Sevonu Liquid for Inhalation 250 mL

SEVONU belongs to a group of medicines called general anaesthetics. These work by temporarily reducing the activity of the body’s central nervous system. This causes a complete loss of sensation in the body, including loss of consciousness allowing surgery to be carried out without pain or distress.

SEVONU is a clear colourless liquid, that when put into a special anaesthetic machine (vaporiser) becomes a gas. This mixes with the oxygen you will be breathing in. Once breathed in (inhaled), SEVONU will induce and maintain a deep, pain ‐ free sleep (general anaesthesia) in adults and children during an operation.

SEVONU should not be given to you:

• If you are allergic (hypersensitive) to sevoflurane or to any other inhaled anaesthetic.
• If you or any member of your family has had a condition called malignant hyperthermia (rapid increase in body temperature and severe muscle contractions) during an operation.
• If you have a neuromuscular disease, especially one called Duchene muscular dystrophy.

Warnings and Precautions

Tell your doctor or health care provider before receiving SEVONU:

• Tell your doctor, surgeon or anaesthetist if you are suffering from any illness, other than those connected with your operation, such as kidney, brain or heart problems, severe headaches, nausea, vomiting, or a neuromuscular disease (a condition that affects muscles e.g. Duchenne muscular dystrophy).
• You have ever had QT prolongation (prolongation of a specific time interval in an ECG) or torsade de pointes (a specific type of heart rhythm), which may also be associated with QT prolongation. SEVONU has sometimes been known to cause these.
• If you have Pompe’s disease (a metabolic disorder). Sevoflurane may produce abnormal heart rhythms, which may be severe in some cases.
• You have a mitochondrial disease, which is a disorder that people may be born with and may affect special cells of the heart, brain, and kidney.
• Tell your doctor, surgeon or anaesthetist if you have a liver condition or if you have previously been exposed to general anaesthetics, particularly if repeated over a short period of time. Some anaesthetics can cause problems in the liver which can cause yellowing of the skin and eyes (jaundice).
• If you have any other kidney problems.
• If you or your child are prone to or at risk for seizures (fits), as SEVONU may increase the risk of seizures.

You will not be expected to give yourself SEVONU. It will be given to you by a person who is qualified to do so. The dose of SEVONU that you receive will be decided by your anaesthetist and will vary depending on your age, weight and type of operation that you are having. SEVONU is a breathed in (inhalation) anaesthetic gas. SEVONU liquid is changed to gas in a vaporiser. Occasionally, patients may be asked to breathe in the SEVONU gas via a mask but usually they will receive an injection of another anaesthetic to make them go to sleep before they receive SEVONU.

If you have the impression that the effect of SEVONU is too strong or too weak, tell your doctor or health care provider.

If you receive more SEVONU than you should

Since a health care provider will administer SEVONU, they will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you have missed a dose of SEVONU

Since a health care provider will administer SEVONU, it is unlikely that the dose will be missed.

SEVONU can have side effects. These side effects can occur both during and after your operation. The following side effects with SEVONU are very serious and will be managed by your surgeon or anaesthetist, as necessary, during the operation. If you experience any of these side effects after your operation get medical help immediately:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to SEVONU. Other very serious side effects include:

• Changes in the way your heart beats (beating faster, slower or irregular), irregular heartbeat or abnormal heart rhythm known as QT prolongation, heart attack, other heart disorders (AV block), which will be closely monitored by your anaesthetist during your operation and may be recognized by dizziness after your operation.
• Shortness of breath, difficulty breathing, coughing, wheezing (bronchospasm).
• Inflammation or damage to the liver. People with liver disease may have abdominal pain or fullness, dark urine, pale or white ‐ coloured stool, yellowing of the eyes, nausea (feeling sick) and vomiting (being sick).
• Kidney failure. People with kidney disease may have tiredness, swelling or puffiness in the face, abdomen, thighs or ankles, passing less urine or problems urinating and back pain.
• Rapid rise in body temperature (malignant hyperthermia).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following after surgery:

Frequent side effects:

• Restlessness (agitation).
• Drowsiness (somnolence), dizziness, headache.
• Low blood pressure (hypotension), high blood pressure (hypertension).
• Coughing, slow shallow breathing, throat spasm.
• Nausea (feeling sick), vomiting (being sick), watering mouth (salivary hypersecretion).
• Chills, fever.
• Increased blood sugar (glucose) level, abnormal liver function test, abnormal white blood cell count, increased blood fluoride.
• Low blood temperature (hypothermia).

Less frequent side effects:

• A decrease or increase in the number of certain white blood cells. A decrease in the number of white blood cells may be associated with dizziness, fatigue, weakness, mouth ulcers and a tendency towards infections.
• Confusion.
• Pauses in breathing, inadequate amount of oxygen, asthma.
• Difficulty in passing urine, glucose in the urine if you have a urine test.
• Abnormal kidney function test results.

Side effects with unknown frequency:

• Convulsions (fits), twitching and jerking movements.
• Fluid in the lungs.
• Itching, skin rash, hives (urticaria).
• Muscle twitching.
• Chest discomfort.

Not all side effects reported for SEVONU are included in this leaflet. Should your general health worsen after taking SEVONU, please consult your doctor, pharmacist or other health care professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SEVONU.

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the label or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).