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FLUTICASONE PROPIONATE 50 MICROGRAMS AQUEOUS NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE MICRONISED

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S1365 LEAFLET Flixonase 20141008

Package Leaflet: Information For The User
®

FLIXONASE AQUEOUS NASAL SPRAY
(fluticasone propionate)
Your medicine is called Flixonase Aqueous Nasal Spray but it will
be referred to as Flixonase throughout this leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Flixonase contains benzalkonium chloride
Benzalkonium chloride may cause problems with your breathing
(bronchospasm).
3

HOW TO USE FLIXONASE

Always use this medicine exactly as yo ur doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Do not use in children under 4 years old.



Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

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





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.

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.

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.

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



In this leaflet:
1 What Flixonase is and what it is used for
2

What you need to know before you use Flixonase

3

How to use Flixonase

4

Possible side effects

5

How to store Flixonase

6

Contents of the pack and other information



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
1

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’).



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).



Steroids work by reducing inflammation.



They reduce swelling and irritation in your nose.

If you use high doses of Flixonase



This helps to relieve itching, sneezing and your blocked or
runny nose.

You may need extra steroids:


in times of extreme stress

Flixonase is used to prevent and treat:



during admission to hospital after a serious accident or injury





before a surgical operation.

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

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

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)



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.

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 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

Immediately after you use your spray

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



You may sneeze a little, but this soon stops.



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

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.

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 (may affect up to 1 in 10 people)


Headache.



Unpleasant taste.



Unpleasant smell.



A dry or painful nose or throat.

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

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

7 Remove the nozzle from this nostril and breathe out through your
mouth.
8 Repeat steps 3 to 6 for your other nostril.



Skin reaction – which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry, cracked
and peeling skin.

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



Problems with your eyes such as pain or blurred vision.



Damage to your nose

Cleaning your spray
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.

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, 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 Shake off the excess water
and let them dry in a warm
place.
6 Put the nozzle back on the
spray.

5

HOW TO STORE FLIXONASE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not put in a refrigerator.

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



Avoid freezing.



Protect from light.



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.

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 product, 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).

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 your medicine shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.
6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Flixonase contains


The active substance is fluticasone propionate



The other ingredients are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose anhydrous, polysorbate 80,
purified water and the preservatives benzalkonium chloride and
phenylethyl alcohol, diluted hydrochloric acid to adjust to pH to
6.3 - 6.5. 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
Flixonase Aqueous Nasal Spray is supplied in an amber glass
bottle fitted with a metering, atomising pump. Pack size of 120
metered sprays.
Each spray contains 50 micrograms of fluticasone propionate.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by GlaxoSmithKline Pharmaceuticals
SA. 60-322 Poznan, Poland.
POM

PL No: 19488/1365

Leaflet revision date: 08 October 2014
Flixonase is a registered trade mark of GlaxoSmithKline group of
companies.
S1365 LEAFLET Flixonase 20141008

S1365 LEAFLET Fluticasone Propionate 20141008

Package Leaflet: Information For The User

FLUTICASONE PROPIONATE 50 MICROGRAMS
AQUEOUS NASAL SPRAY

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

Your medicine is called Fluticasone Propionate Aqueous Nasal
Spray but it will be referred to as Fluticasone Propionate throughout
this leaflet.

3

HOW TO USE FLUTICASONE PROPIONATE

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Do not use in children under 4 years old.

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.


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

If you have any further questions, ask your doctor or
pharmacist.



It takes a few days for this medicine to work. So keep using
it, even though you may not feel better straight away.



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.



Use the spray every day.



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.



Keep this leaflet. You may need to read it again.



In this leaflet:
1

What Fluticasone Propionate is and what it is used for

2

What you need to know before you use Fluticasone Propionate

3

How to use Fluticasone Propionate

4
5

Possible side effects
How to store Fluticasone Propionate

6

Contents of the pack and other information

1

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 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
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
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

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.
1 Hold the bottle as shown and
make sure it is pointed away
from you.
2 Put your forefinger and
middle finger 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.

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)



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
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.

Using your spray

Immediately after you use your spray

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



You may sneeze a little, but this soon stops.



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

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.

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 (may affect up to 1 in 10 people)


Headache.



Unpleasant taste.



Unpleasant smell.



A dry or painful nose or throat.

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

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

7 Remove the nozzle from this nostril and breathe out through your
mouth.
8 Repeat steps 3 to 6 for your other nostril.



Skin reaction – which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry, cracked
and peeling skin.

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



Problems with your eyes such as pain or blurred vision.



Damage to your nose

Cleaning your spray
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.

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, 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 Shake off the excess water
and let them dry in a warm
place.
6 Put the nozzle back on the
spray.

5

HOW TO STORE FLUTICASONE PROPIONATE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not put in a refrigerator.

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



Avoid freezing.



Protect from light.



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.

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 product, 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).

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 your medicine shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.
6

FURTHER INFORMAT ION

What Fluticasone Propionate contains


The active substance is fluticasone propionate



The other ingredients are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose anhydrous, polysorbate 80,
purified water and the preservatives benzalkonium chloride and
phenylethyl alcohol, diluted hydrochloric acid to adjust to pH to
6.3 - 6.5. These other ingredients are needed to make a stable
suspension which will not go off.

What Fluticasone Propionate Aqueous Nasal Spray looks like
and contents of the pack
Fluticasone Propionate Aqueous Nasal Spray is supplied in an
amber glass bottle fitted with a metering, atomising pump. Pack
size of 120 metered sprays.
Each spray contains 50 micrograms of fluticasone propionate.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by GlaxoSmithKline Pharmaceuticals
SA. 60-322 Poznan, Poland.
POM

PL No: 19488/1365

Leaflet revision date: 08 October 2014
S1365 LEAFLET Fluticasone Propionate 20141008

S1365 LEAFLET Flixonase 20141008 new

Package Leaflet: Information For The User
®

FLIXONASE AQUEOUS NASAL SPRAY
(fluticasone propionate)
Your medicine is called Flixonase Aqueous Nasal Spray but it will
be referred to as Flixonase throughout this leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

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).



Keep this leaflet. You may need to read it again.

3



If you have any further questions, ask your doctor or
pharmacist.

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.



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.

Do not use in children under 4 years old.


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

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.



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.



In this leaflet:
1 What Flixonase is and what it is used for
2

What you need to know before you use Flixonase

3

How to use Flixonase

4

Possible side effects

5

How to store Flixonase

6
1

HOW TO USE FLIXONASE

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).

Contents of the pack and other information



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

WHAT FLIXONASE IS AND WHAT IT IS USED FOR



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

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’).

How much to use - children aged 4 to 11 years



Steroids work by reducing inflammation.





They reduce swelling and irritation in your nose.

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



This helps to relieve itching, sneezing and your blocked or
runny nose.



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

Flixonase is used to prevent and treat:


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

If you use high doses of Flixonase



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



in times of extreme stress



during admission to hospital after a serious accident or injury

2

WHAT YOU NEED TO KNOW BEFORE YOU USE
FLIXONASE

You may need extra steroids:

 before a surgical operation.
Your doctor may give you extra steroid medication such as tablets
or an injection.

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)



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.

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

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)

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.



Skin reaction – which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry, cracked
and peeling skin.

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.

Nose bleeds.

Common (may affect up to 1 in 10 people)


Headache.



Unpleasant taste.



Unpleasant smell.



A dry or painful nose or throat.

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



Problems with your eyes such as pain or blurred vision.

8 Repeat steps 3 to 6 for your other nostril.



Damage to your nose

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

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.

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

Reporting of 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.

4 Then rinse under a running tap.
5 Shake off the excess water and let them dry in a warm place.

5

HOW TO STORE FLIXONASE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not put in a refrigerator.

If you use more Flixonase than you should



Avoid freezing.

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.



Protect from light.



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.

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. Do not
take a double dose to make up for the forgotten dose.
If you stop taking Flixonase

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.

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 your medicine shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.

If you have any further questions on the use of this product, 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.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Flixonase contains


The active substance is fluticasone propionate



The other ingredients are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose anhydrous, polysorbate 80,
purified water and the preservatives benzalkonium chloride and
phenylethyl alcohol, diluted hydrochloric acid to adjust to pH to
6.3 - 6.5. 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
Flixonase Aqueous Nasal Spray is supplied in a white plastic bottle
with pump and transparent dust cap. Pack size of 120 metered
sprays.
Each spray contains 50 micrograms of fluticasone propionate.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Glaxo Wellcome S.A., 3 Avenida
de Extremadura, 09400 Aranda de Duero, Burgos, Spain.
POM

PL No: 19488/1365

Leaflet revision date: 08 October 2014
Flixonase is a registered trade mark of GlaxoSmithKline group of
companies.
S1365 LEAFLET Flixonase 20141008 new

S1365 LEAFLET Fluticasone Propionate 20141008 new

Package Leaflet: Information For The User

FLUTICASONE PROPIONATE 50 MICROGRAMS
AQUEOUS NASAL SPRAY
Your medicine is called Fluticasone Propionate Aqueous Nasal
Spray but it will be referred to as Fluticasone Propionate throughout
this leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

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.



Keep this leaflet. You may need to read it again.

Fluticasone Propionate contains benzalkonium chloride



If you have any further questions, ask your doctor or
pharmacist.

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



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.

3



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.

In this leaflet:
1

What Fluticasone Propionate is and what it is used for

2

What you need to know before you use Fluticasone Propionate

3

How to use Fluticasone Propionate

4
5

Possible side effects
How to store Fluticasone Propionate

6

Contents of the pack and other information

1

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 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
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
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:

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.

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



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)

3 Keep your thumb still, and
press down with your fingers
to pump the spray.



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



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.

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

Using your spray
1 Shake the bottle and take
off the dust cap.
2 Blow your nose gently.

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)

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.

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

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



Skin reaction – which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry, cracked
and peeling skin.

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

Nose bleeds.

Common (may affect up to 1 in 10 people)


Headache.



Unpleasant taste.



Unpleasant smell.



A dry or painful nose or throat.



Problems with your eyes such as pain or blurred vision.

8 Repeat steps 3 to 6 for your other nostril.



Damage to your nose

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

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.

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

Reporting of 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.

4 Then rinse under a running tap.
5 Shake off the excess water and let them dry in a warm place.

5

HOW TO STORE FLUTICASONE PROPIONATE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not put in a refrigerator.

If you use more Fluticasone Propionate than you should



Avoid freezing.

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.



Protect from light.



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.

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 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

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.

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 your medicine shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.

If you have any further questions on the use of this product, 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.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluticasone Propionate contains


The active substance is fluticasone propionate



The other ingredients are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose anhydrous, polysorbate 80,
purified water and the preservatives benzalkonium chloride and
phenylethyl alcohol, diluted hydrochloric acid to adjust to pH to
6.3 - 6.5. These other ingredients are needed to make a stable
suspension which will not go off.

What Fluticasone Propionate Aqueous Nasal Spray looks like
and contents of the pack
Fluticasone Propionate Aqueous Nasal Spray is supplied in a white
plastic bottle with pump and transparent dust cap. Pack size of 120
metered sprays.
Each spray contains 50 micrograms of fluticasone propionate.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Glaxo Wellcome S.A., 3 Avenida
de Extremadura, 09400 Aranda de Duero, Burgos, Spain.
POM

PL No: 19488/1365

Leaflet revision date: 08 October 2014
S1365 LEAFLET Fluticasone Propionate 20141008 new

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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