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FLUTICASONE PROPIONATE NASAL SPRAY

Active substance: FLUTICASONE PROPIONATE MICRONISED

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Package Leaflet: Information For The User

Flixonase is used to prevent and treat:

Flixonase contains benzalkonium chloride

Preparing your spray

Flixonase®



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

Each spray has a dust cap which protects the nozzle
and keeps it clean. Remember to take this off before
using the spray.

3 How to use Flixonase

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.

Aqueous Nasal Spray
50micrograms
(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, but it will be referred to as Flixonase throughout the
this leaflet.

What is in this leaflet:
1. What Flixonase is and what it is used for



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 or 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

2. What you need to know before you use Flixonase

• you are taking a type of antiviral medicine known as
protease inhibitor (e.g. ritonavir)

3. How to use Flixonase



4. Possible side effects
5. How to store Flixonase
6. Contents of the pack and other information

1 What Flixonase is and what it is used for

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
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.

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.

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.

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.

• 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 the spray does not work and you think it may be
blocked, you will need to clean it. Please see the
section overleaf, ‘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

If you use high doses of Flixonase

1

Shake the bottle and take off the dust cap.

You may need extra steroids:

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.

• 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.

If you forget to use Flixonase
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.
.

• A dry or painful nose or throat.

6 Contents of the pack and other information

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.

Very rare (may affects up to 1 in 10,000 people)

What Flixonase contains

• 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.




If you stop taking Flixonase

6

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

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.

7

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

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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.

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:

Cleaning your spray

Allergic reactions: get a doctor’s help straight away

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

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:

1

2

3

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.

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,
‘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.



becoming very wheezy, coughing or having difficulty with
breathing



suddenly feeling weak or light-headed (which may lead to
collapse or loss of consciousness)

• 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 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: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

The active substance is 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.

Warning: This product contains benzalkonium chloride
which is an irritant and may cause skin reactions. It may also
cause bronchospasm.
What Flixonase looks like and contents of the pack
Flixonase is a brown glass bottle with white plastic adapter
and a green dust cap. It contains white, opaque suspension.
Each metered spray contains 50micrograms of fluticasone
propionate.
Each bottle of Flixonase provides 120 sprays.

Manufactured by: Glaxo Wellcome SA, Avda Extremadura
3, 09400 Aranda de Duero, Burgos, Spain and Glaxo
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.



swelling around the face, mouth or tongue

5 How to store Flixonase



skin rashes or redness.



Keep out of the sight and reach of children.



Protect from frost and light.

Flixonase Aqueous Nasal Spray
PL No: 18799/1050



Do not store above 30°C.

Leaflet date: 13.04.2015



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.

Flixonase is a trademark of the GlaxoSmithKline group of
companies.



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.

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 (may affects more than 1 in 10 people)
• Nose bleeds.
Common (may affects up to 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.

POM

Package Leaflet: Information For The User

Fluticasone propionate
Aqueous Nasal Spray

Fluticasone propionate 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.

50micrograms
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.

2 What you need to know before you use
Fluticasone propionate
Do not use Fluticasone propionate if:
• You are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions

• 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.

Talk to your doctor or pharmacist before using Fluticasone
propionate:
• If you have ever had an operation on your nose.

• 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.

• If you have an infection in your nose.

The name of your medicine is Fluticasone propionate
Aqueous nasal spray, but it will be referred to as Fluticasone
propionate throughout this leaflet.

Tell your doctor if you are taking or have recently taken or
might take any other medicines, including medicines obtained
without a prescription. This includes herbal medicines.

What is in this leaflet:

Check with your doctor or pharmacist before using your
medicine if:

1. What Fluticasone propionate is and what it is used for

• you have had steroids for a long time, either as an injection
or by your mouth

2. What you need to know before you use Fluticasone
propionate

Other medicines and Fluticasone propionate

3. How to use Fluticasone propionate

• you are taking a type of antiviral medicine known as
protease inhibitor (e.g. ritonavir)

4. Possible side effects



5. How to store Fluticasone propionate
6. Contents of the pack and other information

1 What Fluticasone propionate is and what it
is used for

you are taking certain medicines used to treat fungal
infections (e.g. ketoconazole)

Taking Fluticasone propionate with food and drink
You can use Fluticasone propionate at any time of day, with
or without food.

Pregnancy and breast-feeding
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.

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.

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.

• 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 Fluticasone propionate

• If the spray does not work and you think it may be
blocked, you will need to clean it. Please see the
section overleaf, ‘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.

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.

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

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.

5

Breathe out through your mouth.

6

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

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 stop taking Fluticasone propionate

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

7

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

8

Repeat steps 3 to 6 for your other nostril.

4 Possible side effects

9

After using your spray, wipe the nozzle carefully with
a clean tissue or handkerchief, and replace the dust
cap.

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

Cleaning your spray

Allergic reactions: get a doctor’s help straight away

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

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:

1



becoming very wheezy, coughing or having difficulty with
breathing



suddenly feeling weak or light-headed (which may lead to
collapse or loss of consciousness)

2

3

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.

4

Then rinse under a
running tap.

5

Shake off the excess
water and let them dry in a warm place.

What Fluticasone propionate contains

• 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 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: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5 How to store Fluticasone propionate



skin rashes or redness.



Keep out of the sight and reach of children.



Protect from frost and light.



Do not store above 30°C.



Do not put in a refrigerator.



Do not use Fluticasone propionate 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 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.

Put the nozzle back on the spray.

7

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

Tell your doctor as soon as possible if you notice any of
the following side effects:
Other side effects include:

If you forget to use Fluticasone propionate

• 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.

swelling around the face, mouth or tongue

6

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.

6 Contents of the pack and other information



• Very occasionally you may find you get an unpleasant
taste or smell.

If you use more Fluticasone propionate than you
should

Very rare (may affects up to 1 in 10,000 people)

Very common (may affects more than 1 in 10 people)
• Nose bleeds.
Common (may affects up to 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.



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.




The active substance is 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.

Warning: This product contains benzalkonium chloride
which is an irritant and may cause skin reactions. It may also
cause bronchospasm.
What Fluticasone propionate looks like and
contents of the pack
Fluticasone propionate is a brown glass bottle with white
plastic adapter and a green dust cap. It contains white,
opaque suspension.
Each metered spray contains 50micrograms of fluticasone
propionate.
Each bottle of Fluticasone propionate provides 120 sprays.

Manufactured by: Glaxo Wellcome SA, Avda Extremadura
3, 09400 Aranda de Duero, Burgos, Spain and Glaxo
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
PL No: 18799/1050
Leaflet date: 13.04.2015

POM

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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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