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Flixotide Accuhaler 50 micrograms
Flixotide® Accuhaler® 100 micrograms
Fluticasone Propionate Accuhaler® 100
Flixotide® Accuhaler® 250 micrograms
Fluticasone Propionate Accuhaler® 250
Flixotide® Accuhaler® 500 micrograms
Fluticasone Propionate Accuhaler® 500


 a type of antiviral medicine known as a ‘protease inhibitor’ (such as
 medicines used to treat fungal infections (such as ketoconazole).
If you are not sure if any of the above apply 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
Talk to your doctor before using this medicine if you are pregnant, might
become pregnant or are breast-feeding.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any tools or

(Fluticasone Propionate)
This product is available using any of the above names but will referred to
as Flixotide Accuhaler throughout this leaflet
Read all of this leaflet carefully before you start taking 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:
1. What Flixotide is and what it is used for
2. Before you use Flixotide
3. How to use Flixotide
4. Possible side effects
5. How to store Flixotide
6. Further 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, 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
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
 A different medicine is used for treating sudden attacks (called a
 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 apply to you. If you are not sure,
talk to your doctor, nurse or pharmacist before using Flixotide.
Take special care with Flixotide
Check with your doctor, nurse or pharmacist before taking your medicine
 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.
Taking other medicines
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

Important information about some of the ingredients of Flixotide
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
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
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 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 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.

2 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.
3 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.
4 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.

5 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
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
Your doctor may give you a Flixotide Accuhaler of a higher strength if your  Take the next dose when it is due.
dose is increased.
 Do not take a double dose to make up for the forgotten dose.
If you are using high doses of an inhaled steroid for a long time you
If you stop using Flixotide
may sometimes need extra steroids for example during stressful
 Do not stop treatment even if you feel better unless told to do so by
circumstances such as a road traffic accident or before an operation.
your doctor.
Your doctor may decide to give you extra steroid medicines during
If you have any further questions on the use of this product, ask your
this time.
doctor, nurse or pharmacist.
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 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

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

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.
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
 Bruising.
Very rare (affects less than 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
 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.
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.
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:
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Flixotide
 Keep your Flixotide away from direct heat or sunlight.
 Store in the original package to protect from moisture
 Keep out of the sight and reach of children.
 Store in a dry place below 30°C.
 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.
 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.
 If your medicine shows any sign of deterioration seek the advice of your

6. Further 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 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
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.
Manufacturer and Product Licence Holder:
This product is manufactured by Glaxo Wellcome Production, 27000
Evreux, France. Procured from within the EU and repackaged by the
Product Licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow,
Middlesex HA3 0HD.


50 micrograms
100 micrograms
250 micrograms
500 micrograms


PL 15361/0165
PL 15361/0166
PL 15361/0167
PL 15361/0168

Leaflet revision and issue date (Ref.) 12.11.13[18]
Flixotide and Accuhaler are trademarks of Glaxo Wellcome group of

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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.