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FLUTICASONE PROPIONATE 125 MICROGRAMS EVOHALER

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE® 125 micrograms EVOHALER®/
FLUTICASONE PROPIONATE 125 micrograms EVOHALER®
(fluticasone propionate)
This product is available in the above names but will be referred
to as Flixotide throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will
be referred to throughout 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
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.
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.

 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

2. What you need to know before you use Flixotide
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.

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-bystep guide.

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.

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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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