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FLIXOTIDE 250 ACCUHALER

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

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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.
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.

5. HOW TO STORE FLIXOTIDE
Expiry Date
Do not use this medicine after the expiry date
shown on the carton label. If your doctor tells you
to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
Storage Instructions
• Do not store Flixotide Accuhaler above 30°C.
• Store in a dry place.
• Keep out of sight and reach of children.
• If you notice any signs of deterioration, ask your
doctor or pharmacist for advice.
• 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 the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Flixotide contains
Flixotide is a plastic inhaler device and is available
in different strengths. Your doctor will have
decided which strength you need.
• The active substances are either 250 & 500
micrograms fluticasone propionate.
• The other ingredient is lactose (which is the
carrier).
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.





Flixotide is a two tone orange and brown,
circular device in moulded plastic containing
inhalation powder and with a dose counter
indicating the number of doses remaining.
Flixotide 250 & 500 Accuhaler contains a foil
strip with 60 blisters.

To show when the last five blisters have been
reached, the numbers appears in red. When the
counter shows 0, your inhaler is empty and should
be disposed of.
Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
Production, 23 Rue Lavoisier 27000, Evreux,
France and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0539 - Flixotide 500 Accuhaler/
Fluticasone Propionate 500 Microgram
Accuhaler
PL 15184/0540 - Flixotide 250 Accuhaler/
Fluticasone Propionate 250 Microgram
Accuhaler

This product was originally marketed as Flixotide
Diskus. Flixotide Diskus and Flixotide Acchaler are
the same.
Flixotide, Diskus and Accuhaler are registered
trademarks of the GlaxoSmithKline Group of
Companies.
Leaflet revision date: 16/04/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 053940/160415/1/F
PATIENT INFORMATION LEAFLET
®
FLIXOTIDE 250 ACCUHALER/
FLUTICASONE PROPIONATE 250 MICROGRAM ACCUHALER/
®
FLIXOTIDE 500 ACCUHALER/
FLUTICASONE PROPIONATE 500 MICROGRAM ACCUHALER
(fluticasone propionate)

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.
Your medicine is called Flixotide 250 Accuhaler/
Fluticasone Propionate 250 microgram/Flixotide
500 Accuhaler/Fluticasone Propionate 500
microgram Accuhaler and will be referred to as
Flixotide throughout the rest of this leaflet.
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
Flixotide Accuhaler is a plastic inhaler device
containing a foil strip with 28 or 60 blisters. Each
blister contains 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.
• 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. 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.
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 are breast-feeding, think
you may be pregnant or 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.

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 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 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.
3. 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.

6. 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.
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.

4. 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 (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).
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
Ref: 053940/160415/1/B

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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