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Package leaflet: Information for the user

Flixotide® Evohaler® 125micrograms
(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
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 Evohaler 125micrograms, but it will
be referred to as Flixotide throughout this leaflet. Please note that the leaflet
also contains information about other strength Flixotide Evohaler

What is in this leaflet:

What Flixotide is and what it is used for
What you need to know before you use Flixotide
How to use Flixotide
Possible side effects
How to store Flixotide
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
 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).

It is recommended that children being treated with steroids, including
Flixotide Evohaler have their height checked regularly by their doctor.
Your doctor may give you a Flixotide 250microgram Evohaler if your dose is
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
Evohaler 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 Flixotide
Evohaler 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

Testing your inhaler
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.


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.
Remove the mouthpiece cover (as shown in the first picture).
inside and outside to make sure that the mouthpiece is clean
2 Check
and free of objects.

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
 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

3 4 or 5 times to
ensure that any loose

Shake the inhaler

4 thumb on the base, below the
mouthpiece. Breathe out as far as is

Hold the inhaler upright with your

objects are removed and
that the contents of the
inhaler are evenly mixed.

comfortable. Do not breathe in again

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.

Place the

mouthpiece in your
between your
teeth. Close your lips
around it. Do not bite.

Breathe in through your mouth. Just

6 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

Driving and using machines
If your doctor has told you to take

Flixotide is not likely to affect you being able to drive or use any tools or

two puffs, wait about half a minute
you take another puff by

3 How to use Flixotide

repeating steps 3 to 7.

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
1,000micrograms daily) you should take your medicine via the
Volumatic 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 100micrograms twice a day.
Moderate to severe asthma
 The usual starting dose is 250 to 500micrograms twice a day.
 The most taken should be 1000micrograms twice a day.

Flixotide Evohaler 125 and 250micrograms are not
recommended for children below 16 years of age.

Hold your breath, take

7 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.

Afterwards, rinse your mouth with
water and spit it out.

After use always replace the
10 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
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 Haleraid 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

6 Contents of the pack and other information

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.

What Flixotide contains

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


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
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. 400micrograms 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. Protect from frost and direct sunlight.
Clean the inhaler on a weekly basis and if it becomes blocked as
described under ‘Cleaning’.
The metal canister is pressurised. Do not puncture, break or burn it even
when apparently empty.
Do not use the Evohaler after the expiry date, which is stated on the
carton and canister labels after ‘Exp’. The expiry date refers to the last
day of that month.
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.
Remember if your doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe disposal. Only keep
this medicine 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.

Each puff or actuation provides 125micrograms of the active ingredient
Fluticasone propionate.
The other ingredient is CFC Free propellant, 1,1,1,2-tetrafluoroethane
Flixotide Evohaler 125microgram contains the same medicine as Flixotide
Inhaler, but may taste slightly different because the propellant gas is slightly
Flixotide Evohaler contains the same medicine as Flixotide Inhaler, but may
taste slightly different because the propellant gas is slightly different.

What Flixotide looks like and contents of the pack
Flixotide is a pressurised metered dose inhaler with an orange plastic body
and a light orange cap.
Each canister provides 120 puffs.

Manufactured by: GlaxoWellcome Production, France OR
GlaxoWellcome S.A., Spain.

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® Evohaler® 125micrograms; PL 18799/0005
Leaflet date: 22.11.2017


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Call 0208 515 3763 to obtain the
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