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FLIXOTIDE 250MICROGRAMS ACCUHALER

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

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Package Leaflet: Information for the user

Flixotide® 250 micrograms Accuhaler®
(fluticasone propionate)
The name of your medicine is Flixotide 250 micrograms Accuhaler, but
will be referred to as Flixotide throughout the remainder of 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.
Your medicine is also available in the following strengths, 50, 100 and
500 micrograms.
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 60
blisters. Each blister contains 250 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 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
thumb grip. 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.

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.

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
thumb grip 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

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 in a dry place to protect from moisture
Keep 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 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.
6. Contents of the pack and other information
What Flixotide contains
Each blister contains 250 micrograms fluticasone propionate, and lactose
monohydrate which acts as the ‘carrier’.
Active ingredient in Flixotide Accuhaler is fluticasone propionate, also
contains lactose monohydrate.
The plastic Accuhaler device is provided in a sealed foil wrapper. The
Accuhaler contains foil strips with blisters which contain fluticasone
propionate and lactose monohydrate. The blisters protect the powder for
inhalation from the effects of the atmosphere.
When using your medicine for the first time open the foil wrapper and use
the peelable circular labels to obscure the foreign labels on the Accuhaler
device.
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.

Other side effects include:

The 250 micrograms Flixotide packs contain sixty blisters.

Very common (may affect more than 1 in 10 people)

thrush in the mouth and throat

This medicine is made by Glaxo Wellcome Production, ZI No 2, Rue
Lavoisier, 27000 Evreux La Madelaine, France. Procured from within the
EU. Product Licence holder: Quadrant Pharmaceuticals Ltd. Lynstock
House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by
Maxearn Ltd, Bolton BL6 4SA.

Common (may affect up to 1 in 10 people)

sore tongue or throat

hoarseness of voice

Flixotide 250 micrograms Accuhaler
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

PL 20774/0637

POM

Flixotide, Accuhaler and Diskus are registered trademarks of the
GlaxoSmithKline Group of Companies.
th

Leaflet prepared 9 May 2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant Pharmaceuticals
Ltd – 01204 473081
PP9/0637/V1

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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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