•    Abnormal levels of certain cells or products found In your blood or urine.

•    Liver injury or the inability of your liver to function properly,

•    Changes to the heart rhythm including QT prolongation and torsade de pointes,

Other side effects you may experience:

Those occurring at unknown frequency

•    Agitation

•    Alterations in mood, sometimes extreme, this may last upto 6 days

•    Irregular heart beat or palpitations

•    Convulsions, mental impairment

•    Bleeding

•    Nausea and vomiting

•    Slow shallow breathing, shortness of breath, wheezing, chest discomfort

•    A tightening of your lungs and airways causing a difficulty in breathing

•    Muscles of your intestine may stop working temporarily, causing discomfort, bloating and vomiting,

Those that will be identified following tests:

•    Increases in blood sugar levels

•    Low blood pressure

•    Increases in blood fluoride levels (due to your body breaking down isoflurane) or carbon monoxide levels

•    Fast or slow heart rate Reporting of side effects

If you get any side effects, talk to your doctor or anaesthetist, This includes any possible side effects not listed in this leaflet, You can also report side effects directly (see details below), By reporting side effects you can help provide more information on the safety of this medicine,

United Kingdom

Yellow Card Scheme

Website: www, mhra,gov, uk/yellowcard

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Isoflurane

Keep this medicine out of the sight and reach of children.

Isoflurane should be stored in a tightly closed container not above 25°C, Do not use after the expiry date printed on the packaging,

Medicines should not be disposed of via wastewater or household waste,

6. Contents of the pack and other information

What Isoflurane contains:

The active ingredient is Isoflurane and it is supplied as a pure liquid containing no other ingredients,

What Isoflurane looks like and contents of the pack:

Isoflurane is an inhalation anaesthetic with a mildly pungent odour,

Isoflurane is available in 100ml and 250ml glass bottles,

Not all pack size may be marketed.

ISOFLURANE

_x IMPORTANT INFORMATION

Read all of this leaflet carefully before you are given 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 anaesthetist, ward doctor or nurse,

If you get any side effects, talk to your anaesthetist, ward doctor or nurse, This includes any possible side effect not listed in this leaflet, See section 4,

What is in this leaflet

1,    What isoflurane is and what it is used for

2,    What you need to know before you are given Isoflurane

3,    How Isoflurane is used

4,    Possible side effects

5,    How to store Isoflurane

6,    Contents of the pack and other information

obbvie

1000008210

lllllllll lllllllll

1. What Isoflurane is and what it is used for

Isoflurane belongs to a group of medicines called general anaesthetics. These work by temporarily reducing the activity of the body's central nervous system. This causes a complete loss of sensation in the body, including loss of consciousness allowing surgery to be carried out without pain or distress,

Isoflurane is a clear colourless liquid that when put into a special anaesthetic machine (vaporiser) becomes a gas, This mixes with the oxygen you will be breathing in,

Once breathed in (inhaled), Isoflurane will induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children,

2. What you need to know before you are given Isoflurane

You should not be given Isoflurane if:

•    You have been told that you are allergic to Isoflurane or any other anaesthetic,

•    You or any member of your family has experienced a rapid rise in body temperature during an operation (a condition called malignant hyperthermia),

Warnings and precautions

Tell your Ward Doctor, Surgeon or Anaesthetist if:

•    You have previously received general anaesthetics, particularly if repeated over a short period of time (specifically in the last 3 months), Some anaesthetics can cause jaundice,

•    If you have Cirrhosis, viral hepatitis or other liver disease

•    If you have coronary heart disease

•    You are suffering from any illness other than those connected with your operation, such as severe headaches, nausea, vomiting or a condition that affects muscles (a neuromuscular disease e,g, Duchenne muscular dystrophy or myasthenia gravis),

•    You suffer with bronchoconstriction (a tightening of the lungs and airways leading to coughing, wheezing or shortness of breath),

•    You are pregnant, could be pregnant or are breast feeding,

•    You have ever had QT prolongation (prolongation of a specific time interval in an ECG) or torsade de pointes (a specific type of heart rhythm), which may also be associated with QT prolongation, Isoflurane has sometimes been known to cause these,

•    You have a mitochondrial disease,

Other Medicines and Isoflurane

As with all drugs, it is important that you tell your ward doctor, surgeon or anaesthetist which medications you are taking, This is particularly important if you are taking the following drugs:

•    Amphetamines (stimulants)

•    Beta blockers (used to treat high blood pressure and certain heart conditions)

•    Isoniazid (an antibiotic used to treat tuberculosis)

•    Decongestants (ephedrine)

•    Non-selective MAO-inhibitors (a type of anti-depressants), These should be stopped 15 days before surgery

•    Calcium antagonists

Pregnancy, Breast Feeding and fertility

Tell your ward doctor, surgeon or anaesthetist if you are pregnant, could be pregnant or are breast feeding,

It is not known whether Isoflurane or its by-products are transferred into human milk,

Driving and using machines

You should not drive or operate machinery unti your doctor advises that you may do so,

Your ability to drive or operate machinery may be impaired for 2-4 days, Do not drive or operate machinery if you are affected,

3. How Isoflurane is used

Isoflurane will always be administered to you by an anaesthetist, They will decide on the dose you will receive, depending on your age, weight and the type of operation you are having,

Isoflurane has a strong smell, which is quite normal and will send you to sleep quickly,

Inducing sleep at the start of anaesthesia

Very occasionally you may be asked to breathe in the Isoflurane via a mask, Usually you will receive an injection of another anaesthetic to make you go to sleep before you receive Isoflurane,

Maintaining sleep during anaesthesia

Under the observation of the anaesthetist you will continue to breathe in Isoflurane during the operation via a mask, Waking-up after anaesthesia

Once the anaesthetist stops you from inhaling Isoflurane you will wake up within a few minutes,

4. Possible side effects

As with all anaesthetics, Isoflurane can cause side effects, These can occur both during and after your operation, The following side effects with isoflurane are serious and will be managed by your surgeon or anaesthetist, as necessary, during the operation, If you experience any of these side effects after your operation get medical help immediately, Those occurring with unknown frequency:

•    Allergic reaction

•    Skin rash, swelling of the face

•    Rapid rise in body temperature, shivering or chills

•    Wheezing and breathlessness

•    Cardiac arrest

Those that will be identified following tests:

•    Increases in blood potassium levels

1000008210