SEVREDOL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sevredol 10 mg Film-Coated Tablets

Morphine sulfate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sevredol and what is it used for
2. What you need to know before you take Sevredol
3. How to take Sevredol
4. Possible side effects
5. Storing Sevredol
6. Contents of the pack and other information

1. What is Sevredol and what is it used for

These tablets have been prescribed for you by your doctor to relieve severe pain.

They contain the active substance morphine, which belongs to a group of medicines called strong painkillers.

2. What you need to know before you take Sevredol

Do not take this medicine

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have severe respiratory problems, such as severe chronic obstructive pulmonary 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 make these symptoms worse or mask the extent of the injury;
• if you have a condition where your small intestine does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), or you have severe abdominal pain (acute abdomen);
• if you have a blue-tinged appearance to your skin or mucous membranes;
• if you have recently had liver disease;
• if you are taking a type of medicine known as monoamine oxidase inhibitors (such as tranylcypromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken this type of medicine in the last two weeks;

• if the patient is under 5 years of age.

Tolerance, dependence, and addiction

This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to a lower effectiveness of the medicine (getting used to it, also known as tolerance). Repeated use of this medicine can also lead to dependence, abuse, and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

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

• You or a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health problems.

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 feel calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop using the medicine or control your use.
• You feel unwell when you stop using the medicine, and you feel better once you start taking 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 stop the medicine and how to do so safely (see section 3 "If you stop taking Sevredol").

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine.

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

• have low thyroid activity (hypothyroidism);
• have severe kidney or liver problems, as you may need a dose reduction;
• 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 respiratory capacity. Symptoms may include difficulty breathing and coughing;
• have any bowel obstruction or inflammatory bowel disease;
• have constipation;
• have low blood pressure (hypotension);
• have severe heart disease after a long lung disease (cor pulmonale);
• have pancreatitis (which can cause severe abdominal and back pain) or problems with your gallbladder;
• have adrenal insufficiency (a disorder of the adrenal glands in the kidneys)
• have prostate problems;
• have had seizures, fits, or convulsions;
• have symptoms of withdrawal such as agitation, anxiety, palpitations, tremors, or sweating when you stop taking alcohol or drugs.

It has been reported that acute generalized exanthematous pustulosis (AGEP) is associated with the use of this medicine. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever suffered from a severe skin rash, skin peeling, blisters, and/or sores in the mouth 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) along with fever.

Sleep-related breathing disorders

This medicine may cause sleep-related breathing problems such as sleep apnea (pauses in breathing during sleep) and sleep-related low blood oxygen levels, or worsen existing breathing problems. Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or excessive sleepiness during the day. If you or someone else notices 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:

• Weakness, tiredness, decreased appetite, nausea, vomiting, or low blood pressure. This could indicate that your adrenal glands are not producing enough cortisol hormone and you may need to take hormone supplements.
• Loss of libido, impotence, 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 becoming dependent on this medicine while using it. You may have started to think too much about when you can take the next dose, even if you don't need it for pain.
• Withdrawal symptoms 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 abdominal pain that may radiate to your back, nausea, vomiting, or fever, as it could be symptoms associated with pancreatitis and bile duct problems.

If you are going to have an operation, please tell your doctor that you are taking these tablets.

This medicine should be used with caution when you are taking central nervous system depressant medicines (see "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 a switch to another strong painkiller.

Athletes

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

Other medicines and morphine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is particularly important that you tell your doctor if you are taking:

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

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

This medicine must not be taken at the same time as a type of medicine for depression called monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping them (see section 2 "Do not take...").

The concomitant use of morphine and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes morphine with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and follow your doctor's recommended dose carefully.

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 such symptoms.

Taking this medicine with food and alcohol

Drinking alcohol while taking this medicine can make you feel more drowsy or increase the risk of serious side effects 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The tablets of this medicine should be avoided whenever 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 baby will experience withdrawal symptoms that need to be treated by a doctor.

Driving and using machines

These tablets can cause a number of side effects such as drowsiness, which could affect your ability to drive or use machines (see section 4 for a full 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, you should not drive or use machines.

This medicine contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Sevredol

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Before starting treatment and periodically while treatment continues, your doctor will explain what you can expect from using this medicine, when and for how long you need to take it, when to contact your doctor, and when to stop it (see also the section "If you stop taking Sevredol").

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

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

The recommended dose is

• Adults and adolescents over 12 years:

The dose will depend on the severity of your pain and your previous history of needing painkillers.

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

• Use in elderly patients (over 65 years):

A reduction in the normal adult dose is recommended.

• Use in children:

Not recommended in children under 5 years.

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

Do not increase the dose prescribed by your doctor. If you do, you risk taking too much opioid (see section 4. Possible side effects).

There is a risk of tolerance (needing more dose to relieve pain) and addiction with strong opioid painkillers.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Sevredol than you should

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

The signs of overdose and morphine toxicity are: pinpoint pupils, difficulty breathing, aspiration pneumonia, and low blood pressure. In more severe cases, circulatory failure and deep coma may occur.

People who have taken an overdose may experience a brain disorder (known as toxic leucoencephalopathy) and may suffer from inhalation pneumonia or aspiration of foreign particles; symptoms may include shortness of breath, coughing, and fever.

People who have taken an overdose may also experience breathing difficulties that can lead to 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, contact the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Sevredol

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Sevredol

Do not stop treatment with this medicine unless your doctor tells you to. If you want to stop treatment with this medicine, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms can be general aches and pains, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, palpitations, and dilated pupils. Psychological symptoms include a deep feeling of dissatisfaction, anxiety, and irritability.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

All medicines can cause allergic reactions, although serious allergic reactions are rarely reported. Inform your doctor immediately if you suffer from:

• a severe allergic reaction that causes difficulty breathing or dizziness, sudden wheezing, swelling of the eyelids, face, or lips, rash, or itching of the skin, especially if it covers your entire body.
• severe skin reaction with blisters, widespread skin peeling, pus-filled spots (pustules) along with fever. It could be a disease called acute generalized exanthematous pustulosis (AGEP).

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

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

Very Common Adverse Effects

(May affect more than 1 in 10 patients)

• Constipation (your doctor will prescribe a laxative to treat this problem)
• Nausea

Common Adverse Effects

(May affect up to 1 in 10 patients)

• Drowsiness (which is more common when you start taking this medicine or when the dose is increased, but it should disappear in a few days)
• Dry mouth, loss of appetite, abdominal pain or discomfort
• Vomiting (should disappear after a few days, however, your doctor may prescribe a medicine to prevent them if the problem continues)
• Dizziness, headache, confusion, insomnia
• Involuntary muscle contractions
• Feeling of weakness, fatigue, malaise
• Skin rash or skin itching
• Sweating

Uncommon Adverse Effects

(May affect up to 1 in 100 patients)

• Breathing difficulties or wheezing
• Situations where the intestine does not function properly (ileus)
• Alteration of taste, indigestion
• Agitation, mood changes, hallucinations, feeling of extreme happiness
• Feeling of dizziness or fainting, seizures, attacks, or convulsions
• Blurred vision
• Vertigo
• Unusual muscle stiffness, muscle spasms
• Numbness or tingling
• Difficulty urinating
• Low blood pressure, facial flushing
• Hives
• Elevated liver enzymes (seen in blood tests)
• Swelling of hands, knees, and feet
• Hypersensitivity

Frequency Not Known

(Cannot be estimated from the available data)

• Anaphylactic reaction
• Anaphylactoid reaction
• Feeling of general malaise, abnormal thoughts
• Increased sensitivity to pain or abnormal pain perception
• Reduced pupil size
• Decreased cough reflex
• Impotence, decreased sexual desire, absence of menstruation
• Withdrawal symptoms or dependence (see section 3 "If you stop treatment with Sevredol"), tolerance to the medicine
• Withdrawal syndrome in newborns
• Sleep apnea (pauses in breathing during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the bile duct system, for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

Reporting of Adverse Effects:

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

5. Storage of Sevredol

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

Do not use this medicine 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.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sevredol

The active ingredient is morphine sulfate.

Each tablet contains 10 mg of morphine sulfate.

The other ingredients are:

• Tablet core: anhydrous lactose, pregelatinized corn starch, 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 Package Contents

Blue, film-coated tablets, capsule-shaped, biconvex, with a score line on one side. On either side of the score line, "IR" is engraved on the left and "10" on the right.

The tablets can be divided into two equal doses.

Cartons containing 12 tablets in PVC/PVDC-Al blisters.

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Phone: 913 821 870

Manufacturer

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

Date of the Last Revision of this Leaflet:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)