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FLUTICASONE PROPIONATE 50 MICROGRAM AQUEOUS NASAL SPARY

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Read all of this
leaflet carefully
before you start
using this
medicine.
Keep this leafet.
You may need to
read it again.
If you have
further
questions, ask
your doctor or
pharmacist.

Package Leaflet - Information for the User

Fluticasone Propionate 50 microgram Aqueous Nasal Spray

In this leaflet:

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
mentioned in
this leaflet,
please tell your
doctor or
pharmacist.

1. What Fluticasone Propionate Nasal Spray is and what it is used for
2. Before you use your Fluticasone Propionate Nasal Spray
3. How to use Fluticasone Propionate Nasal Spray
4. Possible side effects
5. How to store Fluticasone Propionate Nasal Spray
6. Further information

1. WHAT FLUTICASONE PROPIONATE NASAL
SPRAY IS AND WHAT IT IS USED FOR
Your medicine is called Fluticasone Propionate 50 microgram
Aqueous Nasal Spray (described as Fluticasone Propionate Nasal
Spray' 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 Nasal Spray 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 of 4 years of
age and over.

2. BEFORE YOU USE FLUTICASONE
PROPIONATE NASAL SPRAY
Do not use Fluticasone Propionate Nasal Spray:
if you are allergic (hypersensitive) to fluticasone propionate or
any of the other ingredients in Fluticasone Propionate Nasal
Spray.
Take special care with Fluticasone Propionate Nasal Spray:
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 Nasal Spray 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.
Taking other medicines
Some medicines can interfere with Fluticasone Propionate Nasal Spray,
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)
Please tell your doctor or your pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without prescription.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant, planning to become
pregnant or breast-feeding. Ask your doctor for advice before taking
any medicine.
Driving and using machines
The medicinal product has no or negligible influence on the ability to
drive and use machines.
Important information about some of the ingredients of
Fluticasone Propionate Nasal Spray
Fluticasone Propionate Nasal Spray contains the ingredient
benzalkonium chloride 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
NASAL SPRAY
Always use Fluticasone Propionate Nasal Spray exactly as your doctor
has told you to. You should check with your doctor if you are not sure.
The usual dose is as follows:
Adults (including the elderly) and children of 12 years of age and
over:
When you first start using Fluticasone Propionate Nasal Spray 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 between ages of 4 and 11:
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
Nasal Spray 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
Nasal Spray 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 Nasal Spray 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 Nasal Spray 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 a further five times – the bottle is
now primed.
If you have not used your Fluticasone Propionate Nasal Spray 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.

Like all medicines, Fluticasone Propionate Nasal Spray can cause side
effects, although not everybody gets them.
If you are using high doses of Fluticasone Propionate Nasal Spray 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. Such an effect is
that 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 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 Nasal Spray 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 Nasal Spray)
epistaxis (nose bleeds).
Side effects occurring commonly (probably affecting up to 1 in 10 patients
taking the Fluticasone Propionate Nasal Spray)
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 Nasal Spray)
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 Nasal Spray)
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.
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.

5. HOW TO STORE FLUTICASONE PROPIONATE
NASAL SPRAY
Keep out of the sight and reach of children.
Do not use Fluticasone Propionate Nasal Spray after the expiry date
stated on the bottle and carton. The expiry date refers to the last day of
that month.
Do not store above 25∞ C.
Discard after 3 months after first use.
Do not use if any signs of deterioration are seen.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer require.
These measures will help protect the environment.

What Fluticasone Propionate Nasal Spray looks like and contents of
the pack
Fluticasone Propionate Nasal Spray 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 Nasal Spray contains suspension capable of delivering 150
sprays.
PL holder
Manx Pharma Ltd, Taylor Group House, Wedgnock Lane, Warwick,
CV34 5YA, UK.
PL 15833/0063
POM
Procured from within the EU.
Manufacturer
Teva Czech Industries s r o, Ostravaská 29, 747 70 Opava-Komárov,
Czech Republic.

This leaflet
was last
revised in
October 2013

6. FURTHER INFORMATION
What Fluticasone Propionate Nasal Spray 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.

WIP URN: 221013XXXX-PIL-03

Fluticasone Propionate 50 microgram Aqueous Nasal Spray

4. POSSIBLE SIDE EFFECTS

Package Leaflet - Information for the User

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 Nasal Spray 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 Nasal Spray than
you were told to use please inform your doctor.
Take this leaflet, and your Fluticasone Propionate Nasal Spray, to show
the doctor.
If you forget to use Fluticasone Propionate Nasal Spray
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 Nasal Spray
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.

Expand Transcript

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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