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FLIXOTIDE 100 ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE

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Package Leaflet: Information for the user

FLIXOTIDE™ 100 ACCUHALER™
FLIXOTIDE™ 250 ACCUHALER™
FLIXOTIDE™ 500 ACCUHALER™
(fluticasone propionate)
The name of your medicine is Flixotide 100 Accuhaler, Flixotide 250
Accuhaler or Flixotide 500 Accuhaler but will be referred to as Flixotide
throughout this 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

1. WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR
Flixotide is a plastic inhaler device containing a foil strip with 60 blisters.
Each blister contains 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) or cobicistat containing products which may increase the
effects of fluticasone propionate. Your doctor may wish to monitor you
carefully if you are taking these medicines.
• 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
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
your 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, place the round
labels from the foil wrapper to the Accuhaler and then 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, attach the round labels from the foil wrapper to 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
• 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






Store your Flixotide away from direct heat or sunlight
Do not store above 30°C
Store in a dry place
Keep this medicine out of the sight and reach of children.
Store the Accuhaler in the foil wrapper until you are ready to use it for
the first time. Once opened, place the round labels on the Accuhaler
and the foil wrapper should be discarded.
• Do not use this medicine after the expiry date which is stated on the
carton {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
Flixotide 100 Accuhaler:
• Each blister contains powder for inhalation providing 100 micrograms of
the active ingredient fluticasone propionate
• The other ingredient is lactose
Flixotide 250 Accuhaler:
• Each blister contains powder for inhalation providing 250 micrograms of
the active ingredient fluticasone propionate
• The other ingredient is lactose
Flixtotide 500 Accuhaler:
• Each blister contains powder for inhalation providing 500 micrograms of
the active ingredient fluticasone propionate
• The other ingredient is lactose
What Flixotide looks like and contents of the pack
Flixotide is a two tone orange and brown colour, circular device in moulded
plastic containing inhalation powder and with a dose counter indicating
number of doses remaining.
Pack size: 60 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.
Flixotide Accuhaler is manufactured by Glaxo Wellcome Production, 100
Route de Versailles, 78163 Marly le Roi Cedex, France or Glaxo Wellcome
Production, Zone Industrielle No. 2, 23 rue Lavoisier, 27000 Evreux,
France.
Procured from within the EU by the parallel import product licence holder,
BR Pharma International Limited, Unit 3, Manor Point, Manor Way,
Borehamwood, Herts WD6 1EE
PL No.16782/0127 Flixotide 100 Accuhaler
PL No.16782/0128 Flixotide 250 Accuhaler
PL No.16782/0129 Flixotide 500 Accuhaler

POM

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a leaflet
in a format suitable for you.
Date of preparation: 20th June 2017

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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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