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NASOFAN AQUEOUS 50 MICROGRAM NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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TEVA UK Ref:

231-30-87161-H LEA FLUTICASONE (NASOFAN) 50MCG SPRAY 150 IVAX Dimensions:

Version:

2

Colours Used:

Length:
Width:

297 mm
148 mm

10 May 2016
PANTONE® 375
PANTONE® 2768 C

Template

Read all of this
leaflet carefully
before you start
using this
medicine
because it
contains
important
information for
you.

What is in this leaflet:

controlling other symptoms such as itching eyes. Please
consult your doctor in such an event.

1.
2.
3.
4.
5.
6.

Other medicines and Nasofan Nasal Spray
Tell your doctor or pharmacist if you are using, have recently
used or might use any other medicines.

1. What Nasofan Nasal Spray is
and what it is used for






Keep this
leaflet. You may
need to read it
again.



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.

If you have
any further
questions, ask
your doctor or
pharmacist.

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.

Fluticasone Propionate



Package leaflet: Information for the user

Nasofan Aqueous 50 microgram Nasal Spray

EXAMPLE



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 Nasofan Nasal Spray is and what it is used for
What you need to know before you use Nasofan Nasal Spray
How to use Nasofan Nasal Spray
Possible side effects
How to store Nasofan Nasal Spray
Contents of the pack and other information

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

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)

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:

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.

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:-

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.

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.

Cleaning your nasal spray
Children aged 4 to 11 yearsa:
1. Remove the dust cap.
For children aged between 4-11 years old the dose is normally 2. Pull the white collar upwards to
one spray in each nostril once a day, preferably in the
remove the nozzle.
morning. Your doctor may increase this to a maximum of one
3. Place the nozzle and dust cap in
spray into each nostril twice a day.
warm water and soak for a few
This product is not suitable for children under 4 years old.
minutes, and then rinse by placing
under a running tap.
Your doctor will prescribe the lowest dose of Nasofan Nasal
4. Shake off the excess water and allow the nozzle and
Spray capable of effectively controlling your symptoms.
dust cap to dry in a warm (not hot) place.
It may take a few days for this medicine to work. Do not stop
5. Re-fit the nozzle.
using your medicine unless you are told to by a doctor.

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
When you first start using Nasofan Nasal Spray you normally
is now primed.
take two sprays in each nostril once a day, preferably in the
If you have not used your Nasofan Nasal Spray for 7 days
morning. Your doctor may increase this to a maximum of two prime until a fine mist is produced.
sprays into each nostril twice a day.




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.

EXAMPLE

TEVA UK Ref:

Version:

231-30-87161-H LEA FLUTICASONE (NASOFAN) 50MCG SPRAY 150 IVAX Dimensions:
Length:
Width:

10 May 2016
PANTONE® 375

Colours Used:
297 mm
148 mm

2

PANTONE® 2768 C

Template

EXAMPLE

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

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:-

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

Side effects occurring very commonly (probably affecting
more than 1 in 10 patients taking the Nasofan Nasal Spray)
epistaxis (nose bleeds).

Keep this medicine out of the sight and reach of children.


••


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.

5. How to store Nasofan Nasal Spray
Do not use this medicine after the expiry date which is stated
on the carton and bottle after EXP. The expiry date refers to
the last day of that month.
Do not store above 25°C.

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.






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

Czech Republic
Germany
Denmark

Spain

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
Finland
medicines you no longer use. These measures will help protect
the environment.
Hungary
Iceland

Side effects occurring rarely (probably affecting fewer than 1 in
6. Contents of the pack and other information
every 1,000 patients taking Nasofan Nasal Spray)
severe allergic reaction giving rise to the sudden onset of a What Nasofan Nasal Spray contains
rash, swelling (usually of the tongue, face or lips) or
The active substance is fluticasone propionate. Each metered
difficulty in breathing.
If you stop using Nasofan Nasal Spray
bronchospasm (the narrowing of the airways in the lungs). spray contains 50 micrograms of fluticasone propionate.
Your nose symptoms may only start to improve after you
Side effects occurring very rarely (probably affecting fewer than The other ingredients are glucose anhydrous, dispersible
cellulose, phenylethyl alcohol, benzalkonium chloride solution
have been using your medicine for a few days – therefore it is 1 in every 10,000 patients taking the Nasofan Nasal Spray)
(40 micrograms per delivered dose), polysorbate 80, and
very important that you use your medicine regularly as
glaucoma (raised pressure in the eye) and cataracts
purified water.
prescribed, and that you keep using your medicine unless your
(clouding of the lens in the eye) have been reported
doctor tells you to stop, even if you feel better.
following prolonged treatment.
What Nasofan Nasal Spray looks like and contents of the
perforation of the nasal septum (the dividing partition in
pack
If you have any further questions on the use of this medicine,
the nose) and ulceration to the nose’s mucus membranes ask your doctor or pharmacist.
Nasofan Nasal Spray consists of a white, opaque suspension
although these usually impact on patients who have had
contained within an amber glass multi-dose bottle fitted with
previous surgery to the nose.
4. Possible side effects
an atomising metering pump to create the spray. Each bottle
Additional side effects in children and adolescents
of Nasofan Nasal Spray contains suspension capable of
Like all medicines, this medicine can cause side effects,
Children may grow more slowly than others, and therefore
delivering 60, 120, 150, 240 (2 bottles each containing 120
although not everybody gets them.
children receiving treatment with nasal corticosteroids over a sprays) or 360 (3 bottles each containing 120 sprays) sprays.
If you are using high doses of Nasofan Nasal Spray you may
long period of time will have their height checked regularly by
Not all pack sizes may be marketed.
require extra steroids in times of extreme stress, or during
their doctor. Your doctor will help prevent this happening by
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.

This medicinal product is authorised in the Member
States of the EEA under the following names

Ireland
Italy
The Netherlands
Poland

Portugal

Slovak Republic
United Kingdom

Nasofan, nasní sprej
Flutica-TEVA 50 Mikrogramm
Nasenspray, Suspension
Fluticasonpropionat "Teva" 50
mikrogram/dosis, næsespray,
suspension
Fluticasona Teva 50 microgramos
suspensión para pulverización
nasal
Nasofan 50 mikrog/annos
nenäsumute
Flutirin orrspray
Nasofan 50 míkróg/skammt
nefúði, dreifa
Nasofan Aqueous 50 microgram
Nasal Spray Suspension
Nasofan 50 microgrammi Spray
Nasale
Fluticasonpropionaat 50 A,
neusspray 50 microgram/dosis
Fanipos, 50 mikrogramów/dawkę
donosową aerosol donosa,
zawiesina
Fluticasona Nasofan 50
microgramas Suspensão para
pulverização nasal
Nasofan 50 mikrogramová nosová
aerodisperzia aer nas
Nasofan Aqueous 50 microgram
Nasal Spray

This leaflet was
last revised in
April 2016

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: IVAX Pharmaceuticals UK,
WF10 5HX
Manufacturer: TEVA Czech Industries s.r.o, Opava, Czech
Republic.

4111307
87161-H

EXAMPLE

Nasofan Aqueous 50 microgram Nasal Spray

Wipe the nozzle carefully with a clean tissue and put the
dust cap back on.

Fluticasone Propionate



Package leaflet: Information for the user

After using your nasal spray

Expand view ⇕

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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