SEVREDOL 20 mg FILM-COATED TABLETS

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 breathing problems, such as severe chronic obstructive airways disease, severe bronchial asthma, or status asthmaticus;
• if you have a head injury that may cause increased pressure inside your skull;
• if you have a condition where your small bowel does not work properly (paralytic ileus), your stomach empties more slowly than normal (delayed gastric emptying), or you have severe abdominal pain;
• if you have a condition where your skin becomes blue (cyanosis) due to poor circulation or inadequate oxygen supply;
• if you have recently had a 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 decrease in the medicine's effectiveness (tolerance) and dependence. Long-term use of this medicine can also lead to addiction, which could result in a potentially life-threatening overdose.

Dependence or addiction can cause a loss of control over the amount of medicine you use or how often you 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 a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs.
• You smoke.
• You have had problems with your mood (depression, anxiety, or personality disorders) 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, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking 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 you start taking this medicine.

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

• have low thyroid function (hypothyroidism);
• have severe kidney or liver problems, as you may need a dose reduction;
• have severe headaches or dizziness, as this may indicate increased pressure in your skull;
• have breathing problems, such as chronic obstructive pulmonary disease, severe lung injury, or reduced respiratory capacity;
• have any blockage of the intestines or an inflammatory bowel disorder;
• have constipation;
• have low blood pressure (hypotension);
• have a severe heart condition after a long lung disease (cor pulmonale);
• have inflammation of the pancreas (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 fits or convulsions;
• have symptoms of withdrawal such as agitation, anxiety, palpitations, tremors, or sweating when you stop taking alcohol or drugs.

A condition called acute generalized exanthematous pustulosis (AGEP) has been reported in association with this medicine. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever suffered from a severe skin rash, skin peeling, blisters, or sores in the mouth after taking morphine or other opioids. Stop taking 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 breathing disorders

This medicine may cause sleep-related breathing problems, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood), or worsen existing breathing problems. Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, 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.

Talk to 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 and you may need to take hormone supplements.
• Loss of sex drive, impotence, or cessation of menstruation. This could be due to decreased production of sex hormones.
• If you have a history of alcohol or drug abuse. Also, tell your doctor if you think you are starting to depend 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 do not need it for pain relief.
• Withdrawal symptoms 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 abdominal pain that may radiate to your back, nausea, vomiting, or fever, as these could be symptoms associated with pancreatitis or bile duct problems.

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

This medicine should be used with caution when taking medicines that depress the central nervous system (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.

Use in 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 tranquilizers, hypnotics, or sedatives).
• 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 or pain caused by nerve problems (neuropathic pain).

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

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

Taking morphine with sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Therefore, 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 useful 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 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.

These tablets should be avoided in pregnant or breastfeeding women whenever possible.

If this medicine is used for a long time during pregnancy, there is a risk that the newborn baby will have withdrawal symptoms that need to be treated by a doctor.

Driving and using machines

These tablets can cause side effects such as drowsiness, which may affect your ability to drive or use machines (see section 4 for a full list of side effects). These effects are more pronounced when you start treatment with the tablets or when your dose is increased. If you are affected, do 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.

This medicine contains Sunset Yellow FCF (E 110)

It may cause allergic reactions.

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

The tablets should be swallowed whole 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, the dose of morphine will need to be increased 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 exceed the dose recommended by your doctor. If you do, you are at risk of taking too much opioid (see section 4. Possible side effects).

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

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

If you take more Sevredol than you should

Contact your doctor or go to your hospital immediately. When you need medical attention, make sure to take this leaflet and any remaining tablets with you to show your doctor.

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, cough, and fever.

People who have taken an overdose may also experience difficulty breathing 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, telephone 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 due time, take a tablet as soon as possible. Take your next tablet at the usual time. If the delay in taking the tablet is more than 4 hours, talk to your doctor or pharmacist.

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

If you stop taking Sevredol

Do not stop taking this medicine unless your doctor tells you to. If you want to stop taking this medicine, ask your doctor how to reduce the dose gradually to avoid withdrawal symptoms. Withdrawal symptoms can include general pain, 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 serious 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 painkillers, 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 this should disappear within a few days)
• Dry mouth, loss of appetite, abdominal pain or discomfort
• Vomiting (should disappear within a few days, however, your doctor may prescribe a medicine to prevent it 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)
• Altered 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
• Newborn withdrawal syndrome
• Sleep apnea (pauses in breathing during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary system, such as 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 above 30°C.

Medicines should not be disposed of via 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 20 mg of morphine sulfate.

The other ingredients 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 orange yellow Sunset (E-110)).

Appearance of Sevredol and Package Contents

Dark pink, 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 "20" 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/)