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FLIXOTIDE 50MICROGRAMS ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE

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Flixotide contains lactose

S1002 Flixotide LEAFLET 20150512

Package Leaflet: Information for the user
®

FLIXOTIDE 50 micrograms ACCUHALER
(fluticasone propionate)

®

Your medicine is known by the above name but will be referred to as
Flixotide or Accuhaler throughout the following leaflet.
Please note that information regarding other strengths of Flixotide
Accuhaler (100 micrograms, 250 micrograms and 500 micrograms)
may also be present in the below leaflet.
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.

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
What is in this leaflet:

Mild asthma

1

What Flixotide is and what it is used for



2

What you need to know before you use Flixotide

Moderate to severe asthma

3

How to use Flixotide



The usual starting dose is 250 to 500 micrograms twice a day

4

Possible side effects



The most taken should be 1000 micrograms twice a day

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 60 blisters. Each blister contains 50 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


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.

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.

The usual starting dose is 100 micrograms twice a day

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
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.
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.

Very rare (may affect up to 1 in 10,000 people)
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.



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)

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

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.

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
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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store in a dry place to protect form moisture.

If you forget to use Flixotide



Do not store above 30°C.



Take the next dose when it is due.





Do not take a double dose to make up for the forgotten dose.

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.



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 the Flixotide shows any signs of deterioration or if it doesn’t
work properly, take it back to your pharmacist.



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.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

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 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.


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



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)




Each Flixotide Accuhaler blister contains powder for inhalation
providing 50 micrograms of the active ingredient fluticasone
propionate per actuation.



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.



Peel off label from enclosed foil pouch and apply to the Accuhaler
when foil pouch is first opened.



Flixotide Accuhaler is an orange and red coloured moulded plastic
inhaler device which contains a foil strip with 60 blisters.



An Accuhaler is an easy to use inhaler which is designed to
release a dose of medicine into your lungs when you take a breath
in.



This device has a counter which counts down from 60 to 0.
Numbers 5 to 0 are red to warn you that the Accuhaler is nearly
empty. When the counter shows 0 the device is empty and should
be disposed of.



The devices are packed in cartons which hold one Accuhaler each
containing 60 inhalations.

your breathing or wheezing gets worse straight after using your
inhaler

Other side effects include:


What Flixotide contains

Product Licence Holder:
Procured from within the EU and re-packaged by the PL holder:
S & M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
Middlesex HA0 1DX, England.A
Manufacturer:
This product is manufactured by either:


Bial – Portela & Ca, S.A., A Av. da Siderurgia Nacional,
4745-457 S. Mamede do Coronado, Portugal or



Glaxo Wellcome Production, 23 Rue Lavoisier, Zone
Industrielle no.2, 27000 Evreux, France.

thrush (candidiasis) in the oesophagus

POM

PL 19488/1002

Leaflet revision date: 12 May 2015
Flixotide and Accuhaler are registered trademarks of the
GlaxoSmithKline group of companies.
S1002 Flixotide LEAFLET 20150512

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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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