SEVOFLURANE ELC 100% LIQUID FOR INHALATION

Introduction

Package Leaflet: Information for the User

Sevoflurano ELC 100% Liquid for Vapor Inhalation EFG

sevoflurane

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sevoflurano ELC is and what it is used for

Sevoflurano ELC contains the active substance sevoflurane, which is a general anesthetic used for surgical interventions and other procedures.

It belongs to a group of medicines called general anesthetics. These work by temporarily reducing the activity of the central nervous system. This causes a total lack of sensitivity in the body, including loss of consciousness, allowing the surgical procedure to be performed without pain or suffering. Sevoflurano ELC is a clear, colorless, volatile liquid that, when introduced into a special anesthesia equipment (vaporizer), turns into gas. This gas is mixed with the oxygen you will breathe. Once inhaled, sevoflurane induces deep sleep and pain-free (general anesthesia) in adults and children.

2. What you need to know before you use Sevoflurano ELC

Sevoflurane should only be administered by healthcare professionals with adequate training in the administration of general anesthesia under the supervision of an anesthesiologist or by an anesthesiologist.

Do not use Sevoflurano ELC if:

• you are allergic to sevoflurane or similar anesthetics.
• you or a family member have a predisposition to be affected by a disorder called malignant hyperthermia (rapid increase in body temperature and intense muscle contractions) during anesthesia.
• you have had an adverse reaction after previous anesthesia with sevoflurane or similar anesthetics, for example, if you have suffered liver problems (such as yellowing of the skin or whites of the eyes, i.e., jaundice), fever, or blood problems.
• you have had a prolonged QT interval (prolongation of a specific time interval on an ECG) or torsades de pointes (a specific type of heart rhythm), which may also be associated with QT interval prolongation. It is known that sevoflurane sometimes causes these.
• you are prone to or at risk of having seizures (attacks).
• you suffer from a mitochondrial disease.

Warnings and precautions

Consult your doctor before starting to use Sevoflurano ELC if:

• you have previously received an inhaled anesthetic, especially if it has occurred more than once during a short period (repeated use)
• you have low blood pressure
• you have hypovolemia (if your blood volume is low) or are weak
• you have kidney problems (altered renal function)
• you are pregnant or breastfeeding
• you have coronary artery disease
• the pressure inside your skull is high (intracranial pressure), derived, for example, from a head injury or brain tumor
• you suffer or have suffered liver problems, such as hepatitis (inflammation of the liver) or yellowing of the skin or whites of the eyes (jaundice)
• you are receiving treatment that may cause you liver problems
• you have been confirmed to suffer from seizures or are at risk of suffering from them (epileptic crises)
• you suffer from a neuromuscular disease, specifically Duchenne muscular dystrophy
• you suffer from any other disorder, apart from those associated with your operation, especially any renal or cardiac problem, low blood pressure, severe headaches, nausea, or vomiting, or Pompe disease in children

In the rare and unforeseen case that you suffer from malignant hyperthermia (a sudden and dangerously high increase in body temperature during surgery or shortly after), your anesthesiologist will interrupt the administration of sevoflurane and you will receive a medication (called dantrolene) to treat malignant hyperthermia and other palliative treatments.

Inform your doctor or pharmacist if you are in any of these circumstances. It may be necessary for you to undergo careful examination and change your treatment.

Other medicines and Sevoflurano ELCInform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. This warning is especially important if you are taking the following medicines:

• Amphetamines (stimulants) used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy)
• Medicines that affect the heart, such as adrenaline or epinephrine.
• Isoprenaline
• Beta blockers or a medicine called verapamil (to treat high blood pressure and certain heart disorders)
• Alcohol
• Barbiturates (depressants)
• Isoniazid (an antibiotic used to treat tuberculosis)
• St. John's Wort (a medicinal plant used to alleviate depression)
• Decongestants (such as ephedrine)
• Tranquilizers (benzodiazepines, for example, diazepam, lorazepam): these are sedative medicines that have a calming effect. They are used when you feel nervous, for example, before surgery
• Potent analgesics such as morphine or codeine
• Non-selective monoamine oxidase inhibitors (MAOIs) (a type of antidepressant).
• Muscle relaxants (myorelaxants) Non-depolarizing such as, for example, vecuronium, pancuronium, atracurium, and depolarizing, such as, for example, succinylcholine): these medicines are used during general anesthesia to relax the muscles
• Other anesthetics, such as nitrous oxide, propofol, opioids (for example, alfentanil and sufentanil), since sevoflurane may affect their functioning if administered at the same time.

Tell your doctor or nurse if you are taking or have recently taken any other medicine, even those without a prescription. This also applies to herbal medicinal products, vitamins, and minerals

Using Sevoflurano ELC with food and drinks

Sevoflurano ELC is a medicine to induce and maintain sleep, so you can undergo surgery. You should ask your doctor, surgeon, or anesthesiologist when and what you can eat or drink after waking up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not receive this medicine if you are pregnant unless it is essential.

Sevoflurane may cause an increase in blood loss after operations that affect the uterus. It is necessary to act with caution when administering this medicine to breastfeeding women, as it is unknown whether it is excreted in breast milk after anesthesia. It is recommended that women interrupt breastfeeding for 48 hours after the administration of sevoflurane and discard the milk produced during this period.

Driving and using machines

Sevoflurano ELC strongly affects your ability to drive and use tools. Do not drive or operate tools or machines until your doctor tells you it is safe. Receiving an anesthetic can affect your alertness for several days. This may affect your ability to perform tasks that require mental vigilance.

Ask your anesthesiologist when it will be safe for you to drive and use machines again.

3. How to use Sevoflurano ELC

This medicine will always be administered by an experienced anesthesiologist in surgical interventions in an operating room or hospital. The anesthesiologist will decide the amount of sevoflurane you need and when it will be administered.

Induction of sleep at the beginning of anesthesia

This medicine is produced from sevoflurane liquid that is introduced into a vaporizer specifically designed for use with sevoflurane. To put you to sleep, you will be asked to breathe the medicine through a mask. However, in most cases, you will be given another anesthetic by injection to fall asleep before receiving Sevoflurano ELC.

Maintenance of sleep during anesthesia

During the operation, you will continue to inhale this medicine through a mask under the supervision of the anesthesiologist.

Waking up after anesthesia

Once the anesthesiologist stops the inhalation of this medicine, you will wake up within a few minutes. In particular, children may wake up restless. Inform your doctor or anesthesiologist if you need deeper pain relief.

If you use more Sevoflurano ELC than you should

This medicine will be administered by a healthcare professional, so it is unlikely that you will receive too much Sevoflurano ELC. If you receive more Sevoflurano ELC than you should, the anesthesiologist will take all appropriate measures.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They can appear during and after the operation.

Severe side effects (can be fatal):

• Anaphylactic and anaphylactoid reactions (see section on unknown side effects for more information).

The following side effects of this medicine are serious and will be treated during the operation by the surgeon or anesthesiologist, if necessary. If you suffer from any of these side effects after your operation, seek medical attention immediately.

Inform your doctor or nurse immediately if you notice any of the following side effects:

• Allergic reactions, which can be severe, with inflammation of the face, tongue, and throat, and difficulty breathing.
• Rapid increase in body temperature (malignant hyperthermia), which can require intensive care and be fatal. This disorder can be hereditary.
• Increased potassium levels in the blood (hyperkalemia), which can lead to cardiac arrhythmias and be fatal for children during the postoperative period. This effect has been observed in patients with neuromuscular diseases, specifically Duchenne muscular dystrophy.

If you suffer from any of the following side effects, inform your doctor or nurse:

Very common (may affect more than 1 in 10 people)

• Restlessness (agitation) in children

• Low heart rate (bradycardia)

• Low blood pressure

• Cough
• Nausea and vomiting

Common (may affect up to 1 in 10 people)

• Headache
• Numbness
• Dizziness
• High heart rate
• Increased blood pressure
• Respiratory disorder
• Airway obstruction
• Slow and shallow breathing
• Laryngospasm, respiratory problems
• Salivation
• Sudden drop in temperature (hypothermia), chills
• Fever
• Anomalies in blood sugar concentration, liver function tests, or white blood cell count
• Increased fluoride levels in the blood

Uncommon (may affect up to 1 in 100 people)

• Confusion
• Anomalies in heart rhythm and beats
• AV block (a disorder of the heart's electrical conduction)
• Interruption of breathing, low oxygen concentration, fluid in the lungs
• Urinary retention, glucose in the urine
• Increased creatinine levels in the blood (an indicator of altered renal function), detected through blood sample analysis

Frequency not known (cannot be estimated from available data)

• Asthma
• Allergic reactions such as:
• skin rash
• redness of the skin
• hives (urticaria)
• itching
• swelling of the eyelids, difficulty breathing
• Anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and can be potentially fatal. The symptoms of anaphylaxis include:
• angioedema (swelling of the skin of the face, limbs, lips, tongue, or throat)
• difficulty breathing
• low blood pressure
• hives (urticaria)
• seizures
• sudden, spastic movements
• cardiac arrest
• bronchospasm
• difficulty breathing or wheezing
• breath-holding
• shortness of breath
• reduced liver function or hepatitis (inflammation of the liver), characterized, for example, by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark urine
• dangerously high increase in body temperature
• chest discomfort
• increased intracranial pressure
• irregular heartbeat or palpitations
• pancreatitis
• increased potassium levels in the blood, as detected through blood sample analysis
• muscle stiffness
• kidney inflammation (symptoms may include fever, confusion, or drowsiness, skin rash, swelling, more or less urine than usual, and blood in the urine)
• swelling

Sometimes, seizures (attacks) have been observed. This can occur when receiving Sevoflurano ELC or up to a day later during recovery. This occurs mainly in children and young adults.

Pediatric patients with Pompe disease, a disease present at birth, may suffer from cardiac arrhythmia during anesthesia with sevoflurane.

Blood fluoride levels may rise slightly during anesthesia and immediately after, but these levels are not considered harmful and return to normal soon.

If any of the side effects you suffer from is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

You can also report side effects directly or through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevoflurano ELC

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

Do not use this medicine after the expiration date stated on the label of the vial and the carton after EXP. The expiration date is the last day of the month indicated.

Sevoflurane is stable if stored under normal ambient lighting conditions.

This medicine does not require special storage conditions.

6. Contents of the pack and other information

Composition of Sevoflurano ELC

The active substance is sevoflurane at 100%. It does not contain any excipients.

Appearance of the product and pack contents

Sevoflurano ELC is a clear, colorless, and volatile liquid.

It is available in a 250 ml amber glass type III vial. The vial has a yellow ring on the neck, sealed with a plastic cap with an LDPE coating and secured with a PET film.

The medicine is provided in a carton with 6 cardboard boxes. Each cardboard box contains 1 vial of 250 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

ELC Group s.r.o.

Pobrežní 394/12, Karlín,

186 00, Prague 8

Czech Republic

Manufacturer

Pharmakorell GmbH

Georges Koehler Strasse 2

Loerrach – 79539

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:November 2023

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The following information is intended for healthcare professionals only.

[Consult the full text of the Summary of Product Characteristics or Package Leaflet.]