Propofol 20 mg/ml Emulsion for injection/infusion

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

1. What Propofol 20 mg/ml is and what it is used for
2. What you need to know before you are given Propofol 20 mg/ml
3. How you are given Propofol 20 mg/ml
4. Possible side effects
5. How to store Propofol 20 mg/ml
6. Contents of the pack and other information.

• if you are allergic to propofol, soybeans, peanuts or any of the other ingredients of this medicine (listed in section 6),
• for the sedation of patients aged 16 years or younger as part of intensive care.
• as anaesthesia in children under 3 years of age.

Talk to your doctor, anaesthetist or nurse before using Propofol 20 mg/ml:

• 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 (hypovolemia).
• 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.

You may feel affected after using Propofol. You should therefore be accompanied by someone when you leave the hospital.

Propofol 20 mg/ml may not be used in children under 3 years of age, since a corresponding titration of Propofol 20 mg/ml for small children is only able to be carried out with difficulty on account of the extraordinarily small volume required.

Propofol may not be used for sedation in patients 16 years of age or younger during intensive care, since the safety and efficacy of Propofol has not been validated for sedation in this age group.

In the case of elderly patients, smaller doses are required for the induction of anaesthesia with Propofol 20 mg/ml . The patient’s general state of health and age should be taken into account. The lowered dose should be administered more slowly and titrated according to the reaction.

Tell your doctor if you are taking/using, have recently taken/used or might take/use any other medicines.

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

• Rifampicin because it can cause low blood pressure in connection with general anesthesia.
• Certain sedative and analgesic medicines such as benzodiazepines and opiates as they may increase the effects of propofol
• Valproate as a reduction in the dose for propofol should be considered if it used concomitantly with propofol

You may not ingest any alcohol after the administration of Propofol 20 mg/ml .

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Propofol 20 mg/ml should only be used during pregnancy if absolutely necessary.

Breast-feeding

Studies with breast-feeding women have shown that Propofol passes into breast milk in small quantities.

Therefore, mothers should suspend breast-feeding, for up to 24 hours after administration of Propofol and discard the corresponding breast milk.

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 20 mg/ml, 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 contains soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium free’.

The administered dose varies depending on the age, body weight, the general physical state of health and the premedication. The doctor will use the appropriate dose for induction and maintenance of anaesthesia or for achieveing the required depth of sedation while carefully observing the physical responses and vital signs (pulse, blood pressure, breathing, etc).

The induction and maintenance of anaesthesia and sedation with Propofol is normally gentle with only a few signs of excitation. The most frequently reported side effects are a decrease in blood pressure and impairment of the response from the breathing centre (respiratory depression). The type, severity and frequency of these effects, which were observed in patients that were receiving Propofol, are dependent on the patient’s state of health, the type of procedure and the therapeutic measures taken.

The following side effects were particularly observed:

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

• Local pain during the first injection

Common (may affect up to 1 in 10 people)

• Spontaneous movements and muscle spasms during induction of anaesthesia, headache during the waking phase
• Slowed pulse
• Decrease in blood pressure
• Condition in which you start to breathe very fast (Hyperventilation) and coughing during induction of anaesthesia, temporary ineffective breathing (respiratory arrest) during induction of anaesthesia
• Hiccups during the induction, nausea and vomiting during the waking phase
• Hot flushes during the induction of anaesthesia

Uncommon (may affect up to 1 in 100 people)

• Clotting of the blood in a part of the circulatory system (Thrombosis) and vein inflammation
• Coughing during maintenance therapy

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

• Feeling of dizziness, chills and perception of cold during the waking phase
• Episodes similar to epilepsy with seizures and spasm of the muscles causing backward arching of the head, neck, and spine (opisthotonus) during induction, maintenance and the waking phase (very rarely delayed by hours to a few days)
• Coughing during the waking phase

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

• Severe allergic reactions (anaphylaxis), which can include angiooedema, respiratory distress due to bronchial cramping, skin redness and a decrease in blood pressure
• Being unconsciousness after operation
• Buildup of fluid in the lungs which can make you very breathless (may also happen when you wake up).
• Inflammation of the pancreas
• Discolouration of urine after longer periods of administration of Propofol 20 mg/ml
• Sexual disinhibition
• Tissue damage
• Fever after surgery

Not known: The frequency cannot be estimated on the basis of the available data

• Excess acid in the blood caused by metabolic functions (metabolic acidosis)
• Elevated potassium values in the blood
• Elevated blood lipid values
• Euphoric mood during the waking phase
• Abuse of the drug and dependency on the drug
• Involuntary movements
• Cardiac arrhythmia
• Heart failure
• Ineffective breathing (Respiratory depression depending on the dosage)
• Liver enlargement
• Dissolution of striated muscle fibres (rhabdomyolysis)
• Kidney failure
• Local pain, swelling after erroneous extravascular application
• Prolonged, often painful erection (priapism)
• ECG changes
• Hepatitis (inflammation of the liver), acute liver failure (symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right-hand side), sometimes with loss of appetite).

After simultaneous administration of lidocaine,the following side effects can occur:

• Dizziness
• Vomiting,
• Drowsiness
• Convulsions
• Bradycardia
• Arrhythmia and
• Shock

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Ireland

The active substance is propofol.

Each ml emulsion for injection/infusion contains 20 mg of propofol.

Each 50 ml vial contains 1000 mg of propofol

The other ingredients are: Soya-bean oil refined, Medium-chain triglycerides, Glycerol, Egg lecithin, Sodium oleate, Sodium Hydroxide (for pH adjustment) and Water for injections.

White oil-in-water emulsion for injection/infusion.

This medicinal product is supplied as:

Emulsion for injection/infusion in colourless glass vial (type II glass) with grey bromo butyl rubber stopper.

Pack sizes:

Colourless glass vial (type II) of 50 ml with a grey bromobutyl rubber closure, packs of 1 and 10 unit

Not all pack sizes may be marketed.