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FLIXOTIDE 250 MCG EVOHALER

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the use

Flixotide™ 250mcg Evohaler™
(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 250 microgram
Evohaler but will be referred to as Flixotide throughout the
remainder of the leaflet.
Flixotide is also available in 125 microgram and 50
microgram strengths.
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 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 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 Evohaler 125 and 250 micrograms are not
recommended for children below 16 years of age.
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 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 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 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 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
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 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 store above 30°C. Do not refrigerate or freeze.
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.
WARNING - the metal canister is pressurised. Do not
puncture, break or burn it even when apparently empty.
Do not use after the date shown as ‘EXP’ on the carton
and label.
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.
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
The active ingredient in Flixotide is fluticasone propionate.
The other ingredient is HFA 134a.
Each puff provides 250 micrograms of the active
ingredient, fluticasone propionate.
Each canister provides 120 puffs
Manufactured by Glaxo Wellcome S.A., Avda.
Extremadura, 3, Pol. Ind. Allendeduero, Aranda de Duero,
09400 Burgos, Spain. Procured from within the EU.
Product Licence holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA.
Repackaged by Maxearn Ltd, Bolton BL6 4SA.
Flixotide 250mcg Evohaler

PL 20774/0614

Flixotide and Evohaler are trademarks of the
GlaxoSmithKline group of companies.
Date of preparation: 29th July 2015

PP8/0614/V2

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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