FLIXOTIDE EVOHALER 125 MICROGRAMS
Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE
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 sideeffects 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.
PACKAGE LEAFLET: INFORMATION FOR USER
FLIXOTIDE EVOHALER 125 micrograms
Your medicine is known by one of the above names but will be
referred to as Flixotide or Flixotide Evohaler throughout the
following patient information leaflet.
Information about other strengths is also available in this leaflet.
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
Adults and Children over 16 years of age
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.
What is in this leaflet:
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
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
A different medicine is used for treating sudden attacks (called
If you have more than one medicine, be careful not to confuse
WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXOTIDE
Do not use:
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
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.
Warnings and precautions
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.
Talk to your doctor, nurse or pharmacist before taking if:
Using your inhaler
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.
It is important to start to breathe as slowly as possible just before
using your inhaler.
if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).
If you are not sure if any of the above applies to you, talk to your
doctor, nurse or pharmacist before using Flixotide.
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.
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
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
3 Shake the inhaler 4 or 5
4 Hold the inhaler upright with
times to ensure that
your thumb on the base,
any loose objects are removed
below the mouthpiece.
and that the contents of the
Breathe out as far as is
inhaler are evenly mixed.
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 medicine.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any
tools or machines.
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-bystep guide.
5 Place the mouthpiece in
your mouth between your
6 Breathe in through your mouth.
Just after starting to breathe in,
teeth. Close your lips
press down on the top of
around it. Do not bite.
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
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
Talk to your doctor as soon as possible if:
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.
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
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:
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.
Remove the mouthpiece cover.
Do not remove the metal canister from the plastic casing at any
Wipe the inside and outside of the mouthpiece and the plastic
casing with a dry cloth or tissue.
HOW TO STORE FLIXOTIDE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Replace the mouthpiece cover.
Do not store at a temperature 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.
WARNING. The metal canister is pressurised. Never puncture
or break the canister or try to burn it even if you think it is
Do not use Inhaler after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of the
If your inhaler shows any signs of deterioration or if it doesn’t
work properly, take it back to your pharmacist.
If you are told to stop taking this medicine take any inhalers
which you haven’t finished back to your pharmacist for safe
CONTENTS OF THE PACK AND OTHER INFORMATION
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.
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
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
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
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
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
depression, feeling restless or nervous. These effects are more
likely to occur in children
What Flixotide contains
Each metered actuation or puff provides 125 micrograms of the
active ingredient fluticasone propionate.
The inhaler also contains a CFC free propellant HFA 134a
What Flixotide Evohaler looks like and contents of the pack
Flixotide Evohaler consists of a pressurised canister contained in an
orange plastic actuator with a mouthpiece cover.
Each inhaler provides 120 metered actuations (puffs).
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
This product is manufactured by
GlaxoWellcome S.A. Burgos, Spain.
GlaxoWellcome Production, France.
PL : 08747/0510
Leaflet revision date: 10 August 2017
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this leaflet hard to see or read?
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leaflet in large print, tape, CD
Flixotide and Evohaler are registered trademarks of Glaxo Group
510 LEAFLET Flixotide Evohaler 20170810
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.