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Package Leaflet: Information for the user

Flixotide® Accuhaler® 50 micrograms, 100 micrograms, 250 micrograms,

500 micrograms

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.
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 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.
 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 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
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, 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
 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

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

 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.
 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 this medicine after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
 Do not throw away any medicines via wastewater or household waste. 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
Other formats:
To 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.

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