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FLUTICASONE PROPIONATE CFC-FREE INHALER 125MICROGRAMS

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

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413 LEAFLET Flixotide Evohaler 20170606

PACKAGE LEAFLET: INFORMATION FOR USER

FLIXOTIDE EVOHALER 125 micrograms
FLIXOTIDE CFC-FREE INHALER 125 micrograms
FLUTICASONE PROPIONATE
CFC-FREE INHALER 125 micrograms
(fluticasone propionate)
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.



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.



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.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, nurse or
pharmacist.

Mild asthma



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.

Moderate to severe asthma



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’.

Adults and Children over 16 years of age



The usual starting dose is 100 micrograms twice a day.
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

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.

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.

Flixotide will not help treat sudden asthma attacks where you feel
breathless.

The medicine is contained in a pressurised canister in a plastic
casing with a mouthpiece.



A different medicine is used for treating sudden attacks (called
a ‘reliever’).

Testing your inhaler



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

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.

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) 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
ketoconazole).

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.

5 Place the mouthpiece in

6 Breathe in through your mouth.

Driving and using machines

your mouth between your

Flixotide is not likely to affect you being able to drive or use any
tools or machines.

teeth. Close your lips

press down on the top of

around it. Do not bite.

the canister to release a puff of

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.

Just after starting to breathe in,

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.

Talk to your doctor as soon as possible if:

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



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

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:

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.



Remove the mouthpiece cover.



Do not remove the metal canister from the plastic casing at any
time.

5

HOW TO STORE FLIXOTIDE



Wipe the inside and outside of the mouthpiece and the plastic
casing with a dry cloth or tissue.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Protect from direct sunlight.

Replace the mouthpiece cover.



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
empty.



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
month.



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
disposal

6

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.
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.






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
(1,1,1,2-tetrafluoroethane).

allergic reactions (may affect up to 1 in 100 people) – the signs
include skin rashes, redness, itching or weals like nettle rash or
hives

What Flixotide Evohaler looks like and contents of the pack

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

Each inhaler provides 120 metered actuations (puffs).

your breathing or wheezing gets worse straight after using your
inhaler

Flixotide Evohaler consists of a pressurised canister contained in an
orange plastic actuator with a mouthpiece cover.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

Other side effects include:
Very common (may affect more than 1 in 10 people)

Manufacturer

 thrush in the mouth and throat
Common (may affect up to 1 in 10 people)

This product is manufactured by Glaxo Wellcome Production, ZI No
2, Rue Lavoisier, 27000 Evreux, France.



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 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

POM

PL 08747/0413

Leaflet revision date: 06 June 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Flixotide and Evohaler are registered trademarks of Glaxo Group
Limited.UK

413 LEAFLET Flixotide Evohaler 20170606

Expand Transcript

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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