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FLIXOTIDE ACCUHALER 100 MCG

Active substance: FLUTICASONE PROPIONATE

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1 What Flixotide is and what it is used for

10000000126663

Package Leaflet: Information for the user

GSK-FRA-Evreux-FREVR

Accuhaler

United Kingdom-GBR

®

50 micrograms,
100 micrograms,
250 micrograms,
500 micrograms

Flixotide
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fluticasone propionate
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162

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.

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• eep this leaflet. You may need to read
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it again.
• f you have any further questions, ask
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your doctor, nurse or pharmacist.
• his medicine has been prescribed for
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you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• f you get any side effects, talk to
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your doctor, nurse or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

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What is in this leaflet:
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2
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4
5
6

TEXT SIZE CONTAINED IN THIS ARTWORK

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

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Leading: 11 pt
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3 How to use Flixotide

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.
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.
• different medicine is used for treating sudden attacks (called a ‘reliever’).
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• If you have more than one medicine, be careful not to confuse them.

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.

2 What you need to know before you use Flixotide
Do not use Flixotide:
• f you are allergic to fluticasone propionate or any of the other
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ingredients of this medicine (listed in Section 6)
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o 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)
• ou are using Flixotide at the same time as taking steroid tablets. Also
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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
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f 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.
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n particular tell your doctor or pharmacist if you are taking any of the
following:
• type of antiviral medicine known as a ‘protease inhibitor’ (such as
a
ritonavir)
• medicines used to treat fungal infections (such as ketoconazole)
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f 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.

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Microtext: No

Pregnancy and breast-feeding
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f 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.

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

PHARMA CODE

Flixotide contains lactose
F
lixotide 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.

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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
• ou should be able to taste the powder on your tongue if you have
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taken it correctly
• t takes a few days for this medicine to work and it is very
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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.
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t 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
• our doctor, nurse or pharmacist should show you how to use your
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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.
• he Accuhaler is provided in a sealed foil wrapper. The wrapper provides
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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.
• here is a counter on top of the Accuhaler which tells you how many
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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

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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.

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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.

4

Hold the Accuhaler away from your mouth, breathe out as
far as is comfortable. Do not breathe into your Accuhaler.
Do not breathe 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.

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To close the Accuhaler, slide the
thumbgrip back 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.

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10000000126663
GSK-FRA-Evreux-FREVR
United Kingdom-GBR
Flixotide

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If you use more Flixotide than you should
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f you use more than you should, talk to your doctor as soon as possible.
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t 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
• o not stop treatment even if you feel better unless told to do so by
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your doctor.
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f you have any further questions on the use of this medicine, ask your
doctor, nurse or pharmacist.

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Cleaning your Accuhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

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TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10 pt
Leading: 11 pt
Horizontal Scale: 100%
Smallest text size: 10 pt
Microtext: No

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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.
• llergic reactions (may affect up to 1 in 100 people) – the signs include
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skin rashes, redness, itching or weals like nettle rash or hives
• evere allergic reactions (may affect up to 1 in 10,000 people) - the
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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):
• neumonia and bronchitis (lung infection). Tell your doctor if you notice
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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)
• leeping problems or feeling worried, over-excited and irritable. These
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effects are more likely to occur in children
• joint pains
• indigestion
• level of sugar (glucose) in your blood may be increased
• he way steroids are produced by your body may be affected when
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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.

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lthough the frequency is not known, the following side effects may also
occur:
• epression, feeling restless or nervous. These effects are more likely to
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occur in children
Talk to your doctor as soon as possible if:
• fter 7 days of using Flixotide your shortness of breath or wheezing
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does not get better, or gets worse
• ou or your child is on high doses of inhaled steroid and become
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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
Reporting of side effects
f you get any side effects, talk to your doctor, pharmacist or nurse.
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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.
B
y reporting side effects you can help provide more information on the
safety of this medicine.

Other formats:
T
o listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Flixotide 50
Flixotide 100
Flixotide 250
Flixotide 500

Reference numbers

10949/0226

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in September 2014.
Flixotide and Accuhaler are trade marks of the GSK group of companies.
© 2014 GSK group of companies. All rights reserved.

5 How to store Flixotide
• Store in a dry place to protect from moisture.
• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• tore the Accuhaler in the foil wrapper until you are ready to use it for
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the first time. Once opened, the foil wrapper should be discarded.
• o not use this medicine after the expiry date which is stated on the
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carton after EXP. The expiry date refers to the last day of that month.
• o not throw away any medicines via wastewater or household waste.
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Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6 Contents of the pack and other information
What Flixotide contains
• The active substance is fluticasone propionate
• The other ingredient is lactose
What Flixotide looks like and contents of the pack
The plastic Accuhaler device is provided in a sealed foil wrapper. The
Accuhaler contains foil strips with blisters which contain fluticasone
propionate and lactose. The blisters protect the powder for inhalation
from the effects of the atmosphere.
Each blister contains 50 micrograms, 100 micrograms, 250 micrograms
or 500 micrograms fluticasone propionate, and lactose which acts as the
‘carrier’.
The 50, 100, 250 or 500 micrograms Flixotide packs contain sixty blisters.
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.
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France

10000000126663

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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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