PATIENT INFORMATION LEAFLET

Sevoflurane Piramal 100% Liquid for inhalation of vapor EFG

Read this leaflet carefully before you start using 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, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section4.

The active ingredient in Sevoflurano Piramal is sevoflurane, a general anesthetic used in surgical operations and other procedures.

It is an inhaled anesthetic that is administered in the form of vapor to breathe, which causes a deep sleep (induction of anesthesia). It also maintains a deep sleep during which surgery can be performed (maintenance of anesthesia). Consult a doctor if you do not feel better or if you feel worse.

Sevoflurane must be administered only by a properly trained healthcare professional in the administration of general anesthesia by an anesthesiologist or under the supervision of one.

Do not use Sevoflurane Piramal

• if you have been told previously that you should not receive general anesthesia.
• if you are allergic (hypersensitive) to sevoflurane or any similar anesthetic.
• if you or a family member are susceptible to a condition known as malignant hyperthermia (rapid increase in body temperature) during anesthesia.
• if you have reacted poorly after previous anesthesia with sevoflurane or similar anesthetics, for example, if you experienced liver problems (such as jaundice), fever, or blood problems.

• if you have ever had prolonged QT (prolongation of a specific interval in an ECG) or torsades de pointes (a specific type of heart rhythm), which can also be associated with QT interval prolongation. It has been known that sevoflurane sometimes causes this.

• if there are medical reasons why you should not receive general anesthesia

Warnings and precautions

Consult your doctor before starting to use Sevoflurane Piramal

• If you have previously undergone general anesthesia, particularly if repeated within a short period of time. You may have a higher risk of developing liver problems.
• If you have any illness other than related to your operation, particularly kidney or heart problems, low blood pressure, severe headaches, nausea, or vomiting, or Pompe disease in children.
• You have a certain type of muscle weakness (myasthenia gravis) because people with this disease are very sensitive to respiratory-inhibiting medications.
• If you have coronary artery disease.
• If you are hypovolemic (reduced blood volume) or weak.
• If you have or have had liver problems, for example, hepatitis (inflammation of the liver) or jaundice.
• If you have a neuromuscular disease, particularly Duchenne muscular dystrophy.
• If you have increased intracranial pressure (pressure in the skull) due to a head injury or brain tumor.
• If you are at risk of seizures.
• If you are pregnant or breastfeeding.
• If you have a mitochondrial disorder, which is a disorder that people can be born with and can affect their own heart, brain, and kidney cells.
• In the rare and unpredictable case of presenting malignant hyperthermia (a rapidly and dangerously high increase in body temperature during surgery or shortly after it).

In this case, your anesthesiologist (doctor) will stop administering sevoflurane and give you a medication to treat malignant hyperthermia (known as dantrolene) and receive additional treatment. Fatal outcomes of malignant hyperthermia with sevoflurane have been reported.

Children

• If you have Down syndrome.

If any of the above circumstances occur, consult your doctor, nurse, or pharmacist. You may need to be carefully examined, and your treatment may be modified.

The following effects may occur during or after the administration of Sevoflurane 100% Inhalation Vapor:

• During the period in which you are anesthetized (induction phase), sevoflurane, as well as similar medications (halogenated anesthetics), may induce coughing. This should be taken into account.
• Like other anesthetics, minor mood changes may occur during several days after sevoflurane administration.
• Young children under six years old are more likely to experience acute confusion (delirium) upon waking from anesthesia. Additionally, young children under six years old are more likely to experience agitation/anxiety upon waking from anesthesia.
• In sensitive patients, inhaled anesthetics (inhalation anesthetics) can cause an increase in muscle metabolic state (hypermetabolic state). This leads to high oxygen requirements by their muscles due to excessively high CO2 levels in the blood (hypercapnia). In that case, you may experience muscle rigidity (rigidity), increased heart rate (tachycardia), increased breathing (tachypnea), blue discoloration of the lips, tongue, skin, and mucous membranes (cyanosis), arrhythmias, and/or unstable blood pressure.
• In rare cases, the use of inhaled anesthetics (inhalation anesthetics) has been associated with an increase in serum potassium levels (elevated potassium levels) that has caused arrhythmias and death in children after surgery.
• Sevoflurane can cause respiratory depression, which may increase with narcotic premedication or other medications that cause respiratory depression. Respiratory control should be monitored, and, if necessary, support should be provided.

Use of Sevoflurane Piramal with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medications, including those obtained without a prescription.

Medications or active principles contained in the medications indicated below may influence each other's effect when used with Sevoflurane Piramal. Some of these medications are administered during surgery by the anesthesiologist, as indicated in the description.

• Amphetamines (stimulants) used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy.
• Medications affecting the heart, such as adrenaline or epinephrine.
• Beta-blockers (e.g., atenolol, propranolol): heart medications often used to treat high blood pressure.
• Alcohol.
• Barbiturates (depressants).
• St. John's Wort (herbal medicine used to help with depression).
• Decongestants (ephedrine).
• Non-selective monoamine oxidase inhibitors (MAOIs) (a type of antidepressant).
• Calcium antagonists.
• Verapamil: a heart medication used to treat high blood pressure or irregular heart rhythm.
• Tranquilizers (benzodiazepines, for example, diazepam, lorazepam): sedative medications that have a calming effect. They are used when one feels nervous, for example, before surgery.
• Potent analgesics such as morphine or codeine.
• Non-depolarizing muscle relaxants (such as, for example, vecuronium, pancuronium, atracurium, and depolarizing, such as, for example, succinylcholine): these medications are used during general anesthesia to relax muscles.
• Isoniazid, used to treat tuberculosis (TB).
• Isoprenaline.
• Other anesthetics, for example, nitrous oxide: a medication used during general anesthesia that will put you to sleep and relieve your pain; propofol, opioids (for example, alfentanil and sufentanil: these medications are strong painkillers and are often used during general anesthesia), as sevoflurane may affect their way of acting if administered at the same time.

Inform your doctor or nurse if you are taking or have taken recently any other medication, including over-the-counter medications. This also applies to herbal medicines, vitamins, and minerals.

Use ofSevoflurane Piramalwith food and drinks

Sevoflurane Piramal is a medication 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 intend to become pregnant, consult your doctor or anesthesiologist before using this medication.

You should not receive Sevoflurane Piramal if you are pregnant, unless it is strictly necessary.

The use of sevoflurane for anesthesia during a cesarean section is safe for you and your baby. Like other anesthetics, sevoflurane can reduce breathing in newborns. Your doctor will determine if you can use sevoflurane.

Driving and using machines

Sevoflurane Piramal has a significant impact on 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 can 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.

Sevoflurane Piramal will be administered by a trained anesthesiologist during surgery or in a hospital. The anesthesiologist will decide the amount of sevoflurane needed and when it will be administered. The dose will vary according to your age, weight, the type of surgery you need, and other medicines that have been administered during surgery.

Sevoflurane Piramal passes from liquid to vapor (gas) in a vaporizer. You will breathe it in as a vapor.

It can be used to put you to sleep before surgery, or if you are put to sleep with an injectable anesthetic, to maintain anesthesia during surgery.

Once the anesthesiologist stops the inhalation of sevoflurane, you will wake up in a few minutes.

If you have any other questions about the use of this medication, ask your anesthesiologist, doctor, or nurse.

If you use more Sevoflurane Piramal than you should

Sevoflurane Piramal will be administered by a healthcare professional and it is unlikely that you will receive too much Sevoflurane Piramal. If you are given too much Sevoflurane Piramal, your anesthesiologist will take all necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. However, it is essential to consult with the attending physician, nurse, or anesthesiologist if you feel unwell.

Severe side effects:(may be fatal):

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

The following side effects are severe and may require immediate medical attention. Hospital staff will monitor your anesthesia and provide immediate assistance when necessary.

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

• Allergic reactions, which can be severe, with swelling of the face, tongue, and throat, and difficulty breathing.

• Malignant hyperthermia (very high temperature), which may require intensive care and can be fatal. This condition may be hereditary.

• Hyperkalemia (elevated potassium levels in the blood), which can result in abnormal heart rhythms and can be fatal in children during the postoperative phase. This has been observed in patients with neuromuscular disease, particularly Duchenne muscular dystrophy.

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

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

• Restlessness (agitation) in children
• Slow heart rate
• Low blood pressure
• Cough
• Nausea and vomiting

Common side effects (may affect up to 1 in 10 people)

• Restlessness (agitation) in adults
• Headache
• Drowsiness
• Dizziness
• Fast heart rate
• Increased blood pressure
• Respiratory disorder
• Airway obstruction
• Slow and shallow breathing
• Throat spasms, respiratory problems
• Excessive salivation
• Decreased body temperature, chills
• Fever
• Abnormal blood sugar levels, abnormal liver function tests, or abnormal white blood cell count, i.e., increased susceptibility to infections.
• Elevated fluoride levels in the blood

Uncommon side effects (may affect up to 1 in 100 people)

The frequency may change by:

• Seizure
• Abnormal heart rhythm
• AV block (a heart conduction disorder)
• Asthma, respiratory arrest, low oxygen levels
• Urinary retention, presence of glucose in urine
• Abnormal white blood cell count
• Abnormal blood enzyme concentrations
• Elevated creatinine levels in the blood (indicating altered renal function), detected through blood sample analysis

Other side effects with unknown frequency (cannot be estimated from available data)

• Pulmonary edema
• Allergic reactions, such as:
• Skin rash
• Skin redness
• Urticaria (hives)
• Itching
• Swelling of the eyelids, difficulty breathing
• Anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and can be potentially fatal. Symptoms of anaphylaxis include:
• Malignant hyperthermia
• Angioedema (swelling of the skin of the face, extremities, lips, tongue, or throat)
• Difficulty breathing
• Low blood pressure
• Urticaria (hives)
• Pseudoepileptic seizures
• Sudden spasmodic movements
• Cardiac arrest
• Respiratory spasms
• Difficulty breathing or wheezing
• Respiratory retention
• Lack of breath

• Reduced liver function or hepatitis (inflammation of the liver), characterized by, for example, loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark urine
• Potentially hazardous increase in body temperature
• Chest discomfort
• Increased intracranial pressure
• Irregular heartbeat or palpitations
• Pancreatitis
• Elevated potassium levels in the blood, as detected through blood sample analysis
• Muscle rigidity
• Yellowish skin
• Renal inflammation (symptoms may include fever, confusion or drowsiness, skin rash, swelling, more or less urine than normal, and blood in the urine)
• Swelling

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

In children with Down syndrome who receive sevoflurano, a decrease in heart rate may occur.

Fluoride levels in the blood may rise slightly during anesthesia immediately after it, but these levels are not considered harmful and return to normal soon.

If any of the side effects you experience are severe or if you notice any side effects not mentioned in the leaflet, inform your doctor or pharmacist.

If you observe any change in how you feel after receiving sevoflurano, inform your doctor or pharmacist. Some side effects may require treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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 vial label and on the product packagingafter CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store the vial in an upright position.

Once opened, the contents of the bottle must be used within 8 weeks. Do not refrigerate.

Keep the vial perfectly closed due to the volatile nature of the anesthetic.

Composition of Sevoflurane Piramal

• The active ingredient is sevoflurane (100%).
• There are no other components.

Appearance of the product and contents of the container

Sevoflurane Piramal is a colourless liquid that is packaged in amber glass bottles of 250 ml (with or without an external PVC coating) with a screw cap or with an integrated closure adapter.

Container of 1 and 6 bottles.

Only some container sizes may be authorized.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor),

2252 TR

Voorschoten

Netherlands

Responsible for manufacturing

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor),

2252 TR

Voorschoten

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

BCNFarma distribution and storage of medicines, S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

This medication is authorized in the member states of the European Economic Area with the following names:

Austria - Sevoflurane Piramal 100 % Liquid for the preparation of a vapour for inhalation

Bulgaria - Sevoflurane Piramal 100 % Inhalation Vapour, liquid

Cyprus - Sevoflurane – Piramal

Czech Republic - Sojourn 100 % liquid for the preparation of an inhalation vapour

Denmark - Sojourn TM

Estonia - Sevoflurane- Piramal, inhalation vapour, liquid 100%

Germany - Sevoflurane Piramal 100 % Liquid for the preparation of a vapour for inhalation

Greece - Sojourn TM Sevoflurane 100 % Inhalation Vapour, liquid

Hungary - Sevoflurane Piramal liquid for inhalation vapour preparation

Iceland - Sevoflurane Piramal 100 % inhalation vapour, liquid

Ireland - Sevoflurane 100 % Inhalation Vapour, liquid

Italy - Sevoflurane Piramal

Latvia - Sevoflurane Piramal 100 % inhalation vapour, liquid

Lithuania - Sevoflurane Piramal 100 % inhalation vapour, liquid

Luxembourg - Sevoflurane 100 %

Malta - Sevoflurane 100 % Inhalation Vapour, liquid

Netherlands - Sevoflurane 100 % (Piramal), Liquid for inhalation vapour

Norway - Sevoflurane Piramal liquid for inhalation vapour

Poland - Sojourn

Portugal - Sevoflurane Ojourn 100 % liquid for inhalation by vaporization

Slovenia - Sevofluran Piramal 250 ml for inhalation, liquid

Spain - Sevoflurane Piramal 100 % liquid for inhalation vapour

Sweden - Sevoflurane Piramal 100 % inhalation vapour, liquid

United Kingdom - Sevoflurane 100 % Inhalation Vapour, liquid

Date of the last review of this prospectus:May 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

<--------------------------------------------------------------------------------------------------------------------------->

Additional information for doctors or other healthcare professionals is included in the product technical file.