FLIXONASE AQUEOUS NASAL SPRAY

Active substance: FLUTICASONE PROPIONATE MICRONISED

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fluticasone propionate
50 micrograms

Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor 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 or pharmacist.
In this leaflet:
1 What Flixonase is and what it is used for
2 Before you use Flixonase
3 How to use Flixonase
4 Possible side effects
5 How to store Flixonase
6 Further information

Flixonase Aqueous Nasal Spray (called ‘Flixonase’ in this
leaflet) contains a medicine called fluticasone propionate.
This belongs to a group of medicines called steroids (also
called ‘cortico-steroids’).
• Steroids work by reducing inflammation.
• They reduce swelling and irritation in your nose.
• This helps to relieve itching, sneezing and your blocked
or runny nose.
Flixonase is used to prevent and treat:
• Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.
• Inflammation in the lining of your nose (rhinitis) due to
year round (perennial) allergies, such as animal allergies.

2 Before you take Flixonase
Do not use Flixonase if:
• You are allergic (hypersensitive) to fluticasone propionate
or any of the other ingredients of Flixonase Aqueous Nasal
Spray (listed in section 6: Further information).
Take special care with Flixonase
• If you have ever had an operation on your nose
• If you have an infection in your nose
If you are unsure if the above apply to you, talk to your
doctor or pharmacist before using Flixonase.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription. This includes herbal medicines.
Check with your doctor or pharmacist before using your
medicine if:
• you have had steroids for a long time, either as an
injection or by your mouth
• you are taking a type of antiviral medicine known as a
protease inhibitor (e.g. ritonavir)
• you are taking certain medicines used to treat fungal
infections (e.g. ketoconazole).
Taking Flixonase with food and drink
You can use Flixonase 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
Flixonase is not likely to affect you being able to drive or
use any tools or machines.
Important information about some of the ingredients of
Flixonase
Flixonase contains benzalkonium chloride which may cause
problems with your breathing (bronchospasm).

3 How to use Flixonase
Always use Flixonase exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
• Do not use in children under 4 years old
• Only use in your nose, contact with eyes should be avoided.
• It takes a few days for this medicine to work. So keep using it,
even though you may not feel better straight away.
• Use the spray every day.
How much to use - adults and children (aged 12 and over)
• The usual starting dose is 2 sprays into each nostril once
a day, preferably in the morning.
• The most you would use over 24 hours is normally
8 sprays (4 sprays per nostril).
• As you become better, your doctor may ask you to use a
lower dose - one spray into each nostril once a day.
• If your symptoms then get worse, your dose may be
increased back to the starting dose.
How much to use - children aged 4 to 11 years
• The usual starting dose is one spray into each nostril
once a day, preferably in the morning
• The most you would use over 24 hours is normally
4 sprays (2 sprays per nostril)
If you use high doses of Flixonase
You may need extra steroids:
• in times of extreme stress
• during admission to hospital after a serious accident or
injury
• before a surgical operation.
Your doctor may give you extra steroid medication such as
tablets or an injection.

Preparing your spray
Each spray has a dust cap which protects the nozzle
and keeps it clean. Remember to take this off before
using the spray.
A new spray (or one that has not been used for a few
days), may not work first time. You need to ‘prime’
the spray by pumping the spray a few times until a
fine mist is produced.
1 Hold the bottle as
shown and make
sure it is pointed
away from you.
2 Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the
bottle.
3 Keep your thumb
still, and press
down with your
fingers to pump the
spray.
• If the spray does not work and you think it may be
blocked, you will need to clean it. Please see the
section below, Cleaning your spray.
• Never try to unblock or enlarge the tiny spray hole
with a pin or other sharp object. This will damage
the way the spray works.

10000000109350

Aqueous Nasal Spray

1 What Flixonase is and what it is used for

Please turn
over the page

PHARMA CODE N° 4274

Package Leaflet: Information For The User

BACK PAGE

Using your spray

Cleaning your spray

1 Shake the bottle and take off the dust cap.
2 Blow your nose gently.
3 Close one nostril
with your finger as
shown, and put the
nozzle in the other
nostril. Tilt your head
forward slightly
and keep the bottle
upright. Hold the
bottle as shown.
4 Start to breathe in
slowly through your
nose. While you are
breathing in press
down firmly on the
collar with your fingers.
A spray of fine mist will go into your nostril.
5 Breathe out through your mouth.
6 Repeat step 4 to use a second spray in the same
nostril.
7 Remove the nozzle from this nostril and breathe
out through your mouth.
8 Repeat steps 3 to 6 for your other nostril.
9 After using your spray, wipe the nozzle carefully
with a clean tissue or handkerchief, and replace
the dust cap.

Clean your spray at least once a week, or more often
if it gets blocked.
1 Take the dust cap off
by gently squeezing the
ribbed sides between
your finger and thumb
and lifting it off. Do not
twist it off.
2 Pull upwards on the
white collar to remove
the nozzle.
3 Soak the nozzle and
dust cap in warm water
for a few minutes.
4 Then rinse under a
running tap.
5 Shake off the excess
water and let them dry
in a warm place.
6 Put the nozzle back on the spray.
7 ‘Prime’ the bottle as described in the section
above, Preparing your spray.
If you forget to use Flixonase
If you miss a dose, just use the next dose when it is due.
If you use more Flixonase than you should
Tell your doctor if you use more than you were told to.
It is important that you take your dose as stated on the
pharmacist’s label or as advised by your doctor. You should
use only as much as your doctor recommends; using more
or less may make your symptoms worse.
If you stop taking Flixonase
Do not stop treatment even if you feel better, unless your
doctor tells you to stop. If you do stop, the symptoms may
come back.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Flixonase can cause side effects, although
not everybody gets them. The following side effects may
happen with this medicine:

Allergic reactions: get a doctor’s help straight away
A small number of people get allergic reactions to Flixonase,
which can develop into a more serious, even life-threatening
problem if not treated. Symptoms include:
• becoming very wheezy, coughing or having difficulty
with breathing
• suddenly feeling weak or light-headed (which may lead
to collapse or loss of consciousness)
• swelling around the face, mouth or tongue
• skin rashes or redness.
If this happens, tell your doctor straight away - you may
need urgent medical treatment.
Allergic reactions to Flixonase are very rare (These affect less
than 1 in 10,000 people).
Immediately after you use your spray
• You may sneeze a little, but this soon stops.
• Very occasionally you may find you get an unpleasant
taste or smell.
Tell your doctor as soon as possible if you notice any of the
following side effects:
Other side effects include:
Very common (affects more than 1 in 10 people)
• Nose bleeds.
Common (affects less than 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.
Very rare (affects less than 1 in 10,000 people)
• Skin reaction - which can range from red, itchy rash
and blotches to a more severe skin reaction such as dry,
cracked and peeling skin.
• Problems with your eyes such as pain or blurred vision.
• Damage to your nose.
Very rarely, the normal production of steroids in your body
may be affected. This is more likely to happen if you use
high doses for a long time. Your doctor will help stop this
happening by making sure you use the lowest dose of steroid
which controls your symptoms. In children this side effect can
rarely cause them to grow more slowly than others. Children
who receive this treatment for a long period of time will have
their height checked regularly by their doctor.
If you notice any side effects not listed in this leaflet tell
your doctor as soon as possible.

5 How to store Flixonase
Keep out of the reach and sight of children.
• Protect from frost and light.
• Do not store above 30°C.
• Do not put in a refrigerator.
• Do not use Flixonase after the expiry date which is stated
on the label and carton after ‘EXP’. The expiry date refers
to the last day of that month.
• If you are told to stop taking this medicine return any
unused spray to your pharmacist to be destroyed.
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 Further Information
What Flixonase Aqueous Nasal Spray contains
• The active substance is fluticasone propionate
• The other ingredients are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose, polysorbate 80, purified
water and the preservatives benzalkonium chloride and
phenylethylalcohol. These other ingredients are needed to
make a stable suspension which will not go off.
What Flixonase Aqueous Nasal Spray looks like and contents
of the pack
Each amber coloured glass bottle delivers 150 sprays. Each
spray contains 50 micrograms of fluticasone propionate.
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd, Trading as Allen and Hanburys,
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Manufacturer
Glaxo Wellcome SA, Aranda de Duero, Burgos, Spain
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
Flixonase Aqueous Nasal Spray
Reference number 10949/0036
This is a service provided by the Royal National Institute of the Blind.
Leaflet date: August 2012
Flixonase is a trademark of the GlaxoSmithKline group of companies.
© 2012 GlaxoSmithKline group of companies

10000000109350

PHARMA CODE N° 4274

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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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