NOVFOL 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).
NOVFOL 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).

Do not use NOVFOL

• 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 NOVFOL 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 you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking NOVFOL.

Warnings and precautions
The use of NOVFOL is not recommended in newborn infants.
Talk to your doctor, anaesthetist or nurse before using NOVFOL.
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.

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 think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking NOVFOL.
 

Other medicines and NOVFOL
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 NOVFOL 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 NOVFOL , 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 NOVFOL, 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.
• NOVFOL contains sodium, soya oil and disodium edetate 
• NOVFOL contains sodium. If you are on a sodium controlled diet, you will need to take this into account.
• NOVFOL contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
• NOVFOL contains disodium edetate. During prolonged use of NOVFOL for intensive care, you may need to be given a zinc (a mineral) supplement.

You will be given NOVFOL 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 NOVFOL varies from one patient to another.
• The amount NOVFOL 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.

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 heartbeat.

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 color 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.
• Buildup 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 NOVFOL 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 NOVFOL has been stopped suddenly.
Common (may affect up to 1 in 10 people)

• Withdrawal symptoms’. These include unusual behavior, 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 NOVFOL, 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.

• Keep this medicine out of the sight and reach of children.
• The doctor and hospital pharmacist are responsible for storing, using and disposing of NOVFOL correctly.
• Store NOVFOL at below 30°C. Do not freeze.
• Do not use NOVFOL after the expiry date which is stated on the carton after EXP