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FLIXOTIDE 250 ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE

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CUSTOMER: Waymade
PRODUCT:

Flixotide 250mcg Accuhaler
POUCH PACK

CODE:

6464/1818E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

16/01/15

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.2 - waymade - 16/01/15

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

FLIXOTIDE®

5. How to store Flixotide
Keep your Flixotide away from direct heat or sunlight.
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.
Keep out of the sight and reach of children.
Do not store above 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.
If your doctor tells you to stop using the Accuhaler, please take it back to the pharmacist for safe disposal.
Only keep the Accuhaler if your doctor tells you to.
If your Accuhaler fails to work properly or shows any signs of deterioration, consult your pharmacist who will
tell you what to do.
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
The active substance is fluticasone propionate.The other ingredient is lactose monohydrate.
What Flixotide looks like and contents of the pack
The plastic Accuhaler device is provided in a sealed foil wrapper. It is presented as a two-tone orange plastic
inhaler device containing a foil strip of 60 blisters.
Each blister contains 250 micrograms of the active ingredient fluticasone propionate, mixed with lactose,
which acts as a 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
Accuhaler is empty and should be disposed of.
POM

PL No: 6464/1818

This product is manufactured by Glaxo Wellcome Production, Evreux, France and is procured from within the
EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 16.01.2015
Flixotide and Accuhaler are registered trademarks of the Glaxo Group Limited.

ACCUHALER®

250
FLUTICASONE PROPIONATE 250 microgram ACCUHALER®
(fluticasone propionate)
Patient Information Leaflet
This product is available as the above names but will be referred to as Flixotide throughout this leaflet. Other
strengths (50, 100 and 500 micrograms) are also available.
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 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 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)

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.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
PRODUCT: Flixotide 250mcg Accuhaler

PRE-PRESS NO.:

06 1257

POUCH PACK

ARTWORKER:

DT

DATE OF PROOF:

16/01/15

CODE:

6464/1818E

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.2 - waymade - 16/01/15

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED SEPTEMBER 2014
REPORTING OF SIDE EFFECTS

Pg 2

Pg 3

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

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.

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

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 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.

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

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.

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.

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.

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.

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.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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