FLUTICASONE PROPIONATE NASAL SPRAY

Active substance: FLUTICASONE PROPIONATE MICRONISED

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Package Leaflet:
Information For The User

Flixonase™

Flixonase is used to prevent and treat:

Driving and using machines



Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.

Flixonase is not likely to affect you being able to drive or
use any tools or machines.



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

Aqueous Nasal Spray
50 micrograms
(fluticasone propionate)
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.
The name of your medicine is Flixonase Aqueous nasal
spray, but it will be referred to as Flixonase throughout the
this leaflet.

2 Before you take Flixonase

Important information about some of the ingredients of
Flixonase
Flixonase contains benzalkonium chloride which may cause
problems with your breathing (bronchospasm).

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.

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.
 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.

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.

 The usual starting dose is 2 sprays into each nostril once
a day, preferably in the morning.

 As you become better, your doctor may ask you to use a
lower dose - one spray into each nostril once a day.

5 How to store Flixonase

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

 If your symptoms then get worse, your dose may be
increased back to the starting dose.

6 Further information



1

Taking Flixonase with food and drink

 The usual starting dose is one spray into each nostril
once a day, preferably in the morning

You can use Flixonase at any time of day, with or without
food.

 The most you would use over 24 hours is normally 4
sprays (2 sprays per nostril)

Pregnancy and breast-feeding

If you use high doses of Flixonase

What Flixonase is and what it is used for

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.

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.

How much to use - adults and children (aged 12 and
over)

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

4 Possible side effects

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.

 Use the spray every day.

 The most you would use over 24 hours is normally
8 sprays (4 sprays per nostril).

3 How to use Flixonase

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

 Do not use in children under 4 years old

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

2 Before you use Flixonase

Preparing your spray

Taking other medicines

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

Your doctor may give you extra steroid medication such as
tablets or an injection.

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

Talk to your doctor before using this medicine if you are
pregnant, might become pregnant, or are breast-feeding.

How much to use - children aged 4 to 11 years

You may need extra steroids:
 in times of extreme stress
 during admission to hospital after a serious accident or
injury
 before a surgical operation.

 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.

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.

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.

4

5

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
Breathe out through your mouth.

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.

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.

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 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 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.

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

6 Further Information

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.

What Flixonase contains

8

Repeat steps 3 to 6 for your other nostril.

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

9

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

Common (affects less than 1 in 10 people)
 Headache.

If you use more Flixonase than you should

 Unpleasant taste.

 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.

 Unpleasant smell.

What Flixonase looks like and contents of the pack

 A dry or painful nose or throat.

Flixonase is a brown glass bottle with white plastic adapter
and a green dust cap. It contains white, opaque suspension.
Each metered spray contains 50 micrograms of fluticasone
propionate.
Each bottle of Flixonase provides 120 sprays.

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

6 Put the nozzle back on the spray.
7 ‘Prime’ the bottle as described in the section
above, Preparing your spray.

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

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:

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.



Manufacturer: 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
Flixonase Aqueous Nasal Spray
PL No: 18799/1050

POM

Leaflet date: 21.11.2012
Flixonase is a trademark of the GlaxoSmithKline group of
companies.

Package Leaflet:
Information For The User

Fluticasone propionate is used to prevent and treat:

Driving and using machines



Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.

Fluticasone propionate

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



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

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

In this leaflet:
1 What Fluticasone propionate is and what it is used for
2 Before you use Fluticasone propionate
3 How to use Fluticasone propionate
4 Possible side effects
5 How to store Fluticasone propionate
6 Further information

2 Before you take Fluticasone propionate

What Fluticasone propionate is and what it
is used for

Fluticasone propionate Aqueous Nasal Spray (called
‘Fluticasone propionate’ 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.

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

Do not use Fluticasone propionate if:
 You are allergic (hypersensitive) to fluticasone propionate
or any of the other ingredients of Fluticasone propionate
Aqueous Nasal Spray (listed in section 6: Further
information).

3 How to use Fluticasone propionate

Take special care with Fluticasone propionate
 If you have ever had an operation on your nose.

 Only use in your nose contact with eyes should be
avoided.

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.

 Do not use in children under 4 years old

 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 Fluticasone propionate.

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)


1

Important information about some of the ingredients of
Fluticasone propionate

Your doctor may give you extra steroid medication such as
tablets or an injection.

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.

Always use Fluticasone propionate exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.

 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 you use high doses of Fluticasone propionate

Pregnancy and breast-feeding

You may need extra steroids:

Talk to your doctor before using this medicine if you are
pregnant, might become pregnant, or are breast-feeding.

 in times of extreme stress
 during admission to hospital after a serious accident or
injury
 before a surgical operation.

 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.

2

Blow your nose gently.

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

3

4

5

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.
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
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
9

Repeat steps 3 to 6 for your other nostril.
After using your spray, wipe the nozzle carefully
with a clean tissue or handkerchief, and replace
the dust cap.

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.

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 you forget to use Fluticasone propionate
If you miss a dose, just use the next dose when it is due.

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 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 product,
ask your doctor or pharmacist.

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

5 How to store Fluticasone propionate

Immediately after you use your spray
 You may sneeze a little, but this soon stops.

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 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.

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

6 Further Information

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).

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

6 Put the nozzle back on the spray.
7 ‘Prime’ the bottle as described in the section
above, Preparing your spray.

If you notice any side effects not listed in this leaflet tell your
doctor as soon as possible.

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.

What Fluticasone propionate contains
 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 Nasal Spray is supplied in an opaque
white plastic bottle fitted with a metering pump and a nasal
applicator. It contains white, opaque suspension.
Each metered spray contains 50 micrograms of fluticasone
propionate.
Each bottle of Fluticasone propionate provides 120 sprays.
Manufacturer: 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
POM
Fluticasone propionate Aqueous Nasal Spray
PL No: 18799/1050
Leaflet date: 21.11.2012

Expand view ⇕

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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