Active ingredient
- sevoflurane
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL41042/0004.
Sevoflurane
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVOFLURANE ®
IMPORTANT INFORMATION
Read all of this leaflet carefully before you receive Sevoflurane.
In this leaflet:
1. What is Sevoflurane and what does it do?
2. What should you know before receiving Sevoflurane?
3. How will you receive Sevoflurane?
4. What will happen after receiving Sevoflurane?
5. How should Sevoflurane be stored?
6. Further information about Sevoflurane.
1. What is Sevoflurane and what does it do?
Sevoflurane 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.
Sevoflurane 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), Sevoflurane will induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children.
2. What should you know before receiving Sevoflurane?
TELL YOUR WARD DOCTOR, SURGEON OR ANAESTHETIST if:
In addition to the above, if Sevoflurane is to be administered to your child, please tell their ward doctor, surgeon or anaesthetist if they:
As with all drugs, it is important that you tell your ward doctor or anaesthetist which medications you are taking. This is particularly important if you are taking the following drugs:
PREGNANCY AND BREAST FEEDING
Tell your ward doctor, surgeon or anaesthetist if you are pregnant, could be pregnant or are breast feeding. It is not known whether Sevoflurane or its by-products are transferred into human milk. It is advisable to stop breast-feeding for 48 hours after Sevoflurane administration and discard any milk that is produced during this period.
DRIVING & USING MACHINERY
You should NOT drive or operate machinery after your operation or procedure, for which the anaesthetic has been administered, until your ward doctor advises that you may do so.
Your ability to drive or operate machinery may be impaired for some time.
3. How will you receive Sevoflurane?
Sevoflurane will ALWAYS be administered to you by an anaesthetist. They will decide on the dose you will receive, depending on your age, weight and the type of operation you are having.
Sevoflurane will send you to sleep quickly and smoothly. It also has a pleasant smell.
Inducing sleep at the start of anaesthesia
To send you to sleep, you may be asked to breathe in Sevoflurane through a mask. However on most occasions you will be given an injection of another anaesthetic to make you go to sleep before receiving Sevoflurane.
Maintaining sleep during anaesthesia
Under the observation of the anaesthetist you will continue to breathe in Sevoflurane during the operation via a mask.
Waking-up after anaesthesia
Once the anaesthetist stops you from inhaling Sevoflurane you will wake up within a few minutes.
4. What will happen after receiving Sevoflurane?
As with all anaesthetics, Sevoflurane can cause side effects.
These can occur both during and after your operation.
The frequency of side effects is classified as follows:
Very common: more than 1 out of 10 persons treated;
Common: less than 1 out of 10, but more than 1 out of 100 persons treated;
Uncommon: less than 1 out of 100, but more than 1 out of 1,000 persons treated;
Rare: less than 1 out of 1,000, but more than 1 out of 10,000 persons treated.
Very rare: less than 1 out of 10,000 persons treated.
Unknown: when an estimation of frequency is not possible.
The following side effects with Sevoflurane are 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.
Those occurring with unknown frequency:
Those occurring very commonly:
Those occurring commonly
Those occurring uncommonly
The frequency of other side effects observed following the use of Sevoflurane are:
Very common frequency:
Common frequency:
Uncommon frequency:
Unknown frequency:
*If you have a blood test, you may be told that you have changes in your liver or kidney enzymes or other products found in the blood. These will not normally cause any symptoms.
**Levels of fluoride in the blood may be raised slightly during and immediately after anaesthesia, due to the body breaking down sevoflurane, but these levels are not believed to be harmful and soon return to normal.
*** If you have a urine test you may be told that you have glucose in your urine. You may not have any symptoms.
There have been very rare reports of cardiac arrest, a condition where the heart stops beating.
After surgery, some children may have irregular heart rhythms, which can potentially be life-threatening, due to changes in blood potassium levels.
Children with Pompe’s disease, a disease that they are born with, may have irregular heart rhythm during anaesthesia with Sevoflurane.
After receiving Sevoflurane
You will come round or wake up within a few minutes. Children in particular, may be restless on awakening. Tell your doctor or anaesthetist if you need additional pain relief.
If you have any other unusual or unexpected symptoms after receiving Sevoflurane anaesthesia, tell your ward doctor or anaesthetist immediately.
If you have any questions about Sevoflurane which are not answered by this leaflet, ask your ward doctor or anaesthetist.
Reporting side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How should Sevoflurane be stored?
Sevoflurane should be stored in a tightly closed container NOT above 25°C. Do NOT use after the expiry date printed on the packaging.
6. Further information about Sevoflurane
Sevoflurane ingredients:
The active ingredient is sevoflurane. Water is also present to provide the Sevoflurane with protection from substances that can cause its breakdown (environmental Lewis acids).
Marketing Authorisation and Manufacturer’s Details
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last updated in April 2020.
For information in large print, tape, CD or Braille, phone 01628 561090 (UK).
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
+44 (0)1628 561 092
+44 (0)1628 561 092