PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol 20 mg/ml, emulsion for injection and infusion

In this leaflet:

1.    What Propofol 20 mg/ml is and what it is used for

2.    Before you use Propofol 20 mg/ml

3.    How to use Propofol 20 mg/ml

4. Possible side effects

5. How to store Propofol 20 mg/ml

6.    Further information

1. What Propofol 20 mg/ml is and what it is used for

Propofol 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 20 mg/ml is used to:

•    induce and maintain general anaesthesia in adults and children > 1 month

•    sedate patients > 16 years of age receiving artificial respiration in intensive care

2. Before you are given Propofol 20

mg/ml

3. How you will be given Propofol 20 mg/ml

Propofol will be given to you by your anaesthetist or intensive care doctor.

The dose you are given will vary depending on your age, body weight and physical condition. The doctor will give 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).

Propofol will be given to you either as an injection or as an infusion into a vein, usually in the back of the hand or in the forearm. Your anaesthetist may use a needle, or a fine plastic tube called a cannula. For long operations and for use in intensive care situations, an electric pump may be used to control the rate at which the injection is given. To reduce pain caused by the initial injection, your doctor may choose to give a local anaesthetic (lidocaine) before injection with propofol. The use of propofol should not exceed 7 days.

If you are given more Propofol 20 mg/ml than you should

If by accident you have received more propofol than you should, your breathing and blood circulation can be impaired. In this case artificial breathing should be applied and your blood pressure will be corrected by additional treatment.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Do not use Propofol 20 mg/ml

•    if you are allergic (hypersensitive) to propofol or any of the other ingredients of Propofol 20 mg/ml

•    if you are allergic to peanut or soya. Propofol contains soya bean oil

•    in patients of 16 years of age or younger for sedation in intensive care

Take special care with Propofol 20 mg/ml

Check if one of the warnings listed below applies to you or applied to you in the past. Tell your doctor or pharmacist:

•    if you are over 55 years of age or weakened, if you have an impaired heart, lung, liver or kidney function or if you have a reduced blood volume (hypovolaemia). The dosage of propofol that you receive might have to be adjusted.

•    if you have ever had a fit. There is an increased risk ofa fit.

•    if you have an increased pressure within the skull (high intracranial pressure), and a low bloodressure (low arterial pressure), the blood supply to your brain might be impaired.

•    if you undergo shock therapy (electronvulsive therapy)

•    if you have very high fat levels in your blood or if you have problems in relation to your body being able to handle or use fat (fat metabolism)

Using other medicines

•    certain medicines to be used before you undergo surgery (premedication), certain medicines to put you to sleep for surgery which are administered by breathing through an anesthesia mask (inhalation anaesthetics), medicines to render part of the body insensitive to pain without affecting consciousness (local anaesthetics). medicines to relieve pain (analgesic agents) or medicines that reduce the tension in the muscles (muscle relaxants). These medicines may increase the anaesthetic effect of propofol and increase the risk of side effects related to the heart and blood pressure.

•    a certain medicine to relieve pain and that has a sedative effect (fentanyl). This can increase the risk of breathing difficulties.

•    a certain muscle relaxant often used during surgery under general anaesthesia (suxamethonium) and an agent to reverse this effect (neostigmine). Slowed heart beat and cardiac arrest may occur.

•    a certain medicine to suppress the immune response (ciclosporin), the combination with propofol can do damage to certain brain tissue (leucoencephalopathy).

Please tell your doctor if you are taking or have recently taken any of the medicines listed above or any other medicines, including medicines obtained without a prescription.

Using Propofol 20 mg/ml with food and drink

Your doctor will inform you about the use of propofol with food and drink.

Pregnancy

Please tell your doctor if you are pregnant. Propofol should not be used during pregnancy since propofol crosses the placenta and may harm your child. Your doctor may decide to give you propofol if the benefit to you outweighs the risk to your child.

Breast-feeding

Please tell your doctor if you are breast-feeding. You should stop breast-feeding after receiving propofol, as propofol is released (in small amounts) into breast milk. You should discard breast milk for 24 hours after receiving propofol.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Do not drive shortly after receiving propofol. Your ability to drive a car or to operate machinery may be affected for some time. Ask your doctor when you can return to work, particularly if you use machinery or heavy equipment.

Important information about some of the ingredients of Propofol 20 mg/ml

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

Like all medicines, Propofol 20 mg/ml can cause side effects, although not everybody gets them.

Very Common side effects (more than 1 in 10 people given Propofol 20 mg/ml will experience these side effects):

Local pain during injection or start of infusion with propofol*

Common side effects (more than 1 in 100, but less than 1 in 10 people given Propofol 20 mg/ml will experience these side effects): Changes in breathing pattern (apnoea) during induction of anaesthesia* • Low blood pressure (hypotension) • Reddening of the face and/or neck in children • Slowed heart beat (bradycardia)

During recovery you may experience: Nausea and vomiting • Headache • Withdrawal symptoms (in children)

Uncommon side effects (more than 1 in 1000, but less than 1 in 100 people given Propofol 20 mg/ml will experience these side effects): Formation of blood cloths in the vein after injection (thrombosis)* • Redness or soreness where the injection was given (phlebitis)*

Rare side effects (more than 1 in 10.000, but less than 1 in 1000 people given Propofol 20 mg/ml will experience these side effects): During induction, maintenance and recovery you may experience: Twitching and shaking of your body* • A fit* • Contraction of the muscles in your head, neck and back causing arching of the body

Very rare side effects (less than 1 in 10.000people given Propofol 20 mg/ml will experience these side effects):

Breakdown of muscle cells causing muscle cramps, fever and a red/brown discolouration of the urine (rhabdomyolysis)* • Fierce pain in the upper abdomen (due to inflammation of a large gland situated close to the stomach) which radiates to the back (pancreatitis)* • Severe hypersensitivity reaction (anaphylaxis) which symptoms can include sudden large decrease in blood pressure, pallor, agitation, weak but rapid pulse rate, clammy skin, swelling/oedema, lapse of consciousness, difficulty breathing, and heart failure* • Accumulation of fluid in the lungs (pulmonary oedema)* • Fainting after undergoing surgery* • Post-operative fever • Discolouration of urine following prolonged use of propofol • Sexual disinhibition •

*These side effects are considered serious. If you experience any of these, inform your doctor immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor

5. How to store Propofol 20 mg/ml

Keep out of the reach and sight of children.

Do not use propofol after the expiry date which is stated on the packaging after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.

Prior to dilution:

•    Do not store above 25"C

•    Store in the original package in order to protect from light.

•    Do not freeze

Diluted product:

•    Dilutions should be prepared aseptically immediately before administration and must be used within 6 hours of preparation

•    Any portion of the contents remaining after first use should be discarded

Shake well before use.

Do not use the product if you notice two layers after shaking the product.

Bijsluiter PRL 20 mg mei 2011.pdf 1

6. Further information

What Propofol 20 mg/ml contains

•    The active substance is propofol.

One ml contains 20 mg propofol.

One 20 ml ampoule contains 400 mg propofol.

One 50 ml vial contains 1000 mg propofol.

One 100 ml vial contains 2000 mg propofol.

•    The other ingredients are glycerol, purified egg-lecithin, refined soya-bean oil, oleic acid, sodium hydroxide and water for injections.

What Propofol 20 mg/ml looks like and contents of the pack

Propofol 20 mg/ml is a white oil-in-water emulsion packaged in a clear colourless glass ampoule or vial.

Propofol 20 mg/ml is available in cartons containing 1, 5 or 10 of either 20 ml ampoules or 50 or 100 ml vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[To be completed nationally]

Manufacturer:

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom	Propofol 20mg/ml, emulsion for injection and infusion
Ireland	Propofol 20 mg/ml, Emulsion for Injection and Infusion
Italy	Propofol IBI 20 mg/ml emulsione per preparazione iniettabile e per infusione
Portugal	Propofol, 20 mg/ml, Emulsao injectavel
Spain	Propofol Hospira 20 mg/ml emulsion para inyeccion y perfusion EFG

This leaflet was last approved in {MM/YYYY} [To be completed nationally]

Bijsluiter PRL 20 mg mei 2011.pdf 2