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Package Leaflet: Information for the user

Flixotide® 125 micrograms Evohaler® /
Fluticasone propionate 125 micrograms Inhaler
(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
 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.
 Your medicine is available using either of the above names but will be
referred to as Flixotide throughout this leaflet.
 Please note that this medicine is also available in other strengths.

Adults and Children over 16 years of age
Mild asthma
 The usual starting dose is 100 micrograms twice a day.

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

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.

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
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
 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).
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).

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.

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.

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

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

Driving and using machines
Flixotide is not likely to affect you being able to drive or use any tools or
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
 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.

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
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
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

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:
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 use Flixotide Evohaler 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 above 30oC. Do not refrigerate or freeze. Protect from
heat, 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.
 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
What Flixotide contains
 Each actuation contains 125 micrograms of fluticasone propionate.
 Also contains a CFC-Free propellant: HFA 134a.
What Flixotide 125 micrograms Evohaler looks like and contents of
the pack
 Flixotide 125 micrograms Evohaler is a white to off-white inhalation
suspension contained within an aluminium pressurised container fitted
with an actuator; having an orange plastic body and a paler orange
plastic cap, contained in a printed cardboard carton.
 Each canister contains 120 metered actuations of 125 micrograms of
fluticasone propionate.
Manufactured by
Glaxo Wellcome S.A., Avda. Extremadura, 3, Pol. Ind. Allendeduero,
Aranda de Duero, 09400 Burgos, Spain
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0427



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

Leaflet dated 8 June 2017
Leaflet coded xxxxxxxx
Flixotide®, Evohaler®, Haleraid® and Volumatic® are registered
trademarks of the GlaxoSmithKline group of companies.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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