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FLIXOTIDE ACCUHALER 250MICROGRAMS

Active substance: FLUTICASONE PROPIONATE

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Package Leaflet: Information for the user

FlixotideTM
AccuhalerTM
250 micrograms

Fluticasone Propionate
AccuhalerTM
250 micrograms

(fluticasone propionate)
Read all of this leaflet carefully before you start
taking this medicine.


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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.



If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.

Your medicine is called by any of the above names,
but will be referred to as Flixotide.
Other strengths are also available.
In this leaflet:
1
2
3
4
5
6

What Flixotide is and what it is used for
Before you use Flixotide
How to use Flixotide
Possible side effects
How to store Flixotide
Further information

1

What Flixotide is and what it is used for

Flixotide Accuhaler is a plastic inhaler device
containing a foil strip with 60 blisters. Each blister
contains 250 micrograms of the active ingredient
fluticasone propionate.
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 ‘antiinflammatory 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.

2

Before you use Flixotide

Do not use Flixotide if you are allergic
(hypersensitive) to:

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
Talk to your doctor before using this medicine if you
are pregnant, might become pregnant or are breastfeeding.
Driving and using machines
Flixotide is not likely to affect you being able to drive
or use any tools or machines.
Important information about some of the
ingredients of Flixotide
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.

• fluticasone propionate

3

• lactose or milk protein

Flixotide comes in four different strengths. Your
doctor will have decided which strength you need.
Always use Flixotide exactly as your doctor has told
you. You should 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.

• any of the other ingredients of Flixotide (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.
Take special care with Flixotide
Check with your doctor, nurse or pharmacist before
taking your medicine 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.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are
taking or have recently taken 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.

How to use Flixotide

• 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.
your
2 To open outerAccuhaler,
hold the
case in one

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.

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.

• 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
product, ask your doctor, nurse or pharmacist.

3

4

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.
Accuhaler
4Hold theout as far asaway from your mouth,
breathe
is comfortable. Do not
breathe into your Accuhaler.
Do not breath in again yet.

5 Put the mouthpiece to your
lips; breathe in steadily and
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.
the Accuhaler,
6 To close thumbgrip back
slide the
towards 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.

Possible side effects

Like all medicines, Flixotide 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 (affects less than 1 in 100 people)
- the signs include skin rashes, redness, itching or
weals like nettle rash or hives
• severe allergic reactions (affects less than 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 (affects more than 1 in 10 people)
• thrush in the mouth and throat
Common (affects less than 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.
Very rare (affects less than 1 in 10,000 people)

5

How to store Flixotide

• Store below 30°C in a dry place
• Keep out of the sight and reach of children
• Do not use Flixotide after the expiry date which is
stated on the carton (EXP). The expiry date refers
to the last day of that month
• If your Accuhaler fails to work properly or you notice
any other signs of deterioration in the disks, you
should seek the advice of your pharmacist

• joint pains

• 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.

• indigestion

6

• level of sugar (glucose) in your blood may be
increased.

What Flixotide contains
• The active substance is fluticasone propionate.
Each blister contains 250 micrograms fluticasone
propionate.
• The other ingredient is lactose which acts as the
‘carrier’.
What Flixotide looks like and contents of the pack
The Accuhaler is a plastic device containing a foil
strip with 60 blisters. The plastic Accuhaler device is
provided in a sealed foil wrapper.

• sleeping problems or feeling worried, over-excited
and irritable. These effects are more likely to occur
in children

• 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).
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.
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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.

Further information

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.
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle 2
23 Rue Lavoisier
F-27000 Evreux
France
Procured from within the EU. Product Licence Holder
and repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath
Industrial Estate, Throsk, Stirling, FK7 7NP.
POM

PL 30984/0182

Flixotide Accuhaler
250 micrograms

Leaflet date: 10.08.2012
FlixotideTM and AccuhalerTM are trademarks of the
Glaxo Group Limited.

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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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