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FORANE INHALATION ANAESTHETIC

Active substance(s): ISOFLURANE

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Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK

NOTE: Artwork studio checks pre-press suitability of this artwork
only. Ensure the artwork has been thoroughly checked for textual
accuracy and has been approved as such!

Product name: Isoflurane UK/Malta (Banded in 6’s)
Creation date: 16/Dec/2015
DCMF No: 89538
Operator: TC
Commodity: 1000009566
Ref no: CR-0001885-2015
Core spec size: 255x150 Banded
Revision: Update to ensure both leaflets align with SmPC following CSP alignment
Amended by:
Page no: 1 of 2

Approved by:







Skin rash, swelling of the face
Rapid rise in body temperature, shivering or chills
Wheezing and breathlessness
Cardiac arrest
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.
• There have been reports of rhabdomyolysis following use
of isoflurane. This may be identified by muscle pain and
dark urine.
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
• Muscles of your intestine may stop working temporarily,
causing discomfort, bloating and vomiting.
Those that will be identified following tests:
• 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

Modification date:

Date:

Font size body text: 9pt
Pharma code: 403
Colours:
Black

Proof no: 01
For QA Use Only
Issued by:

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.
Marketing Authorisation and
Manufacturer’s Details
Marketing Authorisation Holder:
AbbVie Ltd
Maidenhead,
SL6 4UB, UK
Manufacturer:
Aesica Queenborough Limited,
Queenborough, Kent,
ME11 5EL, United Kingdom.
This leaflet was last updated in November 2015.

Date

ISOFLURANE
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

1000009566

Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK

NOTE: Artwork studio checks pre-press suitability of this artwork
only. Ensure the artwork has been thoroughly checked for textual
accuracy and has been approved as such!

Product name: Isoflurane UK/Malta (Banded in 6’s)
Creation date: 16/Dec/2015
DCMF No: 89538
Operator: TC
Commodity: 1000009566
Ref no: CR-0001885-2015
Core spec size: 255x150 Banded
Revision: Update to ensure both leaflets align with SmPC following CSP alignment
Amended by:
Page no: 2 of 2

Modification date:

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.

Font size body text: 9pt
Pharma code: 403
Colours:
Black

Proof no: 01

• 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
• Opioids and other sedatives
• Sympathomimetic agents such as isoprenaline
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 until
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.

Your child should be monitored closely during the
administration of Isoflurane.
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.
Isoflurane is not recommended in infants and children for
inducing sleep at the start of anaesthesia.
Medication before anaesthesia
Anaesthetist may decide to give your child medication to
counter act the possible reduction in breathing and heart
rate effects which may occur with the use of 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 or
your childs’s 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
or your child experience any of these side effects after an
operation tell your doctor or anaesthetist immediately.The
most commonly reported side effects are:
• A tightening of your lungs and airways causing a difficulty
in breathing
• Increases in blood sugar levels or potassium levels.
There have been rare reports of abnormal heartbeat
(arrhythmias) and death associated with the use of
inhaled anaesthetics in children shortly after surgery
• Allergic reaction
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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