FLIXOTIDE NEBULES 2MG/ML
Active substance(s): FLUTICASONE PROPIONATE
• after 7 days of using Flixotide your shortness of
breath or wheezing does not get better, or gets
• 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 or
pharmacist. This includes any possible side effects
not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store. By reporting side effects, you can help
provide more information on the safety of this
5. HOW TO STORE FLIXOTIDE
Do not use this medicine after the expiry date
shown on the carton label or blister. If your doctor
tells you to stop taking this medicine, return any
unused medicine to your pharmacist (chemist) for
safe disposal. Only keep this medicine, if your
doctor tells you to. If your medicine becomes
discoloured or shows any other signs of
deterioration, consult your pharmacist (chemist)
who will tell you what to do.
STORING YOUR MEDICATION
• Do not open the foil wrap until the Nebules are
• Store the Nebules in the foil wrap inside the
• 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 expiry 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
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help protect the
6. CONTENTS OF THE PACK AND OTHER
What Flixotide contains
Each 2ml of liquid contains 2mg of fluticasone
propionate as the active ingredient.
Your medicine also contains the following inactive
ingredients: polysorbate 20, sorbitan monolaurate,
sodium acid phosphate, sodium phosphate,
sodium chloride and water for injections.
What Flixotide looks like and contents of the
The medicine is a plastic ampoule containing 2ml
of buffered, isotonic saline suspension containing
2mg fluticasone propionate.
Flixotide Nebules are provided as a strip of 5
nebules in a foil wrap. Each box contains 10
Manufacturer and Licence Holder
Flixotide Nebules is manufactured by
GlaxoSmithKline Australia PTY Ltd, Boronia,
Victoria, Australia and are procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.
PL 15184/0871 - Flixotide Nebules 2mg/2ml/
Fluticasone Propionate Nebules 2mg/2ml.
Flixotide and Nebules are registered trademarks of
the GlaxoSmithKline Group of Companies.
Leaflet revision date: 16/11/17
Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you
PATIENT INFORMATION LEAFLET
FLIXOTIDE NEBULES 2MG/2ML/
FLUTICASONE PROPIONATE NEBULES 2MG/2ML
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
• 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
Your medicine is called Flixotide Nebules
2mg/2ml/ Fluticasone Propionate Nebules
2mg/2ml and will be referred to as Flixotide
throughout the rest of this leaflet.
What is in this leaflet:
1. What Flixotide is and what it is used for
2. What you need to know before you use
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
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 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
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
• 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
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) or cobicistat
containing products which may increase the
effects of fluticasone propionate. Your doctor
may wish to monitor you carefully if you are
taking these medicines.
• medicines used to treat fungal infections (such
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Using Flixotide with food and drink
You can use Flixotide at any time of day, with or
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 medicine.
Driving and using machines
Flixotide is not likely to affect you being able to
drive or use any tools or machines.
3. HOW TO USE FLIXOTIDE
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
• The jet nebuliser produces a fine mist which
you breathe in through a mouthpiece or face
• 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
• 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
• 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
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.
Flixotide Nebules 2 mg/2 ml are not for use in
children under 16 years of age.
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
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
3. put the open end of the Nebule into the
nebuliser bowl and squeeze slowly to empty
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
• 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.
• 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
• 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
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
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
4. POSSIBLE SIDE EFFECTS
4. assemble the nebuliser and use it as directed
5. repeat steps 2 to 4 to make up the dose
needed if necessary
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
• 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
• your breathing or wheezing gets worse straight
after using your inhaler.
Other side effects include:
Very common (may affect more than 1 in 10
• 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.
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
• level of sugar (glucose) in your blood may be
• 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
- 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
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
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.