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FLIXOTIDE 100 MICROGRAMS ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE

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Package Leaflet: Information for the
user

Flixotide® 100 microgram
Accuhaler® /

Fluticasone Propionate
100 microgram Accuhaler
®

Flixotide

®

250 microgram

®

Accuhaler /

Fluticasone Propionate
250 microgram Accuhaler

®

Flixotide® 500 microgram
Accuhaler® /

Fluticasone Propionate
500 microgram Accuhaler
(fluticasone propionate)

®

This product is available as any of the
above names but will be referred to as
Flixotide throughout the remainder of
this leaflet. Please note this leaflet also
contains information about other
strengths (Flixotide 50 microgram
Accuhaler).
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

Using Flixotide with food and drink
You can use Flixotide at any time of day, with or without
food.

Flixotide Accuhaler is a plastic inhaler device containing a
foil strip with 28 or 60 blisters. Each blister contains 50,
100, 250 or 500 micrograms of the active ingredient
fluticasone propionate.

Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, think you may
be pregnant or planning to have a baby, ask your doctor
for advice before taking this medicine.

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. They have what is called an ‘anti-inflammatory
action’.
Flixotide helps to prevent asthma attacks in people who
need regular treatment. This is why they are sometimes
called ‘preventers’. They need 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.

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

2 What you need to know before you use
Flixotide
Do not use Flixotide:
• If you are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in Section 6).
Do not use Flixotide if any of the above applies to you. If
you are not sure, talk to your doctor, nurse or pharmacist
before using Flixotide.
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 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.

Flixotide contains lactose
Flixotide contains lactose (a type of sugar). If you have
been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to
your doctor before using this medicine.

3 How to use Flixotide
Flixotide comes in four 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 Accuhaler.
• 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
• You should be able to taste the powder on your tongue
if you have taken it correctly
• 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
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 Accuhaler 250 micrograms and Flixotide
Accuhaler 500 micrograms are not recommended for
children 16 years and under.
It is recommended that children being treated with
steroids, including Flixotide Accuhaler have their height
checked regularly by their doctor. Your doctor may give
you a Flixotide Accuhaler 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 Accuhaler 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 Accuhaler
properly or as prescribed may mean that it will not help
your asthma as it should.
• The Accuhaler is provided in a sealed foil wrapper. The
wrapper provides protection from moisture and should
only be opened when you are ready to use it for the first
time. Once opened the foil wrapper should be
discarded.
• The Accuhaler device holds blisters containing Flixotide
as a powder.
• There is a counter on top of the Accuhaler which tells
you how many doses are left. It counts down to 0. The
numbers 5 to 0 will appear in red to warn you when
there are only a few doses left. Once the counter shows
0, your inhaler is empty.
Do not use your inhaler more often than the doctor told
you to. Tell your doctor if your medicine does not seem to
be working as well as usual, as your chest problem may
be getting worse and you may need a different medicine.
Your doctor may have told you to take more than this as
an emergency treatment if your wheezing or breathing
gets very bad. It is very important that you keep to your
doctor’s instructions as to how many blisters to take and
how often to use your inhaler.
Using your inhaler

1

Inside the carton, your Accuhaler is provided in a
sealed foil wrapper. To open this wrapper, tear
along the jagged edge, then remove the Accuhaler, and
throw the wrapper away.
If you have trouble tearing the foil, do not use scissors
or any other sharp objects as you may harm yourself or
the Accuhaler. Ask someone to help you.

2

To open your Accuhaler,
hold the outer case in one
hand and put the thumb of your
other hand on the thumbgrip.
Push your thumb away from you
as far as it will go. You will hear
a click.
This will open a small hole in the
mouthpiece.

Hold your Accuhaler with
the mouthpiece towards
you. You can hold it in either
your right or left hand. Slide the
lever away from you as far as it
will go. You will hear a click.
This places a dose of your
medicine in the mouthpiece.
Every time the lever is pulled back a blister is opened
inside and the powder made ready for you to inhale. Do
not play with the lever as this opens the blisters and
wastes medicine.

3

4
5

Hold
Hold the Accuhaler away from your mouth, breathe
out
out as far as is comfortable. Do not breathe into
your Accuhaler. Do not breathe in again yet.
Put
Put the mouthpiece to your
lips;
lips; breathe in steadily and
deeply
deeply through the Accuhaler
with your mouth, not through
your nose. Remove the
Accuhaler from your mouth.
Hold your breath for about 10
seconds or for as long as is
comfortable. Breathe out slowly.

6

To
T
o close the Accuhaler,
slide the thumbgrip back
slide
towar
towards
ds you, as far as it will go.
You will hear a click. The lever
will return to its original position

and is reset.
Your Accuhaler is now ready
for you to use again.
Afterwards, rinse your mouth with
water and spit it out.
Cleaning your Accuhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to
clean it.
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.

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

propionate. The device has a counter
which tells you the number of blisters
remaining. It counts down from 60 to 0.
To show when the last five blisters have
been reached the numbers appear in
red. When the counter shows 0 your
inhaler is empty and should be disposed
of.

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

Manufacturer
Flixotide is manufactured by Glaxo
Wellcome Production, Zone Industrielle
2, Rue Lavoiser 23, F-27000 Evreux,
France and is procured from within the
EU by the Product Licence holder:
Caseview (PL) Ltd., 20 Alliance Court,
Alliance Road, London W3 0RB and
repackaged by OPD Laboratories Ltd,
Unit 6 Colonial Way, Watford, Herts
WD24 4PR.

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.

POM

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.
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)

5 How to store Flixotide










Keep out of the sight and reach of children.
Do not store above 30°C. Store in a dry place to protect
from moisture. Store the Accuhaler in the foil wrapper
until you are ready to use it for the first time. Once
opened, the foil wrapper should be discarded.
If you are told to stop taking this medicine return
Flixotide Accuhaler to the pharmacist for disposal.
Do not use Flixotide after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
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 your medicine become discoloured or show signs of
any deterioration, you should seek the advice of your
pharmacist.

6 Contents of the pack and other information
What Flixotide contains
Flixotide is provided in a sealed foil wrapper.
Flixotide Accuhaler contains the active ingredient
fluticasone propionate and the inactive ingredient lactose
monohydrate which acts as the ‘carrier’. It is a two tone
orange and brown colour, circular device in moulded
plastic containing inhalation powder and with a dose
counter indicating number of doses remaining. The blister
protects the powder for inhalation from the effects of the
atmosphere. Each blister contains 100, 250 or 500
micrograms of the active ingredient fluticasone

PL 13826/0553
Flixotide® 100 micrograms Accuhaler® /
Fluticasone Propionate 100 micrograms
Accuhaler®
PL 13826/0554
Flixotide® 250 micrograms Accuhaler® /
Fluticasone Propionate 250 micrograms
Accuhaler®
PL 13826/0555
Flixotide® 500 micrograms Accuhaler® /
Fluticasone Propionate 500 micrograms
Accuhaler®
Leaflet revision date (ref): 13.03.2015.
Flixotide and Accuhaler are trademarks
of the GSK group of companies.
To request a copy of this leaflet in
Braille, large print or audio please call
01923 332 796.

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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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