Sevoflurane Piramal

PACKAGE LEAFLET: INFORMATION FOR THE

PATIENT
Sevoflurane Piramal, 100% liquid for
inhalation Sevoflurane
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Sevoflurane Piramal is and what it is used for

The active substance in Sevoflurane Piramal is sevoflurane, a general anaesthetic used for surgical operations and other procedures.
It is an inhaled anaesthetic administered as a vapour to be breathed in.
It causes deep sleep (induction of anaesthesia). It also maintains a pain-free state of deep sleep during which surgery can be performed (maintenance of anaesthesia).
Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking sevoflurane piramal

Sevoflurane must be administered only by a healthcare professional experienced in the administration of general anaesthesia under the supervision of an anaesthetist, or by an anaesthetist.
Do not take Sevoflurane Piramal if any of the following apply to you, and in such cases, inform your doctor:

• If there are medical reasons why you should not undergo general anaesthesia.
• If you have previously been advised not to undergo general anaesthesia.
• If you are allergic to sevoflurane or to other similar anaesthetics.
• If you or someone in your family is susceptible to a condition called malignant hyperthermia (sudden increase in body temperature) during anaesthesia.
• If you have liver problems or have previously undergone general anaesthesia, particularly if repeated after a short interval. Some anaesthetics may occasionally cause liver problems, which can lead to yellowing of the eyes and skin (jaundice).
• If you have ever had QT interval prolongation (prolongation of a specific time interval on the ECG) or torsades de pointes (a specific type of cardiac rhythm), which may also be associated with QT prolongation. Sevoflurane has occasionally been reported to cause these problems.
• If you are prone to or at risk of seizures.
• If you suffer from a mitochondrial disorder.

Warnings and precautions
Talk to your doctor before taking Sevoflurane Piramal:

• If you have previously received general anaesthesia, particularly if repeated within a short time. You may have an increased risk of liver problems.
• If you have any illness not related to your surgical procedure, especially kidney or heart problems, low blood pressure, severe headaches, nausea or vomiting, or Pompe disease in children (a metabolic disorder). Sevoflurane may cause irregular heartbeat, which can be serious in some cases.
• If you have coronary artery disease.
• If you are hypovolemic (reduced blood volume) or weak.
• If you have neuromuscular diseases, particularly Duchenne muscular dystrophy.
• If you have increased pressure in the skull (intracranial hypertension) due to head trauma or brain tumour.
• If you have seizures or seizure disorders, as sevoflurane may increase the risk of seizures.
• If you are pregnant or breastfeeding.

Children

• If you have Down's syndrome.

If any of the above conditions apply to you, inform your doctor, nurse or pharmacist. You may need to be closely monitored and your treatment may need to be adjusted.
Other medicines and Sevoflurane Piramal
Inform your doctor if you are taking, or have recently taken, any of the following medicines:
The medicines or active substances listed below may interact with each other when used together with Sevoflurane Piramal. Some of these medicines are administered during surgery by your anaesthetist, as described.

• Amphetamines (stimulants): used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy.
• Medicines that affect the heart, such as adrenaline or epinephrine.
• Beta-blockers (e.g. atenolol, propranolol): these are heart medications often used to treat high blood pressure.
• Alcohol.
• Barbiturates (sedatives).
• St. John’s wort (an herbal medicine used to relieve depression).
• Decongestants (ephedrine): used as decongestants and commonly found in cough and cold medicines.
• Non-selective monoamine oxidase inhibitors (MAO inhibitors) (a type of antidepressant).
• Calcium antagonists.
• Verapamil: this is a heart medication used to treat high blood pressure or irregular heartbeat.
• Tranquillisers (benzodiazepines, e.g. diazepam, lorazepam): these are sedative medicines that have a calming effect. They are used when you feel anxious, for example before surgery.
• Strong painkillers such as morphine or codeine.
• Muscle relaxants (non-depolarising, e.g. vecuronium, pancuronium, atracurium, and depolarising, e.g. succinylcholine): these medicines are used during general anaesthesia to relax muscles.
• Isoniazid, used in the treatment of tuberculosis (TB).
• Isoprenaline.
• Other anaesthetics, such as nitrous oxide: this is a medicine used during general anaesthesia to induce sleep and relieve pain; propofol, opioids (e.g. alfentanil and sufentanil): these are strong painkillers often used during general anaesthesia, like sevoflurane, and may influence effects if administered simultaneously.

Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to herbal products, vitamins and minerals.
Sevoflurane Piramal with food and drink
Sevoflurane Piramal is a medicine used to put you to sleep and keep you asleep during surgery. Ask your surgeon or anaesthetist when and what you may eat or drink after waking up.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or anaesthetist before receiving this medicine. It is not known whether Sevoflurane or its metabolites pass into breast milk. Breastfeeding is recommended to be interrupted for 48 hours after administration of Sevoflurane, and milk produced during this period should be discarded. You should not take Sevoflurane Piramal during pregnancy unless absolutely essential.
Driving and using machines
Sevoflurane Piramal severely affects your ability to drive and use machines. Do not drive or operate machinery until your doctor tells you it is safe. Receiving an anaesthetic may affect your level of alertness for several days. This may impair your ability to perform tasks requiring mental alertness.
Ask your anaesthetist when it will be safe for you to drive and use machines again.

3. How to take Sevoflurane Piramal

Sevoflurane Piramal will be administered to you by a specialist anaesthetist in a hospital or
operating theatre. The anaesthetist will decide how much sevoflurane you need and when
to administer it. The dose will vary depending on your age, weight, type of surgery you require,
and other medicines you will be given during surgery.
Sevoflurane Piramal is converted into vapour (gas) using a vaporiser. You will inhale it as a vapour.
It can be used to put you to sleep before surgery or, if you are put to sleep with an injection, to
maintain anaesthesia during a surgical procedure.
When the anaesthetist stops your inhalation of Sevoflurane Piramal, you will wake up within
a few minutes.
If you have any doubts about the use of this medicine, consult your anaesthetist, doctor, or
nurse.
If you receive 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. If you are given too much Sevoflurane Piramal, your anaesthetist will take
all necessary measures.

4. Possible side effects

Like all medicines, Sevoflurane Piramal can cause side effects, although not everyone experiences them. However, it is important to consult your doctor, nurse or anaesthetist if you do not feel well.

Rare serious side effects (may be life-threatening):

• Anaphylaxis and anaphylactoid reactions (see the section on unknown side effects for further information). The following side effects are serious and may require immediate medical treatment. Hospital staff will monitor you during anaesthesia and provide immediate assistance if needed. Inform your doctor or nurse immediately if you experience any of the following side effects:

• Allergic reactions, which may be severe, with swelling of the face, tongue or throat, and breathing difficulties.

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

• Increased levels of potassium in the blood (hyperkalaemia), which may cause heart rhythm abnormalities and may be fatal in children during the postoperative period. This has been observed in patients with neuromuscular diseases, particularly those affected by Duchenne muscular dystrophy.

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

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

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

Common (may affect up to 1 in 10 people)

• Headache
• Drowsiness
• Dizziness
• Fast heart rate
• Increased blood pressure
• Breathing problems
• Airway obstruction
• Slow and shallow breathing
• Spasm of the throat, breathing difficulties
• Excessive salivation
• Hypothermia, shivering
• Fever
• Abnormal blood sugar levels, abnormal liver function tests or abnormal white blood cell count (i.e. increased susceptibility to infections)
• Increased levels of fluoride in the blood

Uncommon (may affect up to 1 in 100 people)

• Confusion
• Abnormal heart rhythms and changes in heartbeat
• AV block (a disturbance in the heart's electrical conduction)
• Asthma, respiratory arrest, low oxygen levels, fluid in the lungs
• Urinary retention, presence of glucose in urine
• Increased levels of creatinine in the blood (an indicator of impaired kidney function), as detected by a blood test

Other side effects [frequency not known (frequency cannot be estimated from the available data)]

Asthma
Allergic reactions such as:

• Skin rash
• Redness of the skin
• Urticaria (hives)
• Itching
• Swelling of the eyelids, breathing difficulties
• Anaphylaxis, anaphylactoid reactions. These allergic reactions occur rapidly and can be potentially fatal. Symptoms of anaphylaxis include:
• Angioedema (swelling of the skin of the face, limbs, lips, tongue or throat)
• Breathing difficulties
• Low blood pressure
• Urticaria (hives)
• Epilepsy-like seizures
• Sudden, involuntary movements
• Cardiac arrest
• Airway cramps
• Difficulty breathing or wheezing
• Respiratory spasm
• Shortness of breath
• Reduced liver function or hepatitis (liver inflammation) characterized by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice and dark urine
• Dangerous increase in body temperature
• Chest discomfort
• Increased intracranial pressure
• Irregular heartbeat or palpitations
• Pancreatitis (inflammation of the pancreas)
• Increased levels of potassium in the blood, as detected by a blood test
• Muscle rigidity
• Yellowing of the skin
• Kidney inflammation (symptoms may include fever, confusion or insomnia, skin rash, swelling, more or less frequent urination than normal, and blood in the urine)
• Swelling

Seizures may occasionally occur. These may happen during administration of Sevoflurane Piramal or up to one day later during recovery. These occur mainly in children and young adults.

In children with Down's syndrome receiving sevoflurane, slowing of the heart rate may occur. In children with Pompe disease, a congenital disorder, irregular heartbeat may occur during anaesthesia with Sevoflurane.

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

If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevoflurane Piramal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the
vial label and carton. The expiry date refers to the last day of that month.
The abbreviation "EXP" is used on labels to indicate the expiry date. Do not store above 25°C.
Store the vial in an upright position.
Once opened, the contents of the vial should be used within 8 weeks.
Do not refrigerate.
Keep the cap tightly closed due to the volatile nature of the anaesthetic.

6. Package contents and other information

What Sevoflurane Piramal contains:
Sevoflurane Piramal contains 100% of the active substance
sevoflurane. There are no other components.

Description of the appearance of Sevoflurane Piramal and contents of the pack:
Sevoflurane is a colourless liquid available in 250 ml amber glass bottles (with or without an outer PVC coating) with a screw cap or a closure with an integrated adapter.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor)
2252 TR, Voorschoten
The Netherlands

Manufacturer
Piramal Critical Care Limited
Suite 4, Ground Floor,
Heathrow Boulevard - East Wing,
280 Bath Road,
West Drayton, UB7 0DQ,
United Kingdom
Fax: 0044 1670562604

and
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor),
2252 TR
Voorschoten
The Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria - Sevoflurano Piramal 100% liquid for vapour for inhalation
Belgium - Sevoflurane- Piramal 100% liquid for inhalation vapour
Bulgaria - Sevoflurano Piramal 100% for inhalation vapours, liquid
Cyprus - Sevoflurano - Piramal
Czech Republic - Sojourn 100% liquid for preparation of inhalation vapour
Denmark - Sojourn TM
Estonia - Sevoflurane- Piramal, inhalatsiooniaur, vedelik 100%
Finland - Sevoflurano Piramal 100% inhalaatiohöyry, Neste
Germany - Sevoflurano Piramal 100% liquid for producing inhalation vapour
Greece - Sojourn TM Sevoflurane 100% inhalation vapour, liquid
Hungary - Sevoflurano Piramal folyadék inhalációs Gőz képzéséhez
Iceland - Sevoflurano Piramal 100% innöndunargufa, vökvi
Ireland - Sevoflurano 100% vapour for inhalation, liquid
Italy - Sevoflurane Piramal, 100% liquid for inhalation
Latvia - Sevoflurano Piramal 100% for inhalation vapours, liquid
Lithuania - Sevoflurano Piramal 100% inhaliaciniai Garai skystis
Luxembourg - Sevoflurano 100%
Malta - Sevoflurano 100% vapour for inhalation, liquid
Netherlands - Sevoflurano 100% (Piramal), vloeistof voor inhalatiedamp
Norway - Sevoflurano Piramal væske til inhalasjonsdamp
Poland - Sojourn
Portugal - Sevoflurano Ojourn 100% líquido para inalação por vaporização
Romania - Sojourn liquid for inhalation vapours.
Slovakia - Sevoflurano Piramal
Slovenia - Sevoflurano Piramal 250 ml para za inhaliranje, tekocina
Spain - Sevoflurano Piramal 100% Liquid for inhalation vapour
Sweden - Sevoflurano Piramal 100% inhalationsånga, vätska
United Kingdom - Sevoflurane 100% vapour for inhalation, liquid

INFORMATION FOR HEALTHCARE PROFESSIONALS
Sevoflurane Piramal
Sevoflurane 100% liquid for inhalation
Generic medicinal product

The Summary of Product Characteristics will be provided in addition to the label/patient leaflet.