Sevredol

Leaflet accompanying the packaging: patient information

Sevredol,20 mg, coated 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 as yours.
• 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 Sevredol and what is it used for
• 2. Important information before taking Sevredol
• 3. How to take Sevredol
• 4. Possible side effects
• 5. How to store Sevredol
• 6. Contents of the packaging and other information

1. What is Sevredol and what is it used for

Sevredol contains morphine sulfate as the active substance, which is a strong pain reliever belonging to the group of opioid medicines.
Sevredol is used to treat moderate to severe pain that does not respond to weaker pain relievers.

2. Important information before taking Sevredol

When not to take Sevredol

• if the patient is allergic (hypersensitive) to morphine sulfate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe chronic obstructive pulmonary disease,
• if the patient has severe bronchial asthma,
• if the patient has severe respiratory depression with hypoxia and/or hypercapnia (slowing or inhibition of respiratory function),
• if the patient has paralytic ileus or suspected paralytic ileus,
• if the patient has acute abdominal syndrome,
• if the patient has acute liver disease,
• if the patient has uncontrolled seizures,
• during breastfeeding.
• Tolerance, dependence on the medicine, and addiction This medicine contains morphine, which is an opioid medicine. Repeated use of opioid medicines can lead to reduced efficacy of the medicine (the patient gets used to it, which is called tolerance). Repeated use of Sevredol can also lead to dependence and abuse, which can lead to life-threatening overdose. The risk of these side effects may increase with increasing dose and longer duration of use.

These side effects may include tolerance, dependence, or addiction. 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 addiction to Sevredol may be higher if:

• the patient or anyone in their family has ever abused or been addicted to 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

Particular caution should be exercised when taking Sevredol:

• if the patient is dependent on opioid medicines (see below),
• if the patient has a history of substance abuse or alcohol abuse,
• in case of tolerance, physical dependence, and withdrawal (see below)
• if the patient has severe respiratory disorders,
• if the patient has respiratory depression,
• if the patient has sleep apnea,
• if the patient has severe right ventricular heart disease, known as severe pulmonary heart disease,
• if the patient has a head injury, intracranial changes, or increased intracranial pressure,
• if the patient has altered consciousness of unknown origin,
• if the patient has low blood pressure due to decreased circulating blood volume (e.g., due to bleeding),
• if the patient has prostatic hyperplasia causing urinary retention,
• if the patient has urethral stricture,
• if the patient has renal colic,
• if the patient has biliary tract disorders,
• if the patient has intestinal obstruction or inflammatory bowel disease, resulting in slow movement of food through the stomach and intestines (see section 3),
• if the patient has a pheochromocytoma,
• if the patient has pancreatitis or problems with the gallbladder caused by the presence of gallstones
• if the patient has severe renal impairment,
• if the patient has severe hepatic impairment,
• if the patient has hypothyroidism,
• if the patient has epilepsy or increased seizure susceptibility,
• if the patient is taking MAO inhibitors or has stopped taking MAO inhibitors within the last two weeks,
• if the patient is taking other medicines that affect the central nervous system (see section 2, "Sevredol and other medicines"),
• if the patient has constipation (see also section 4).

The patient should consult their doctor if they experience severe abdominal pain that radiates to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and biliary tract disease.
If any of the following symptoms occur during treatment with Sevredol, the patient should consult their doctor, pharmacist, or nurse:

• Increased sensitivity to pain, despite increased doses of the medicine (hyperalgesia). The doctor will decide whether to change the dose 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 hormone supplements may be necessary.
• Loss of sexual desire, impotence, amenorrhea. This may be due to decreased production of sex hormones.
• If the patient has a history of substance abuse or alcohol abuse. The patient should also tell their doctor if they notice that they are becoming dependent on Sevredol 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 addiction. 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 Sevredol

Acute generalized exanthematous pustulosis (AGEP) has been reported in patients treated with Sevredol. 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 exfoliation after taking Sevredol or other opioids, or if they have had blisters and/or ulcers in the mouth.
The patient should stop taking Sevredol 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 respiratory function in the central nervous system is a significant risk in case of opioid overdose.
Sleep-related breathing disorders
Sevredol 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.
If the patient is taking Sevredol and is going to have surgery, they should tell their doctor before the surgery that they are taking this medicine. The medicine is not recommended before surgery and for 24 hours after surgery.
If the patient has adrenal gland disorders (e.g., Addison's disease), the doctor will recommend testing for adrenal gland hormone (cortisol) levels and, if necessary, prescribe appropriate medication.
Morphine may mask the occurrence of severe abdominal complications, such as perforation (rupture) of the intestinal wall.
During treatment, especially when taking high doses, hyperalgesia (increased sensitivity to pain) may occur, which does not respond to further increases in the morphine dose (see also section 3).
Before prescribing Sevredol to men and women of childbearing age, the doctor will recommend using effective contraception.
The medicine may give a positive result in doping tests.
Morphine may increase the risk of seizures in patients with epilepsy.
Morphine has an addictive potential similar to other strong opioid medicines.
In controlled conditions, dependence on morphine occurs very rarely. In patients who are dependent on medicines or alcohol, currently or in the past, Sevredol should be used with particular caution.
Dependence and withdrawal syndrome
During long-term use, the patient may develop tolerance to the active substance (requiring increasingly higher doses of the medicine to achieve a constant pain-relieving effect). Sevredol, like other opioids, may cause physical dependence when used for a long time. If treatment is stopped suddenly, withdrawal symptoms may occur (including diarrhea, pain, and cardiovascular disorders). If the doctor decides that treatment with Sevredol is no longer necessary, they will recommend gradually reducing the dose to avoid withdrawal symptoms. (See section 3, "Stopping Sevredol treatment").
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 has had problems with bowel motility before taking morphine.

Children

See section 3.

Sevredol and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.
This is especially important when taking the following medicines:

• 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.
• Concomitant use of Sevredol and sedative medicines, such as benzodiazepines or derivatives, increases the risk of excessive sedation (drowsiness), breathing difficulties (respiratory depression), or coma, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available. If Sevredol is taken with sedative medicines, the doctor should limit the dose and duration of concomitant use. The patient should tell their doctor about all sedative medicines 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.
• If the patient is taking MAO inhibitors or has stopped taking MAO inhibitors within the last two weeks, they should use Sevredol with particular caution (see "Warnings and precautions" above).

Concomitant use of morphine and certain medicines may increase the risk of side effects. These medicines include:

• Anesthetics, other opioid medicines, sleeping medicines, neuroleptics, barbiturates, antidepressants (including phenothiazines), antihistamines, antiemetics, and alcohol. Morphine enhances their effects: respiratory depression (manifested by decreased breathing rate or inhibition of respiratory function), excessive sedation, low blood pressure, which can lead to coma and even death;
• Psychotropic medicines, antihistamines, antiemetics, medicines used to treat Parkinson's disease, which can lead to constipation, dry mouth, or urinary disorders;
• Cimetidine (a medicine used to treat stomach ulcers)
• Gabapentin or pregabalin used to treat epilepsy and pain caused by nervous system disorders (neuropathic pain).
• Muscle relaxants (since morphine can enhance the effects of these medicines).

Concomitant use of morphine and other pain relievers with agonist-antagonist effects on opioid receptors (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine) may cause withdrawal symptoms (see "Stopping Sevredol treatment" section).
If the patient notices any of the following symptoms while taking Sevredol, it may indicate that they are developing tolerance to the medicine or becoming dependent:

• the patient needs to take the medicine for longer than prescribed by the doctor;
• the patient needs to take a higher dose than prescribed;
• the patient is taking 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 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 section 3, "Stopping Sevredol treatment").

Sevredol with food, drink, or alcohol

The patient should not consume alcohol while taking Sevredol, as it may lead to respiratory depression, among other symptoms.

Pregnancy

Sevredol should not be taken during pregnancy, unless the doctor considers morphine treatment to be absolutely necessary. If Sevredol was taken during pregnancy for a long time, there is a risk of withdrawal symptoms in the newborn, which should be treated by a doctor.

Breastfeeding

Morphine is excreted into breast milk, so breastfeeding is not recommended during treatment with Sevredol.

Fertility

Due to the mutagenic properties of morphine, effective contraception should be used during treatment with Sevredol.

Driving and using machines

Sevredol may affect reaction time, causing 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.

Sevredol contains lactose and orange yellow S

Sevredol contains lactose as an excipient. One 20 mg Sevredol tablet contains 197.5 mg of lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Sevredol.
One 20 mg Sevredol tablet contains 0.023 mg of orange yellow S (E110), which may cause allergic reactions.

Sevredol contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Sevredol

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Before starting and regularly during treatment, the doctor will discuss with the patient what to expect from Sevredol, when and for how long to take it, when to consult a doctor, and when to stop taking the medicine (see also "Stopping Sevredol treatment" in this section).
The dose of Sevredol should be determined based on the severity of the pain, the patient's age, and their response to previously taken pain relievers.
Adults and adolescentsover 12 years of age
10 mg (half a 20 mg Sevredol tablet)
or 20 mg of morphine sulfate (1 Sevredol 20 mg tablet)
every 4 hours.
Childrenbetween 6 and 12 years of age
10 mg of morphine sulfate (half a 20 mg Sevredol tablet)
every 4 hours.
The coated tablets should be swallowed with a sufficient amount of liquid. The tablets can be divided into two equal doses along the score line if the doctor recommends it. There is no need to take the medicine with food.
Pain severity or tolerance to the medicine (reduced efficacy of the medicine due to repeated administration) may require increasing the dose or changing the medicine. The occurrence of hyperalgesia (increased sensitivity to pain) may require reducing the dose or changing to another medicine.

Duration of treatment

The doctor will decide on the duration of treatment based on the patient's pain.
If the patient feels that the effect of Sevredol is too strong or too weak, they should consult their doctor.

Patients with liver, kidney, or gastrointestinal disorders

In patients with liver or kidney disorders, as well as those with prolonged movement of food through the stomach and intestines, the dose of Sevredol should be determined with caution.

Elderly or frail patients

Elderly patients and those in poor general health may be more sensitive to morphine. In these patients, the doctor may recommend longer intervals between doses or the use of a medicine with a lower active substance content.

Taking a higher dose of Sevredol than recommended

If a higher dose of Sevredol than recommended is taken, the patient should contact their doctor immediately, as overdose of strong opioids can be fatal.
Sensitivity to morphine varies from patient to patient, so overdose symptoms may occur in adult patients even after taking a single dose recommended by the doctor. Symptoms of Sevredol overdose include: slowed breathing up to respiratory arrest, decreased blood pressure (initially slow and then very rapid), weakness, drowsiness, muscle spasms (especially in children), irregular heartbeat, decreased body temperature, loss of consciousness.
Morphine overdose can lead to brain disorders (toxic leukoencephalopathy).
If a higher dose of Sevredol than recommended is taken, respiratory failure due to aspiration of vomit or foreign bodies may occur. Symptoms may include shortness of breath, cough, and fever. Additionally, overdose symptoms may include breathing difficulties leading to loss of consciousness and even death.
First aid in case of Sevredol overdose:
The patient should be transported to the hospital immediately. While waiting for medical help, the patient should be kept conscious, given breathing commands, and assisted with breathing, e.g., by placing them in a sitting position.

Missing a dose of Sevredol

Taking a lower dose of Sevredol than recommended or missing a dose may lead to insufficient pain relief.
Sevredol should not be taken more frequently than every 4 hours.
A double dose should not be taken to make up for a missed dose.

Stopping Sevredol treatment

If the patient wants to stop taking Sevredol, they should first discuss the conditions for stopping the medicine and further treatment with their doctor.
Sevredol should not be stopped unless the doctor recommends it. To stop taking Sevredol, the patient should consult their doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Physical withdrawal symptoms (abstinence symptoms) may include: body aches, seizures, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense dissatisfaction, anxiety, and irritability.

4. Possible side effects

Like all medicines, Sevredol can cause side effects, although not everybody gets them.
The severity and nature of many side effects of morphine vary from person to person, depending on the individual, the dose, and the duration of treatment.
If any of the following symptoms occur, the patient should stop taking Sevredol 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 drowsiness,
• bronchospasm,
• morphine can cause severe allergic reactions leading to breathing difficulties or dizziness,
• 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).

The patient should consult their doctor immediately if they experience any serious side effects.
When evaluating side effects, the following frequency is taken into account:
Very common (more than 1 in 10 people treated):
constipation (during long-term treatment), nausea, mood changes, mainly euphoria, but also depression.
Common (less than 1 in 10 but more than 1 in 100 people treated):
weakness, itching, asthenia, fatigue, malaise, urinary disorders, excessive sweating, rash, vomiting (especially at the start of treatment), abdominal pain, anorexia, dry mouth, decreased appetite up to loss of appetite, headache, dizziness, drowsiness, muscle spasms, changes in activity level (usually decreased, but also increased activity or agitation), insomnia, changes in cognitive and sensory function (e.g., thinking disorders, perception disorders, and/or hallucinations).
Uncommon (less than 1 in 100 but more than 1 in 1,000 people treated):
peripheral edema, urinary retention, hives, increased liver enzyme activity, intestinal obstruction, dyspepsia, taste disorders, non-cardiogenic pulmonary edema (also due to rapid dose increase), bronchospasm, respiratory depression, clinically significant hypotension, clinically significant hypertension, flushing, tachycardia, bradycardia, vertigo, visual impairment, seizures, increased muscle tone, paresthesia, syncope, hypersensitivity reactions.
Rare (less than 1 in 1,000 but more than 1 in 10,000 people treated):
withdrawal symptoms or dependence (see also section 3, "Stopping Sevredol treatment"), renal colic, biliary colic, increased pancreatic enzyme activity, or pancreatitis.
Very rare (less than 1 in 10,000 people treated):
chills, muscle spasms, muscle stiffness, other rashes, such as exanthema, changes in dentition, but the exact relationship with morphine treatment has not been established, dyspnea, blurred vision, diplopia, and nystagmus, dependence (see also section 2), erectile dysfunction, amenorrhea, syndrome of inappropriate antidiuretic hormone secretion (SIADH; main symptom: hyponatremia), tremors.
Frequency not known (cannot be estimated from available data):
tolerance to the medicine, neonatal withdrawal syndrome, biliary colic, decreased cough reflex, palpitations, heart failure, miosis, increased sensitivity to pain (feeling pain in situations that do not cause pain in healthy people), sweating, dysphoria, anaphylactic reactions (severe allergic reactions causing breathing difficulties or dizziness), pseudoanaphylactic reactions, decreased libido.
Other possible side effects:
Frequency not known (frequency cannot be estimated from 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);
• symptoms related to pancreatitis and biliary tract disease, such as severe abdominal pain radiating to the back, nausea, vomiting, or fever.

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 Drug Safety Monitoring, 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 will help gather more information on the safety of the medicine.

5. How to store Sevredol

Store at a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the words "Expiry date" or "EXP". The expiry date refers to the last day of the month.
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 Sevredol contains

The active substance of Sevredol is morphine.
One coated tablet contains 20 mg of morphine sulfate (Morphini sulphas).
The other ingredients are:
Lactose anhydrous, cornstarch, povidone (K25), talc, magnesium stearate, Opadry 85F240092 (pink) [containing polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, erythrosine (E127), orange yellow S (E110), purified water].

What Sevredol looks like and contents of the pack

Sevredol 20 mg coated tablet, biconvex, capsule-shaped, pink, one side smooth, the other side with a score line, with "IR" on the left and "20" on the right of the score line. The tablet can be divided into two equal doses.
Blisters of PVC/PVCD/Al or polypropylene containers with a PE lid in a cardboard box.
Package sizes:

• 20, 30, or 60 tablets in blisters of 10
• 20 or 56 tablets in polypropylene containers

Not all pack sizes may be marketed.

Marketing authorization holder

Mundipharma A/S
Frydenlundsvej 30
2950 Vedbæk, Denmark

Importer and 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