Sevredol 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sevredol 20 mg film-coated tablets

Morphine sulfate

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

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

Leaflet contents

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

1. What Sevredol is and what it is used for

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

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

2. What you need to know before taking Sevredol

Do not take this medicine

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6);

• if you have respiratory problems, such as severe airway obstruction, 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 a head injury causing severe headache or dizziness. This is because the tablets may worsen these symptoms or mask the extent of the injury;

• if you have a condition in which the small intestine does not function properly (paralytic ileus), delayed gastric emptying, or sudden severe abdominal pain (acute abdomen);

• if you have bluish discoloration of the skin or mucous membranes;

• if you have a recent liver disease;

• if you are taking a type of medicine known as monoamine oxidase inhibitors (such as tranilcipromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or if you have taken such medicines within 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 may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of this medicine may 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 higher doses and prolonged use.

Dependence or addiction may cause a feeling of losing control over how much medicine you need to take or how often you need to take 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 been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a 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 prescribed, for example, "to stay calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again ("withdrawal effects").

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 so safely (see section 3 "If you stop taking Sevredol").

Warnings and precautions

Talk to 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 gland activity (hypothyroidism);
• have severe kidney or liver problems, as you may need a lower dose;
• have severe headache or dizziness, as this may indicate increased pressure in your skull;
• have respiratory problems such as chronic obstructive pulmonary disease (COPD), severe lung injury, or reduced respiratory capacity. Symptoms may include difficulty breathing and coughing;
• have intestinal obstruction or inflammatory bowel disorder;
• have constipation;
• have low blood pressure (hypotension);
• have severe heart problems due to long-term lung disease (cor pulmonale);
• have inflammation of the pancreas (which may cause severe abdominal and back pain) or gallbladder problems;
• have adrenal insufficiency (a disorder of the adrenal glands in the kidneys);
• have prostate problems;
• have had or currently suffer from epileptic seizures, fits, or convulsions;
• experience withdrawal symptoms such as restlessness, anxiety, palpitations, tremors, or sweating when stopping alcohol or drugs.

Acute generalized exanthematous pustulosis (AGEP) has been reported with treatment using this medicine. Symptoms usually occur within the first 10 days of treatment. Inform your doctor if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking morphine or other opioids. Stop using this medicine and seek immediate medical attention 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 disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels), or worsen existing breathing problems. Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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

• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This could indicate that your adrenal glands are producing insufficient cortisol hormone, and you may need hormonal supplements.
• Loss of libido, impotence, or cessation of menstruation. This could be due to reduced production of sex hormones.
• If you have a history of alcoholism or drug addiction. Also inform your doctor if you think you are beginning to depend on this medicine while using it. You may have started thinking excessively about when you can take the next dose, even if you do not 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 adjust the dosing interval.

Contact your doctor if you experience severe upper abdominal pain that may radiate to your back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or bile ducts.

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

This medicine should be used with caution if you are taking central nervous system (CNS) 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 whether you need a change in dose or a switch to another strong painkiller.

Use in athletes

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

Other medicines and morphine

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

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

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

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

This medicine must not be administered simultaneously if you are taking a type of medicine for depression called monoamine oxidase inhibitors (MAOIs) or within two weeks after stopping such medicines (see section 2 "Do not take...").

Concomitant use of morphine and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes morphine together with sedative medicines, your doctor must limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and follow the recommended dose carefully.

It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such 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 serious adverse reactions such as shallow breathing (with risk of respiratory arrest) 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

These tablets 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 require medical treatment.

Driving and using machines

These tablets may cause 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 first start treatment or when your dose is increased. If affected, you must not drive or use machinery.

This medicine contains lactose

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

This medicine contains Sunset Yellow FCF (E-110).

It may cause allergic reactions.

3. How to take Sevredol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will explain to you what to expect from using this medicine, when and for how long you need to take it, when to contact your doctor, and when you should stop taking 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 may lead to serious adverse effects that could be fatal.

Recommended dose:

• Adults and adolescents over 12 years of age:

The dose will depend on the intensity of your pain and your previous history of analgesic use.

A patient experiencing severe pain should start with an oral dose of one or two 10 mg tablets every 4 hours. As pain intensity increases or tolerance to morphine develops, the morphine dose may need to be increased until the desired pain relief is achieved. Your doctor will determine the number of tablets you should take.

• Use in elderly patients (over 65 years of age):

A reduction of the normal adult dose is recommended.

• Use in children:

Not recommended for children under 5 years of age.

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

Do not exceed the dose prescribed by your doctor. Doing so increases the risk of opioid overdose (see section 4. Possible side effects).

There is a risk of tolerance (requiring higher doses to relieve pain) and addiction with strong opioid analgesics.

If you feel that the effect of this medicine 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 seeking medical attention, make sure to bring this leaflet and any tablets you have left, so you can show them to your doctor.

Signs of morphine overdose and toxicity include pinpoint or small pupils, difficulty breathing, aspiration pneumonia, and hypotension. In more severe cases, circulatory failure may occur, potentially leading to deep coma.

Individuals who have taken an overdose may develop a brain disorder (known as toxic leukoencephalopathy) and may suffer from pneumonia due to inhalation of vomit or foreign particles; symptoms may include shortness of breath, cough, 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 engage in any activity requiring alertness, such as driving a car.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Sevredol

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

Do not take a double dose to make up for a missed dose.

If you stop taking Sevredol

Do not stop treatment with this medicine unless approved by your doctor. If you wish to discontinue treatment with this medicine, ask your doctor how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include generalized aches, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, palpitations, and pupil dilation. Psychological symptoms may include a profound sense of dissatisfaction, anxiety, and irritability.

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

4. Possible adverse effects

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

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

• a severe allergic reaction causing difficulty breathing or dizziness, sudden wheezing, swelling of the eyelids, face or lips, skin rash or itching, especially if it spreads all over your body.
• a severe skin reaction with blisters, widespread skin peeling, pus-filled spots (pustules) together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).

The most serious adverse effect, although uncommon, 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 addiction or physical and psychological dependence on 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 (more common when starting treatment with this medicine or when the dose is increased, but this should disappear within a few days)
• Dry mouth, loss of appetite, abdominal pain or discomfort
• Vomiting (should resolve within a few days; however, your doctor may prescribe a medicine to prevent them if the problem persists)
• Dizziness, headache, confusion, insomnia
• Involuntary muscle contractions
• Feeling of weakness, fatigue, malaise
• Skin rash or itching
• Sweating

Uncommon adverse effects

(May affect up to 1 in 100 patients)

• Breathing difficulties or wheezing
• Conditions in which the intestine does not function properly (ileus)
• Taste disturbances, indigestion
• Agitation, mood changes, hallucinations, feeling of extreme happiness
• Feeling of dizziness or fainting, fits, seizures or convulsions
• Blurred vision
• Dizziness
• Unusual muscle stiffness, muscle spasms
• Tingling or numbness
• Difficulty urinating
• Low blood pressure, facial flushing
• Hives (urticaria)
• Elevated liver enzymes (seen in blood tests)
• Swelling of hands, knees and feet
• Hypersensitivity

Frequency not known

(Cannot be estimated from available data)

• Anaphylactic reaction
• Anaphylactoid reaction
• Feeling of general malaise, abnormal thoughts
• Increased sensitivity to pain or abnormal perception of pain
• Constriction of the pupils of the eyes
• Decreased cough reflex
• Impotence, decreased libido, absence of menstruation
• Withdrawal symptoms or dependence (see section 3 “If you stop taking Sevredol”), drug tolerance
• Neonatal withdrawal syndrome
• Sleep apnoea (pauses in breathing during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary 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 adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister pack and carton, after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevredol

The active substance is morphine sulfate.

Each tablet contains 20 mg of morphine sulfate.

The other components are:

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

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

Appearance of Sevredol and pack contents

Dark pink, film-coated, capsule-shaped, biconvex tablets, with a score line on one side. On each side of the score line, “IR” is printed on the left and “20” on the right.

The tablets can be divided into two equal doses.

Carton packs containing 12 tablets in PVC/PVDC-Al blisters.

Marketing Authorization Holder

Mundipharma Pharmaceuticals, S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Telephone: 913 821 870

Manufacturer

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

Date of the most recent review of this leaflet: November 2024

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