FLIXOTIDE DISKHALER 250 MICROGRAMS

Active substance: FLUTICASONE PROPIONATE

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Package Leaflet: Information for the user
FlixotideTM DiskhalerTM 100 micrograms, 250 micrograms, 500 micrograms
fluticasone propionate
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1 What Flixotide is and what it is used for
2 Before you use Flixotide
3 How to use Flixotide
4 Possible side effects
5 How to store Flixotide
6 Further information

1

What Flixotide is and what it is used for

Flixotide Diskhaler consists of RotadisksTM and an inhaler called a DiskhalerTM . Rotadisks
have foil blisters in a strip with 4 blisters. Each blister contains 100, 250 or 500 micrograms
of the active ingredient fluticasone propionate. Refill packs only contain the Rotadisks and
not the Diskhaler.
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 even if you
do not have symptoms.
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

Before you use Flixotide

Do not use Flixotide if you are allergic (hypersensitive) to:
fluticasone propionate
lactose or milk protein
any of the other ingredients of Flixotide (listed in Section 6).

Do not use Flixotide if any of the above apply to you. If you are not sure, talk to your doctor,
nurse or pharmacist before using Flixotide.
Take special care with Flixotide
Check with your doctor, nurse or pharmacist before taking your medicine 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.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken 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 apply 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
Talk to your doctor before using this medicine if you are pregnant, might become pregnant or
are breast-feeding.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Flixotide
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 Flixotide exactly as your doctor has told you. You should 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 a Diskhaler.
Make sure that you have one and can use it properly.
Instructions on how to use the Diskhaler are given as a step-by-step guide below.
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 to 100 micrograms twice a day.
The most taken should be 200 micrograms twice a day.
Flixotide Diskhaler 250 micrograms and Flixotide Diskhaler 500 micrograms are not
recommended for children 16 years and under.
It is recommended that children being treated with steroids, including Flixotide Diskhaler
have their height checked regularly by their doctor.
Your doctor may give you a Flixotide Diskhaler 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 Diskhaler 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.

Using your Diskhaler

The Diskhaler has a number of parts:
an outer body with a hinged lid and piercing needle
a cleaning brush which fits into a space at the rear of the body
a mouthpiece cover
a white wheel on which the disk is placed. The wheel is fitted to –
a white sliding tray with mouthpiece

Loading a disk into the Diskhaler
1

Take off the mouthpiece cover and check inside and outside to make sure that the
mouthpiece is clean, and that there are no foreign objects.

2

Hold the corners of the white tray and pull out gently until you can see all the plastic
ridges on the sides of the tray.

3

Put your finger and thumb on the ridges, squeeze inwards and gently pull the tray out of
the body of the Diskhaler.

4

Place a disk on the wheel so that the numbers face upwards and then slide the tray back
into the Diskhaler.

Getting ready for the first dose
5

Hold the corners of the tray as shown in the picture and slide the tray out and in. This will
rotate the disk.

6

Continue until the number '4' appears in the small window. The disk is now ready for
use. As you use each dose the number of doses remaining is shown in the window.

Opening the blister to release a dose
7

Keep the Diskhaler level. Lift up the back of the lid as far as it will go and until it is fully
upright. The lid must be raised until fully upright to pierce both the top and bottom of
the blister. This will need firm pressure.

Then close the lid. The Diskhaler is now ready for use.
Do not try to lift the lid until the white sliding tray is pushed fully in or is completely
removed e.g. when cleaning the Diskhaler.
Inhaling your medicine
8

Breathe out as far as is comfortable.

9

Keep the Diskhaler level and raise it to your mouth. Place the mouthpiece between your
teeth and close your lips firmly around it but do not bite it.
Do not cover the small air holes on either side of the mouthpiece.

10 Suck in through your mouth as quickly and as deeply as you can.
11 Hold your breath and remove the Diskhaler from your mouth. Continue to hold your
breath for a few seconds or as long as is comfortable.
Getting ready for the next dose
12 Do not open the blister until you are ready to take the next dose. Turn the disk to the next
number ('3') by gently pulling out the tray and pushing it in once.
When you need to take another dose repeat steps 7 to 12.
Always wipe the mouthpiece with a tissue and replace the cover after use.
Replacing the Disk when it is empty
13 Each disk has four blisters. As you use up each blister, numbers will count backwards i.e.
'4', '3', '2', ‘1’ etc. When the number '4' reappears, the disk is empty and should be
replaced. To take out the old disk and put in the new one, repeat steps 2 to 4.
Cleaning your Diskhaler
14 There is a brush in the small space under the lid at the rear of the Diskhaler body.

a) Remove the tray from the Diskhaler body.
b) Brush away any powder left behind on the parts of the Diskhaler.
c) Replace the tray and mouthpiece cover.
You may need to replace your Diskhaler after about three months of use.
Flixotide disks should only be used in a Flixotide Diskhaler.
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 product, ask your doctor, nurse or
pharmacist.

4

Possible Side Effects

Like all medicines, Flixotide 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 (affects less than 1 in 100 people) – the signs include skin rashes,
redness, itching or weals like nettle rash or hives
severe allergic reactions (affects less than 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 (affects more than 1 in 10 people)
thrush in the mouth and throat
Common (affects less than 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.
Very rare (affects less than 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
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.

5

How to store Flixotide
Keep your Flixotide away from direct heat or sunlight.
Store in the original package to protect from moisture
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not puncture the blister on the Rotadisk™ until you are ready to inhale a dose.
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.
If you are told to stop using this medicine return any unused Rotadisks to your pharmacist
to be destroyed.

6

Further information

What Flixotide contains
The active substance is fluticasone propionate
The other ingredient is lactose.
What Flixotide looks like and contents of the pack
The RotadiskTM contains powder in four foil blisters around its edge.
Each blister contains 100 micrograms, 250 micrograms or 500 micrograms fluticasone
propionate, and lactose which acts as the 'carrier'.
The 100, 250 or 500 micrograms Flixotide Diskhaler packs contain fifteen Rotadisks.
Flixotide Diskhaler refill packs contain only the Rotadisks and not the Diskhaler.
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited trading as:
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No. 2
23 rue Lavoisier
27000 Evreux
France
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
FlixotideTM DiskhalerTM 100 Micrograms
FlixotideTM DiskhalerTM 250 Micrograms
FlixotideTM DiskhalerTM 500 Micrograms
Reference numbers

10949/0006; 10949/0007; 10949/0008

This is a service provided by the Royal National Institute of the Blind.
Leaflet date: August 2012
Diskhaler, Flixotide, Rotadisk and Rotadisks are trademarks of the GlaxoSmithKline group of
companies.
© 2012 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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