FLIXOTIDE NEBULES 0.5MG/2ML

Active substance: FLUTICASONE PROPIONATE MICRONISED

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3 How to use Flixotide

Package leaflet: Information for the user

fluticasone propionate
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 section.
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 Nebules contain a medicine called 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. It has
what is called an ‘anti-inflammatory action’.
Flixotide help 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:
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 apply 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, nurse 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 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
If you are pregnant or breast-feeding, think you may be pregnant or
are 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 Nebules come in two 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
Do not inject or swallow the liquid. Flixotide Nebules should
only be inhaled using your jet nebuliser. Using Flixotide Nebules
with ultrasonic nebulisers is not generally recommended.
The jet nebuliser produces a fine mist which you breathe in
through a mouthpiece or face mask.
Do not let the liquid, or the mist produced by the nebuliser
get into your eyes. You can wear glasses or goggles to protect
them.
Each small plastic container (Nebule®) contains some liquid.
The liquid is put into a nebuliser. This makes a fine mist for you
to breathe in through a face mask or mouthpiece. Use of a
mouthpiece prevents the medicine affecting the skin of your
face, which may occur if you use a face mask over a long period
of time. If you prefer to use a face mask, or you are using a face
mask for your child, then you must protect the skin on your (or
your child’s) face with a barrier cream or wash your (or your
child’s) face thoroughly after treatment.
Use your nebuliser in a well-ventilated room as some of the mist
will be released into the air and may be breathed in by others.
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
The usual starting dose is 0.5 to 2.0 mg (500 to 2000 micrograms)
twice a day.
Flixotide Nebules 0.5 mg/2 ml provides you with a dose of
500 micrograms.
Flixotide Nebules 2.0 mg/2 ml provides you with a dose of
2000 micrograms.
Children (4 to 16 years of age)
The usual starting dose is 1 mg (1000 micrograms) twice a day.
It is recommended that children being treated with steroids, including
Flixotide Nebules have their height checked regularly by their doctor.
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 Nebules 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 Nebules
the Nebules are in a foil pack. Do not open the pack until
you need to use them

1
2

hold the top of the Nebule you have just removed. Twist
the body to open it

3

put the open end of the Nebule into the nebuliser bowl
and squeeze slowly to empty the content

4
5

assemble the nebuliser and use it as directed
repeat steps 2 to 4 to make up the dose needed if
necessary

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Diluting your Nebules
Do not dilute the contents of a Nebule unless you are told to
by your doctor
if your doctor has told you to dilute the solution, empty the
contents of the Nebule into the nebuliser bowl
add the amount of sterile sodium chloride 0.9% solution your
doctor has told you to use
put the top on the nebuliser bowl and shake gently to mix the
contents
If dilution is necessary then only sterile sodium chloride 0.9%
solution should be used.
After use
use a fresh Nebule for each dose. Only open a new one when you
are ready to use it. If there is any liquid left over, throw it away.
Do not save it to use again
throw away any solution remaining in the nebuliser bowl
clean your nebuliser in the recommended way
If you use more Flixotide than you should
If you use more than you were told, 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
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 Flixotide Nebules in the foil wrap, inside the carton.
Do not store above 30°C. Keep the container in the outer carton
in order to protect from light. Do not freeze. Store upright.
If the foil wrap has not been opened, do not use this medicine
after the expiry date which is stated on the pack after ‘EXP’. The
date refers to the last day of that month.
Nebules removed from the foil wrap should be protected from
light and used within 28 days.
Opened Nebules should be stored in a fridge and used within
12 hours of opening
Keep this medicine out of the sight and reach of children.
Do not throw away medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. 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 ingredients are polysorbate 20, sorbitan laurate,
monosodium phosphate dihydrate, dibasic sodium phosphate
anhydrous, sodium chloride (salt), water.
What Flixotide looks like and contents of the pack
Flixotide Nebules are provided as a strip of 5 nebules in a foil wrap.
Each box contains 10 Flixotide Nebules
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Manufacturer:
Glaxo Wellcome GmbH & Co
Bad Oldesloe
Germany.
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
Flixotide Nebules 0.5 mg/2 ml.
PL
10949/0297
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in April 2014
Flixotide, Nebules and Nebule are registered trade marks of the
GSK group of companies.
© 2014 GSK group of companies. All rights reserved.

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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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