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Flixotide® 2mg/2ml Nebules®
(fluticasone propionate)
This product is available as above but will be referred to as Flixotide
throughout the remainder of this leaflet.
Package leaflet: Information for the user
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
• 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

Flixotide contains 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 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
• If you have more than one medicine, be careful not to confuse them.

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
If you are not sure if any of the above applies to you, talk to your doctor,
nurse or pharmacist before using Flixotide.

Flixotide comes 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 should only be inhaled
using your jet nebuliser. Using Flixotide 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
• Flixotide 0.5mg/2ml Nebules provide you with a dose of 500 micrograms.
• Flixotide 2mg/2ml Nebules provide you with a dose of 2000 micrograms.
Flixotide is not for use in children under 16 years of age.
It is recommended that children being treated with steroids, including
Flixotide 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
Patients who have been on high doses of steroids, including Flixotide
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
1 the Nebules are in a foil pack. Do not open the pack until you need to
use them
2 hold the top of the Nebule you have just removed. Twist the body to
open it


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
• a type of antiviral medicine known as a ‘protease inhibitor’ (such as
• 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 are breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any tools or

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


4 assemble the nebuliser and use it as directed
5 repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules
Do not dilute the contents of a Nebule unless you are told to by your
• 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
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.

Although the frequency is not known, the following side effects may also
• 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

If you stop using Flixotide
• Do not stop treatment even if you feel better unless told to do so by your
If you have any further questions on the use of this medicine, ask your
doctor, nurse or pharmacist.

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



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

Keep out of the sight and reach of children.
Do not store above 30°C. Keep the Nebules in the outer carton in order to
protect from light. Do not freeze. Store upright.
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
Do not use the unopened pack after the date shown as 'EXP' on the carton
and foil blisters. The expiry date refers to the last day of that month.
If your Flixotide does not work properly or shows any other signs of
deterioration consult your pharmacist who will advise you what to do.
If you are told to stop taking this medicine return your Flixotide to your
pharmacist for safe disposal. Only keep the inhaler if your doctor tells you to.
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 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
• 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.

Flixotide contains a liquid which is nebulised (turned into a mist) in a
nebuliser and then inhaled. The nebules are plastic ampoules containing
white, opaque, freely dispersed suspension, sealed in foil blisters. Each
nebule provides 2mg fluticasone propionate in 2ml normal saline.
Other ingredients are polysorbate 20, sorbitan monolaurate, monosodium
phosphate dihydrate, dibasic sodium phosphate anhydrous, sodium chloride
and water for injection.
A strip of 5 nebules in a foil wrap. Each box contains 10 Flixotide Nebules.
Flixotide are manufactured by GlaxoSmithKline Australia Ltd., Australia and
are procured from within the EU by the Product Licence holder: Caseview
(PL) Ltd., 20 Alliance Court, Alliance Road, London W3 0RB. Repackaged by
O.P.D Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1015


Flixotide® 2mg/2ml Nebules®
Leaflet revision date (ref.) 17/06/2015
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.
Flixotide and Nebules are registered Trade Marks 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.