Leaflet: information for the user

MST CONTINUS 15 mg prolonged-release tablets

Morphine sulfate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking MST CONTINUS

3. How to take MST CONTINUS

4. Possible side effects

5. Storage of MST CONTINUS

6. Contents of the pack and additional information

These tablets have been prescribed by your doctor to relieve intense pain for a period of 12 hours. They contain the active substance morphine, which belongs to a group of powerful pain-relieving medications.

Do not take this medicine

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6);
• if you have respiratory problems, such as severe obstructive airway disease, respiratory depression, or acute and severe bronchial asthma. Symptoms may include difficulty breathing, coughing, or slower and weaker breathing than expected;
• if you have any head injury that causes severe headache or dizziness. This is because the tablets may worsen or mask the extent of the injury;
• if you have a condition where your small intestine does not function properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have severe abdominal pain;
• if you have a blue discoloration of the skin or mucous membranes;
• if you have recent liver disease;
• if you are taking a type of medicine called monoamine oxidase inhibitors (such as tranilcipromina, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken this type of medicine in the last two weeks;
• if the patient is under one year of age.

Tolerance, dependence, and addiction

This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to a decrease in the effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of this medicine can also lead to dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a lack of control over the amount of medicine you should use or the frequency with which you should use it.

The risk of dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to this medicine if:

• You or any member of your family has abused or had dependence on prescription or illegal drugs ("addiction").
• You smoke.
• You have had any problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking this medicine, it could be a sign of dependence or addiction:

• You need to take the medicine for a longer time than recommended by your doctor.
• You need to take a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to keep calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal symptoms").

If you notice any of these symptoms, consult your doctor to determine the best course of treatment for you, including when it is appropriate to discontinue the medicine and how to do it safely (see section 3 "If you interrupt treatment with MST CONTINUS").

If you are to undergo surgery, please tell your doctor that you are taking these tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Before starting treatment with these tablets, inform your doctor or pharmacist if you:

Generalized acute pustular exanthema (PEGA) associated with treatment with this medicine has been reported. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever suffered a severe skin rash or skin peeling, blisters, or mouth sores after taking morphine or other opioids. Stop using this medicine and seek medical attention immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pus-filled points (pustules) along with fever.

Respiratory disorders related to sleep

This medicine may cause sleep-related respiratory disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood), or worsen existing respiratory problems. Symptoms may include pauses in breathing during sleep, nocturnal awakening due to dyspnea, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Consult your doctor or pharmacist if you experience any of the following symptoms while taking this medicine:

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as it could be a sign of pancreatitis and bile duct inflammation.

This medicine should be used with caution when taking central nervous system depressants (see section "Taking MST CONTINUS with other medicines").

You may experience increased sensitivity to pain due to taking increasing doses of these tablets (hyperalgesia). Your doctor will decide if you need a change in dose or switch to another potent analgesic.

Use in athletes

This medicine contains morphine, which can produce a positive result in doping control tests.

Other medicines and morphine

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

It is particularly important to inform your doctor if you are taking:

Also inform your doctor if you have recently been treated with an anesthetic.

This medicine should not be administered simultaneously if you are taking a type of medicine to treat depression, called monoamine oxidase inhibitors (MAOIs) or within two weeks after stopping their use (see section 2 "Do not take...).

The concomitant use of morphine and sedatives such as benzodiazepines or related medicines increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine along with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's recommended dose closely.

It may be helpful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Taking this medicine with food and alcohol

Drinking alcohol while taking this medicine may make you feel more drowsy or increase the risk of severe adverse reactions such as shallow breathing with the risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while taking MST CONTINUS.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The tablets of this medicine should be avoided as much as possible in patients who are pregnant or breastfeeding.

If this medicine is used for a prolonged period during pregnancy, there is a risk that the newborn may experience withdrawal symptoms that should be treated by a doctor.

Driving and operating machines

These tablets may cause a range of side effects such as drowsiness, which could affect your ability to drive or operate machinery (see section 4 for a complete list of side effects). These effects are more noticeable when you start treatment with the tablets, or when your dose is increased. If you are affected, do not drive or operate machinery.

This medicine contains lactose:

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will explain what you can expect from the use of this medication, when and how long you need to take it, when to contact your doctor and when to interrupt it (see also the section “If you interrupt MST CONTINUS treatment”).

The tablets should be swallowed whole and not chewed with a glass of water.

Do not chew, crush or dissolve.

The tablets of this medication are designed to work properly for 12 hours when taken whole. If the tablet is broken, crushed, dissolved or chewed, the full 12-hour dose may be absorbed quickly by your body. This can be hazardous, causing severe problems such as an overdose, which can be fatal.

You should always take the tablets by mouth. The tablets should never be crushed or injected, as this can lead to severe adverse effects with a fatal outcome.

Do not increase the dose indicated by your doctor. If you do, you are at risk of taking an excessive amount of opioids (see section 4. Possible adverse effects).

There is a risk of tolerance (you need more doses to calm the pain) and addiction with strong opioid analgesics.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

You should take your tablets every 12 hours. Therefore, if you take a tablet at 8 am, you should take the next one at 8 pm.

Severe chronic pain:

Adults:

The usual initial dose is one 30 mg tablet every 12 hours.

This dose will depend on the intensity of your pain, your age and your previous history with analgesic therapy. Your doctor will decide how many tablets you should take.

Patients treated with other morphine oral preparations who switch to a treatment with morphine prolonged-release tablets should receive the same total daily dose of morphine, but divided into two doses (one in the morning and one at night).

Children:

In the case of severe and chronic pain, an initial dose of between 0.2 and 0.8 mg/kg every 12 hours is recommended.

Older adults (> 65 years): A dose reduction is advised.

Postoperative pain:

Adults: It is not recommended for use in the first 24 hours post-operatively; subsequently and always at the doctor's discretion, the following dosing schedule is suggested:

20 mg tablets every 12 hours in patients weighing less than 70 kg.

30 mg tablets every 12 hours in patients weighing more than 70 kg.

Children: This medication is not recommended for the treatment of postoperative pain in children.

Older adults (> 65 years):A dose reduction is advised

If you take more MST CONTINUS than you should

Inform your doctor immediately or go to the hospital. When you need medical attention, make sure to bring this leaflet with you and the tablets you have available to show to your doctor.

The signs of overdose and morphine toxicity are: small or pinpoint pupils, difficulty breathing, aspiration pneumonia and hypotension. In more severe cases, circulatory failure and eventually deep coma may occur.

People who have taken an overdose may suffer from aspiration pneumonia; symptoms may include shortness of breath, cough and fever.

People who have taken an overdose may also experience difficulty breathing that can cause loss of consciousness or even death.

If you have taken too many tablets, under no circumstances should you put yourself in a situation that requires you to be alert, for example, driving a car.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take MST CONTINUS

If you forgot to take a dose within 4 hours of the due time, take a tablet as soon as possible. Take your next tablet at your usual time. If the delay in taking is more than 4 hours, consult your doctor or pharmacist.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with MST CONTINUS

Do not stop treatment with this medication unless your doctor approves it. If you want to stop treatment with this medicationask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include generalised pain, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, palpitations and dilated pupils. Psychological symptoms consist of a deep sense of dissatisfaction, anxiety and irritability.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are reported in rare cases. Inform your doctor immediately if you experience:

• a severe allergic reaction that causes difficulty breathing or dizziness, sudden gasping, swelling of the eyelids, face, or lips, rash or itching on the skin, especially if it covers your entire body.
• a severe skin reaction with blisters, widespread skin peeling, pus-filled spots (pustules) accompanied by fever. It could be a condition called generalized acute pustular psoriasis (GAPP).

The most severe side effect, although rare, is when your breathing becomes slower or weaker than normal (respiratory depression, a typical risk of opioid overdose).

Like all strong painkillers, there is a risk of physical and psychological addiction or tolerance to these tablets.

Very common side effects

(May affect more than 1 in 10 patients)

Common side effects

(May affect up to 1 in 10 patients)

Uncommon side effects

(May affect up to 1 in 100 patients)

• Elevated liver enzymes (seen in blood tests)
• Swelling of hands, knees, and feet
• Hypersensitivity

• Anaphylactic reaction
• Anaphylactoid reaction
• General feeling of discomfort, abnormal thoughts
• Increased sensitivity to pain or abnormal perception of pain
• Pupil constriction
• Decreased cough reflex
• Impotence, decreased libido, absence of menstruation
• Withdrawal symptoms or dependence (see section 3 “If you stop taking MST CONTINUS”), tolerance to the medication
• Neonatal withdrawal syndrome
• Sleep apnea (pauses in breathing during sleep)
• Symptoms associated with pancreatitis and biliary tract disease, such as severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.