Skip to Content

FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY 50 MICROGRAMS

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

View full screen / Print PDF » Download PDF ⇩
Transcript
S0058 LEAFLET Flixonase 20141008

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

FLIXONASE AQUEOUS NASAL SPRAY 50 micrograms
(fluticasone propionate)
This medicine is known as Flixonase Aqueous Nasal Spray
50 micrograms but will be referred to as Flixonase in 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
4

How to use Flixonase
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.



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

If you use high doses of Flixonase
You may need extra steroids:


in times of extreme stress



during admission to hospital after a serious accident or injury

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

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:

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

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



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)

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 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.

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

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.

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

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


Nose bleeds.

Common (may affect up to 1 in 10 people)


Headache.



Unpleasant taste.



Unpleasant smell.

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



A dry or painful nose or throat.

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

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


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



Problems with your eyes such as pain or blurred vision.

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

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.

 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.

2 Pull upwards on the white
collar to remove the nozzle.

Reporting of side effects

Cleaning your spray

3 Soak the nozzle and dust
cap in warm water for a few
minutes.
4 Then rinse under a running
tap.
5 Shake off the excess water
and let them dry in a warm
place.
6 Put the nozzle back on the
spray.

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 FLIXONASE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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



Do not store above 25°C.



Do not use after the expiry date printed on the carton or bottle
label.

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 the spray fails to work properly or shows any signs of
deterioration please return it to the pharmacist. If your doctor
tells you to stop using the spray, please take it back to the
pharmacist for safe disposal. Only keep the spray if the doctor
tells you to.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

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



Each metered spray contains 50 micrograms of the active
ingredient fluticasone propionate.



The suspension also contains benzalkonium chloride,
phenylethyl alcohol, microcrystalline cellulose/sodium
carboxymethylcellulose (Avicel RC591), dextrose anhydrous,
polysorbate 80, dilute hydrochloric acid and purified water.

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

4

What Flixonase contains

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.



Each bottle of Flixonase Aqueous Nasal Spray delivers 150
metered sprays.
What Flixonase looks like and contents of the pack
Flixonase is a cloudy solution (suspension) contained in an amber
glass bottle fitted with a white spray device and a green plastic dust
cap.
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 SA, Avda de
Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
POM

PL 19488/0058

Leaflet revision date: 08 October 2014
Flixonase is a registered trade mark of Glaxo Group Ltd, UK.
S0058 LEAFLET Flixonase 20141008

S0058 LEAFLET Fluticasone Propionate 20141008

Package Leaflet: Information For The User

FLUTICASONE PROPIONATE
AQUEOUS NASAL SPRAY 50 micrograms
This medicine is known as Fluticasone Propionate Nasal Spray 50
micrograms but will be referred to as Fluticasone Propionate in this
leaflet.
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.

Driving and using machines
Fluticasone Propionate is not likely to affect you being able to drive
or use any tools or machines.
Fluticasone Propionate contains benzalkonium chloride
Benzalkonium chloride may cause problems with your breathing
(bronchospasm).
3

HOW TO USE FLUTICASONE PROPIONATE

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


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



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



Use the spray every day.

In this leaflet:
1

What Fluticasone Propionate is and what it is used for

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

2

What you need to know before you use Fluticasone Propionate



3

How to use Fluticasone Propionate

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

4
5

Possible side effects
How to store Fluticasone Propionate



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

6

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.


1

WHAT FLUTICASONE PROPIONATE IS AND WHAT IT IS
USED FOR

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

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:


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.

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.

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

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

HOW TO STORE FLUTICASONE PROPIONATE



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use after the expiry date printed on the carton or bottle
label.



If the spray fails to work properly or shows any signs of
deterioration please return it to the pharmacist. If your doctor
tells you to stop using the spray, please take it back to the
pharmacist for safe disposal. Only keep the spray if the doctor
tells you to.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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

6

CONTENTS OF THE PACK AND OTHER INFORMATION

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.



Each metered spray contains 50 micrograms of the active
ingredient fluticasone propionate.

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



The suspension also contains benzalkonium chloride,
phenylethyl alcohol, microcrystalline cellulose/sodium
carboxymethylcellulose (Avicel RC591), dextrose anhydrous,
polysorbate 80, dilute hydrochloric acid and purified water.



Each bottle of Fluticasone Propionate Aqueous Nasal Spray
delivers 150 metered sprays.

7 ‘Prime’ the bottle as described in the section above, Preparing
your spray
If you use more Fluticasone Propionate than you should
Tell your doctor if you use more than you were told to.
It is important that you take your dose as stated on the pharmacist’s
label or as advised by your doctor. You should use only as much as
your doctor recommends; using more or less may make your
symptoms worse.
If you forget to use Fluticasone Propionate

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).

What Fluticasone Propionate Aqueous Nasal Spray contains

What Fluticasone Propionate Aqueous Nasal Spray looks like
and contents of the pack
Fluticasone Propionate is a cloudy solution (suspension) contained
in an amber glass bottle fitted with a white spray device and a green
plastic dust cap.
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 SA, Avda de
Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
POM

PL 19488/0058

Leaflet revision date: 08 October 2014
S0058 LEAFLET Fluticasone Propionate 20141008

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.

Hide