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FLUTICASONE PROPIONATE 50 MICROGRAM NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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Nasofan® Aqueous 50 microgram Nasal Spray/Fluticasone propionate 50 microgram Nasal Spray
(fluticasone propionate)
Your medicine is available using any of the above names but will be
referred to as Nasofan Nasal Spray in the rest of this leaflet.
Patient Information 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.
What is in this leaflet:
1) What Nasofan Nasal Spray is and what it is used for
2) What you need to know before you use Nasofan Nasal Spray
3) How to use Nasofan Nasal Spray
4) Possible side effects
5) How to store Nasofan Nasal Spray
6) Contents of the pack and other information

1) What Nasofan Nasal Spray is and what it is used for
Your medicine is called Nasofan Aqueous 50 microgram Nasal Spray
(described as 'Nasofan 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.
Nasofan 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 aged 4 years and older.

2) What you need to know before you use Nasofan Nasal
Spray
Do not use Nasofan Nasal Spray :
 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 Nasofan 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.
Nasofan Nasal Spray 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 Nasofan Nasal Spray
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines.
Some medicines can interfere with Nasofan 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)
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.

Nasofan Nasal Spray contains benzalkonium chloride solution
Nasofan Nasal Spray 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 Nasofan Nasal Spray
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 Nasofan 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 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 Nasofan 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 Nasofan 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 Nasofan 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 Nasofan 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 until a further five
times – the bottle is now primed.
If you have not used your Nasofan 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.
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 Nasofan 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 Nasofan Nasal Spray than you were told to
use please inform your doctor.
Take this leaflet, and your Nasofan Nasal Spray, to show the doctor.
If you forget to use Nasofan 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 Nasofan 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 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 Nasofan 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. 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
Nasofan 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 Nasofan Nasal Spray)
 epistaxis (nose bleeds).
Side effects occurring commonly (probably affecting up to 1 in 10 patients
taking the Nasofan 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 Nasofan 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 Nasofan 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.
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 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 Nasofan Nasal Spray





Keep out of the sight and reach of children.
Do not store above 25°C.
Discard 3 months after first use.
Do not use this medicine after the expiry date which is stated on the
carton and the bottle. The expiry date refers to the last day of the month.
 If your medicine becomes discoloured or shows any sign of deterioration,
return it to 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) Contents of the pack and other Information
What Nasofan 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
What Nasofan Nasal Spray looks like and contents of the pack:
Nasofan Nasal Spray is an opaque white coloured aqueous suspension
contained in an amber glass multidose bottle fitted with a white plastic
metering pump spray and a clear plastic cap.
Each pack contains one bottle.
Each bottle delivers 150 metered sprays.
PL 10383/2117 Nasofan® Aqueous 50 microgram Nasal Spray/
Fluticasone propionate 50 microgram Nasal Spray

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Teva Czech Industries s.r.o., Ostravská
29, 747 70 Opava-Komárov, Czech Republic. Procured from within the EU
and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 13.08.2015
Nasofan is a registered trademark of Norton Healthcare Limited.

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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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