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FLUTICASONE PROPIONATE 50 MICROGRAMS NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the user

Fluticasone propionate 50 micrograms nasal spray

What is in this leaflet:
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
50 micrograms nasal
spray, but it will be
referred to as Fluticasone
propionate throughout this
leaflet.

1. What Fluticasone propionate is and what it is used
for
2. What you need to know before you use 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

1. What Fluticasone propionate is and
what it is used for
Fluticasone propionate 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. hay fever) 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 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 seasonally
allergy rhinitis (hay fever) 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 solution (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.
It may also cause bronchospasm.

3. How to use Fluticasone propionate
Always use this medicine 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 hay
fever 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 until 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
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.
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.

6. Contents of the pack and other
information

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.

What Fluticasone propionate looks like and the
contents of the pack
The medicinal product consists of a white, opaque
aqueous suspension contained within an amber glass
multidose bottle fitted with a metering pump.
Fluticasone propionate delivers 150 sprays.

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.

What Fluticasone propionate contains
Each metered spray contains 50 micrograms fluticasone
propionate.
The other ingredients are: glucose (anhydrous),
microcrystalline cellulose, carmellose sodium,
phenylethyl alcohol, benzalkonium chloride
(40 micrograms per delivered dose), polysorbate 80,
purified water.

Manufactured by: Teva Czech Industries sro,
Ostravska 29, 747 70 Opava- Komarov, Czech
Republic.
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 50 micrograms nasal spray
PL 18799/2909
Leaflet prepared: 06.06.2016

5. How to store Fluticasone
propionate
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use nasal spray after the expiry date which is
stated on the carton label and bottle label after
‘Exp’. The expiry date refers to the last day of that
month.
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.

POM

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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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