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FLIXOTIDE ACCUHALER 500 MICROGRAMS

Active substance: FLUTICASONE PROPIONATE

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341 Flixotide LEAFLET 20120806

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLIXOTIDE ACCUHALER 500 micrograms
(fluticasone propionate)

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant,
might become pregnant or are breast-feeding.
Driving and using machines

Your medicine is known as the above name but will be referred to
as Flixotide or Flixotide Accuhaler throughout the following leaflet.

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

Please note that information for other strengths of this medicine is
also included in below leaflet.

Important information about some of the ingredients of
Flixotide

Read all of this leaflet carefully before you start taking this
medicine.

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.



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.

In this leaflet:

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. You should check with your doctor, nurse
or pharmacist if you are not sure.
Using this medicine

1

What Flixotide is and what it is used for

The medicine in Flixotide should be inhaled using a special kind of
inhaler called an Accuhaler.

2

Before you use Flixotide



Make sure that you have one and can use it properly

3

How to use Flixotide



4

Possible side effects

Instructions on how to use the inhaler are given as a step-bystep guide

5

How to store Flixotide



6

Further information

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.

1. WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR

Adults and Children over 16 years of age

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

Mild asthma

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.

Moderate to severe asthma

Flixotide works by reducing swelling and irritation in the lungs. They
have what is called an ‘anti-inflammatory action’.



The usual starting dose is 100 micrograms twice a day.



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.

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.



The most taken should be 200 micrograms twice a day.

Flixotide will not help treat sudden asthma attacks where you feel
breathless.

It is recommended that children being treated with steroids,
including Flixotide Accuhaler have their height checked regularly by
their doctor.



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:


fluticasone propionate



lactose or milk protein



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

Flixotide Accuhaler 250 micrograms and Flixotide Accuhaler 500
micrograms are not recommended for children 16 years and under.

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.



If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Flixotide.

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.



Taking other medicines

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.

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.

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.
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).

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.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Flixotide.

Using your inhaler

Using Flixotide with food and drink

1

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

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.

Very rare (affects less than 1 in 10,000 people)
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
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.

6



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.
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.

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 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.
5. HOW TO STORE FLIXOTIDE

If you use more Flixotide than you should



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

If you use more than you should, talk to your doctor as soon as
possible.



Do not store above 30°C.



Store in a dry place to protect from moisture.

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.



Store the Accuhaler in the foil wrapper until you are ready to
use it for the first time. Once opened, the foil should be
discarded.

If you forget to use Flixotide



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.



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 product, ask
your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Flixotide can cause side effects, although not
everybody gets them.

What Flixotide Accuhaler contains

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.



Each Flixotide Accuhaler blister contains powder for inhalation
providing 500 micrograms of the active ingredient fluticasone
propionate per actuation.



The other ingredient is lactose.



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

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.





your breathing or wheezing gets worse straight after using your
inhaler.

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



Flixotide Accuhaler is a two-tone orange and brown coloured
moulded plastic inhaler device which contains a foil strip. 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.

What Flixotide looks like and contents of the pack

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.

Product Licence Holder:

The following side effects have also been reported in patients with
Chronic Obstructive Pulmonary Disease (COPD):

Procured from within the EU and re-packaged by the PL holder:
Chemilines Ltd, Chemilines House, Alperton Lane, Wembley,
Middlesex HA0 1DX, England.AT



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

Manufacturer:

Bruising.

Leaflet revision date: 6 August 2012



This product is manufactured by Glaxo Wellcome Production,
27000 Evreux, France or Glaxo Operations UK Ltd., England.
POM

PL No: 08747/0341

Flixotide and Accuhaler are registered trademarks of the
GlaxoSmithKline group of companies.
341 Flixotide LEAFLET 20120806

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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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