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NASOFAN AQUEOUS 50 MICROGRAM NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE

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ZINC Ref:

EAS678b LEA FLUTICASONE (NASOFAN) 50MCG SPRAY 150 IVAX Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
297 mm
148 mm
N/A
N/A

Version:

2

05 June 2017

Colours Used:

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.




Package leaflet: Information for the user



Fluticasone Propionate

Nasofan Aqueous 50 microgram Nasal Spray

EXAMPLE



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

Contact your doctor if you experience blurred vision or other
visual disturbances.

morning. Your doctor may increase this to a maximum of two If you have not used your Nasofan Nasal Spray for 7
days prime until a fine mist is produced.
sprays into each nostril twice a day.

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

Other medicines and Nasofan Nasal Spray
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.

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.

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

Some medicines can interfere with Nasofan Nasal Spray, in
particular tell your doctor or pharmacist if you are taking:
1. What Nasofan Nasal Spray is
Any medicines used in the treatment of fungal
infections (e.g. ketoconazole)
and what it is used for
Some medicines may increase the effects of Nasofan
Your medicine is called Nasofan Aqueous 50 microgram Nasal
Nasal Spray and your doctor may wish to monitor you
Spray (described as ‘Nasofan Nasal Spray’ throughout this
carefully if you are taking these medicines (including
leaflet) and contains 50 micrograms of the active ingredient,
some medicines for HIV: ritonavir, cobicistat).
fluticasone propionate, in each spray. Fluticasone propionate
Pregnancy and breast-feeding
is one of a group of medicines known as corticosteroids.
Nasofan Nasal Spray has anti-inflammatory properties. When If you are pregnant or breast-feeding, think you may be
sprayed into your nose it will reduce swelling and irritation. It is pregnant or are planning to have a baby, ask your doctor or
used to prevent and treat seasonal allergic rhinitis (e.g. hayfever) pharmacist for advice before taking this medicine.




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.

••



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. Unless such products
are available another pharmaceutical form should be taken. It
may also cause bronchospasm.

3. How to use Nasofan Nasal Spray

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.
For children aged between 4-11 years old the dose is normally 2. Pull the white collar upwards to
remove the nozzle.
one spray in each nostril once a day, preferably in the
morning. Your doctor may increase this to a maximum of one 3.
spray into each nostril twice a day.
4. Place the nozzle and dust cap in
warm water and soak for a few
This product is not suitable for children under 4 years old.
minutes, and then rinse by placing
Your doctor will prescribe the lowest dose of Nasofan Nasal
under a running tap.
Spray capable of effectively controlling your symptoms.
5. Shake off the excess water and allow the nozzle and
It may take a few days for this medicine to work. Do not stop
dust cap to dry in a warm (not hot) place.
using your medicine unless you are told to by a doctor.
6. Re-fit the nozzle.
You must not take a larger dose, or use your Nasofan Nasal
7. ‘Prime’ the bottle as necessary by pumping the spray a
Spray more often, than is prescribed by your doctor. It is
few times until a fine mist is produced.
important not to use more of your medicine than your doctor
You should clean your nasal spray at least once a week
has told you to.
to stop it from getting blocked up. Additional cleaning is
If your eyes remain itchy or watery as a result of hayfever
required when your spray becomes blocked.
despite using this medicine tell your doctor. He/she may be
You must NEVER attempt to unblock or enlarge the
able to give you another medicine to treat your eye symptoms.
spray hole with a pin or other sharp object because
this will destroy the spray mechanism.
Before you use your nasal spray
Children aged 4 to 11 years:




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.

Always use this medicine exactly as your doctor or pharmacist 2. Hold the bottle upright with your
has told you. Check with your doctor or pharmacist if you are
thumb under the bottle and your index
not sure.
finger and middle finger on either side
of the nozzle. Ensure that the nozzle is
The recommended dose is as follows:
pointing away from you when you do this.
Adults (including the elderly) and children aged 12 years
3. Press down with fingers in order to pump the spray
and older:
When you first start using Nasofan Nasal Spray you normally 4. Repeat steps 2 and 3 until a further five times – the bottle
is now primed.
take two sprays in each nostril once a day, preferably in the

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.

EXAMPLE

ZINC Ref:

EAS678b LEA FLUTICASONE (NASOFAN) 50MCG SPRAY 150 IVAX Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
297 mm
148 mm
N/A
N/A

Version:

Colours Used:

2

05 June 2017
PANTONE® 375
PANTONE® 2768 C
Template

EXAMPLE

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.

Very common: may affect more than 1 in 10 people
epistaxis (nose bleeds).


••






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
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.

Very rare: may affect up to 1 in 10,000 people
glaucoma (raised pressure in the eye) and cataracts
(clouding of the lens in the eye) have been reported
following prolonged treatment.
Your nose symptoms may only start to improve after you
perforation of the nasal septum (the dividing partition
have been using your medicine for a few days – therefore it is
in the nose) and ulceration to the nose’s mucus
very important that you use your medicine regularly as
membranes - although these usually impact on patients
prescribed, and that you keep using your medicine unless your
who have had previous surgery to the nose.
doctor tells you to stop, even if you feel better.

The active substance is fluticasone propionate. Each metered
spray contains 50 micrograms of fluticasone propionate.

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

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

Czech Republic
Germany
Denmark

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

Common: may affect up to 1 in 10 people
headache.
unpleasant taste in the mouth or an unpleasant smell in
the nose.
dryness and irritation of the throat and nasal passages
and sneezing.

If you accidentally use more Nasofan Nasal Spray than you
were told to use please inform your doctor.

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

Do not store above 25°C.

Spain

Finland

Do not throw away any medicines via wastewater or
Hungary
household waste. Ask your pharmacist how to throw away
Rare: may affect up to 1 in 1,000 people
Iceland
severe allergic reaction giving rise to the sudden onset medicines you no longer use. These measures will help protect
of a rash, swelling (usually of the tongue, face or lips) or the environment.
Ireland
difficulty in breathing.
6. Contents of the pack and other information
bronchospasm (the narrowing of the airways in the
Italy
lungs).
What Nasofan Nasal Spray contains

Not known: frequency cannot be estimated from available
data
blurred vision.

The other ingredients are glucose anhydrous, dispersible
cellulose, phenylethyl alcohol, benzalkonium chloride solution
(40 micrograms per delivered dose), polysorbate 80, and
purified water.
What Nasofan Nasal Spray looks like and contents of the
pack

Nasofan Nasal Spray consists of a white, opaque suspension
contained within an amber glass multi-dose bottle fitted with
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
Children may grow more slowly than others, and therefore
Like all medicines, this medicine can cause side effects,
children receiving treatment with nasal corticosteroids over a delivering 60, 120, 150, 240 (2 bottles each containing 120
although not everybody gets them.
long period of time will have their height checked regularly by sprays) or 360 (3 bottles each containing 120 sprays) sprays.
If you are using high doses of Nasofan Nasal Spray you may
their doctor. Your doctor will help prevent this happening by
Not all pack sizes may be marketed.
require extra steroids in times of extreme stress, or during
prescribing the lowest dose of steroid capable of adequately
Marketing Authorisation Holder and Manufacturer
admission to hospital after a serious accident or injury, or
controlling the symptoms.
before a surgical operation. Treatment with nasal
Marketing Authorisation Holder: IVAX Pharmaceuticals UK,
Reporting of side effects
corticosteroids may affect the production of steroids in the
WF10 5HX
If you get any side effects, talk to your doctor or pharmacist.
body. The likelihood of such an incidence is increased by use
Manufacturer: TEVA Czech Industries s.r.o, Opava, Czech
of a high dose over a long period of time. Your doctor will help This includes any possible side effects not listed in this leaflet.
Republic.
prevent this happening by prescribing the lowest dose of



Malta:
The Netherlands

Poland

Portugal

Slovak Republic
United Kingdom

Nasofan, nosní 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
Nasofan Aqueous 50 microgram
Nasal Spray Suspension
Fluticasonpropionaat Mylan 50,
microgram/dosis, neusspray,
suspensie
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
May 2017

XXXXX
EAS678b

EXAMPLE

Nasofan Aqueous 50 microgram 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:-

Fluticasone Propionate

After using your nasal spray

steroid capable of adequately controlling your symptoms.

Package leaflet: Information for the user

7. Repeat steps 3 to 6 with your other
nostril.

+ Expand Transcript

Further information

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