Skip to Content

FLUTICASONE PROPIONATE 50MCG AQUEOUS NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package Leaflet: Information For The User

Flixonase™
50 mcg Aqueous Nasal Spray
(fluticasone propionate)
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
 If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Flixonase 50 mcg Aqueous
Nasal Spray but it will be referred as Flixonase throughout
this leaflet.
What is 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

1

What Flixonase is and what it is used for

Flixonase contains a medicine called fluticasone propionate.
This belongs to a group of medicines called steroids (also
called ‘cortico-steroids’).
 Steroids work by reducing inflammation.
 They reduce swelling and irritation in your nose.
 This helps to relieve itching, sneezing and your blocked
or runny nose.

Flixonase is used to prevent and treat:
 Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.
 Inflammation in the lining of your nose (rhinitis) due to
year round (perennial) allergies, such as animal allergies.

2

What you need to know before you use
Flixonase

Do not use Flixonase if:
 You are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Flixonase:
 If you have ever had an operation on your nose.
 If you have an infection in your nose
Other medicines and Flixonase
Tell your doctor if you are taking, have recently taken or
might take any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines.
Check with your doctor or pharmacist before using your
medicine if:
• you have had steroids for a long time, either as an
injection or by your mouth
• you are taking a type of antiviral medicine known as a
protease inhibitor (e.g. ritonavir)
• you are taking certain medicines used to treat fungal
infections (e.g. ketoconazole)
Taking Flixonase with food and drink
You can use Flixonase at any time of day, with or without
food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
Driving and using machines
Flixonase is not likely to affect you being able to drive or use
any tools or machines.

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

3 How to use Flixonase
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
• Do not use in children under 4 years old.
• Only use in your nose, contact with eyes should be
avoided.
• It takes a few days for this medicine to work. So keep
using it, even though you may not feel better straight
away.
• Use the spray every day.
How much to use - adults and children
(aged 12 and over)
• The usual starting dose is 2 sprays into each nostril once
a day, preferably in the morning.
• The most you would use over 24 hours is normally 8
sprays (4 sprays per nostril).
• As you become better, your doctor may ask you to use a
lower dose - one spray into each nostril once a day.
• If your symptoms then get worse, your dose may be
increased back to the starting dose.
How much to use - children aged 4 to 11 years
• The usual starting dose is one spray into each nostril
once a day, preferably in the morning.
• The most you would use over 24 hours is normally 4
sprays (2 sprays per nostril).
If you use high doses of Flixonase
You may need extra steroids:
• in times of extreme stress
• during admission to hospital after a serious accident or
injury
• before a surgical operation.
Your doctor may give you extra steroid medication such as
tablets or an injection.

Preparing your spray
Each spray has a dust cap which protects the
nozzle and keeps it clean. Remember to take
this off before using the spray.
A new spray (or one that has not been used for
a few days), may not work first time. You need
to ‘prime’ the spray by pumping the spray a
few times until a fine mist is produced.
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.



If the spray does not work and you think it
may be blocked, you will need to clean it.
Please see the section below, Cleaning
your spray.



Never try to unblock or enlarge the tiny
spray hole with a pin or other sharp object.
This will damage the way the spray works.

Using your spray
1 Shake the bottle and take off the dust cap.
2 Blow your nose gently.
3 Close one nostril
with your finger
as shown, and put
the nozzle in the
other nostril. Tilt
your head forward
slightly and keep
the bottle upright.
Hold the bottle
as shown.
4 Start to breathe in
slowly through your
nose. While you are
breathing in press
down firmly on the collar with your fingers.
A spray of fine mist will go into your nostril

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

5 Breathe out through your mouth.
6 Repeat step 4 to use a second spray in the same
nostril.
7 Remove the nozzle from this nostril and breathe
out through your mouth.
8 Repeat steps 3 to 6 for your other nostril.
9 After using your spray, wipe the nozzle carefully
with a clean tissue or handkerchief, and replace the
dust cap.

If you use more Flixonase than you should
Tell your doctor if you use more than you were told to.
It is important that you take your dose as stated on the
pharmacist’s label or as advised by your doctor. You should
use only as much as your doctor recommends; using more
or less may make your symptoms worse.
If you forget to use Flixonase
If you miss a dose, just use the next dose when it is due. Do
not take a double dose to make up for the forgotten dose.
If you stop taking Flixonase
Do not stop treatment even if you feel better, unless your
doctor tells you to stop. If you do stop, the symptoms may
come back.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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

Allergic reactions: get a doctor’s help straight away
A small number of people get allergic reactions to Flixonase,
which can develop into a more serious, even life-threatening
problem if not treated. Symptoms include;
 becoming very wheezy, coughing or having difficulty with
breathing
 suddenly feeling weak or light-headed (which may lead to
collapse or loss of consciousness)
 swelling around the face, mouth or tongue
 skin rashes or redness.
If this happens, tell your doctor straight away – you may
need urgent medical treatment.
Allergic reactions to Flixonase are very rare (These affect
less than 1 in 10,000 people).
Immediately after you use your spray
 You may sneeze a little, but this soon stops.
 Very occasionally you may find you get an unpleasant
taste or smell.
Tell your doctor as soon as possible if you notice any of
the following side effects:
Other side effects include:
Very common (may affect more than 1 in 10 people)
• Nose bleeds.
Common (may affect up to 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.
Very rare (may affect up to 1 in 10,000 people)
 Skin reaction - which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry,
cracked and peeling skin.
• Problems with your eyes such as pain or blurred vision.
• Damage to your nose
Very rarely, the normal production of steroids in your body
may be affected. This is more likely to happen if you use high
doses for a long time. Your doctor will help stop this
happening by making sure you use the lowest dose of
steroid which controls your symptoms. In children this side
effect can rarely cause them to grow more slowly than
others. Children who receive this treatment for a long period
of time will have their height checked regularly by their
doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, 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.
• Protect from frost and light.
• Do not store above 30°C.
• Do not put in a refrigerator.
• Store in the original package.
• Do not use this medicine 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.

6 Contents of the pack and other
information
What Flixonase contains
• The active substance is fluticasone propionate.
• The other ingredients are glucose, microcrystalline
cellulose, sodium carboxymethylcellulose,
phenylethylalcohol, benzalkonium chloride, polysorbate
80 & purified water. These other ingredients are needed
to make a stable suspension which will not go off.
What Flixonase looks like and contents of the pack
Flixonase is supplied in an amber glass bottle fitted with a
metering, atomising pump containing a white opaque
suspension.
Each amber coloured glass bottle delivers 150 sprays.
Each spray contains 50 micrograms of fluticasone
propionate.
Manufactured by: Glaxo Wellcome SA, Aranda de Duero
Burgos, Spain
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, Slough, SL1 4NL.

Flixonase® 50 mcg Aqueous Nasal Spray,
PL: 39352/0012
®

Flixonase is a trademark of the GlaxoSmithKline group of
companies.
POM
Leaflet date: 21.08.2014

Package Leaflet: Information For The User

Fluticasone
propionate
50 mcg Aqueous Nasal Spray
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
 If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Fluticasone propionate 50 mcg
Aqueous Nasal Spray but it will be referred as Fluticasone
propionate Aqueous Nasal Spray throughout this leaflet.
What is in this leaflet:
1 What Fluticasone propionate Aqueous Nasal Spray is and
what it is used for
2 What you need to know before you use Fluticasone
propionate Aqueous Nasal Spray
3 How to use Fluticasone propionate Aqueous Nasal Spray
4 Possible side effects
5 How to store Fluticasone propionate Aqueous Nasal
Spray
6 Contents of the pack and other information

1

What Fluticasone propionate Aqueous
Nasal Spray is and what it is used for

Fluticasone propionate Aqueous Nasal Spray contains a
medicine called fluticasone propionate. This belongs to a
group of medicines called steroids (also called ‘corticosteroids’).
 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 Aqueous Nasal Spray 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 Aqueous Nasal
Spray

Do not use Fluticasone propionate Aqueous Nasal Spray
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 Aqueous Nasal Spray:
 If you have ever had an operation on your nose.
 If you have an infection in your nose
Other medicines and Fluticasone propionate Aqueous
Nasal Spray
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 Aqueous Nasal Spray
with food and drink
You can use Fluticasone propionate Aqueous Nasal Spray 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 Aqueous Nasal Spray is not likely to
affect you being able to drive or use any tools or machines.

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

3 How to use Fluticasone propionate
Aqueous Nasal Spray
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

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.

avoided

• It takes a few days for this medicine to work. So keep


2.

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
Aqueous Nasal Spray
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.

3.

Hold the bottle as
shown and make
sure it is pointed
away from you.
Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the bottle.
Keep your thumb
still, and press down
with your fingers to pump the spray.



If the spray does not work and you think it
may be blocked, you will need to clean it.
Please see the section below, Cleaning
your spray.



Never try to unblock or enlarge the tiny
spray hole with a pin or other sharp object.
This will damage the way the spray works.

Using your spray
1

Shake the bottle and take off the dust cap.

2

Blow your nose gently.

3

Close one nostril
with your finger
as shown, and put
the nozzle in the
other nostril. Tilt
your head forward
slightly and keep
the bottle upright.
Hold the bottle
as shown.

4

Start to breathe in
slowly through your
nose. While you are
breathing in press
down firmly on the collar with your fingers.
A spray of fine mist will go into your nostril

5

Breathe out through your mouth.

6

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

7

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

8

Repeat steps 3 to 6 for your other nostril.

9

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

Cleaning your spray
Clean your spray at least once a week, or more often
if it gets blocked.
1 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.
7 ‘Prime’ the bottle as described in the section
above, Preparing your spray

If you use more Fluticasone propionate Aqueous Nasal
Spray 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 Aqueous
Nasal Spray
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 Aqueous Nasal
Spray
Do not stop treatment even if you feel better, unless your
doctor tells you to stop. If you do stop, the symptoms may
come back.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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

Allergic reactions: get a doctor’s help straight away
A small number of people get allergic reactions to
Fluticasone propionate Aqueous Nasal Spray, 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 Fluticasone propionate Aqueous Nasal
Spray are very rare (These affect less than 1 in 10,000
people).
Immediately after you use your spray
 You may sneeze a little, but this soon stops.
 Very occasionally you may find you get an unpleasant
taste or smell.
Tell your doctor as soon as possible if you notice any of
the following side effects:
Other side effects include:
Very common (may affect more than 1 in 10 people)
• Nose bleeds.
Common ((may affect up to 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.
Very rare (may affect up to 1 in 10,000 people)
 Skin reaction - which can range from red, itchy rash and
blotches to a more severe skin reaction such as dry,
cracked and peeling skin.
• Problems with your eyes such as pain or blurred vision.
• Damage to your nose
Very rarely, the normal production of steroids in your body
may be affected. This is more likely to happen if you use high
doses for a long time. Your doctor will help stop this
happening by making sure you use the lowest dose of
steroid which controls your symptoms. In children this side
effect can rarely cause them to grow more slowly than
others. Children who receive this treatment for a long period
of time will have their height checked regularly by their
doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, 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
Aqueous Nasal Spray
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.
• Store in the original package.
• Do not use this medicine 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.

6 Contents of the pack and other information
What Fluticasone propionate Aqueous Nasal Spray
contains
• The active substance is fluticasone propionate.
• The other ingredients are glucose, microcrystalline
cellulose, sodium carboxymethylcellulose,
phenylethylalcohol, benzalkonium chloride, polysorbate
80 & purified water. 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
containing a white opaque suspension.
Each amber coloured glass bottle delivers 150 sprays.
Each spray contains 50 micrograms of fluticasone
propionate.
Manufactured by: Glaxo Wellcome SA, Aranda de Duero
Burgos, Spain
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, Slough, SL1 4NL.

Fluticasone propionate 50 mcg Aqueous Nasal
Spray,
PL: 39352/0012
Leaflet date: 21.08.2014

POM

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