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PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol 20 mg/ml Emulsion for injection/infusion

Propofol

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have any furtherquestions, askyourdoctororpharmacist.

•    If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell yourdoctor or pharmacist.

In this leaflet:

1.    What Propofol is and what it is used for    4.    Possible side effects

2.    Before you are given Propofol    5.    How to store Propofol

3.    How you are given Propofol    6.    Furtherinformation.

1.    What Propofol is and what it is used for

Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause unconsciousness (deep sleep) while surgical operations or other procedures are being carried out. They can also be used to sedate you (make you sleepy without sending you to sleep).

Propofol is used to:

■    induce and maintain general anaesthesia in adults, adolescents and children > 3 years

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

■    sedate adults and children >3 years during diagnostic and surgical procedures, alone or in combination with local orregional anaesthesia

2.    Before you are given Propofol Do not use Propofol:

■    in patients allergic (hypersensitive) to propofol, or any of the other ingredients of this medicinal product

■    in patients allergic (hypersensitive) to soya or peanut

■    in patients of 16 years of age or youngerforsedation in intensive care

Take special care with Propofol

You should not receive Propofol, oronly under extreme caution and intensive monitoring, ifyou:

■    have advanced heartfailure

■    have any other serious disease of the heart

■    are receiving electroconvulsive therapy (ECT, a treatmentfor psychiatric problems)

Propofol is not recommended in children < 3 years of age

Special care should also be observed when administering Propofol to children less than 3 years of age. However, evidence now available does not suggest that this is any less safe than in older children. The safety of propofol for sedation in children and adolescents 16 years of age and younger in the intensive care unit has not been demonstrated. In general, Propofol should be given with caution to elderly or weak patients.

Before receiving Propofol, tell your anaesthetist or intensive care doctor if you have:

■    heart disease

■    lung disease

■    kidney disease

■    liver disease

■    seizures (epilepsy)

■    a raised pressure inside the skull (raised intracranial pressure). In combination with low blood pressure the amount of blood reaching the brain may be decreased.

■    altered levels of fat in the blood. Ifyou receiving total parenteral nutrition (feeding through a vein), the levels of fat in your blood must be monitored.

Ifyou have any of the following conditions, they must be treated before you receive Propofol:

■    heartfailure    ■ when there is insufficient blood reaching the tissues

■    severe breathing problems (respiratoryfailure)    (circulatoryfailure)

■    dehydration (hypovolaemia)    ■ seizures (epilepsy)

Propofol may increase the risk of

■    epileptic seizures

■    a nervous reflex that slows the heart rate (vagotonia, bradycardia)

■ changes in the blood flow to the organs of the body (haemodynamic effects on the cardiovascular system) ifyou are overweight and receive high doses of Propofol.

Involuntary movements can occur during sedation with Propofol. The doctors will take into account how this might affect surgical procedures being performed under sedation and will take the necessary precautions.

Very occasionally, after anaesthesia, there may be a period of unconsciousness associated with stiffness of the muscles. This requires observation by the medical staff but no other treatment. It will resolve spontaneously.

The injection of Propofol can be painful. A local anaesthetic can be used to reduce this pain but can have its own side effects. You will not be allowed to leave the hospital until you are fully awake.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes medicines, herbal medicines, health foods or supplements that you have bought yourself.

You must take special care ifyou are also taking any of the following medicines:

o premedications (youranaesthetistwill knowthis) o anaesthetics o analgesics (painkillers) o drugs that relax muscles, e.g. suxamethonium o benzodiazepines (drugsforanxiety), e.g. valium o parasympatholytic drugs (drug that inhibit the actions of the parasympathetic nervous system which control smooth muscle contraction, regulate heart muscle, or stimulate or inhibit glandular secretion.)

Using Propofol with food and drink

Alcohol and propofol make the sedative effects of each othi

orjust afteryou have Propofol until fully recovered.

o drugs that affect many of the internal body functions such as the heart rate, e.g. atropine o strong painkillers, e.g. fentanyl o alcohol

o neostigmine (a treatment for muscle weakness) o ciclosporin (used to prevent rejection of an organ)

•. Therefore you should not drink alcohol just before

Pregnancy and breast-feeding

Ask your doctoror pharmacist for advice before taking any medicine.

Propofol should not be given to pregnant women unless clearly necessary.. If you are breast-feeding your child you should stop nursing and discard breast milkfor24 hours afteryou have received Propofol. Propofol is excreted in small amounts into the breast milk.

Driving and using machines

Afteryou have been given Propofol, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone and should not drink alcohol until fully recovered.

Important information about some of the ingredients of Propofol:

Propofol contains soya-bean oil. Ifyou are allergic to peanut or soya, do not use this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) sodium in 20 ml, i.e. essentially'sodium free'.

3. How you are given Propofol

Dosage

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

The amount of Propofol you need depends on your age, size, fitness and the level of sleepiness or sleep that is needed. 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). It can also be affected by other medicines you may betaking. Most people need 1.5-2.5mg per kg of body weight to make them sleepy or to put them to sleep, and then 4 to 12 mg/kg (body weight)/hour after this. For sedation, doses of 0.3 to 4.0 mg propofol per kg body weight per hourare usually sufficient.

Adults

For sedation during surgical and diagnostic procedures in adults, most patients will require 0.5 -1 mg propofol per kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol infusion to the desired level of sedation. Most patients will require 1.5-4.5 mg propofol per kg body weight per hour.

The infusion may be supplemented by bolus administration of 10-20 mg propofol (0.5-1 ml Propofol 20 mg/ ml) if a rapid increase of the depth of sedation is required.

Propofol is given as an injection or infusion into a vein, usually on the back of the hand or in the forearm. Your anaesthetist may use a needle or cannula (a fine plastic tube). An electric pump may be used to give the injection for long operations and for use in intensive care.

Elderly and weak patients may require lower doses.

Children

Children usually require slightly higher doses. The dose should be adjusted according to age and/or body weight.

When used for sedation, Propofol must not be administered for more than 7 days.

Ifyou received more Propofol than you should

It is unlikely that this occurs because the doses you receive are very carefully controlled.

Ifyou are accidentally given an overdose, this could lead to depression of heart function, circulation and breathing. In this case yourdoctor will employ any necessary treatment immediately.

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

4. Possible side effects

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

These effects depend on the propofol dose administered but also on the type of premedication and other concomitant medication.

Very common (affects more than 1 user in 10) • local pain during the injection.

Common (affects 1 to 10 users in 100)

•    low blood pressure (hypotension)

•    spontaneous movements

•    rapid heartbeat (tachycardia)

•    temporary apnoea (stopping breathing)

•    hiccups (singultus)

•    hypertriglyceridemia (high blood cholesterol or triglycerides)

shallow breathing (respiratory depression) slow heartbeat (bradycardia) hot flushes

coughing after anaesthesia hyperventilation (increased breathing)

Uncommon (affects 1 to 10 users in 1,000)

• severe low blood pressure (hypotension)    • coughing during anaesthesia

Rare (affects 1 to 10 users in 10,000)

•    anaphylaxis (a severe allergic reaction)    • euphoria (feeling happy) and sexually aroused during

•    nausea orvomitting    recovery

•    headache    • vertigo (spinning dizziness)

•    shivering and sensations of cold during the recovery period • epileptiform movements (resembling epilepsy)

•    irregular heartbeat (arrhythmia) during recovery    •    coughing during recovery

•    discoloration of urine    •    post-operative fever

•    blood clots (thrombosis) and    inflammation of the blood    •    red inflammation ofthe skin (erythema)

vessels (phlebitis)    •    bronchospasm (a condition that causes difficulty in

•    low blood pressure (hypotension)    breathing)

Very rare (affects less than 1 user in 10,000)

•    delayed epileptiform attacks (epilepsy like symptoms after recovery)

•    inflammation of the pancreas (pancreatitis)

•    Post operative unconsciousness

•    rhabdomyolysis (breakdown of muscle fibres)

•    high blood potassium (hyperkalaemia)

•    fluid in the lungs (pulmonary oedema)

•    severe tissue responses after accidental injection into tissues

•    metabolic acidosis (acidic blood)

•    heart (cardiac) failure

When Propofol is administered in combination with lidocaine (a local anaesthetic used to reduce the pain at the site of injection), certain side effects may occurrarely:

■    dizziness    ■    vomiting

■    sleepiness    ■    fits

■    aslowingoftheheartrate(bradycardia)    ■    irregular heartbeat (cardiac arrhythmias)

■    shock

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

5.    Howto store Propofol

Keep out of the reach and sight of children.

Do not use Propofol after the expiry date which is stated on the vial and the outer carton after “Exp.”. The expiry date refers to the last day of that month.

Store below 25° C. Do not freeze.

After opening the product must be used immediately.

Containers should be shaken before use.

If two layers can be seen after shaking the emulsion should not be used.

Use only homogeneous preparations and undamaged containers.

For single use. Any unused emulsion must be discarded.

Your anaesthetist and hospital pharmacist are responsible for the correct storage, use and disposal of Propofol.

6.    Further information What Propofol contains

The active substance is propofol. Each ml of 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 Waterfor injections.

What Propofol looks like and the content of the pack

White oil-in-wateremulsion 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 grey bromobutyl rubberclosure, packs of 1 and 10 unit Not all pack sizes may be marketed.

Marketing Authorisation Holder:    Manufacturer:

UAB Norameda    Peckforton Pharmaceuticals Limited

Didzioji Vandens 7-8, Klaipeda, Lithuania    Crewe Hall, Crewe, Cheshire, CW1 6UL, United Kingdom

This medicinal product is authorized in the Member States of EEAunder the following names:

This Leaflet was last revised in 09/2014

The following information is intended for medical or healthcare professionals only:

Propofol must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia orin the care of patients in intensive care.

Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.

For sedation during surgical and diagnostic procedures Propofol should not be administered by the same person conducting the surgical ordiagnostic procedure.

When Propofol is infused, it is recommended that equipment such as burettes, drop counter, syringe pumps or volumetric infusion pumps should always be used to control infusion rates.

Containers should be shaken before use. If two layers can beseenaftershaking, the emulsion should not be used.

Use only homogeneous preparations and undamaged containers.

For single use only. Any portion of contents remaining after use must be discarded.

Prior to use, the rubber membrane should be cleaned using an alcohol spray or a swab dipped in alcohol. After use, tapped containers must be discarded.

Propofol is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of microorganisms.

The emulsion must be drawn aseptically into a sterile syringe or administration set immediately after breaking the vial seal. Administration must commence without delay.

Asepsis must be maintained for both Propofol and infusion equipment throughout the infusion period. Co-administration of other medicinal products or fluids added to the Propofol infusion line must occur close to the cannula site using a Y-piececonnectorora three-way valve.

Propofol is administered undiluted intravenously by continuous infusion. Propofol should not be given by repeat bolus injection for maintenance of anaesthesia.

Propofol must not be mixed with other solutions for injection or infusion. However, co-administration of Propofol together with glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) solution for injection and preservative-free lidocaine 10 mg/ml (1 %) solution for injection via a Y-connector close to the injection site is possible.

Propofol must not be administered via a microbiological filter.

Propofol and any infusion equipment containing Propofol are for single administration in an individual patient.Afteruse remaining solution of Propofol has to be discarded.

Infusion of undiluted Propofol:

When Propofol is infused undiluted, it is recommended that equipment such as burettes, drop counter, syringe pumps or volumetric infusion pumps should always be used to control infusion rates.

As usual forfat emulsions, the infusion of Propofol via one infusion system must not exceed 12 hours. After 12 hours, the infusion system and reservoir of Propofol must be discarded or replaced if necessary.

Propofol must not be mixed with other solutions for infusion or injection. But 5% w/v glucose solution, 0.9% w/v sodium chloride solution or 0.18% w/v sodium chloride and 4% w/v glucose solution may be administered via suitable appendages at the cannula site.

To reduce pain at the injection site, Propofol should be administered in a larger vein or lidocaine injection solution may be administered before induction of anaesthesia with Propofol.

The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as Propofol without flushing.