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FLIXOTIDE 250 EVOHALER

Active substance(s): FLUTICASONE PROPIONATE

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5. HOW TO STORE FLIXOTIDE
Expiry date
Do not use this medicine after the expiry date
shown on the metal canister label or carton label.
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.
Storing your medicine
• Keep out of the sight and reach of children.
• Do not store above 30°c. Protect from heat,
direct sunlight and frost. Do not refrigerate.
• Do not puncture, break or burn the metal
canister even when apparently empty.
• If your inhaler gets very cold, remove the metal
canister from the plastic case and warm it in
your hands for a few minutes before use. Never
warm it in any other way.
• If you notice any signs of deterioration ask your
doctor or pharmacist for advice
Important
Remember this medicine is for you. Only a doctor
can prescribe it. Never give your medicine to other
people. It may harm them, even if their symptoms
are the same as yours. This leaflet does not tell
you everything about your medicine. If you have
any questions or are not sure about anything, ask
your doctor or pharmacist (chemist). He/she will
have additional information about this medicine
and will be able to advise you.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Flixotide Evohaler contains
• Each metered actuation contains 125
micrograms or 250 micrograms of the active
ingredient Fluticasone Propionate
• The other ingredients are CFC-free propellant,
1,1,1,2 tetrafluoroethane (HFA 134a)
What Flixotide Evohaler looks like and
contents of the pack
• The Flixotide Evohaler is a pressurised metered
dose inhaler.
• The 125 evohaler has an orange plastic body
and a peach coloured dust cap, the 250
evohaler has a reddish plastic body and a peach
coloured dust cap. Each canister contains 120
metered actuations or puffs.
• Each metered actuation contains 125
micrograms or 250 micrograms of the active
ingredient Fluticasone Propionate.
Manufacturer and Licence Holder
Flixotide Evohaler is manufactured by Glaxo
Wellcome S.A., Avda. Extremadura, 3, Pol. Ind,
Allendeduero, Aranda de Duero, 09400 Burgos,
Spain and procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

Flixotide 125 Evohaler / Fluticasone
Propionate 125 microgram Evohaler
PL 15184/0596
Flixotide 250 Evohaler / Fluticasone
Propionate 250 microgram Evohaler
PL 15184/0595

PATIENT INFORMATION LEAFLET

Ref: 05956/190216/2/F

®

Flixotide® 125

Evohaler /
Fluticasone Propionate 125 microgram Evohaler ®
Flixotide® 250 Evohaler ®/
Fluticasone Propionate 250 microgram Evohaler ®
(fluticasone propionate)

Flixotide, Evohaler, Haleraid and Volumatic are
registered trademarks of the GlaxoSmithKline
Group of Companies.
Leaflet revision date: 19/02/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.
Your medicine is called Flixotide 125 Evohaler/
Fluticasone Propionate 125 microgram Evohaler/
Flixotide 250 Evohaler/Fluticasone Propionate 250
Evohaler but will be referred to as Flixotide
throughout this leaflet.
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.

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.

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

3

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.

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.

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.

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

5

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

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.

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.

6

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.

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.

9

Afterwards, rinse your
mouth with water and
spit it out

After use always replace the mouthpiece
cover straight away to keep out dust. Replace
the cover by firmly pushing and clicking into
position

10

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.

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

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.

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.

Ref: 05956/190216/2/B

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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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