What is a Patient Information Leaflet and why is it useful?

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 can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL39699/0074.

Diprivan 1%

Package leaflet: Information for the user

Diprivan 10 mg/ml (1%) Emulsion for Injection or Infusion

propofol

Read all of this leaflet carefully before you start having this medicine because it contains important information for you.

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

What is in this leaflet

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

1. What Diprivan is and what it is used for

Diprivan 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).

Diprivan will be given to you as an injection by a doctor.

In adults and children over 1 month 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 Diprivan

Do not use Diprivan:

  • 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 Diprivan contains soya oil.
  • If you are pregnant (see the section called ‘Pregnancy and breast-feeding’).
  • 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 Diprivan and tell your doctor, anaesthetist or nurse. If you are not sure, talk to one of these people before having Diprivan.

Warnings and precautions

The use of Diprivan is not recommended in newborn infants.

Talk to your doctor, anaesthetist or nurse before using Diprivan.

Before you have this medicine, tell your doctor, anaesthetist or nurse

  • 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.

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

Other medicines and Diprivan

Tell your doctor if you are taking or 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)

Pregnancy and breast-feeding

Do not have Diprivan if you are pregnant.

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 Diprivan, 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 Diprivan, 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.

Diprivan contains sodium, soya oil and disodium edetate

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

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

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

3. How to use Diprivan

You will be given Diprivan 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 using a needle or 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 Diprivan varies from one patient to another. The amount of Diprivan 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.

Side effects that can happen during anaesthesia

The following side effects can happen during anaesthesia (while the injection is being given to you or when you are sleepy or asleep). Your doctor will be looking out for these. If they happen, your doctor will give you appropriate treatment.

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

  • A feeling of pain at the site of the injection (while the injection is being given, before you fall asleep).

Common (may affect up to 1 in 10 people)

  • Low blood pressure.
  • Changes in your breathing pattern.
  • Slow heart beat.

Rare (may affect up to 1 in 1,000 people)

  • Twitching and shaking of your body, or a fit (may also happen when you wake up).
  • Unusual colour of urine (may also happen when you wake up).

Very rare (may affect up to 1 in 10,000 people)

  • Allergic reactions.
  • Stopping of your heart beat.
  • Build up of fluid in the lungs which can make you very breathless (may also happen when you wake up).

Not known: frequency cannot be estimated from the available data:

  • Shallow breathing.

Side effects that can happen after anaesthesia

The following side effects can happen after anaesthesia (when you are waking up or after you have woken up).

Common (may affect up to 1 in 10 people)

  • Feeling sick (nausea).
  • Being sick (vomiting).
  • Headache.

Uncommon (may affect up to 1 in 100 people)

  • Swelling and redness along a vein or blood clots.

Very rare (may affect up to 1 in 10,000 people)

  • Feeling sexually aroused.
  • High temperature (fever).
  • Redness or soreness where the injection was given.
  • Being unconscious after the operation. (When this has happened, the patients have recovered without problems.)
  • Tissue damage.

Not known: frequency cannot be estimated from the available data

  • A feeling of pain at the site of the injection.
  • Swelling at the site of injection.

Other possible side effects

The following side effects have been seen when Diprivan is used in intensive care at higher doses than recommended.

Very rare (may affect up to1 in 10,000 people)

  • Heart failure.
  • Inflamed pancreas (pancreatitis) which causes severe stomach pain.
  • Too much acid in your blood. This may make you breathe more quickly.
  • Increased amount of potassium in your blood.
  • High blood level of a type of fat called lipids.
  • Abnormal heart beat.
  • Enlargement of the liver.
  • Kidney failure.

The following side effects have been seen in children in intensive care when Diprivan has been stopped suddenly.

Common (may affect up to 1 in 10 people)

  • ‘Withdrawal symptoms’. These include unusual behaviour, sweating, shaking and feeling anxious.
  • Flushing of the skin.

Do not be concerned by this list of possible side effects. You may not get any of them.

Not known: frequency cannot be estimated from the available data

  • Euphoric mood.
  • Involuntary movements.
  • Drug abuse and dependence on Diprivan, 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diprivan

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

6. Contents of the pack and other information

What Diprivan contains

The active substance is propofol. There is 10 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 Diprivan looks like and contents of the pack

Diprivan 1% is a milky, white liquid. It comes in glass ampoules of 20 ml, glass vials of 50 ml or 100 ml, or pre-filled syringes of 20 ml or 50 ml.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Diprivan 1% is held by

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: +44 (0)1 748 828 391

Diprivan 1% is manufactured by

AstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK

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 Diprivan 1%

Reference number 39699/0074

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

This leaflet was last revised in November 2016.

Diprivan is a trade mark of the AstraZeneca group of companies.

© AstraZeneca 2015