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FLIXOTIDE 500MICROGRAMS ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE

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Package Leaflet: Information for the user
®

Flixotide 500 micrograms Accuhaler

®

(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 again.
 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 leaflet. See section 4.
The name of your medicine is Flixotide 500 micrograms Accuhaler,
but it will be referred to as Flixotide or Flixotide Accuhaler
throughout this leaflet. Please note that this leaflet also contains
information about the other strengths such as Flixotide
50 micrograms, 100 micrograms and 250 micrograms Accuhaler.
What is in this leaflet:
1 What Flixotide is and what it is used for
2 What you need to know before you use Flixotide
3 How to use Flixotide
4 Possible side effects
5 How to store Flixotide
6 Contents of the pack and other information
1 What Flixotide is and what it is used for
Flixotide Accuhaler is a plastic inhaler device containing a foil strip
with 28 or 60 blisters. Each blister contains 50, 100, 250 or
500 micrograms of the active ingredient 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.
They have what is called an ‘anti-inflammatory action’.
Flixotide helps 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.
2 What you need to know before you use Flixotide
Do not use Flixotide:
 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 applies 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 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.

Children (4 to 16 years of age)
 The usual starting dose is 50 micrograms twice a day
 The most taken should be 200 micrograms twice a day
Flixotide Accuhaler 250 micrograms and Flixotide Accuhaler 500
micrograms are not recommended for children 16 years and under.
It is recommended that children being treated with steroids,
including Flixotide Accuhaler have their height checked regularly
by their doctor.
Your doctor may give you a Flixotide Accuhaler of a higher
strength if your dose is increased.
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 Accuhaler 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.

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) or cobicistat containing products which may
increase the effects of fluticasone propionate. Your doctor may
wish to monitor you carefully if you are taking these medicines.
 medicines used to treat fungal infections (such as
ketoconazole)
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Flixotide.
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 are breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor for advice
before taking this medicine.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any
tools or machines.
Flixotide contains lactose
Flixotide contains lactose (a type of sugar). If you have been told
by your doctor that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to your doctor before
using this medicine.
3 How to use Flixotide
Flixotide comes in four 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
The medicine in Flixotide should be inhaled using a special kind of
inhaler called an Accuhaler.
 Make sure that you have one and can use it properly
 Instructions on how to use the inhaler are given as a step-bystep guide
 You should be able to taste the powder on your tongue if you
have taken it correctly

It takes a few days for this medicine to work and it is very
important that you use it regularly

Adults and Children over 16 years of age
Mild asthma
 The usual starting dose is 100 micrograms twice a day
Moderate to severe asthma
 The usual starting dose is 250 to 500 micrograms twice a day
 The most taken should be 1000 micrograms twice day

Instructions for use
 Your doctor, nurse or pharmacist should show you how to use
your inhaler. They should check how you use it from time to
time. Not using the Flixotide Accuhaler properly or as
prescribed may mean that it will not help your asthma as it
should.
 The Accuhaler is provided in a sealed foil wrapper. The
wrapper provides protection from moisture and should only be
opened when you are ready to use it for the first time. Once
opened the foil wrapper should be discarded.



The Accuhaler device holds blisters containing Flixotide as a
powder.
 There is a counter on top of the Accuhaler which tells you how
many doses are left. It counts down to 0. The numbers 5 to 0
will appear in red to warn you when there are only a few doses
left. Once the counter shows 0, your inhaler is empty.
Do not use your inhaler more often than the doctor told you to. Tell
your doctor if your medicine does not seem to be working as well
as usual, as your chest problem may be getting worse and you
may need a different medicine.
Your doctor may have told you to take more than this as an
emergency treatment if your wheezing or breathing gets very bad.
It is very important that you keep to your doctor’s instructions as to
how many blisters to take and how often to use your inhaler.

Using your inhaler
Inside the carton, your Accuhaler is provided in a sealed foil
wrapper. To open this wrapper, tear along the jagged edge,
then remove the Accuhaler, and throw the wrapper away.
If you have trouble tearing the foil, do not use scissors or any
other sharp objects as you may harm yourself or the Accuhaler.
Ask someone to help you.

1

2

To open your Accuhaler, hold the
outer case in one hand and put
the thumb of your other hand on the
thumbgrip. Push your thumb away
from you as far as it will go.
You will hear a click.
This will open a small hole in the
mouthpiece.

3

Hold your Accuhaler with the
mouthpiece towards you. You
can hold it in either your right or left
hand. Slide the lever away from you
as far as it will go. You will hear a
click. This places a dose of your
medicine in the mouthpiece.
Every time the lever is pulled back
a blister is opened inside and the
powder made ready for you to inhale. Do not play with the lever
as this opens the blisters and wastes medicine.
Hold the Accuhaler away from your mouth, breathe out as
far as is comfortable. Do not breathe into your Accuhaler.
Do not breathe in again yet.

4
5

Put the mouthpiece to your
lips; breathe in steadily and
deeply through the Accuhaler with
your mouth, not through your nose.
Remove the Accuhaler from your
mouth. Hold your breath for about
10 seconds or for as long as is
comfortable. Breathe out slowly.

6

To close the Accuhaler, slide the
thumbgrip back towards you, as
far as it will go. You will hear a click.
The lever will return to its original
position and is reset.
Your Accuhaler is now ready for you
to use again.
Afterwards, rinse your mouth with
water and spit it out.

Cleaning your Accuhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

If you use more Flixotide than you should
If you use more than you should, 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.
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.
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 pharmacist.
4. Possible side effects
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
hives
 severe allergic reactions (may affect up to 1 in 10,000 people)
– 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 people)
 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 children
 joint pains
 indigestion
 level of sugar (glucose) in your blood may be increased
 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 slowly
- 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 eye)
Your doctor will help stop this happening by making sure you use
the lowest dose of steroid which controls your symptoms.
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
 nosebleeds
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 worse
 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 any side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Flixotide
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in a dry place to protect from moisture.
Store the Accuhaler in the foil wrapper until you are ready to use it
for the first time. Once opened, the foil wrapper should be
discarded.
Do not use the Accuhaler after the expiry date which is stated on
the carton and accuhaler label after ‘Exp’. The expiry date refers to
the last day of that month.
If the Accuhaler shows any signs of damage, seek the advice of
your pharmacist.
Remember if your doctor tells you to stop using this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this Accuhaler if your doctor tells you to.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other Information
4
What
Flixotide contains
The active substance is fluticasone propionate
The other ingredient is lactose.
What Flixotide looks like and contents of the pack
The plastic Accuhaler device is provided in a sealed foil wrapper.
It is a two-tone orange, circular accuhaler, with a dose counter
counting down from 60 to 0. To show when the last 5 blisters have
been reached the number appears in red. When the counter shows
‘0’ the Accuhaler is empty and should be disposed of.
Each blister contains 500 micrograms of the active ingredient
fluticasone propionate, mixed with lactose monohydrate (which
acts as a 'carrier').
The fine powdered medicine in each blister is inhaled into the lungs
using the Accuhaler.
Manufactured by: Glaxo Wellcome Production, Evreux, France.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

®

Flixotide 500 micrograms Accuhaler ; PL 18799/2086
Leaflet date: 30.05.2017

POM

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Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
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you.

Package Leaflet: Information for the user

Fluticasone propionate 500 micrograms
Accuhaler®
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 again.
 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 leaflet. See section 4.
The name of your medicine is Fluticasone propionate
500 micrograms Accuhaler, but it will be referred to as Fluticasone
propionate or Fluticasone propionate Accuhaler throughout this
leaflet. Please note that this leaflet also contains information about
the other strengths such as Fluticasone propionate 50 micrograms,
100 micrograms and 250 micrograms Accuhaler.
What is in this leaflet:
1 What Fluticasone propionate is and what it is used for
2 What you need to know before you use Fluticasone propionate
3 How to use Fluticasone propionate
4 Possible side effects
5 How to store Fluticasone propionate
6 Contents of the pack and other information
1 What Fluticasone propionate is and what it is used for
Fluticasone propionate Accuhaler is a plastic inhaler device
containing a foil strip with 28 or 60 blisters. Each blister contains
50, 100, 250 or
500 micrograms of the active ingredient 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.
Fluticasone propionate works by reducing swelling and irritation in
the lungs. They have what is called an ‘anti-inflammatory action’.
Fluticasone propionate helps 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.
Fluticasone propionate 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.
2

What you need to know before you use Fluticasone
propionate
Do not use Fluticasone propionate:
 If you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in Section 6)

Do not use Fluticasone propionate if any of the above applies to
you. If you are not sure, talk to your doctor, nurse or pharmacist
before using Fluticasone propionate.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Fluticasone
propionate if:
 you have ever been treated for tuberculosis (TB)
 you are using Fluticasone propionate 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 or pharmacist before using Fluticasone propionate.
Other medicines and Fluticasone propionate
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) or cobicistat containing products which may
increase the effects of fluticasone propionate. Your doctor may
wish to monitor you carefully if you are taking these medicines.
 medicines used to treat fungal infections (such as
ketoconazole)
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Fluticasone propionate.
Using Fluticasone propionate with food and drink
You can use Fluticasone propionate at any time of day, with or
without food.
Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor for advice
before taking this medicine.
Driving and using machines
Fluticasone propionate is not likely to affect you being able to drive
or use any tools or machines.
Fluticasone propionate contains lactose
Fluticasone propionate contains lactose (a type of sugar). If you
have been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to your
doctor before using this medicine.
3 How to use Fluticasone propionate
Fluticasone propionate comes in four 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
The medicine in Fluticasone propionate should be inhaled using a
special kind of inhaler called an Accuhaler.
 Make sure that you have one and can use it properly





Instructions on how to use the inhaler are given as a step-bystep guide
You should be able to taste the powder on your tongue if you
have taken it correctly
It takes a few days for this medicine to work and it is very
important that you use it regularly

Adults and Children over 16 years of age
Mild asthma
 The usual starting dose is 100 micrograms twice a day
Moderate to severe asthma
 The usual starting dose is 250 to 500 micrograms twice a day
 The most taken should be 1000 micrograms twice day
Children (4 to 16 years of age)
 The usual starting dose is 50 micrograms twice a day
 The most taken should be 200 micrograms twice a day
Fluticasone propionate Accuhaler 250 micrograms and Fluticasone
propionate Accuhaler 500 micrograms are not recommended for
children 16 years and under.
It is recommended that children being treated with steroids,
including Fluticasone propionate Accuhaler have their height
checked regularly by their doctor.
Your doctor may give you a Fluticasone propionate Accuhaler of a
higher strength if your dose is increased.
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
Fluticasone propionate Accuhaler 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.
Instructions for use
 Your doctor, nurse or pharmacist should show you how to use
your inhaler. They should check how you use it from time to
time. Not using the Fluticasone propionate Accuhaler properly
or as prescribed may mean that it will not help your asthma as
it should.
 The Accuhaler is provided in a sealed foil wrapper. The
wrapper provides protection from moisture and should only be
opened when you are ready to use it for the first time. Once
opened the foil wrapper should be discarded.




The Accuhaler device holds blisters containing Fluticasone
propionate as a powder.
There is a counter on top of the Accuhaler which tells you how
many doses are left. It counts down to 0. The numbers 5 to 0
will appear in red to warn you when there are only a few doses
left. Once the counter shows 0, your inhaler is empty.

Do not use your inhaler more often than the doctor told you to. Tell
your doctor if your medicine does not seem to be working as well
as usual, as your chest problem may be getting worse and you
may need a different medicine.
Your doctor may have told you to take more than this as an
emergency treatment if your wheezing or breathing gets very bad.
It is very important that you keep to your doctor’s instructions as to
how many blisters to take and how often to use your inhaler.
Using your inhaler
Inside the carton, your Accuhaler is provided in a sealed foil
wrapper. To open this wrapper, tear along the jagged edge,
then remove the Accuhaler, and throw the wrapper away.
If you have trouble tearing the foil, do not use scissors or any
other sharp objects as you may harm yourself or the Accuhaler.
Ask someone to help you.

1

2

To open your Accuhaler, hold the
outer case in one hand and put
the thumb of your other hand on the
thumbgrip. Push your thumb away
from you as far as it will go.
You will hear a click.
This will open a small hole in the
mouthpiece.

3

Hold your Accuhaler with the
mouthpiece towards you. You
can hold it in either your right or left
hand. Slide the lever away from you
as far as it will go. You will hear a
click. This places a dose of your
medicine in the mouthpiece.
Every time the lever is pulled back
a blister is opened inside and the
powder made ready for you to inhale. Do not play with the lever
as this opens the blisters and wastes medicine.
Hold the Accuhaler away from your mouth, breathe out as
far as is comfortable. Do not breathe into your Accuhaler.
Do not breathe in again yet.

4
5

Put the mouthpiece to your
lips; breathe in steadily and
deeply through the Accuhaler with
your mouth, not through your nose.
Remove the Accuhaler from your
mouth. Hold your breath for about
10 seconds or for as long as is
comfortable. Breathe out slowly.

6

To close the Accuhaler, slide the
thumbgrip back towards you, as
far as it will go. You will hear a click.
The lever will return to its original
position and is reset.
Your Accuhaler is now ready for you
to use again.
Afterwards, rinse your mouth with
water and spit it out.

Cleaning your Accuhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.
If you use more Fluticasone propionate than you should
If you use more than you should, 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.
If you forget to use Fluticasone propionate
 Take the next dose when it is due.
 Do not take a double dose to make up for the forgotten dose.
If you stop using Fluticasone propionate
 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 pharmacist.
4. Possible side effects
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
hives
 severe allergic reactions (may affect up to 1 in 10,000 people)
– 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 people)
 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 children
 joint pains
 indigestion
 level of sugar (glucose) in your blood may be increased
 the way steroids are produced by your body may be affected
when using Fluticasone propionate. 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 slowly
- 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 eye)
Your doctor will help stop this happening by making sure you use
the lowest dose of steroid which controls your symptoms.
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
 nosebleeds
Talk to your doctor as soon as possible if:
after 7 days of using Fluticasone propionate your shortness of
breath or wheezing does not get better, or gets worse
 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 any side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Fluticasone propionate
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in a dry place to protect from moisture.
Store the Accuhaler in the foil wrapper until you are ready to use it
for the first time. Once opened, the foil wrapper should be
discarded.
Do not use the Accuhaler after the expiry date which is stated on
the carton and accuhaler label after ‘Exp’. The expiry date refers to
the last day of that month.
If the Accuhaler shows any signs of damage, seek the advice of
your pharmacist.
Remember if your doctor tells you to stop using this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this Accuhaler if your doctor tells you to.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other Information
4
What
Fluticasone propionate contains
The active substance is fluticasone propionate
The other ingredient is lactose.
What Fluticasone propionate looks like and contents of the
pack
The plastic Accuhaler device is provided in a sealed foil wrapper.
It is a two-tone orange, circular accuhaler, with a dose counter
counting down from 60 to 0. To show when the last 5 blisters have
been reached the number appears in red. When the counter shows
‘0’ the Accuhaler is empty and should be disposed of.
Each blister contains 500 micrograms of the active ingredient
fluticasone propionate, mixed with lactose monohydrate (which
acts as a 'carrier').
The fine powdered medicine in each blister is inhaled into the lungs
using the Accuhaler.
Manufactured by: Glaxo Wellcome Production, Evreux, France.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

Fluticasone propionate 500 micrograms Accuhaler ;
PL 18799/2086
Leaflet date: 30.05.2017

POM

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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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