Propofol 20mg/ml (2%) emulsion for injection or infusion – patient leaflet, side effects, dosage

1. What Propofol 2% is and what it is used for

Propofol 2% contains a medicine called propofol. This belongs to a group of medicines called ‘general anaesthetics’. General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are sleepy but not completely asleep).

Propofol 2% will be given to you as an injection by a doctor.

In adults and children over 3 years of age it is used to:

• Help put you to sleep before an operation or other procedure.
• Keep you asleep during an operation or other procedure.
• Sedate you during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.

In people over 16 years of age it is also used to:

• Sedate you when receiving artificial respiration in an Intensive Care Unit (ICU).

2. What you need to know before you use Propofol 2%

Do not use Propofol 2%:

• If you are allergic to propofol or any of the other ingredients of this medicine (listed in Section 6).
• If you are allergic to peanut or soya. This is because Propofol 2% contains soya oil.
• If you are 16 years of age or younger for sedation in intensive care.

If any of the above apply to you, do not have Propofol 2% and tell your doctor, anaesthetist or nurse. If you are not sure, talk to one of these people before having Propofol 2%.

Warnings and precautions

Propofol 2% is not recommended in children aged less than 3 years. Talk to your doctor, anaesthetist or nurse before using Propofol 2%:

• If you have ever had a fit or convulsion.
• If you have ever been told that you have very high levels of fat in your blood.
• If you have ever been told that your body has problems using fat.
• If your body has lost lots of water (you are dehydrated).
• If you have any other health problems, such as problems with your heart, breathing, kidneys or liver.
• If you have been generally unwell for some time.
• If you have mitochondrial disease.

Studies in young animals and clinical data suggest that repeated or lengthy use of general anaesthetics or sedation drugs in children younger than 3 years or in pregnant women during their third trimester may have negative effects on the development of the child’s brain. Parents and caregivers should discuss the benefits, risks, timing and length of surgery or procedures requiring anaesthetics or sedation with your doctor.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Propofol 2%.

In rare cases, when receiving propofol over a prolonged period, you may develop a condition called Propofol Infusion Syndrome (PIS). This can harm your heart, muscles, kidneys, cause other serious problems, and may result in death. However, your doctor will monitor you closely and take steps to prevent this from happening.

Other medicines and Propofol 2%

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

In particular, tell your doctor, anaesthetist or nurse if you are taking any of the following medicines:

• Rifampicin (for tuberculosis – TB).
• Dexmedetomidine (used to induce sedation (a very relaxed state of calm, drowsiness or sleep)).
• Midazolam (used to induce sedation - a very relaxed state of calm. drowsiness or sleep - and to relieve anxiety and muscle tension).

Pregnancy, breast-feeding and fertility

• Do not have Propofol 2% if you are pregnant unless absolutely necessary.
• Studies have shown that small amounts of propofol can pass into breast milk. Therefore, you should not breastfeed your baby for 24 hours after taking propofol.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

After having propofol, you may still feel sleepy for some time. Do not drive or use any tools or machines until you are sure the effects have worn off.

• If you are able to go home shortly after having Propofol 2%, do not drive a car or use any tools or machines.
• Ask your doctor when you can start doing these activities again and when you can go back to work.

Propofol 2% contains sodium, soya oil and disodium edetate.

Propofol 2% contains sodium. If you are on a sodium controlled diet, you will need to take this into account.

Propofol 2% contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

Propofol 2% contains disodium edetate. During prolonged use of Propofol 2% for intensive care, you may need to be given a zinc (a mineral) supplement.

3. How to use Propofol 2%

You will be given Propofol 2% by a doctor. It will be given to you as an injection into a vein. This is usually in the back of your hand or in your forearm.

• The doctor will give you the injection through a fine plastic tube called a ‘cannula’.
• The doctor can also use an electric pump to control how fast the injection is given. This may be done if you are having a long operation or if you are in an Intensive Care Unit.

The dose of Propofol 2% varies from one patient to another. The amount of propofol that you need depends on your age, size, physical fitness and the level of sleepiness or sleep that you need. The doctor will give you the correct dose to start and to sustain anaesthesia or to achieve the required level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure, breathing etc.).

You may need several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy way and to keep your blood pressure steady. The doctor will decide which medicines you need and when you need them.

4. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Page:

2 of 2 AW Version:

1

5701703

5701200

Market

United Kingdom

Number of Colours:

1

Manufacturing Site:

Aspen Small Volumes Parenteral

Drawing Reference:

SVP-PI-006

Drawing Version:

02

Originated on:

12 Aug 2025

Amended on:

N/A

Not known: frequency cannot be estimated from the available data

• Euphoric mood.
• Involuntary movements.
• Drug abuse and dependence on propofol, mostly by healthcare professionals.
• Abnormal ECG.
• Breakdown of muscle cells (rhabdomyolysis). If you think you have a side effect or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www. mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Propofol 2%

• Keep this medicine out of the sight and reach of children.
• The doctor and hospital pharmacist are responsible for storing, using and disposing of Propofol 2% correctly.
• Store Propofol 2% between 2°C and 25°C. Do not freeze.
• Do not use Propofol 2% after the expiry date which is stated on the carton after EXP.

6. Contents of the pack and other information

What Propofol 2% contains

The active substance is propofol. There is 20 mg of propofol in each millilitre. The other ingredients are glycerol, purified egg phosphatide, sodium hydroxide, soya bean oil, water for injections, nitrogen and disodium edetate. What Propofol 2% looks like and contents of the pack

Propofol 2% is a milky, white liquid. It comes in glass vials of 50 ml or pre-filled syringes of 50 ml.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Propofol 2% are held by Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Tel: +44 (0)1 748 828 391

Propofol 2% is manufactured by Corden Pharma S.P.A, Viale dell’ Industria 3, 20867 Caponago, Italy.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Propofol 20mg/ml (2%)

emulsion for injection or infusion

Reference number 39699/0075 or

This is a service provided by the Royal National Institute of the Blind.

This leaflet was last revised in 2025.

Trademarks are owned by or licensed to the Aspen Group of companies. © 2025 Aspen Group of companies or its licensor. All rights reserved. 2D Datamatrix N° 5701703

Page:

1 of 2 AW Version:

1

5701703

5701200

Market

United Kingdom

Number of Colours:

1

Manufacturing Site:

Aspen Small Volumes Parenteral

Drawing Reference:

SVP-PI-006

Drawing Version:

02

Originated on:

12 Aug 2025

Amended on:

N/A

Target Controlled Infusion – Administration of Propofol 2% by a Diprifusor TCI System in adults

Administration of Propofol 2% by a Diprifusor TCI system is restricted to induction and maintenance of general anaesthesia in adults. It is not recommended for use in ICU sedation or in children.

Propofol may be administered by TCI only with a Diprifusor TCI system incorporating Diprifusor TCI software.

Such systems will operate only on recognition of electronically tagged pre-filled syringes containing Propofol 1% or 2% Injection. The Diprifusor TCI system will automatically adjust the infusion rate for the concentration of propofol recognised. Users must be familiar with the infusion pump users manual, and with the administration of Propofol 2% by TCI and with the correct use of the syringe identification system.

The Diprifusor allow the anaesthetist to achieve and control a desired speed of induction and depth of anaesthesia by setting and adjusting target (predicted) blood concentrations of propofol. An alternative effect-site mode of administration may be accessible on some Diprifusors, but its safety and efficacy have not yet been established.

The Diprifusor TCI system assumes that the initial blood propofol concentration in the patient is zero. Therefore, in patients who have received prior propofol, there may be a need to select a lower initial target concentration when commencing Diprifusor TCI. Similarly, the immediate recommencement of Diprifusor TCI is not recommended if the pump has been switched off.

Guidance on propofol target concentrations is given below. In view of interpatient variability in propofol pharmacokinetics and pharmacodynamics, in both premedicated and unpremedicated patients the target propofol concentration should be titrated against the response of the patient in order to achieve the depth of anaesthesia required.

In adult patients under 55 years of age anaesthesia can usually be induced with target propofol concentrations in the region of 4–8 micrograms/ml. An initial target of 4 micrograms/ml is recommended in premedicated patients and in unpremedicated patients an initial target of 6 micrograms/ml is advised. Induction time with these targets is generally within the range of 60–120 seconds. Higher targets will allow more rapid induction of anaesthesia

but may be associated with more pronounced

haemodynamic and respiratory depression.

A lower initial target concentration should be used in

patients over the age of about 55 years and in patients of ASA Grades 3 and 4. The target concentration can then be increased in steps of 0.5–1 microgram/ml at intervals of 1 minute to achieve a gradual induction of anaesthesia. Supplementary analgesia will generally be required and the extent to which target concentrations for maintenance of anaesthesia can be reduced will be influenced by the amount of concomitant analgesia administered. Target propofol concentrations in the region of 3–6 micrograms/ml usually maintain satisfactory anaesthesia.

The predicted propofol concentration on waking is generally in the region of 1–2 microgram/ml and will be influenced by the amount of analgesia given during maintenance.

This leaflet was last revised in August 2025.

Trademarks are owned by or licensed to the Aspen Group of companies. © 2025 Aspen Group of companies or its licensor. All rights reserved.