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FLUTICASONE PROPIONATE 500MICROGRAMS ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE

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PATIENT INFORMATION LEAFLET

1661/1662/1663//1664
03.07.15[14]

Flixotide® 50 micrograms Accuhaler®
Fluticasone propionate 50 micrograms
Accuhaler®
Flixotide® 100 micrograms Accuhaler®
Fluticasone propionate 100 micrograms
Accuhaler®
Flixotide® 250 micrograms Accuhaler®
Fluticasone propionate 250 micrograms
Accuhaler®
Flixotide® 500 micrograms Accuhaler®
Fluticasone propionate 500 micrograms
Accuhaler®
(Fluticasone Propionate)
Your medicine is available under any of the above names but will be
referred to as Flixotide throughout the 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.
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

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.

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 Moderate to severe asthma
 The usual starting dose is 250 to 500 micrograms twice a day.
active ingredient fluticasone propionate.
 The most taken should be 1000 micrograms twice a day.
Fluticasone propionate belongs to a group of medicines called
Children (4 to 16 years of age)
corticosteroids (often just called steroids). A very small dose of steroid is
 The usual starting dose is 50 micrograms twice a day.
needed when it is inhaled. This is because it is inhaled straight to your
 The most taken should be 200 micrograms twice a day.
lungs.
Flixotide Accuhaler 250 micrograms and Flixotide Accuhaler 500
Flixotide works by reducing swelling and irritation in the lungs. They have micrograms are not recommended for children 16 years and under.
what is called an ‘anti-inflammatory action’.
It is recommended that children being treated with steroids, including
Flixotide Accuhaler have their height checked regularly by their doctor.
Flixotide helps to prevent asthma attacks in people who need regular
treatment. This is why they are sometimes called 'preventers'. They need
Your doctor may give you a Flixotide Accuhaler of a higher strength if your
to be used regularly, every day.
dose is increased.
Flixotide will not help treat sudden asthma attacks where you feel
If you are using high doses of an inhaled steroid for a long time you
breathless.
may sometimes need extra steroids for example during stressful
 A different medicine is used for treating sudden attacks (called a ‘reliever’).
circumstances such as a road traffic accident or before an operation.
 If you have more than one medicine, be careful not to confuse them.
Your doctor may decide to give you extra steroid medicines during
this time.
2. What you need to know before you use Flixotide
Do not use Flixotide:
Patients who have been on high doses of steroids, including
 If you are allergic to fluticasone propionate or any of the other
Flixotide Accuhaler for a long time, must not stop taking their
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, medicine suddenly without talking to their doctor. Suddenly
stopping treatment can make you feel unwell and may cause
talk to your doctor, nurse or pharmacist before using Flixotide.
symptoms such as vomiting, drowsiness, nausea, headache,
tiredness, loss of appetite, low blood sugar level and fitting.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Flixotide if:
Instructions for use
 you have ever been treated for tuberculosis (TB)
 you are using Flixotide at the same time as taking steroid tablets. Also if you  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
have just finished taking steroid tablets. In both cases, you should carry a
the Flixotide Accuhaler properly or as prescribed may mean that it will
steroid warning card until your doctor tells you not to carry one
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  The Accuhaler is provided in a sealed foil wrapper. The wrapper
provides protection from moisture and should only be opened when you
pharmacist before using Flixotide.
are ready to use it for the first time. Once opened the foil wrapper
should be discarded.
Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken  The Accuhaler device holds blisters containing Flixotide as a powder
or might take any other medicines, including medicines obtained without a  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
prescription. This includes herbal medicines. Remember to take this
medicine with you if you have to go into hospital.

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
with two round peelable labels. The labels should be removed from the foil
and applied to the device over the existing labels. 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.

5. How to store Flixotide
 Keep your Flixotide away from direct heat or sunlight.
 Do not store above 30°C. Store in a dry place to protect from moisture.
 Store the Accuhaler in the foil wrapper until you are ready to use it for
If you notice any of the following serious side effects, stop using this
the first time. Once opened, the foil wrapper should be discarded
medicine and talk to your doctor straight away. You may need urgent  Keep out of the sight and reach of children.
medical treatment.
 Do not use Flixotide after the expiry date which is stated on the carton
 allergic reactions (may affect up to 1 in 100 people) – the signs include
{EXP}. The expiry date refers to the last day of that month.
skin rashes, redness, itching or weals like nettle rash or hives
 Medicines should not be disposed of via wastewater or household
 severe allergic reactions (may affect up to 1 in 10,000 people) - the
waste. Ask your pharmacist how to dispose of medicines no longer
signs include swelling of your face, lips, mouth, tongue or throat which
required. These measures will help to protect the environment.
may cause difficulty in swallowing or breathing, itchy rash, feeling faint
 If your medicine shows any sign of deterioration seek the advice of your
and light headed and collapse
pharmacist.
 your breathing or wheezing gets worse straight after using your inhaler.
6. Contents of the pack and other information
Other side effects include:
What Flixotide contains
Very common (may affect more than 1 in 10 people)
 The active substance is fluticasone propionate
 thrush in the mouth and throat
 The other ingredient is lactose.
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.
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

What Flixotide looks like and contents of the pack
The plastic Accuhaler device is provided in a sealed foil wrapper. 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
‘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.
Manufacturer and Product Licence holder
This product is manufactured by Glaxo Wellcome Production, 23 rue
Lavoisier, 2700 Evreux, France and is procured from within the EU by
Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

50 micrograms
100 micrograms
250 micrograms
500 micrograms

- PL 20636/1661
- PL 20636/1662
- PL 20636/1663
- PL 20636/1664

Leaflet revision and issue date (Ref.) 03.07.15[14]
Flixotide and Accuhaler are trademarks of Glaxo Wellcome group of
companies.

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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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