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FLUTICASONE PROPIONATE NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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Package Leaflet: Information For The User

Flixonase® Aqueous Nasal
Spray 50 micrograms
(fluticasone propionate)
Read all of this leaflet carefully before you start using 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 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Flixonase Aqueous Nasal
Spray 50 micrograms but it will be referred to as Flixonase
throughout this leaflet.

What is in this leaflet:
1
2
3
4
5
6

What Flixonase is and what it is used for
What you need to know before you use Flixonase
How to use Flixonase
Possible side effects
How to store Flixonase
Contents of the pack and other information

1 What Flixonase is and what it is used for
Flixonase 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 What you need to know before you use
Flixonase
Do not use Flixonase if:
 You are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Flixonase:
 If you have ever had an operation on your nose.
 If you have an infection in your nose

Other medicines and Flixonase
Tell your doctor if you are taking, have recently taken or might
take 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) 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
 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
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
Flixonase is not likely to affect you being able to drive or use
any tools or machines.

Flixonase contains benzalkonium chloride
Benzalkonium chloride may cause problems with your
breathing (bronchospasm).

3 How to use Flixonase
Always use this medicine exactly as your doctor has told you.
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.

1

2

3

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.

Hold the bottle as
shown and make
sure it is pointed
away from you.
Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the
bottle.
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
1
2
3

Shake the bottle and take off the dust cap.
Blow your nose
gently.
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.

Cleaning your spray
Clean your spray at least once a week, or more often if it
gets blocked.
1

2
3
4
5
6
7

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.
Pull upwards on the white collar
to remove the nozzle.
Soak the nozzle and dust cap
in warm water for a few minutes.
Then rinse under a running tap.
Shake off the excess water and
let them dry in a warm place.
Put the nozzle back on the spray.
‘Prime’ the bottle as described in
the section above, Preparing your spray

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 forget to use Flixonase
If you miss a dose, just use the next dose when it is due. Do
not take a double dose to make up for the forgotten dose.

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 medicine,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine 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.

5 How to store Flixonase






Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use the spray after the expiry date which is stated
on the carton and bottle labels after ‘Exp’. The expiry date
refers to the last day of that month.
If the medicine becomes discoloured or shows any signs
of deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your pharmacist
for safe disposal. Only keep this medicine 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.

Tell your doctor as soon as possible if you notice any of
the following side effects:
Other side effects include:
Very common (may affect more than 1 in 10 people)
 Nose bleeds.



Common (may affect up to 1 in 10 people)
 Headache.
 Unpleasant taste.
 Unpleasant smell.
 A dry or painful nose or throat.

6 Contents of the pack and other information

Very rare (may affect up to 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 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 medicine.

What Flixonase contains
The active substance is fluticasone propionate
Each metered spray contains 50 micrograms of fluticasone
propionate.
The other ingredients are dextrose (anhydrous),
microcrystalline cellulose, carmellose sodium, polysorbate 80,
purified water and hydrochloric acid, dilute and the
preservatives benzalkonium chloride and phenylethyl alcohol

What Flixonase looks like and contents of the pack
Flixonase is a white, opaque suspension.
It is available in a polypropylene bottle, with atomiser-dosing
pump, nasal adapter and cap.
Each bottle of Flixonase provides 120 sprays.
Manufactured by: : Glaxo Wellcome SA,
Avda Extremadura 3, E-09400 Aranda de Duero, Burgos,
Spain.
OR
Glaxo Wellcome Operations UK, Ltd, Harmire Road,
Barnard Castle County Durham DL12 8DT, UK.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Flixonase® Aqueous Nasal Spray 50 micrograms;
PL 18799/1050
Leaflet date: 15.01.2018

POM

Flixonase is a trademark of the GlaxoSmithKline group of
companies.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

Package Leaflet: Information For The User

®

Fluticasone propionate
Aqueous Nasal Spray 50
micrograms



Inflammation in the lining of your nose (rhinitis) due to year
round (perennial) allergies, such as animal allergies.

2 What you need to know before you use
Fluticasone propionate

(fluticasone propionate)
Do not use Fluticasone propionate if:
Read all of this leaflet carefully before you start using 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 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Fluticasone propionate
Aqueous Nasal Spray 50 micrograms but it will be referred to
as Fluticasone propionate throughout this leaflet.

What is in this leaflet:
1
2
3
4
5
6

What Fluticasone propionate is and what it is used for
What you need to know before you use Fluticasone
propionate
How to use Fluticasone propionate
Possible side effects
How to store Fluticasone propionate
Contents of the pack and other information

 You are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Fluticasone
propionate:
 If you have ever had an operation on your nose.
 If you have an infection in your nose

Other medicines and Fluticasone propionate
Tell your doctor if you are taking, have recently taken or might
take 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) 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
 you are taking certain medicines used to treat fungal
infections (e.g. ketoconazole)

Taking Fluticasone propionate with food and drink

1 What Fluticasone propionate is and what it
is used for
Fluticasone propionate 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.
Fluticasone propionate is used to prevent and treat:
 Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.

You can use Fluticasone propionate 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
Fluticasone propionate is not likely to affect you being able to
drive or use any tools or machines.

Fluticasone propionate contains benzalkonium
chloride
Benzalkonium chloride may cause problems with your
breathing (bronchospasm).

3 How to use Fluticasone propionate
Always use this medicine exactly as your doctor has told you.
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.

1

2

3

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 Fluticasone propionate
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.

Hold the bottle as
shown and make
sure it is pointed
away from you.
Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the
bottle.
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
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.

Cleaning your spray
Clean your spray at least once a week, or more often if it
gets blocked.
1

2
3
4
5
6
7

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.
Pull upwards on the white collar
to remove the nozzle.
Soak the nozzle and dust cap
in warm water for a few minutes.
Then rinse under a running tap.
Shake off the excess water and
let them dry in a warm place.
Put the nozzle back on the spray.
‘Prime’ the bottle as described in
the section above, Preparing your spray

If you use more Fluticasone propionate 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 forget to use Fluticasone propionate
If you miss a dose, just use the next dose when it is due. Do
not take a double dose to make up for the forgotten dose.

If you stop taking Fluticasone propionate
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 medicine,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine 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 Fluticasone
propionate, which can develop into a more serious, even lifethreatening 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 Fluticasone propionate 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.

5 How to store Fluticasone propionate






Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use the spray after the expiry date which is stated
on the carton and bottle labels after ‘Exp’. The expiry date
refers to the last day of that month.
If the medicine becomes discoloured or shows any signs
of deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your pharmacist
for safe disposal. Only keep this medicine 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.

Tell your doctor as soon as possible if you notice any of
the following side effects:
Other side effects include:
Very common (may affect more than 1 in 10 people)
 Nose bleeds.



Common (may affect up to 1 in 10 people)
 Headache.
 Unpleasant taste.
 Unpleasant smell.
 A dry or painful nose or throat.

6 Contents of the pack and other information

Very rare (may affect up to 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 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 medicine.

What Fluticasone propionate contains
The active substance is fluticasone propionate
Each metered spray contains 50 micrograms of fluticasone
propionate.
The other ingredients are dextrose (anhydrous),
microcrystalline cellulose, carmellose sodium, polysorbate 80,
purified water and hydrochloric acid, dilute and the
preservatives benzalkonium chloride and phenylethyl alcohol

What Fluticasone propionate looks like and
contents of the pack
Fluticasone propionate is a white, opaque suspension.
It is available in a polypropylene bottle, with atomiser-dosing
pump, nasal adapter and cap.
Each bottle of Fluticasone propionate provides 120 sprays.
Manufactured by: : Glaxo Wellcome SA,
Avda Extremadura 3, E-09400 Aranda de Duero, Burgos,
Spain.
OR
Glaxo Wellcome Operations UK, Ltd, Harmire Road,
Barnard Castle County Durham DL12 8DT, UK.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Fluticasone propionate® Aqueous Nasal Spray
50 micrograms; PL 18799/1050
POM
Leaflet date: 15.01.2018

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

+ Expand Transcript

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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