Leaflet: information for the user

Sevredol 10 mg film-coated tablets

Morphine sulfate

Read the entire leaflet carefully before starting to take the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Sevredol and for what it is used

2. What you need to know before starting to take Sevredol

3. How to take Sevredol

4. Possibleadverse 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.

Do not take this medication

• if you are allergic to the active ingredient or any of the other components of this medication (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 medication known as monoamine oxidase inhibitors (such as tranilcipromina, fenelcina, isocarboxacida, moclobemida, and linezolid), or if you have taken this type of medication in the past two weeks;

• if the patient is under five years of age.

Tolerance, dependence, and addiction

This medication contains morphine, which is an opioid. Repeated use of opioids can lead to a decrease in the effectiveness of the medication (becoming accustomed to it, known as tolerance). Repeated use of this medication can also lead to dependence, abuse, and addiction, which could result in 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 feeling of lack of control over the amount of medication 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 medication if:

• You or any member of your family has abused or had dependence on prescription medications 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 medication, it could be a sign of dependence or addiction:

• You need to take the medication for a longer time than recommended by your doctor.
• You need to take a higher dose than recommended.
• You are using the medication 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 medication or control its use.
• You feel unwell when you stop using the medication, 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 medication 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 medication.

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 can 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 a history of seizures, attacks, or convulsions;
• have symptoms of withdrawal, such as agitation, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs.

Generalized acute pustular exanthema (PEGA) associated with treatment with this medication 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 medication and seek medical attention immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pus-filled points (pustules) with fever.

Sleep-related respiratory disorders

This medication 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 medication:

• Weakness, fatigue, decreased appetite, nausea, vomiting, or low blood pressure. This could 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 could 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 medication 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 appear, your doctor may change medication or modify the interval between doses.

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.

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

This medication should be used with caution when taking central nervous system depressants (see section "Taking Sevredol with other medications").

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

Other medications and morphine

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

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

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

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

This medication should not be administered simultaneously if you are taking a type of medication 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 medications increases the risk of somnolence, 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 medication with food and alcohol

Drinking alcohol while taking this medication 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 medication.

Pregnancy and breastfeeding

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

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

If this medication 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 machinery

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 medication contains lactose

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

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 Sevredol treatment”).

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 can 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 10 mg tablets every 4 hours. As the intensity of pain or tolerance to morphine increases, the dose of morphine will need to be increased to achieve the desired relief. Your doctor will decide how many tablets you should take.

A reduction of the normal adult dose is recommended.

Not recommended in children under 5 years old.

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

Do not increase the dose indicated by your doctor. If you do, you risk 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.

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 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, such as 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 Sevredol treatment

Do not interrupt treatment with this medication unless your doctor approves it. If you want to interrupt treatment with this medication, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include generalized pain, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, palpitations, and dilated pupils. Psychological symptoms include 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)

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 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at 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 principle is morphine sulfate.

Each tablet contains 10 mg of morphine sulfate.

The other components are:

• Tablet core: anhydrous lactose, pregelatinized cornstarch, magnesium stearate, povidone (K25), talc.
• Tablet coating: Opadry 06B20843 blue (contains: hypromellose, macrogol 400, titanium dioxide (E-171), brilliant blue (E-133)).

Appearance of Sevredol and contents of the packaging

Blue tablets, coated with a film, in capsule form, biconvex, with a groove on one side. On either side of the groove, "IR" is engraved on the left side and "10" 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 of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)