Mst Continus

Leaflet accompanying 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 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 packaging 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 pain reliever belonging to the group of opioid medicines.
MST Continus is used:

• to treat moderate to severe pain that does not respond to weaker pain relievers;
• 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 bronchial 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 make the patient feel like they have lost control over the dose they take or how often they take it.
The risk of dependence on MST Continus 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 peristalsis 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 suffers from delirium tremens,
• if the patient has impaired consciousness,
• if the patient has severe disorders of respiratory center function (part of the nervous system responsible for breathing frequency and depth) or lung function. The patient should also be cautious if they have any other condition that may lead to breathing disorders,
• 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 prostate hypertrophy causing urine retention in the bladder (risk of bladder rupture due to urine retention),
• if the patient has urethral stricture,
• if the patient has renal colic,
• if the patient has severe renal function disorders,
• if the patient has severe liver function disorders,
• 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 a period of 2 weeks after stopping MAO inhibitor treatment,
• 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 blood pressure-lowering 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).

If the patient experiences any of the following symptoms, they should consult their doctor:

• Increased sensitivity to pain, despite increased dose of the medicine (hyperalgesia). The doctor will decide whether to change the dosage or use a stronger pain reliever (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 may require hormone supplements.
• Loss of sexual desire, impotence, amenorrhea. This may be due to decreased production of sex hormones.
• If the patient has a history of drug or alcohol dependence. The patient 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 this case, the doctor may change the medicine or the time between doses.

When to exercise particular caution when taking MST Continus

In connection with MST Continus treatment, acute generalized exanthematous pustulosis (AGEP) has been reported. Symptoms usually occur within the first 10 days of treatment. The patient should tell their doctor if they have ever experienced severe skin rash or skin peeling after taking MST Continus or other opioids, or if they have had blisters and/or ulcers in the mouth. The patient should stop taking MST Continus and consult their doctor immediately if they notice any of the following symptoms: blisters, widespread skin peeling, or pustular rash 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 risk in the event 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 staying asleep, or excessive daytime sleepiness. The patient 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 they 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 risk in the event 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 pain reliever.
The medicine, due to its potential 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 experiences increased sensitivity to pain 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 relief 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 pain relievers 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 cessation 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 "Discontinuation of 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 stopping MAO inhibitor treatment.
If the patient has adrenal cortex disorders (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. The patient should discuss this with their doctor. The doctor may recommend taking laxatives from the start of morphine treatment, especially if the patient had problems with intestinal peristalsis 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 and MST Continus at the same time may enhance the side effects of MST Continus; it is recommended to avoid concurrent use.

Children

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

MST Continus and other medicines

The patient 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 that are 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 their derivatives, increase the risk of sedation, breathing difficulties (respiratory depression), or coma that can be life-threatening. 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. 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 these symptoms occur, the patient 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 at the same time or within 2 weeks of stopping MAOI treatment.
• 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 blood pressure-lowering 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 drugs for Parkinson's disease, as they can enhance some of the side effects of opioids: constipation, dry mouth, or urinary disorders.
• other pain relievers with agonist-antagonist effects on opioid receptors, such as pentazocine, nalbuphine, butorphanol, buprenorphine, as they may cause withdrawal symptoms (see section 3, Discontinuation of 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 infection), 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 the patient notices any of the following symptoms while taking MST Continus, 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 the doctor recommended;
• the patient needs to take a higher dose than recommended;
• the patient takes the medicine for reasons other than those recommended by the doctor, such as "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 the patient notices any of these symptoms, they should discuss the best treatment strategy with their doctor, including when it is appropriate to stop treatment and how to do so safely (see "Discontinuation of 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 between meals.
The remains of the tablet can be seen in the stool. The patient 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 sedation or increase the risk of serious side effects, such as shallow breathing with a risk of apnea 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, making the patient react insufficiently or too slowly to unexpected or sudden events.
The patient should consult their doctor about the possibility and conditions of driving a vehicle.

MST Continus contains lactose and orange yellow

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 patient's doctor has informed them 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 (E110), which may cause allergic reactions.

3. How to take MST Continus

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they 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 "Discontinuation of 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 pain relievers. 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.
The prolonged-release tablets should be swallowed whole, without breaking, chewing, or crushing.
Administration of a broken, chewed, or crushed prolonged-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, the patient should consult their doctor. The doctor will increase the dose of MST Continus or prescribe an additional morphine-containing medicine in the form of immediate-release tablets or injections.
In the treatment of post-operative pain, but not earlier than 24 hours after surgery: in patients with a body weight of less than 70 kg, 2 tablets of 10 mg are used every 12 hours; in patients with a body weight of more than 70 kg, 1 tablet of 30 mg is used 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
The prolonged-release tablets should be swallowed whole, without chewing, crushing, or dividing. The patient 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, the patient should immediately contact 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, even death, sedation deepening to coma, pinpoint pupils, muscle flaccidity, hypotension, 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 instructions, 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.
The patient should not take MST Continus more often than every 12 hours.
The patient should not take a double dose to make up for a missed dose.

Discontinuation of MST Continus

The patient should not stop taking MST Continus unless their doctor recommends it. To stop taking MST Continus, the patient should consult their doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Sudden cessation of treatment may lead to the occurrence of a withdrawal syndrome. These symptoms 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.
If the patient experiences any of the following symptoms, they should stop taking MST Continus and consult their doctor 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 sedation.
• 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 skin peeling, pustular rash 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, headaches, involuntary muscle contractions, sedation, abdominal pain, anorexia, dry mouth, vomiting (especially at the start of treatment), loss of appetite, excessive sweating, rash, urinary disorders, weakness, asthenia, fatigue, malaise.
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 after stopping 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 skin peeling, pustular rash with fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP), anaphylactic reactions, pseudoanaphylactic 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.

Changes in dental status have been observed, but the exact relationship with morphine treatment has not been established.
Palpitations, decreased heart rate, and heart failure may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they 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 stated.
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 MST Continus contains

The active substance of the medicine is morphine.
One prolonged-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-brown) containing polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (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.
Pack sizes: 20, 30, or 60 tablets in blisters of 10.
Not all pack 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, the patient 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