Package Leaflet: Information for the User

Sevredol 20 mg Film-Coated Tablets

Morphine Sulfate

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

• Keep this package 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 should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

1. What is Sevredol and what it is used for

2. What you need to know before starting Sevredol

3. How to take Sevredol

4. Possible side effects

5. Storage of Sevredol

6. Contents of the pack and additional information

These tablets have been prescribed by your doctor to relieve intense pain.

They contain the active substance morphine, which belongs to a group of powerful pain-relieving medications known as potent analgesics.

Do not take this medicine

• if you are allergic to the active ingredient or 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/or 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 and sudden 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, fenelcina, isocarboxazida, moclobemida, and linezolid), or if you have taken this type of medicine in the last two weeks;

• if the patient is under five years 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 longer 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 Sevredol).

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:

• have low thyroid activity (hypothyroidism);
• have severe kidney or liver problems, as you may need a reduced dose;
• have severe headache or dizziness, as this may indicate increased pressure in your skull;
• have respiratory problems such as chronic obstructive pulmonary disease, severe lung injury, or reduced lung capacity. Symptoms may include difficulty breathing and coughing;
• have any intestinal obstruction or inflammatory bowel disease;
• have constipation;
• have low blood pressure (hypotension);
• have severe heart problems after a long-standing lung disease (cor pulmonale);
• have pancreatitis (inflammation of the pancreas, which may cause severe abdominal and back pain) or problems with your gallbladder;
• have adrenal insufficiency (alteration of the adrenal glands in the kidneys);
• have prostate problems;
• have had or have epilepsy, seizures, or convulsions;
• have symptoms of withdrawal, such as agitation, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs.

A generalized acute pustular exanthema (PEGA) has been reported in association with treatment with this medicine. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever had 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 spots (pustules) with fever.

Sleep-related respiratory disorders

This medicinemay 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.The 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 thedose.

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

• Weakness, fatigue, decreased appetite, nausea, vomiting, or low blood pressure. This may indicate that your adrenal glands are producing insufficient amounts of cortisol, and you may need to take hormone supplements.
• Loss of libido, impotence, or cessation of menstruation. This may be due to decreased production of sex hormones.
• If you have a history of alcoholism or drug addiction. Also inform your doctor if you think you are starting to depend on this medicine while using it. You may have started thinking too much about when you can take the next dose, even though you don't need it for pain.
• Symptoms of withdrawal or dependence. The most common withdrawal symptoms are described in section 3. If they occur, your doctor may change your medicine or modify the interval between doses.

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

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

This medicine should be used with caution when taking central nervous system depressants (see section "Taking Sevredol 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 your dose or switch to another potent analgesic.

Use in athletes

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

Other medicines and morphine

Inform your doctor or pharmacist if you aretaking, havetakenrecently or maytakeany other medicine.

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

• Medicines to help you sleep or stay calm (such as tranquilizers, hypnotics, or sedatives).
• Medicines to treat depression.
• Medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics).
• Other strong analgesics.
• Muscle relaxants.
• Medicines to treat high blood pressure.
• Cimetidine may increase the effect of morphine (a medicine for stomach ulcers, indigestion, or heartburn).
• Antihistamines to prevent or relieve symptoms of an allergic reaction.
• Rifampicin to treat tuberculosis reduces the effect of morphine.
• Some medicines used to prevent or treat blood clots (such as clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect when taken with morphine.
• Ritonavir to treat HIV.
• Medicines to treat Parkinson's disease.
• Gabapentin or pregabalin to treat epilepsy or pain caused by nerve problems (neuropathic pain).

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 drowsiness, 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 morphine 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 mentioned 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 this medicine.

Pregnancy and breastfeeding

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

This medicine tablet 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 symptomsthat should be treated by a doctor.

Driving and operating machinery

These tablets may cause a range of side effects, including drowsiness, which may 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.

This medicinecontains Sunset Yellow FCF (E 110).

It may cause allergic reactions.

Follow exactly the administration instructions of this medication 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 treatment with Sevredol”).

The tablets should be swallowed whole and without chewing, with a glass of water.

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

The recommended dose is

The dose will depend on the intensity of your pain and your previous history of needing analgesics.

A patient presenting intense pain should start with an oral dose of one or two tablets of 10 mg every 4 hours. As the intensity of pain or tolerance to morphine increases, it will be necessary to increase the dose of morphine to achieve the desired relief. Your doctor will decide how many tablets you should take.

A reduction of the normal dose in adults is recommended.

Not recommended in children under 5 years.

In children from 5 to 12 years: 10 mg every 4 hours.

Do not increase the dose indicated by your doctor. If you do, you are at risk of taking an overdose 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.

If you take more Sevredol 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 a 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 present difficulty breathing that may 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 Sevredol

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 treatment with Sevredol

Do not interrupt treatment with this medication unless your doctor approves. Ifyou want to interrupt treatment with this medication, ask your doctorhow to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptomscan be generalized pain, tremors, diarrhea, 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.
• 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)

Unknown frequency

(Cannot be estimated from available data)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and carton, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30º C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sevredol

The active ingredient is morphine sulfate.

Each tablet contains 20 mg of morphine sulfate.

The other components are:

• Tablet core: anhydrous lactose, pregelatinized cornstarch, magnesium stearate, povidone (K25), talc.

- Tablet coating:Opadry 85F240092 pink(contains: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, erythrosine (E-127) and yellow orange Sunset (E-110)).

Appearance of Sevredol and content of the packaging

Pinkish-brown tablets, coated with a film, in capsule shape, biconvex, with a groove on one face. On either side of the groove, “IR” is engraved on the left side and “20” on the right side.

The tablets can be divided into two equal doses.

Carton packaging containing 12 tablets in PVC/PVCD-Al blisters.

Holder of the authorization

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Phone: 913 821 870

Responsible for manufacturing

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

Date of the last review of this leaflet:May 2024

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)