FLIXONASE NASAL SPRAY

Active substance: FLUTICASONE PROPIONATE

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Package Leaflet: Information For The User

Flixonase® Nasal Spray /
Fluticasone Propionate
50 microgram Nasal Spray
(fluticasone propionate)
This medicine is known by any of the above names
but will be referred to as Flixonase Nasal Spray
throughout this leaflet.
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 Nasal Spray is and what it is
used for
2. Before you use Flixonase Nasal Spray
3. How to use Flixonase Nasal Spray
4. Possible side effects
5. How to store Flixonase Nasal Spray
6. Further information

1. What Flixonase Nasal Spray is and
what it is used for
Flixonase Nasal Spray contains a medicine called
fluticasone propionate. This belongs to a group of
medicines called steroids (also called ‘corticosteroids’).
 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 Nasal Spray 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 Nasal Spray
Do not use Flixonase Nasal Spray if:
 You are allergic (hypersensitive) to fluticasone
propionate or any of the other ingredients of
Flixonase Nasal Spray (listed in section 6:
Further information).
Take special care with Flixonase Nasal Spray
 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
Nasal Spray.
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 Nasal Spray with food and
drink
You can use Flixonase Nasal Spray 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 Nasal Spray 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 Nasal Spray
Flixonase Nasal Spray contains benzalkonium
chloride which may cause problems with your
breathing (bronchospasm).

3. How to use Flixonase Nasal Spray
Always use Flixonase Nasal Spray 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 Nasal Spray
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.

Using your spray

Cleaning your spray

1. Shake the bottle
and take off the
dust cap.

Clean your spray at least once a week, or more
often if it gets blocked.

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.

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. Repeat step 4 to use a second spray in the
same nostril.

6. Put the nozzle back on the spray.

7. Remove the nozzle from this nostril and
breathe out through your mouth.

7. ‘Prime’ the bottle as described in the section
above, Preparing your spray.

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.

If you forget to use Flixonase Nasal Spray
If you miss a dose, just use the next dose when it
is due.
If you use more Flixonase Nasal Spray 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 Nasal Spray
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

5. How to store Flixonase Nasal Spray

Like all medicines, Flixonase Nasal Spray 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.




Keep out of the sight and reach of children.
Store the Flixonase Nasal Spray below 30°C.
Do not use after the expiry date shown as
‘EXP’ on the carton and nasal spray label.
If you are told to stop taking this medicine
return your inhaler to your pharmacist to be
destroyed.
If the nasal spray shows any other signs of
deterioration consult your pharmacist who will
advice you what to do.
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 Nasal Spray contains
Flixonase Nasal Spray is a metered-dose
atomising nasal spray. Each spray provides 50
micrograms of the active ingredient, fluticasone
propionate.
It also contains other substances needed to make
a stable suspension. These are microcrystalline
cellulose, sodium carboxymethylcellulose, glucose
anhydrous, polysorbate 80, purified water and the
preservatives benzalkonium chloride and
phenylethyl alcohol.
Each Flixonase Nasal Spray contains 120 sprays.
Flixonase Nasal Spray is manufactured by Glaxo
Operations UK Limited, Barnard Castle, England or
Glaxo Wellcome S.A., Aranda de Duero (Burgos),
Spain and is procured from within the EU by the
Product Licence holder: Caseview (PL) Ltd, 20
Alliance Court, Alliance Road, London W3 0RB
and repackaged by OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
PL No: 13826/0172
POM
Flixonase Nasal Spray
Leaflet revision and issue date (Ref.) 05/12/2012
‘Flixonase’ is a registered trademark 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.

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