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Although the frequency is not known, the following
side effects may also occur:
• depression, feeling restless or nervous. These
effects are more likely to occur in children
Talk to your doctor as soon as possible if:
• after 7 days of using Flixotide your shortness of
breath or wheezing does not get better, or gets
• you or your child is on high doses of inhaled
steroid and become unwell with vague
symptoms such as tummy ache, sickness,
diarrhoea, headache or drowsiness. This can
happen during an infection such as a viral
infection or stomach upset. It is important that
your steroid is not stopped suddenly as this
could make your asthma worse and could also
cause problems with the body’s hormones
Reporting of side effects
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 Yellow Card
Scheme at
By reporting side effects, you can help provide
more information on the safety of this medicine.

What Flixotide contains
Each 2ml of liquid contains 0.5mg of fluticasone
propionate as the active ingredient. Your medicine
also contains the following inactive ingredients:
polysorbate 20, sorbitan monolaurate, sodium acid
phosphate, sodium phosphate, sodium chloride
and water for injections.
What Flixotide looks like and contents of the
The medicine is a plastic ampoule containing 2ml
of buffered, isotonic saline suspension containing
2mg fluticasone propionate.
Flixotide Nebules are provided as a strip of 5
nebules in a foil wrap. Each box contains 10
Flixotide Nebules.
Manufacturer and Licence Holder
Flixotide is manufactured by GlaxoSmithKline
Australia Pty Ltd, 1061 Mountain Highway, Boronia
VIC 3155, Australia and are procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

If the foil pack has not been opened, do not use
this medicine after the expiry date which is stated
on the pack after ‘EXP’. The date refers to the last
day of that month.
If your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist
(chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to. If your
medicine becomes discoloured or shows any other
signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
• Do not open the foil wrap until the Nebules are
• Opened Nebules should be refrigerated and used
within 12 hours of opening.
• Store in the outer carton. Do not store above 30°C.
Protect from light. Do not freeze. Store upright.
• Do not leave suspension in your nebuliser once
your have finished a treatment.
• Nebules removed from the foil wrap should be
protected from light and used within 28 days.

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PL 15184/0870 - Flixotide Nebules 0.5mg/2ml/
Fluticasone Propionate Nebules 0.5mg/2ml.
Flixotide and Nebules are registered trademarks of
the GlaxoSmithKline Group of Companies.
Leaflet revision date: 01/12/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.


Ref: 0870/011214/1/F


(fluticasone propionate)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
• If you have any further questions, ask your
doctor, nurse or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
section. See section 4.
Your medicine is called Flixotide Nebules
0.5mg/2ml/ Fluticasone Propionate Nebules
0.5mg/2ml and will be referred to as Flixotide
throughout the rest of this leaflet.
What is in this leaflet:
1. What Flixotide is and what it is used for
2. What you need to know before you use
3. How to use Flixotide
4. Possible side effects
5. How to store Flixotide
6. Contents of the pack and other information
Flixotide Nebules contain a medicine called
fluticasone propionate.
Fluticasone propionate belongs to a group of
medicines called corticosteroids (often just called
steroids). A very small dose of steroid is needed
when it is inhaled. This is because it is inhaled
straight to your lungs.
Flixotide works by reducing swelling and irritation
in the lungs. It has what is called an
‘anti-inflammatory action’.
Flixotide help to prevent asthma attacks in people
who need regular treatment. This is why they are
sometimes called ‘preventers’. They need to be
used regularly, every day.
Flixotide will not help treat sudden asthma attacks
where you feel breathless.
• A different medicine is used for treating sudden
attacks (called a ‘reliever’).
• If you have more than one medicine, be careful
not to confuse them.

Do not use:
• if you are allergic to fluticasone propionate or
any of the other ingredients of this medicine
(listed in Section 6).
Do not use Flixotide if any of the above apply to
you. If you are not sure, talk to your doctor, nurse
or pharmacist before using Flixotide.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before
taking Flixotide if:
• you have ever been treated for tuberculosis (TB)
• you are using Flixotide at the same time as
taking steroid tablets.
Also if you have just finished taking steroid
tablets. In both cases, you should carry a steroid
warning card until your doctor tells you not to
carry one
If you are not sure if any of the above applies to
you, talk to your doctor, nurse or pharmacist
before using Flixotide.
Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription. This includes herbal medicines.
Remember to take this medicine with you if you
have to go into hospital.
In particular tell your doctor or pharmacist if you
are taking any of the following:
• a type of antiviral medicine known as a ‘protease
inhibitor’ (such as ritonavir)
• medicines used to treat fungal infections (such
as ketoconazole)
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Using Flixotide with food and drink
You can use Flixotide at any time of day, with or
without food.
Pregnancy and breast-feeding
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
Driving and using machines
Flixotide is not likely to affect you being able to
drive or use any tools or machines.

Flixotide Nebules come in two different strengths.
Your doctor will have decided which strength you
need. Always use this medicine exactly as your
doctor has told you. Check with your doctor, nurse
or pharmacist if you are not sure.
Using this medicine
• Do not inject or swallow the liquid. Flixotide
Nebules should only be inhaled using your jet
nebuliser. Using Flixotide Nebules with
ultrasonic nebulisers is not generally
• The jet nebuliser produces a fine mist which
you breathe in through a mouthpiece or face
• Do not let the liquid, or the mist produced by
the nebuliser get into your eyes. You can
wear glasses or goggles to protect them.
• Each small plastic container (Nebule ®)
contains some liquid.
• The liquid is put into a nebuliser. This makes a
fine mist for you to breathe in through a face
mask or mouthpiece. Use of a mouthpiece
prevents the medicine affecting the skin of your
face, which may occur if you use a face mask
over a long period of time. If you prefer to use a
face mask, or you are using a face mask for
your child, then you must protect the skin on
your (or your child’s) face with a barrier cream
or wash your (or your child’s) face thoroughly
after treatment.
• Use your nebuliser in a well-ventilated room as
some of the mist will be released into the air
and may be breathed in by others.
• It takes a few days for this medicine to work
and it is very important that you use it
Adults and Children over 16 years of age
• The usual starting dose is 0.5 to 2.0 mg (500 to
2000 micrograms) twice a day.
• Flixotide Nebules 0.5 mg/2 ml provides you with
a dose of 500 micrograms.
• Flixotide Nebules 2.0 mg/2 ml provides you with
a dose of 2000 micrograms.

Children (4 to 16 years of age)
• The usual starting dose is 1 mg (1000
micrograms) twice a day.
It is recommended that children being treated with
steroids, including Flixotide Nebules have their
height checked regularly by their doctor.
If you are using high doses of an inhaled
steroid for a long time you may sometimes
need extra steroids for example during
stressful circumstances such as a road traffic
accident or before an operation. Your doctor
may decide to give you extra steroid medicines
during this time.
Patients who have been on high doses of
steroids, including Flixotide Nebules for a long
time, must not stop taking their medicine
suddenly without talking to their doctor.
Suddenly stopping treatment can make you
feel unwell and may cause symptoms such as
vomiting, drowsiness, nausea, headache,
tiredness, loss of appetite, low blood sugar
level and fitting.
Using your Nebules

1. the Nebules are in a foil pack. Do not open the
pack until you need to use them

2. hold the top of the Nebule you have just

Diluting your Nebules
Do not dilute the contents of a Nebule unless
you are told to by your doctor
• if your doctor has told you to dilute the solution,
empty the contents of the Nebule into the
nebuliser bowl
• add the amount of sterile sodium chloride 0.9%
solution your doctor has told you to use
• put the top on the nebuliser bowl and shake
gently to mix the contents.
If dilution is necessary then only sterile sodium
chloride 0.9% solution should be used.
After use
• use a fresh Nebule for each dose. Only open a
new one when you are ready to use it. If there
is any liquid left over, throw it away. Do not
save it to use again
• throw away any solution remaining in the
nebuliser bowl
• clean your nebuliser in the recommended way
If you use more Flixotide than you should
If you use more than you were told, talk to your
doctor as soon as possible.
It is important that you take your dose as stated on
the pharmacist’s label or as advised by your
doctor. You should not increase or decrease your
dose without seeking medical advice.

removed. Twist the body to open it
If you forget to use Flixotide
• Take the next dose when it is due.
• Do not take a double dose to make up for the
forgotten dose.


3. put the open end of the Nebule into the
nebuliser bowl and squeeze slowly to empty
the content

If you stop using Flixotide
• Do not stop treatment even if you feel better
unless told to do so by your doctor.
If you have any further questions on the use of
this medicine, ask your doctor, nurse or


4. assemble the nebuliser and use it as directed
5. repeat steps 2 to 4 to make up the dose

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you notice any of the following serious side
effects, stop using this medicine and talk to
your doctor straight away. You may need urgent
medical treatment.

allergic reactions (may affect up to 1 in 100
people) – the signs include skin rashes,
redness, itching or weals like nettle rash or

severe allergic reactions (may affect up to 1 in
10,000 people)

needed if necessary

- the signs include swelling of your face, lips,
mouth, tongue or throat which may cause
difficulty in swallowing or breathing, itchy rash,
feeling faint and light headed and collapse
• your breathing or wheezing gets worse straight
after using your inhaler.
Other side effects include:
Very common (may affect more than 1 in 10
• thrush in the mouth and throat
Common (may affect up to 1 in 10 people)
• sore tongue or throat
• hoarseness of voice
Problems with your mouth and throat can be
reduced by doing certain things straight after
inhaling your dose. These are brushing
your teeth, rinsing your mouth or gargling with
water and spitting it out. Tell your doctor if you
have these problems with your mouth or throat,
but do not stop treatment unless you are told to.
The following side effects have also been reported
in patients with Chronic Obstructive Pulmonary
Disease (COPD):
• Pneumonia and bronchitis (lung infection). Tell
your doctor if you notice any of the following
symptoms: increased sputum production,
change in sputum colour, fever, chills, increased
cough, increased breathing problems.
• Bruising
Rare (may affect up to 1 in 1,000 people)
• thrush (candidiasis) in the oesophagus
Very rare (may affect up to 1 in 10,000 people)
• sleeping problems or feeling worried,
over-excited and irritable.
These effects are more likely to occur in
• joint pains
• indigestion
• level of sugar (glucose) in your blood may be
• the way steroids are produced by your body
may be affected when using Flixotide. This is
more likely to happen if you use high doses for
a long period of time. This can cause:
- children and young people to grow more
- something called ‘Cushing’s syndrome’. This
happens when you have too much steroid in
your body and it can cause thinning of your
bones and eye problems (such as cataracts
and glaucoma which is high pressure in the
Your doctor will help stop this happening by
making sure you use the lowest dose of steroid
which controls your symptoms.
Ref: 0870/011214/1/B

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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.