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FLUTICASONE PROPIONATE AQUEOUS 50 MICROGRAMS NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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perforation of the nasal septum (the dividing
partition in the nose) and ulceration to the
nose’s mucus membranes - although these
usually impact on patients who have had
previous surgery to the nose.

Additional side effects in children and
adolescents
Children may grow more slowly than others, and
therefore children receiving treatment with nasal
corticosteroids over a long period of time will have
their height checked regularly by their doctor. Your
doctor will help prevent this happening by
prescribing the lowest dose of steroid capable of
adequately controlling the symptoms.
Reporting of side effects
If you get side effects, talk to your doctor or
pharmacist. 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
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
• Do not store above 25°C
• Discard after 3 months after first use.
• Do not use this medicine after the expiry date
shown on the carton label or bottle. If your
doctor tells you to stop taking this medicine,
take any remaining medicine back to the
pharmacist for safe disposal.
Only keep this medicine if your doctor tells you
to.
• If your medicine becomes discoloured or show
any other signs of deterioration, ask your
pharmacist who will advise you what to do.
• Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Fluticasone Propionate contains
The active substance is fluticasone propionate.
Each metered spray contains 50 micrograms of
fluticasone propionate.

The other ingredients are glucose anhydrous,
microcrystalline cellulose, carmellose sodium,
phenylethyl alcohol, benzalkonium chloride,
polysorbate 80 and purified water.
What Fluticasone Propionate looks like and
contents of the pack
Fluticasone Propionate consists of a white,
opaque suspension contained within an amber
glass multi-dose bottle fitted with an atomising
metering pump to create the spray. Each bottle of
Fluticasone Propionate contains suspension
capable of delivering 150 metered sprays.
Manufacturer and Licence Holder
This medicine is manufactured by Teva Czech
Industries s.r.o, Ostravska 29, 747 70
Opava- Komarov, Czech Republic 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.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PATIENT INFORMATION LEAFLET

Fluticasone Propionate Aqueous 50 microgram 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.
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 your
Fluticasone Propionate
3. How to use Fluticasone Propionate
4. Possible side effects
5. How to store Fluticasone Propionate
6. Contents of the pack and other information

POM
PL 15184/1314 - Fluticasone Propionate Aqueous
50 microgram Nasal Spray
Leaflet revision date: 05/05/15

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

Ref: 1314/050515/1/F

1. WHAT FLUTICASONE PROPIONATE IS AND
WHAT IT IS USED FOR
Your medicine is called Fluticasone Propionate
Aqueous 50 microgram Nasal Spray (described as
‘Fluticasone Propionate’ throughout this leaflet)
and contains 50 micrograms of the active
ingredient, fluticasone propionate, in each spray.
Fluticasone propionate is one of a group of
medicines known as corticosteroids.
Fluticasone Propionate has anti-inflammatory
properties. When sprayed into your nose it will
reduce swelling and irritation. It is used to prevent
and treat seasonal allergic rhinitis (e.g. hayfever)
and perennial rhinitis (e.g. blocked or runny nose
and sneezing and itching caused by house dust
mites or animals such as cats and dogs). It can be
used by adults and children aged 4 years and
older.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE YOUR 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 to your nose.
• if you are suffering or have recently suffered
from an infection of the nasal airways.
• if you are suffering or have recently suffered
from any type of untreated infection or from
tuberculosis or ocular herpes.
• if you have recently been treated with injected
steroids, or you have been taking oral steroids
for a long time.
Fluticasone Propionate will usually control
seasonal allergic rhinitis (hayfever) however if you
are exposed to excessive amounts of pollen
additional therapy may be helpful for controlling
other symptoms such as itching eyes. Please
consult your doctor in such an event.
Other medicines and Fluticasone Propionate
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
Some medicines can interfere with Fluticasone
Propionate, in particular tell your doctor or
pharmacist if you are taking:
• Any medicines used in the treatment of fungal
infections (e.g. ketoconazole)
• Any antiviral medicine such as those used to
treat HIV infection (e.g. ritonavir)
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 or pharmacist for advice before
taking this medicine.
Driving and using machines
The medicinal product has no or negligible
influence on the ability to drive and use machines.
Fluticasone Propionate contains benzalkonium
chloride solution
Fluticasone Propionate contains the ingredient
benzalkonium chloride (40 micrograms per
delivered dose) which is an irritant and may cause
skin reactions. If used for longer periods, the
preservative benzalkonium chloride may cause
nasal mucosa swelling.

In case of such a reaction (persistently congested
nose) medicinal products for nasal use without
preservative should be used if possible.
It may also cause bronchospasm. Unless such
products are available another pharmaceutical
form should be taken.
3. HOW TO USE FLUTICASONE PROPIONATE
Always use Fluticasone Propionate exactly as
your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
Adults (including the elderly) and children
aged 12 years and older:
When you first start using Fluticasone Propionate
you normally take two sprays in each nostril once
a day, preferably in the morning. Your doctor may
increase this to a maximum of two sprays into
each nostril twice a day.
Once your symptoms are under control your
doctor may reduce your dose to one spray into
each nostril once a day. If the use of such a
reduced dose signals a worsening in your
symptoms, your dose may be increased back to
the starting dose.
Children aged 4 to 11 years:
For children aged between 4-11 years old the
dose is normally one spray in each nostril once
a day, preferably in the morning. Your doctor may
increase this to a maximum of one spray into
each nostril twice a day.
This product is not suitable for children under
4 years old.
Your doctor will prescribe the lowest dose of
Fluticasone Propionate capable of effectively
controlling your symptoms.
It may take a few days for this medicine to work.
Do not stop using your medicine unless you are
told to by a doctor.
You must not take a larger dose, or use your
Fluticasone Propionate more often, than is
prescribed by your doctor. It is important not to
use more of your medicine than your doctor has
told you to.
If your eyes remain itchy or watery as a result of
hayfever despite using this medicine tell your
doctor. He/she may be able to give you another
medicine to treat your eye symptoms.

Before you use your nasal spray
Your Fluticasone Propionate has a dust cap that
protects the nozzle and keeps it clean – this must
be taken off prior to using the spray and then
replaced after use.
When your Fluticasone Propionate is new the
bottle must be primed as follows:1. Shake the bottle gently and
then remove the dust cap.
2. Hold the bottle upright with
your thumb under the bottle
and your index finger and
middle finger on either side of
the nozzle. Ensure that the nozzle
is pointing away from you when you do this.
3. Press down with fingers in order to pump the
spray
4. Repeat steps 2 and 3 for a further five times –
the bottle is now primed.
If you have not used your Fluticasone Propionate
for 7 days prime until a fine mist is produced.
If after attempting to prime the bottle the spray still
does not work and you think it may be blocked
you may clean the spray using the following
procedure:Cleaning your nasal spray
1. Remove the dust cap.
2. Pull the white collar upwards to
remove the nozzle.
3. Place the nozzle and dust cap
in warm water and soak for a
few minutes, and then rinse by
placing under a running tap.
4. Shake off the excess water and
allow the nozzle and dust cap
to dry in a warm (not hot) place.
5. Re-fit the nozzle.
6. Prime’ the bottle as necessary by pumping the
spray a few times until a fine mist is produced.
• You should clean your nasal spray at least once
a week to stop it from getting blocked up.
Additional cleaning is required when your spray
becomes blocked.
• You must NEVER attempt to unblock or enlarge
the spray hole with a pin or other sharp object
because this will destroy the spray mechanism.
Using your nasal spray
1. Shake the bottle and remove the dust cap.
2. Gently blow your nose.

3. Close one nostril by pressing your finger
against it and place the nozzle of the spray in
your other nostril. Tilt your head forward slightly
so that the bottle is kept upright.
4. Breathe in slowly through your
open nostril and, at the same
time, press the collar of the
nozzle down firmly with your
fingers to squirt a spray of
fine mist into your nostril.
5. Breathe out through your
mouth. Repeat step 4 to take a
second spray into the same
nostril.
6. Remove the nozzle from this
nostril and breathe out through
your mouth.
7. Repeat steps 3 to 6 with your other nostril.
After using your nasal spray
• Wipe the nozzle carefully with a clean tissue
and put the dust cap back on.
If you use more Fluticasone Propionate than
you should
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 accidentally use more Fluticasone
Propionate than you were told to use please
inform your doctor.
Take this leaflet, and your Fluticasone Propionate,
to show the doctor.
If you forget to use Fluticasone Propionate
Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose at the
right time, take it as soon as you remember. If it is
almost time to take the next dose, wait until then
and then carry on as before.
If you stop using Fluticasone Propionate
Your nose symptoms may only start to improve
after you have been using your medicine for a few
days – therefore it is very important that you use
your medicine regularly as prescribed, and that
you keep using your medicine unless your doctor
tells you to stop, even if you feel better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluticasone Propionate can
cause side effects, although not everybody gets
them.
If you are using high doses of Fluticasone
Propionate you may require extra steroids in times
of extreme stress, or during admission to hospital
after a serious accident or injury, or before a
surgical operation. Treatment with nasal
corticosteroids may affect the production of
steroids in the body. The likelihood of such an
incidence is increased by use of a high dose over
a long period of time. Your doctor will help prevent
this happening by prescribing the lowest dose of
steroid capable of adequately controlling your
symptoms.
Some side effects are more serious than
others and if you should experience any
of the following events you should discontinue
taking Fluticasone Propionate and consult with
your doctor as soon as possible:Side effects occurring very commonly (probably
affecting more than 1 in 10 patients taking the
Fluticasone Propionate)
• epistaxis (nose bleeds).
Side effects occurring commonly (probably
affecting up to 1 in 10 patients taking the
Fluticasone Propionate)
• headache
• unpleasant taste in the mouth or an unpleasant
smell in the nose
• dryness and irritation of the throat and nasal
passages and sneezing.
Side effects occurring rarely (probably affecting
fewer than 1 in every 1,000 patients taking
Fluticasone Propionate)
• severe allergic reaction giving rise to the
sudden onset of a rash, swelling (usually of the
tongue, face or lips) or difficulty in breathing
• bronchospasm (the narrowing of the airways in
the lungs).
Side effects occurring very rarely (probably
affecting fewer than 1 in every 10,000 patients
taking the Fluticasone Propionate)
• glaucoma (raised pressure in the eye) and
cataracts (clouding of the lens in the eye) have
been reported following prolonged treatment
Ref: 1314/050515/1/B

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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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