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FLIXOTIDE 125 MICROGAMS EVOHALER

Active substance(s): FLUTICASONE PROPIONATE

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5. How to store Flixotide
 Keep out of the sight and reach of children.
 Clean you 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 30°C. Do not refrigerate
or freeze. Keep pressurised canister away
from heat and light.
 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 provides either 125 or 250
micrograms of the active ingredient,
fluticasone propionate.
 It also contains a propellant, Norflurane (HFA
134a).
What Flixotide Evohaler looks like and
contents of the pack
 Flixotide 125 Evohaler is available as a
pressurised metered dose inhaler within an
orange casing with a brownish-orange
removable cap.
Flixotide 250 Evohaler is available as a
pressurised metered dose inhaler within a
reddish-brown casing with an orange
removable cap.
 Each canister provides 120 metered
actuations (or puffs).
Manufacturer and Product Licence Holder:
Flixotide Evohaler is manufactured by Glaxo
Wellcome SA, Avenida Extremadura, 3, 09400
Aranda de Duero, Burgos, Spain.
Procured from within the EU Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge
Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

Flixotide 125 micrograms
Evohaler
PL 20636/1457
Flixotide 250 micrograms
Evohaler
PL 20636/1458

Leaflet revision and issue date (Ref) 06.07.15[14]
Evohaler and Flixotide are trademarks of the
GlaxoSmithKline group of companies.

PATIENT INFORMATION LEAFLET

1457/1458
06.07.15[14]

FLIXOTIDE® 125 MICROGRAMS EVOHALER®
FLIXOTIDE® 250 MICROGRAMS EVOHALER®
(fluticasone propionate)
Your medicine is available as one of the above
names but will be referred to as Flixotide
throughout this leaflet.

If you are not sure if any of the above applies
to you, talk to your doctor, nurse or
pharmacist before using Flixotide.

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.

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.

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 ‘antiinflammatory 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.

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, overexcited 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.

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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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