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FLIXONASE AQUEOUS NASAL SPRAY 50 MICROGRAMS

Active substance: FLUTICASONE PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXONASE® AQUEOUS NASAL SPRAY 50 micrograms
(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.
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 Aqueous Nasal Spray 50 micrograms (called ‘Flixonase’ in
this leaflet) contains a medicine called fluticasone propionate. This
belongs to a group of medicines called steroids (also called
‘cortico-steroids’).
 Steroids work by reducing inflammation.
 They reduce swelling and irritation in your nose.
 This helps to relieve itching, sneezing and your blocked or runny
nose.
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)

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

Using your spray

3.

2. Blow your nose gently.

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).

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. 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.

 As you become better, your doctor may ask you to use a lower dose

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

- one spray into each nostril once a day.
 If your symptoms then get worse, your dose may be increased back
to the starting dose.

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

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.

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 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.

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.

1. Shake the bottle and take off the dust cap.

4.
 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.

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.
Store below 30°C.
Do not put in a refrigerator.
Do not use Flixonase after the expiry date which is stated on the label
and carton after ‘EXP’. The expiry date refers to the last day of that
month.
 If you are told to stop taking this medicine return any unused spray to
your pharmacist to be destroyed.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6.

Contents of the pack and other information

What Flixonase contains
 Each metered spray contains 50 micrograms of the active ingredient
fluticasone propionate.
 Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, sodium carboxymethylcellulose, glucose,
polysorbate 80, purified water, benzalkonium chloride,
phenylethylalcohol and dilute hydrochloric acid.
What Flixonase looks like and contents of the pack
Your medicine comes as a white opaque aqueous nasal spray delivered
by a metering atomising pump in an amber glass bottle with a green
dust cover. Each bottle provides 150 metered sprays.
Manufacturer:
This product is manufactured by Glaxo Wellcome S.A., Avda. De
Extremadura, 3, 09400 Aranda de Duero, Burgos - Spain.
It is procured from within the EU. Parallel Import Product Licence
holder: G Pharma Ltd, Salford M50 2PU.
PL No. 16369/0580
Flixonase™ Aqueous Nasal Spray

POM
28/01/2015

‘Flixonase’ is a trademark of the GlaxoSmithKline Group of
Companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXONASE® AQUEOUS NASAL SPRAY 50 micrograms
(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.
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 Aqueous Nasal Spray 50 micrograms (called ‘Flixonase’ in
this leaflet) contains a medicine called fluticasone propionate. This
belongs to a group of medicines called steroids (also called
‘cortico-steroids’).
 Steroids work by reducing inflammation.
 They reduce swelling and irritation in your nose.
 This helps to relieve itching, sneezing and your blocked or runny
nose.
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)

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

Using your spray

3.

2. Blow your nose gently.

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).

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. 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.

 As you become better, your doctor may ask you to use a lower dose

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

- one spray into each nostril once a day.
 If your symptoms then get worse, your dose may be increased back
to the starting dose.

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

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.

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 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.

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.

1. Shake the bottle and take off the dust cap.

4.
 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.

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.
Store below 30°C.
Do not put in a refrigerator.
Do not use Flixonase after the expiry date which is stated on the label
and carton after ‘EXP’. The expiry date refers to the last day of that
month.
 If you are told to stop taking this medicine return any unused spray to
your pharmacist to be destroyed.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6.

Contents of the pack and other information

What Flixonase contains
 Each metered spray contains 50 micrograms of the active ingredient
fluticasone propionate.
 Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, sodium carboxymethylcellulose, glucose,
polysorbate 80, purified water, benzalkonium chloride,
phenylethylalcohol and dilute hydrochloric acid.
What Flixonase looks like and contents of the pack
Your medicine comes as a white opaque aqueous nasal spray delivered
by a metering atomising pump in an amber glass bottle with a green
dust cover. Each bottle provides 150 metered sprays.
Manufacturer:
This product is manufactured by Glaxo Wellcome S.A., Avda. De
Extremadura, 3, 09400 Aranda de Duero, Burgos - Spain.
It is procured from within the EU. Parallel Import Product Licence
holder: G Pharma Ltd, Salford M50 2PU.
PL No. 16369/0580
Flixonase™ Aqueous Nasal Spray

POM
28/01/2015

‘Flixonase’ is a trademark of the GlaxoSmithKline Group of
Companies.

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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