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, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their illness 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 intestinal obstruction;
• 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 no longer have control over the dose of the medicine they take or how often they take it.
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 suffers from delirium tremens,
• if the patient has impaired consciousness,
• if the patient has severe disturbances 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 disturbances,
• 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 enlargement 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 impairment,
• if the patient has severe hepatic impairment,
• if the patient has biliary tract dysfunction,
• 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 stopping MAO inhibitors,
• if the patient is taking drugs 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 death).
• if the patient is taking anticholinergic drugs, such as antihistamines (anti-allergic), antiemetics, and anti-Parkinson's disease drugs, as they may enhance some of the side effects of opioids: constipation, dry mouth, or urinary disturbances.
• if the patient is taking other pain relievers with agonist-antagonist action on opioid receptors, such as pentazocine, nalbuphine, butorphanol, buprenorphine, as they may cause withdrawal symptoms (see section 3, Stopping MST Continus).
• if the patient is taking cimetidine (a drug used to treat stomach ulcers) and other drugs that hinder the metabolic process in the liver, as they may inhibit the breakdown of morphine and thus increase morphine concentrations in the blood.
• if the patient is taking ritonavir (used to treat HIV infection), as it may decrease morphine concentrations in the blood.
• if the patient is taking gabapentin or pregabalin for the treatment of epilepsy and pain caused by nervous system disorders (neuropathic pain).
• if the patient is taking opioid receptor antagonists (e.g., naloxone), as they may 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 prescribed by the doctor;
• the patient needs to take a higher dose than recommended;
• the patient uses the medicine for reasons other than those prescribed 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 effects").

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

MST Continus with food, drink, and alcohol

Taking the tablets is independent of meal times, the medicine can be taken both during and between meals.
The remains of the tablet can be seen in the stool. Do 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 long time, there is a risk of the newborn developing withdrawal symptoms (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 while taking the medicine.
Due to the mutagenic properties of morphine, effective contraception should be used while taking MST Continus.

Driving and using machines

MST Continus affects reaction time, which may cause the patient to 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 sunset yellow FCF

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 taking MST Continus.
MST Continus 30 mg and 60 mg tablets contain the dye sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take MST Continus

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a 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 "Stopping 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, not broken, chewed, or crushed.
Administering 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).

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 consult a 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 weakness, 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.
Do not take MST Continus more often than every 12 hours.
Do not take a double dose to make up for a missed dose.

Stopping MST Continus

Do not stop taking MST Continus unless the doctor advises otherwise. To stop taking MST Continus, consult a doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Abruptly stopping treatment may be associated with 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 abruptly. 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 experiencing any of the following symptoms, the patient should stop taking MST Continus and immediately consult a doctor:

• constipation is a characteristic side effect of long-term treatment.
• intestinal obstruction
• morphine causes dose-dependent respiratory depression and sedation of varying degrees, from mild fatigue to drowsiness.
• 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, purulent eruptions with concurrent fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP).

In assessing side effects, the following frequency of their occurrence 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 activity level), insomnia, changes in cognitive and sensory functions (e.g., perception disorders, confusion), dizziness, headaches, involuntary muscle contractions, drowsiness, abdominal pain, anorexia, dry mouth, vomiting (especially at the beginning of treatment), loss of appetite, excessive sweating, rash, urinary disturbances, weakness, asthenia, fatigue, malaise, itching.
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 disturbances, dyspepsia, increased liver enzyme activity, hives, urinary retention, peripheral edema (transient after stopping morphine), tachycardia (rapid heart rate).
Rare (less than 1 in 1,000 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 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 breathing cessation during sleep),
• severe skin reaction with blisters, widespread skin peeling, purulent eruptions with concurrent fever. This may be a condition called acute generalized exanthematous pustulosis (AGEP), anaphylactic reactions, pseudoanaphylactic reactions, thought disorders, depressed mood, pinpoint pupils, excessive sweating, decreased cough reflex,
• symptoms related to pancreatitis and biliary tract disease, 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 "Stopping MST Continus" in section 3).

Changes in dentition 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to: the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, the 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store 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 "Expiry date" or "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, hydroxyethyl cellulose, 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, hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-6708 (purple).
MST Continus 60 mg
Lactose anhydrous, hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-3508 (orange).
MST Continus 100 mg
Hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry OY-8215 (gray).
MST Continus 200 mg
Hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc.
Coating: Opadry 06B21168 (green), polyethylene glycol 400.

What MST Continus looks like and contents of the pack

Blisters of PVC/Al 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