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FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY 50 MICROGRAMS

Active substance(s): FLUTICASONE PROPIONATE

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Package Leaflet: Information For The User

Fluticasone Propionate Aqueous
Nasal Spray 50 Micrograms
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
Aqueous Nasal Spray 50 Micrograms, but it will be referred to
as Fluticasone Propionate throughout this leaflet.

What is in this leaflet:
1. What Fluticasone Propionate is and what it is used for
2. What you need to know before you use Fluticasone
Propionate

2 What you need to know before you use
Fluticasone Propionate
Do not use Fluticasone Propionate if:
You are allergic to fluticasone propionate or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Fluticasone
Propionate:
If you have ever had an operation on your nose.
If you have an infection in your nose

Other medicines and Fluticasone Propionate
Tell your doctor if you are taking or 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)

3. How to use Fluticasone Propionate

Taking Fluticasone Propionate with food and drink

4. Possible side effects

You can use Fluticasone Propionate at any time of day, with
or without food.

5. How to store Fluticasone Propionate

3 How to use Fluticasone Propionate

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.

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

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

during admission to hospital after a serious accident or
injury

They reduce swelling and irritation in your nose.
This helps to relieve itching, sneezing and your blocked or
runny nose.

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

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

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 overleaf, ‘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.

You may need extra steroids:

1 What Fluticasone Propionate is and what it
is used for

Fluticasone Propionate contains benzalkonium
chloride

3

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.

in times of extreme stress

Steroids work by reducing inflammation.

Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the
bottle.

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).

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.

Fluticasone Propionate is not likely to affect you being able to
drive or use any tools or machines.

2

Use the spray every day.

Pregnancy and breast-feeding

Fluticasone Propionate contains a medicine called fluticasone
propionate. This belongs to a group of medicines called
steroids (also called ‘cortico-steroids’).

Hold the bottle as
shown and make
sure it is pointed
away from you.

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

6. Contents of the pack and other information

Driving and using machines

1

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.

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,
‘Preparing your spray’.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine:
Allergic reactions: get a doctor’s help straight away
A small number of people get allergic reactions to Fluticasone
Propionate, which can develop into a more serious, even lifethreatening problem if not treated. Symptoms include:
becoming very wheezy, coughing or having difficulty with
breathing
suddenly feeling weak or light-headed (which may lead to
collapse or loss of consciousness)
swelling around the face, mouth or tongue
skin rashes or redness.
If this happens, tell your doctor straight away - you may
need urgent medical treatment.
Allergic reactions to Fluticasone Propionate are very rare
(These affect less than 1 in 10,000 people).
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:

If you use more Fluticasone Propionate than you
should

Other side effects include:

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.

Common (may affects up 1 in 10 people)

If you forget to use Fluticasone Propionate
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
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.

Very common (may affects more than 1 in 10 people)
Nose bleeds.
Headache.
Unpleasant taste.
Unpleasant smell.
A dry or painful nose or throat.
Very rare (may affects up 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 side effects

Manufactured by:
Glaxo Wellcome SA, Avda Extremadura 3, 09400 Aranda de
Duero, Burgos, Spain.
Procured from within the EU and repackaged by the
product licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex HA4 0NU, UK.
POM
Fluticasone Propionate Aqueous Nasal Spray
50 Micrograms PL No: 18799/0768

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

You will be able to find out more information about prescribed
medicines from books in public libraries.
The information in this leaflet only applies to Fluticasone
Propionate Aqueous Nasal Spray 50 Microgram.

By reporting side effects, you can help provide more
information on the safety of this medicine.

Leaflet prepared: 16.07.2015

5 How to store Fluticasone Propionate
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use this nasal spray after the date shown as 'Exp'
on the label and carton.
Remember if your doctor tells you to stop taking this
medicine, return any unused tablets to your pharmacist for
safe disposal. Only keep this medicine if your doctor tells
you to.

6 Contents of the pack and other information
REMEMBER: This medicine is for YOU. Only a doctor can
prescribe it for you. Never give it to someone else. It may
harm them even if their symptoms are similar.
This leaflet does not tell you everything about your medicine.
If you have any questions or are not sure about anything, ask
your doctor or the pharmacist.
What Fluticasone Propionate Nasal Spray contains
Each metered spray contains 50 micrograms of the active
ingredient fluticasone propionate. It also contains other
substances needed to make a stable suspension, which will
not go off.
These are microcrystalline cellulose, sodium
carboxymethylcellulose, dextrose, polysorbate 80, purified
water, dilute hydrochloric acid and the preservatives
benzalkonium chloride and phenylethylalcohol.
Each bottle of Fluticasone Propionate Nasal Spray provides
120 metered sprays.

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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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