).
MST Continus 100 mg
Hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-8215 (gray).
MST Continus 200 mg
Hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry 06B21168 (green), polyethylene glycol 400.

What MST Continus looks like and contents of the pack

PVC/Al foil blisters in a cardboard box.
Package sizes: 20, 30, or 60 tablets in blisters of 10.
Not all package sizes may be marketed.

Marketing authorization holder

Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Manufacturer

Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden, Netherlands
To obtain more detailed information about this medicine, patients should contact the representative of the marketing authorization holder: Mundipharma Polska Sp. z o.o., ul. Międzyborska 11B, lok. 104, 04-041 Warsaw, tel. +48 22 3824850.
Date of last revision of the leaflet:09/2024