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FLIXOTIDE 500 MICROGRAMS ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE

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Flixotide Accuhaler contains lactose monohydrate

Flixotide Accuhaler contains lactose monohydrate (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.

FLIXOTIDE™ 500 MICROGRAMS ACCUHALER™
FLUTICASONE PROPIONATE 500 MICROGRAMS ACCUHALER™
(fluticasone propionate)

3.

PATIENT INFORMATION LEAFLET
Flixotide Accuhaler is available in the following strengths: 50mcg, 100mcg, 250mcg and
500mcg.
This leaflet only applies to Flixotide 500 microgram Accuhaler/Fluticasone Propionate 500
micrograms Accuhaler but will be referred to as Flixotide Accuhaler throughout this leaflet.

Using this medicine

The medicine in Flixotide Accuhaler 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.

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.

Adults and Children over 16 years of age
Mild asthma


The usual starting dose is 100 micrograms twice a day.

Moderate to severe asthma

What is in this leaflet:
1. What Flixotide Accuhaler is and what it is used for
2. What you need to know before you use Flixotide Accuhaler
3. How to use Flixotide Accuhaler
4. Possible side effects
5. How to store Flixotide Accuhaler
6. Contents of the pack and other information
1.

HOW TO USE FLIXOTIDE ACCUHALER

Flixotide Accuhaler 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.




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 500 micrograms Accuhaler is 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.

WHAT FLIXOTIDE ACCUHALER IS AND WHAT IT IS USED FOR

Flixotide Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters. Each blister
contains 500 micrograms of the active ingredient fluticasone propionate.

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.

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.

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.

Flixotide Accuhaler works by reducing swelling and irritation in the lungs. It has what is called
an ‘anti-inflammatory action’.
Flixotide Accuhaler helps to prevent asthma attacks in people who need regular treatment. This
is why it is sometimes called a ‘preventer’. It needs to be used regularly, every day.
Flixotide Accuhaler 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.

Instructions for use

2.





WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXOTIDE
ACCUHALER

Do not use Flixotide Accuhaler:




If you are allergic to fluticasone propionate or any of the other ingredients of this medicine
(listed in Section 6).
Do not use Flixotide Accuhaler if any of the above applies to you. If you are not sure, talk to
your doctor, nurse or pharmacist before using Flixotide Accuhaler.


Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Flixotide Accuhaler if:
• you have ever been treated for tuberculosis (TB).
• you are using Flixotide Accuhaler 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 Accuhaler.

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.

Other medicines and Flixotide Accuhaler

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 Accuhaler.

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 Accuhaler 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.

Using Flixotide Accuhaler with food and drink

You can use Flixotide Accuhaler 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 Accuhaler is not likely to affect you being able to drive or use any tools or machines.
Page 1 of 2

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.

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:

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.



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.

Cleaning your Accuhaler

Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.






If you use more Flixotide Accuhaler 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.
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 Accuhaler


Do not stop treatment even if you feel better unless told to do so by your doctor.

6.

POSSIBLE SIDE EFFECTS

What Flixotide Accuhaler looks like and contents of the pack

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)

sore tongue or throat
hoarseness of voice

Flixotide Accuhaler is manufactured by: Glaxo Wellcome Production, Zone Industrielle No. 2,
23 Rue Lavoisier, 27000 Evreux, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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 No: 08929/0103








POM

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302
365000 and ask for the Regulatory Department.

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)

Flixotide Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters. The device is
provided in a sealed foil wrapper. Each blister contains powder for inhalation containing 500
micrograms of the active ingredient fluticasone propionate. Your medicine also contains lactose
which acts as the carrier. The blisters protect the powder for inhalation from the effects of the
atmosphere. 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

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.



Your Flixotide Accuhaler is a two tone orange plastic device containing a foil strip with 60
regularly placed blisters each containing a mixture of microfine fluticasone propionate and larger
particle size lactose.

This leaflet does not contain the complete information about your medicine. If you have any
questions, or are not sure about something, ask your doctor or pharmacist who have access to
additional information.

thrush in the mouth and throat

Common (may affect up to 1 in 10 people)




CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is fluticasone propionate.
The other ingredient is lactose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.



HOW TO STORE FLIXOTIDE ACCUHALER

Keep out of the sight and reach of children.
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 the first time. Once
opened, the foil wrapper should be discarded.
Do not use after the date shown as 'EXP' on the carton and device. The expiry date refers to
the last day of that month.
If the device doesn't appear to be working properly, or is damaged, consult your pharmacist
for advice.
If you are told to stop taking this medicine, return your Flixotide Accuhaler to your
pharmacist to be destroyed.
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.

What Flixotide Accuhaler contains

If you have any further questions on the use of this medicine, ask your doctor, nurse or
pharmacist.

4.




If you forget to use Flixotide Accuhaler




after 7 days of using Flixotide Accuhaler 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.

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
Accuhaler. 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.

Please be ready to give the following information:
Product name
Flixotide 500mcg Accuhaler/
Fluticasone Propionate 500mcg Accuhaler
Reference number
08929/0103
Leaflet revision and issue date (Ref.): 27.10.15
Flixotide™ and Accuhaler™ are trademarks of GlaxoSmithKline 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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