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FLUTICASONE PROPIONATE 400MICROGRAMS NASAL DROPS

Active substance(s): FLUTICASONE PROPIONATE

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Package Leaflet: Information for the User

Flixonase® 400micrograms
Nasule® drops
(fluticasone propionate)
Read all of this leaflet carefully before you start
using this medicine.
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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Flixonase
400micrograms Nasule drops but will be referred to
as Flixonase Nasule drops throughout this leaflet.
In this leaflet:
1. What Flixonase Nasule drops are and what they
are used for
2. Before you use Flixonase Nasule drops
3. How to use Flixonase Nasule drops
4. Possible side effects
5. How to store Flixonase Nasule drops
6. Further information
1. What Flixonase Nasule drops are and what
they are used for
Flixonase Nasule drops contain 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.
Flixonase Nasule drops are used to treat:
Small growths inside the nose (polyps).
Symptoms associated with nasal obstruction.
Flixonase Nasule drops are provided in small plastic
containers (Nasules).
2. Before you use Flixonase Nasule drops
Do not use Flixonase Nasule drops if:
you are allergic (hypersensitive) to fluticasone
propionate or any of the other ingredients of
Flixonase Nasule drops (listed in section 6).
Take special care with Flixonase Nasule drops
Check with your doctor or pharmacist before using
your medicine if:
you have an infection in your nose.

If you are not sure if the above applies to you, talk to
your doctor or pharmacist before using Flixonase
Nasule Drops.
Flixonase Nasule drops may lower the normal
production of steroid hormones in your body,
particularly if doses higher than those recommended
are used for a long time. In this situation people may
need to take extra steroids in times of extreme stress,
following serious injury or before a surgical operation.
It is important therefore that you are taking the lowest
dose of Flixonase Nasule drops to control your
symptoms. Your doctor will check you for signs of any
problems.

What the plastic container looks like

Top tab

Pregnancy and breast-feeding
Do not use Flixonase Nasule drops if you are
pregnant, or planning to become pregnant, or if you
are breast-feeding, unless your doctor or pharmacist
tells you to.
Driving and using machines
Flixonase Nasule drops are not likely to affect you
being able to drive or use any tools or machines.
3. How to use Flixonase Nasule drops
Always use Flixonase Nasule drops exactly as your
doctor has told you to. Don’t exceed the
recommended dose. Check with your doctor or
pharmacist if you’re not sure.
Do not use in children or young people under 16
years old.
Only use in your nose, contact with the eyes
should be avoided.
It may take a few weeks for this medicine to work.
So keep using it, even though you may not feel
better straight away.
You should use Flixonase Nasule drops every day.
How much to use - adults (over 16 years of age)
The usual starting dose is one single-use plastic
container (400micrograms) divided equally
between each nostril, once or twice a day.
As your symptoms improve, your doctor may ask
you to use a lower dose.
If your symptoms do not improve after 4 to 6
weeks your doctor may change your medicine.

If these positions are difficult you can lie on a bed with
your head tilted over the edge. After you have put the
drops in, rest your head sideways on the bed for at
least one minute.

Bottom tab
Using your Flixonase Nasule drops
1. Open the foil pack by tearing off one side. Do not
open the pack until the drops are needed.
2. Take out the strip of plastic containers from the foil
and pull off one container.
Be careful not to get the drops in your eyes or on
broken skin. If you do, rinse your eyes or skin with
water immediately.

Taking other medicines
Please tell your doctor if you are taking or have
recently taken 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 are taking a type of antiviral medicine known
as a protease inhibitor (such as ritonavir)
you are taking a medicine used to treat fungal
infections (such as ketoconazole)
you have had steroids for a long time, either as an
injection or by your mouth.

7. Stay with your head down for at least one minute
after putting the drops in.

If you forget to use Flixonase Nasule drops
3. Put the remaining containers back into the foil
pack and put the pack back in the box.
4. Flick and shake the plastic container several
times. The contents of the container must be well
mixed before use.
5. Then shake downwards to make sure the liquid is
not in the neck of the container.
6. Hold the bottom tab of the container firmly. Twist
and remove the top tab to open it.

If you miss a dose, just use the next dose when it is
due. Do not use a double dose to make up for a
forgotten dose.
If you use more Flixonase Nasule drops than you
should
Tell your doctor if you use more than you were told to.
If you stop taking Flixonase Nasule drops
Do not stop treatment even if you feel better, unless
your doctor tells you to stop. If you do stop, the
symptoms may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects

How to put the drops in
Before you put the drops in, you must choose one of
the positions shown in these pictures. Although they
may not be easy, the positions will make sure the
drops get to where they are needed.
1. Gently blow your nose to clear it.
2. While standing up, bend right over.

3. If you can’t do this, kneel down and then bend
right over.

4. Put the opened container into one nostril and
gently squeeze.
5. Keep squeezing until the sides of the container
touch each other. This will mean that about half
the dose has been given (about 6 drops).
6. Repeat this step to use the rest in your other
nostril.

Like all medicines, Flixonase Nasule drops 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 Nasule drops, 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 your face, mouth or tongue
skin rashes or redness.
In many cases, these symptoms will be signs of less
serious side effects. But you must be aware that they
are potentially serious — so, if you notice any of these
symptoms:
See a doctor as soon as possible.
Allergic reactions to Flixonase Nasule drops are very
rare (these affect less than 1 in 10,000 people).
Other side effects include:
Very common (affects more than 1 in 10 people)
Nose bleeds.

Common (affects less than 1 in 10 people)
A dry or irritated nose or throat.
Very rare (affects less than 1 in 10,000 people)
Cloudy lens (cataract), increased pressure in the
eye that can cause problems with vision
(glaucoma). These eye problems occurred in
people who used Flixonase Nasule drops for a
long time.
Small holes (perforations) in the ridge inside the
nose that separates the nostrils.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.
In addition, the 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.
Reporting 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 Nasule drops
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not freeze.
Keep in the foil wrapper, in the carton, in an
upright position.
Do not take your Flixonase Nasule drops after the
expiry date which is stated on the carton and
blister label after ‘Exp’. The expiry date refers to
the last day of that month.
Discard any unused Flixonase Nasule drops 28
days after first opening the foil wrapper.
If your Flixonase Nasule drops become
discoloured or show any signs of deterioration,
seek the advice of your pharmacist.
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. Further information
What Flixonase Nasule drops contains:
The active ingredient in Flixonase Nasule drops is
fluticasone propionate.
Each Nasule contains 400micrograms of
fluticasone propionate.
The other ingredients are polysorbate 20, sorbitan
laurate, sodium dihydrogen phosphate dihydrate,
dibasic sodium phosphate anhydrous, sodium
chloride and water for injections.
What Flixonase Nasule drops looks like and
contents of the pack:
Flixonase Nasule drops are a white to off-white
powder in an aqueous suspension.
Each pack contains 28 Nasules.
Manufactured by: GlaxoSmithKline Australia Ltd,
Australia.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
®

Flixonase 400micrograms Nasule drops,
PL 18799/2869
POM
Leaflet date: 25.02.2016

Package Leaflet: Information for the User

Take special care with Fluticasone propionate
Nasal drops

Fluticasone propionate
400micrograms Nasal
drops

Check with your doctor or pharmacist before using
your medicine if:
you have an infection in your nose.
If you are not sure if the above applies to you, talk to
your doctor or pharmacist before using Fluticasone
propionate Nasal Drops.
Fluticasone propionate Nasal drops may lower the
normal production of steroid hormones in your body,
particularly if doses higher than those recommended
are used for a long time. In this situation people may
need to take extra steroids in times of extreme stress,
following serious injury or before a surgical operation.
It is important therefore that you are taking the lowest
dose of Fluticasone propionate Nasal drops to control
your symptoms. Your doctor will check you for signs
of any problems.

Read all of this leaflet carefully before you start
using this medicine.
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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Fluticasone propionate
400micrograms Nasal drops but will be referred to as
Fluticasone propionate Nasal drops throughout this
leaflet.
In this leaflet:
1. What Fluticasone propionate Nasal drops are and
what they are used for
2. Before you use Fluticasone propionate Nasal
drops
3. How to use Fluticasone propionate Nasal drops
4. Possible side effects
5. How to store Fluticasone propionate Nasal drops
6. Further information
1. What Fluticasone propionate Nasal drops
are and what they are used for
Fluticasone propionate Nasal drops contain 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 Nasal drops are used to treat:
Small growths inside the nose (polyps).
Symptoms associated with nasal obstruction.
Fluticasone propionate Nasal drops are provided in
small plastic containers (Nasals).
2. Before you use Fluticasone propionate
Nasal drops
Do not use Fluticasone propionate Nasal drops if:
you are allergic (hypersensitive) to fluticasone
propionate or any of the other ingredients of
Fluticasone propionate Nasal drops (listed in
section 6).

Taking other medicines
Please tell your doctor if you are taking or have
recently taken 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 are taking a type of antiviral medicine known
as a protease inhibitor (such as ritonavir)
you are taking a medicine used to treat fungal
infections (such as ketoconazole)
you have had steroids for a long time, either as an
injection or by your mouth.
Pregnancy and breast-feeding
Do not use Fluticasone propionate Nasal drops if you
are pregnant, or planning to become pregnant, or if
you are breast-feeding, unless your doctor or
pharmacist tells you to.
Driving and using machines
Fluticasone propionate Nasal drops are not likely to
affect you being able to drive or use any tools or
machines.
3. How to use Fluticasone propionate Nasal
drops
Always use Fluticasone propionate Nasal drops
exactly as your doctor has told you to. Don’t exceed
the recommended dose. Check with your doctor or
pharmacist if you’re not sure.
Do not use in children or young people under 16
years old.
Only use in your nose, contact with the eyes
should be avoided.
It may take a few weeks for this medicine to work.
So keep using it, even though you may not feel
better straight away.
You should use Fluticasone propionate Nasal
drops every day.

How much to use - adults (over 16 years of age)
The usual starting dose is one single-use plastic
container (400micrograms) divided equally
between each nostril, once or twice a day.
As your symptoms improve, your doctor may ask
you to use a lower dose.
If your symptoms do not improve after 4 to 6
weeks your doctor may change your medicine.

4. Put the opened container into one nostril and
gently squeeze.
5. Keep squeezing until the sides of the container
touch each other. This will mean that about half
the dose has been given (about 6 drops).
6. Repeat this step to use the rest in your other
nostril.
7. Stay with your head down for at least one minute
after putting the drops in.

What the plastic container looks like

If these positions are difficult you can lie on a bed with
your head tilted over the edge. After you have put the
drops in, rest your head sideways on the bed for at
least one minute.

Top tab

Bottom tab
Using your Fluticasone propionate Nasal drops
1. Open the foil pack by tearing off one side. Do not
open the pack until the drops are needed.
2. Take out the strip of plastic containers from the foil
and pull off one container.

Be careful not to get the drops in your eyes or on
broken skin. If you do, rinse your eyes or skin with
water immediately.
If you forget to use Fluticasone propionate Nasal
drops
If you miss a dose, just use the next dose when it is
due. Do not use a double dose to make up for a
forgotten dose.

3. Put the remaining containers back into the foil
pack and put the pack back in the box.
4. Flick and shake the plastic container several
times. The contents of the container must be well
mixed before use.
5. Then shake downwards to make sure the liquid is
not in the neck of the container.
6. Hold the bottom tab of the container firmly. Twist
and remove the top tab to open it.

If you use more Fluticasone propionate Nasal
drops than you should
Tell your doctor if you use more than you were told to.
If you stop taking Fluticasone propionate Nasal
drops
Do not stop treatment even if you feel better, unless
your doctor tells you to stop. If you do stop, the
symptoms may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects

How to put the drops in
Before you put the drops in, you must choose one of
the positions shown in these pictures. Although they
may not be easy, the positions will make sure the
drops get to where they are needed.
1. Gently blow your nose to clear it.
2. While standing up, bend right over.

3. If you can’t do this, kneel down and then bend
right over.

Like all medicines, Fluticasone propionate Nasal
drops 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 Nasal drops, 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 your face, mouth or tongue
skin rashes or redness.

In many cases, these symptoms will be signs of less
serious side effects. But you must be aware that they
are potentially serious — so, if you notice any of these
symptoms:
See a doctor as soon as possible.
Allergic reactions to Fluticasone propionate Nasal
drops are very rare (these affect less than 1 in 10,000
people).
Other side effects include:
Very common (affects more than 1 in 10 people)
Nose bleeds.
Common (affects less than 1 in 10 people)
A dry or irritated nose or throat.
Very rare (affects less than 1 in 10,000 people)
Cloudy lens (cataract), increased pressure in the
eye that can cause problems with vision
(glaucoma). These eye problems occurred in
people who used Fluticasone propionate Nasal
drops for a long time.
Small holes (perforations) in the ridge inside the
nose that separates the nostrils.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, tell your
doctor or pharmacist.
In addition, the 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.
Reporting 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 Nasal
drops
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not freeze.
Keep in the foil wrapper, in the carton, in an
upright position.
Do not take your Fluticasone propionate Nasal
drops after the expiry date which is stated on the
carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
Discard any unused Fluticasone propionate Nasal
drops 28 days after first opening the foil wrapper.
If your Fluticasone propionate Nasal drops
become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.

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. Further information
What Fluticasone propionate Nasal drops
contains:
The active ingredient in Fluticasone propionate
Nasal drops is fluticasone propionate.
Each Nasal contains 400micrograms of fluticasone
propionate.
The other ingredients are polysorbate 20, sorbitan
laurate, sodium dihydrogen phosphate dihydrate,
dibasic sodium phosphate anhydrous, sodium
chloride and water for injections.
What Fluticasone propionate Nasal drops looks
like and contents of the pack:
Fluticasone propionate Nasal drops are a white to offwhite powder in an aqueous suspension.
Each pack contains 28 Nasules.
Manufactured by: GlaxoSmithKline Australia Ltd,
Australia.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Fluticasone propionate 400micrograms Nasal
drops,
POM
PL 18799/2869
Leaflet date: 25.02.2016

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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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