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FLIXOTIDE 50 MICROGRAMS EVOHALER

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the user
®

50 micrograms

Flixotide evohaler

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

®

fluticasone propionate

• K eep 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.

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What is in this leaflet:
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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 ‘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 the other ingredients of
this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Flixotide 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.

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.

Children (4 to 16 years of age)
• The usual starting dose is 50 micrograms twice a day.
• The most taken should be 200 micrograms twice a day.
Flixotide Evohaler 50 micrograms is not recommended for children
below 4 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 Evohaler of a higher strength 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.

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Stand or sit upright when using your inhaler.
R emove 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.

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.

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4

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.

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.

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3 How to use Flixotide
Flixotide comes in three different strengths. Your doctor will have
decided which strength you need. Always use this medicine 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.

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

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.

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• I t takes a few days for this medicine to work and it is very
important that you use it regularly.

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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.

United Kingdom-GBR

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Afterwards, rinse your mouth
with water and spit it out

Flixotide evohaler

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.

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

P ractise 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.
Young children may need help and their parents may need to
operate the inhaler for them. Encourage the child to breathe out
and operate the inhaler just after the child starts to breathe in.
Practise the technique together. You may find the Volumatic ® spacer
device with a face mask, or the Babyhaler® device, useful if you have
to give Flixotide Evohaler to a baby or a child under 5 – speak to
your doctor if you think you might need one of these.
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

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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
• T ake 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
• D
 o 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 children






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:
- children and 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:
• a fter 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
• K eep this medicine 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 this medicine 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. 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.
• The metal canister is pressurised. Do not puncture, break or burn it
even when apparently empty.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help 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
• T he active substance is fluticasone propionate
• The other ingredient is HFA 134a.

What Flixotide Evohaler looks like and contents of the pack
• F lixotide Evohaler comprises an aluminium alloy can sealed with a
metering valve, actuator and dust cap.
• Each canister contains 120 doses of 50 micrograms of fluticasone
propionate.

Marketing Authorisation Holder:
Glaxo Wellcome UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Manufacturer:
Glaxo Wellcome S.A.
Aranda de Duero
Burgos
Spain.

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Flixotide 50 mcg Evohaler
Reference numbers 10949/0324
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in December 2014
Flixotide and Evohaler are registered trade marks of the GSK group of
companies.
© 2014 GSK group of companies. All rights reserved.

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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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