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FLUTICASONE PROPIONATE 125MICROGRAMS CFC-FREE INHALER

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the user
FLIXOTIDE® 125 MICROGRAMS EVOHALER®

FLIXOTIDE® 250 MICROGRAMS EVOHALER®
(fluticasone propionate)
The name of you medicine is Flixotide 125 micrograms Evohaler or
Flixotide 250 micrograms Evohaler but will be referred to as Flixotide
throughout this leaflet.
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.
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
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 helps to prevent asthma attacks in people who need regular
treatment. This is why it is sometimes called a ‘preventer’. It needs 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:
 if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking 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 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 breast-feeding, think you may be pregnant or are
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.

3. HOW TO USE FLIXOTIDE
Flixotide comes in three different strengths. Your doctor will have decided
which strength you need. Always use Flixotide 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 Evohaler.
 Make sure that you have one and can use it properly.
 Instructions on how to use the inhaler are given as a step-by-step guide.
 If you are over 16 years of age and are on higher doses (above 1,000
micrograms daily) you should take your medicine via the VolumaticTM
large-volume spacer device to help reduce side-effects in the mouth and
throat. Your doctor, nurse or pharmacist will be able to advise you about
this.
 Some people find it difficult to release a puff of medicine just after they
start to breathe in. The Volumatic spacer device helps to overcome this
problem. Your doctor, nurse or pharmacist will be able to advise you
about this.
 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 a day.
Flixotide 125 micrograms Evohaler and Flixotide 250 micrograms
Evohaler are not recommended for children below 16 years of age.
It is recommended that children being treated with steroids, including
Flixotide have their height checked regularly by their doctor.
Your doctor may give you a Flixotide 250 microgram Evohaler 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
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 Flixotide
properly or as prescribed, may mean that the medicine will not help your
asthma as it should.
The medicine is contained in a pressurised canister in a plastic casing with
a mouthpiece.
Testing your inhaler
1. When using the inhaler for the first time,
test that it is working. Remove the
mouthpiece cover by gently squeezing the
sides with your thumb and forefinger and
pull apart.
2. To make sure that it works, shake it
well, point the mouthpiece away from you
and press the canister to release a puff into the air. If you have not used
the inhaler for a week or more, release two puffs of medicine into the air.
Using your inhaler
It is important to start to breathe as slowly as possible just before using
your inhaler.
1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (as shown in the first picture). Check
inside and outside to make sure that the mouthpiece is clean and free of
objects.
3. Shake the inhaler 4 or 5 times to ensure that any
loose objects are removed and that the contents of the
inhaler are evenly mixed.

4. Hold the inhaler upright with your thumb on the
base, below the mouthpiece. Breathe out as far as is
comfortable. Do not breathe in again yet.

5. Place the mouthpiece in your mouth between your
teeth. Close your lips around it. Do not bite.

6. Breathe in through your mouth. Just after starting to
breathe in, press down on the top of the canister to
release a puff of medicine. Do this while still breathing
in steadily and deeply.

7. Hold your breath; take the inhaler from your mouth
and your finger from the top of the inhaler.
Continue holding your breath for a few seconds, or as
long as is comfortable.
8. If your doctor has told you to take two puffs, wait
about half a minute before you take another puff by repeating steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out.
10. After use always replace the mouthpiece cover straight away to keep
out dust. Replace the cover by firmly pushing and clicking into position.
Practise in front of a mirror for the first few times. If you see a ‘mist’ coming
from the top of your inhaler or the sides of your mouth you should start
again.
Older children or people with weak hands may find it easier to hold the
inhaler with both hands. Put the two forefingers on top of the inhaler and
both thumbs on the bottom below the mouthpiece. If this does not help, a
special device called a HaleraidTM may make it easier. Your doctor, nurse
or pharmacist will be able to advise you.
Cleaning your Evohaler
To stop your inhaler blocking, it is important to clean it at least once a
week.
To clean your inhaler:
 Remove the mouthpiece cover.
 Do not remove the metal canister from the plastic casing at any time.
 Wipe the inside and outside of the mouthpiece and the plastic casing
with a dry cloth or tissue.
 Replace the mouthpiece cover.
Do not put the metal canister in water.
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 young people
 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 (e.g. 400 micrograms daily in children). This can cause:
- 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 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 this medicine out of the sight and reach of children.
 Clean your inhaler on a weekly basis and if it becomes blocked as
described under ‘Cleaning’.
 Do not use this medicine after the expiry date, which is stated on the
label and carton after ‘EXP’. The expiry date refers to the last day of that
month.
 Do not store the inhaler above 30C. Protect from frost and direct
sunlight.
 If the inhaler gets very cold, take the metal canister out of the plastic
case and warm it in your hands for a few minutes before use. Never use
anything else to warm it up.
 The metal canister is pressurised. Do not puncture, break or burn it even
when apparently empty.
 Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
 If you are told to stop taking this medicine, return the inhaler to your
pharmacist to be destroyed.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flixotide contains
Each actuation of Flixotide 125 micrograms Evohaler contains 125
micrograms of fluticasone propionate.
Each actuation of Flixotide 250 micrograms Evohaler contains 250
micrograms of fluticasone propionate.
 Also contains a CFC-free propellant 1,1,1,2 tetrafluoroethane (HFA
134a).
What Flixotide looks like and contents of the pack
 Flixotide comprises an aluminium alloy can sealed with a metering valve,
actuator and dust cap.
 Each canister contains 120 doses of 125 or 250 micrograms of
fluticasone propionate.
This medicine is manufactured by Glaxo Wellcome GmbH, 23840 Bad
Oldesloe, Germany or Glaxo Wellcome S.A., Avda. Extremadura, 3, Pol.
Ind. Allendeduero, Aranda de Duero, 09400 Burgos, Spain and is procured
from within the EU by the Product Licence holder BR Pharma International
Limited, Unit 3 Manor Point, Manor Way, Borehamwood, Herts. WD6 1EE.
PL No.: 16782/0084 - Flixotide 125 micrograms Evohaler
PL No.: 16782/0083 – Flixotide 250 micrograms Evohaler
Flixotide, Evohaler, Haleraid and Volumatic are trademarks of the
GlaxoSmithKline group of companies.
Date of Preparation: 22nd June 2016

POM

Package leaflet: Information for the user

FLUTICASONE PROPIONATE 125
MICROGRAMS CFC-FREE INHALER
FLUTICASONE PROPIONATE 250
MICROGRAMS CFC-FREE INHALER
(fluticasone propionate)
The name of you medicine is Fluticasone propionate 125 micrograms CFCfree inhaler or Fluticasone propionate 250 micrograms CFC-free inhaler
but will be referred to as Fluticasone propionate throughout this leaflet.
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.
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 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. It has what is called an ‘anti-inflammatory action’.
Fluticasone propionate helps to prevent asthma attacks in people who
need regular treatment. This is why it is sometimes called a ‘preventer’. It
needs 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:
 if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking 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,
nurse 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)
 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 breast-feeding, think you may be pregnant or are
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.

3. HOW TO USE FLUTICASONE PROPIONATE
Fluticasone propionate comes in three different strengths. Your doctor will
have decided which strength you need. Always use Fluticasone propionate
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 Cfc-free inhaler.
 Make sure that you have one and can use it properly.
 Instructions on how to use the inhaler are given as a step-by-step guide.
 If you are over 16 years of age and are on higher doses (above 1,000
micrograms daily) you should take your medicine via the VolumaticTM
large-volume spacer device to help reduce side-effects in the mouth and
throat. Your doctor, nurse or pharmacist will be able to advise you about
this.
 Some people find it difficult to release a puff of medicine just after they
start to breathe in. The Volumatic spacer device helps to overcome this
problem. Your doctor, nurse or pharmacist will be able to advise you
about this.
 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 a day.
Fluticasone propionate 125 micrograms CFC-free inhaler and
Fluticasone propionate 250 micrograms CFC-free inhaler are not
recommended for children below 16 years of age.
It is recommended that children being treated with steroids, including
Fluticasone propionate have their height checked regularly by their doctor.
Your doctor may give you a Fluticasone propionate 250 microgram CFCfree inhaler 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 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 Fluticasone
propionate properly or as prescribed, may mean that the medicine will not
help your asthma as it should.
The medicine is contained in a pressurised canister in a plastic casing with
a mouthpiece.
Testing your inhaler
1. When using the inhaler for the first time,
test that it is working. Remove the
mouthpiece cover by gently squeezing the
sides with your thumb and forefinger and
pull apart.
2. To make sure that it works, shake it
well, point the mouthpiece away from you
and press the canister to release a puff into the air. If you have not used
the inhaler for a week or more, release two puffs of medicine into the air.
Using your inhaler
It is important to start to breathe as slowly as possible just before using
your inhaler.
1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (as shown in the first picture). Check
inside and outside to make sure that the mouthpiece is clean and free of
objects.
3. Shake the inhaler 4 or 5 times to ensure that any
loose objects are removed and that the contents of the
inhaler are evenly mixed.

4. Hold the inhaler upright with your thumb on the
base, below the mouthpiece. Breathe out as far as is
comfortable. Do not breathe in again yet.

5. Place the mouthpiece in your mouth between your
teeth. Close your lips around it. Do not bite.

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

6. Breathe in through your mouth. Just after starting to
breathe in, press down on the top of the canister to
release a puff of medicine. Do this while still breathing
in steadily and deeply.

7. Hold your breath; take the inhaler from your mouth
and your finger from the top of the inhaler.
Continue holding your breath for a few seconds, or as
long as is comfortable.
8. If your doctor has told you to take two puffs, wait
about half a minute before you take another puff by repeating steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out.
10. After use always replace the mouthpiece cover straight away to keep
out dust. Replace the cover by firmly pushing and clicking into position.
Practise in front of a mirror for the first few times. If you see a ‘mist’ coming
from the top of your inhaler or the sides of your mouth you should start
again.
Older children or people with weak hands may find it easier to hold the
inhaler with both hands. Put the two forefingers on top of the inhaler and
both thumbs on the bottom below the mouthpiece. If this does not help, a
special device called a HaleraidTM may make it easier. Your doctor, nurse
or pharmacist will be able to advise you.
Cleaning your CFC-free inhaler
To stop your inhaler blocking, it is important to clean it at least once a
week.
To clean your inhaler:
 Remove the mouthpiece cover.
 Do not remove the metal canister from the plastic casing at any time.
 Wipe the inside and outside of the mouthpiece and the plastic casing
with a dry cloth or tissue.
 Replace the mouthpiece cover.
Do not put the metal canister in water.
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

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 young people
 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 (e.g. 400 micrograms daily in children).
This can cause:
- 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 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 this medicine out of the sight and reach of children.
 Clean your inhaler on a weekly basis and if it becomes blocked as
described under ‘Cleaning’.
 Do not use this medicine after the expiry date, which is stated on the
label and carton after ‘EXP’. The expiry date refers to the last day of that
month.
 Do not store the inhaler above 30C. Protect from frost and direct
sunlight.
 If the inhaler gets very cold, take the metal canister out of the plastic
case and warm it in your hands for a few minutes before use. Never use
anything else to warm it up.
 The metal canister is pressurised. Do not puncture, break or burn it even
when apparently empty.
 Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
 If you are told to stop taking this medicine, return the inhaler to your
pharmacist to be destroyed.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluticasone propionate contains
Each actuation of Fluticasone propionate 125 micrograms CFC-free inhaler
contains 125 micrograms of fluticasone propionate.
Each actuation of Fluticasone propionate 250 micrograms CFC-free inhaler
contains 250 micrograms of fluticasone propionate.
 Also contains a CFC-free propellant 1,1,1,2 tetrafluoroethane (HFA
134a).
What Fluticasone propionate looks like and contents of the pack
 Fluticasone propionate comprises an aluminium alloy can sealed with a
metering valve, actuator and dust cap.
 Each canister contains 120 doses of 125 or 250 micrograms of
fluticasone propionate.
This medicine is manufactured by Glaxo Wellcome GmbH, 23840 Bad
Oldesloe, Germany or Glaxo Wellcome S.A., Avda. Extremadura, 3, Pol.
Ind. Allendeduero, Aranda de Duero, 09400 Burgos, Spain and is procured
from within the EU by the Product Licence holder BR Pharma International
Limited, Unit 3 Manor Point, Manor Way, Borehamwood, Herts. WD6 1EE.
PL No.: 16782/0084 - Fluticasone propionate 125 micrograms CFCfree inhaler
PL No.: 16782/0083 – Fluticasone propionate 250 micrograms CFCfree inhaler
POM
Date of Preparation: 22nd June 2016

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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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