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FLUTICASONE PROPIONATE 50 MICROGRAM AQUEOUS NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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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 (affects more than 1 in 10 people)
• Nose bleeds.
Common (affects less than 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.
Very rare (affects less than 1 in 10,000 people)
• Skin reaction - which can range from red, itchy
rash and blotches to a more severe skin reaction
such as dry, cracked and peeling skin.
• Problems with your eyes such as pain or blurred
vision.
• Damage to your nose.
Very rarely, the normal productionof 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
other. 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.



Do not use this medicine after the expiry date
shown on the carton label or plastic container.
If your doctor tells you to stop taking this
medicine, return any unused medication to your
pharmacist (chemist) for safe disposal. Only
keep this medicine, if your doctor tells you to.
If the medicine shows any other signs of
deterioration, consult your pharmacist (chemist)
who will tell you what to do.

6. FURTHER INFORMATION
What Flixonase Aqueous Nasal Spray contains
• Each metered spray contains 50 micrograms of
the active ingredient fluticasone propionate.
• Your medicine also contains the following
inactive ingredients: Microcrystalline cellulose,
carboxymethylcellulose sodium, glucose
(anhydrous), polysorbate 80, purified water,
benzalkonium chloride, phenylethylbalcohol and
dilute hydrochloric acid.
What Flixonase Aqueous Nasal Spray looks
like and contents of the pack
It is available as a suspension in a spray pump,
and each bottle delivers 120 sprays.

Manufacturer and Licence Holder
Flixonase is manufactured by Glaxo Wellcome
S.A., Avda de Extremadura 3, 09400 - Arranda de
Duero - Burgos, Spain and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/0338 Flixonase Aqueous Nasal Spray

Flixonase is a trademark of the GlaxoSmithKline
Group of Companies.
Leaflet revision date: 14/01/15

5. HOW TO STORE FLIXONASE




Keep this medicine out of the sight and reach of
children.
Do not store above 30°C.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: 0338/140115/1/F

®

FLIXONASE AQUEOUS NASAL SPRAY
(fluticasone propionate)
Read all of this leaflet carefully before you
start using this medicine because it contains
important infromation 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. Do
not pass it on to others. It may harm them, even
if their symptoms 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FLIXONASE

Your medicine is called Flixonase Aqueous Nasal
Spray but will referred to as Flixonase throughout
this leaflet

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

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.

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

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 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 Flixonase exactly as your doctor has
told you. You should 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
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.

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 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 forgotton 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, Flixonase can cause side
effects, although not everybody gets them.
The following side effects may happen with this
medicine:

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.

Ref: 0338/140115/1/B

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 Fluticasone 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 (affects more than 1 in 10 people)
• Nose bleeds.
Common (affects less than 1 in 10 people)
• Headache.
• Unpleasant taste.
• Unpleasant smell.
• A dry or painful nose or throat.
Very rare (affects less than 1 in 10,000 people)
• Skin reaction - which can range from red, itchy
rash and blotches to a more severe skin reaction
such as dry, cracked and peeling skin.
• Problems with your eyes such as pain or blurred
vision.
• Damage to your nose.
Very rarely, the normal productionof 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
other. 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.

PATIENT INFORMATION LEAFLET



Do not use this medicine after the expiry date
shown on the carton label or plastic container.
If your doctor tells you to stop taking this
medicine, return any unused medication to your
pharmacist (chemist) for safe disposal. Only
keep this medicine, if your doctor tells you to.
If the medicine shows any other signs of
deterioration, consult your pharmacist (chemist)
who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Fluticasone Aqueous Nasal Spray
contains
• Each metered spray contains 50 micrograms of
the active ingredient fluticasone propionate.
• Your medicine also contains the following
inactive ingredients: Microcrystalline cellulose,
carboxymethylcellulose sodium, glucose
(anhydrous), polysorbate 80, purified water,
benzalkonium chloride, phenylethylbalcohol and
dilute hydrochloric acid.
What Fluticasone Aqueous Nasal Spray looks
like and contents of the pack
It is available as a suspension in a spray pump,
and each bottle delivers 120 sprays.
Manufacturer and Licence Holder
Fluticasone is manufactured by Glaxo Wellcome
S.A., Avda de Extremadura 3, 09400 - Arranda de
Duero - Burgos, Spain and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/0338 Fluticasone Propionate 50 micrograms
Aqueous Nasal Spray

Leaflet revision date: 14/01/15
5. HOW TO STORE FLUTICASONE




Keep this medicine out of the sight and reach of
children.
Do not store above 30°C.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0338/140115/2/F

FLUTICASONE PROPINATE 50 MICROGRAMS
AQUEOUS NASAL SPARY
Read all of this leaflet carefully before you
start using this medicine because it contains
important infromation 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. Do
not pass it on to others. It may harm them, even
if their symptoms 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.
Your medicine is called Fluticasone Propinate
Aqueous Nasal Spray but will referred to as
Fluticasone throughout this leaflet
What is in this leaflet:
1. What Fluticasone is and what it is used for
2. What you need to know before you use
Fluticasone
3. How to use Fluticasone
4. Possible side effects
5. How to store Fluticasone
6. Contents of the pack and other infromation
1. WHAT FLUTICASONE IS AND WHAT IT IS
USED FOR
Fluticasone 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 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
TAKE FLUTICASONE
Do not use Fluticasone 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:
• If you have ever had an operation on your nose.
• If you have an infection in your nose
Other medicines and Fluticasone
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 protease inhibitor (e.g. ritonavir)
• you are taking certain medicines used to treat
fungal infections (e.g. ketoconazole)
Taking Fluticasone 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.
Fluticasone contains benzalkonium chloride
Benzalkonium chloride may cause problems with
your breathing (bronchospasm).

3. HOW TO USE FLUTICASONE
Always use Fluticasone exactly as your doctor has
told you. You should 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
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
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.

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 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 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
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 forgotton dose.
If you stop taking Fluticasone
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, Fluticasone 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.

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

Ref: 0338/150115/2/B

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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