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NASONEX 50 MICROGRAMS/ACTUATION NASAL SPRAY SUSPENSION

Active substance(s): MOMETASONE FUROATE / MOMETASONE FUROATE MONOHYDRATE MICRONISED

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500363A01

Yellow

Nasonex® 50 micrograms/actuation
Nasal Spray, Suspension
Mometasone Furoate
Please read 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. 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.

When corticosteroid nasal sprays are
used at high doses for long periods of
time, side effects may occur due to
the drug being absorbed in the body.

What is in this leaflet
1. What Nasonex is and what it is
used for
2. What you need to know before you
use Nasonex
3. How to use Nasonex
4. Possible side effects
5. How to store Nasonex
6. Contents of the pack and other
information

Other medicines and Nasonex
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.

1. What Nasonex is and what it is
used for
What is Nasonex?
Nasonex Nasal Spray contains
mometasone furoate, one of a group
of medicines called corticosteroids.
When mometasone furoate is sprayed
into the nose, it can help to relieve
inflammation (swelling and irritation
of the nose), sneezing, itching and
a blocked up or runny nose.
What is Nasonex used for?
Hayfever and perennial rhinitis
Nasonex is used to treat the symptoms
of hayfever (also called seasonal
allergic rhinitis) and perennial rhinitis in
adults and children aged 3 and older.
Hayfever, which occurs at certain
times of the year, is an allergic
reaction caused by breathing in pollen
from trees, grasses, weeds and also
moulds and fungal spores. Perennial
rhinitis occurs throughout the year
and symptoms can be caused by
a sensitivity to a variety of things
including house dust mite, animal
hair (or dander), feathers and certain
foods. Nasonex reduces the swelling
and irritation in your nose and thereby
relieving sneezing, itching and a
blocked-up or runny nose caused by
hayfever or perennial rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps
in adults aged 18 and over.
Nasal polyps are small growths on the
lining of the nose and usually affect
both nostrils. Nasonex reduces the
inflammation in the nose, causing the
polyps to gradually shrink, thereby
relieving a blocked feeling in the nose
which may affect breathing through
the nose.
2. What you need to know before
you use Nasonex
Do not use Nasonex
• if you are allergic (hypersensitive)
to mometasone furoate or any
of the other ingredients of this
medicine (listed in section 6).
• if you have an untreated infection in
your nose. Use of Nasonex during
an untreated infection in your nose,
such as herpes, can worsen the
infection. You should wait until the
infection is resolved before you
start using the nasal spray.
• if you have recently had an
operation on your nose or you
have injured your nose. You should
not use the nasal spray until your
nose has healed.
Warnings and precautions
Talk to your doctor or pharmacist
before using Nasonex
• if you have or have ever had
tuberculosis.
• if you have any other infection.
• if you are taking other corticosteroid
medicines, either by mouth or by
injection.
• if you have cystic fibrosis.
While you are using Nasonex, talk to
your doctor
• if your immune system is not
functioning well (if you have
difficulty in fighting infection) and
you come into contact with anyone
with measles or chickenpox. You
should avoid coming into contact
with anyone who has these
infections.
• if you have an infection of the nose
or throat.
• if you are using the medicine for
several months or longer.
• if you have persistent irritation to
the nose or throat.

IN62GV_5
2
220714
130x520
Folding Size 130 x 23

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1/2

Package leaflet:
Information for the user

If your eyes are itching or irritated,
your doctor may recommend that you
use other treatments with Nasonex.
Children
When used at high doses for long
periods of time, corticosteroid nasal
sprays may cause certain side-effects,
such as slowed growth rate in children.
It is recommended that the height of
children receiving long-term treatment
with nasal corticosteroids is regularly
monitored and if any changes are
noted, their doctor should be notified.

If you are taking other corticosteroid
medicines for allergy, either by mouth
or injection, your doctor may advise
you to stop taking them once you begin
using Nasonex. A few people may
find that once they discontinue oral
or injected corticosteroids they suffer
from some undesirable effects, such
as joint or muscular pain, weakness
and depression. You may also seem to
develop other allergies, such as itchy,
watering eyes or patches of red and
itchy skin. If you develop any of these
effects, you should contact your doctor.
Pregnancy and breast-feeding
There is little or no information on the
use of Nasonex in pregnant women.
It is not known if mometasone furoate
is found in breast milk.
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
There is no known information on the
effect of Nasonex on the ability to
drive or use machinery.
Nasonex contains benzalkonium
chloride
Nasonex contains benzalkonium chloride
which may cause nasal irritation.
3. How to use Nasonex
Always use Nasonex exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure. Do not use a larger dose
or use the spray more often or for
longer than your doctor tells you to.
Treatment of Hayfever and Perennial
Rhinitis
Use in adults and children over
12 years old
The usual dose is two sprays into
each nostril once a day.
• Once your symptoms are under
control, your doctor may advise
you to decrease the dose.
• If you do not start to feel any better,
you should see your doctor and he
or she may tell you to increase the
dose; the maximum daily dose is four
sprays into each nostril once a day.
Use in children aged 3 to 11 years
The usual dose is one spray into
each nostril once daily.
In some patients Nasonex begins to
relieve symptoms within 12  hours
after the first dose; however full
benefit of treatment may not be
seen in the first two days. Therefore,
you should continue regular use to
achieve full benefit of treatment.
If you or your child suffer badly from
hayfever, your doctor may tell you
to start using Nasonex some days
before the start of the pollen season,
as this will help to prevent your
hayfever symptoms from occurring.
Nasal Polyps
Use in adults over 18 years old
The usual starting dose is two
sprays into each nostril once daily.
• If symptoms are not controlled
after 5 to 6 weeks, the dose may
be increased to two sprays in each
nostril twice daily. Once symptoms
are under control, your doctor may
advise you to decrease your dose.
• If no improvement in symptoms is
seen after 5  to 6  weeks of twice
daily administration, you should
contact your doctor.
Preparing your nasal spray for use
Your Nasonex Nasal Spray has a dust
cap which protects the nozzle and
keeps it clean. Remember to take
this off before using the spray and to
replace it after use.

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Technical Info

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500363A01

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Technical Info

Profile

If you are using the spray for the first
time you need to ‘prime’ the bottle by
pumping the spray 10  times until a
fine mist is produced:
1. Gently shake the bottle.
2. Put your forefinger and middle
finger either side of the nozzle and
your thumb underneath the bottle.
Do Not pierce the nasal applicator.
3. Point the nozzle away from you
and  then press down with your
fingers to pump the spray 10 times
until a fine mist is produced.
If you have not used the spray
for 14  days or more, you need to
“re-prime” the bottle by pumping
the spray 2 times until a fine mist is
produced.

Other side effects
Most people do not have any problems
after using the nasal spray. However,
some people, after using Nasonex
or other corticosteroid nasal sprays,
may find that they suffer from:

How to use your nasal spray

Not known (frequency cannot be
estimated from the available data):
• increase in pressure in the eye
(glaucoma)
and/or
cataracts
causing visual disturbances,
• damage to the partition in the nose
which separates the nostrils
• changes in taste and smell

difficulty in breathing and/or
wheezing

1.
Shake the bottle Figure 1
gently and remove
the
dust
cap.
(Figure 1)
2.
Gently blow your
nose.
3. Close one nostril Figure 2
and put the nozzle
into
the
other
nostril as shown.
(Figure 2) Tilt your
head
forward
slightly, keeping the bottle upright.
4. Start to breathe in gently or slowly
through your nose and whilst you
are breathing in squirt a spray of
fine mist into your nose by pressing
down ONCE with your fingers.
5. Breathe out through your mouth.
Repeat step 4  to inhale a second
spray in the same nostril if
applicable.
6.
Remove the nozzle from this
nostril and breathe out through the
mouth.
7. Repeat steps 3  to Figure 3
6  for the other
nostril (Figure 3).
After using the spray,
wipe
the
nozzle
carefully with a clean
handkerchief
or tissue and replace the dust cap.
Cleaning your nasal spray
• It is important to clean your nasal
spray regularly, otherwise it may
not work properly.
• Remove the dust cap and gently
pull off the nozzle.
• Wash the nozzle and dust cap in
warm water and then rinse under
a running tap.
• Do not try to unblock the nasal
applicator by inserting a pin or
other sharp object as this will
damage the applicator and
cause you not to get the right
dose of medicine.
• Allow the dust cap and nozzle to
dry in a warm place.
• Push the nozzle back onto the
bottle and replace the dust cap.
• The spray will need to be primed
again with 2  sprays when first
used after cleaning.
If you use more Nasonex than you
should
Tell your doctor if you accidentally use
more than you were told.
If you use steroids for a long time or
in large amounts they may, rarely,
affect some of your hormones. In
children this may affect growth and
development.
If you forget to use Nasonex
If you forget to use your nasal spray
at the right time, use it as soon as
you  remember, then carry on as
before. Do not take a double dose to
make up for a forgotten dose.
If you stop using Nasonex
In some patients Nasonex should
begin to relieve symptoms 12  hours
after the first dose; however full
benefit of treatment may not be seen
for up to two days. It is very important
that you use your nasal spray
regularly. Do not stop your treatment
even if you feel better unless told to
do so by your doctor.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Immediate hypersensitivity (allergic)
reactions may occur after use of this
product. These reactions may be
severe. You should stop taking Nasonex
and get immediate medical help if you
experience symptoms such as:
• swollen face, tongue or pharynx
• trouble swallowing
• hives
• wheezing or trouble breathing
When corticosteroid nasal sprays are
used at high doses for long periods of
time, side effects may occur due to
the drug being absorbed in the body.

IN62GV_5
2
220714
130x520
Folding Size 130 x 23

Common side effects (may affect up
to 1 in 10 people):
• headache
• sneezing

nose bleeds [occurred very
commonly (may affect more than
1 in 10 people) in people with nasal
polyps receiving Nasonex two
sprays in each nostril twice a day]
• sore nose or throat
• ulcers in the nose
• respiratory tract infection

Reporting of side effects
If you get any 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 (see details below). By
reporting side effects you can help
provide more information on the
safety of this medicine.
United Kingdom: Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
Malta:
ADR
Reporting
at:
www.medicinesauthority.gov.mt/adrportal
5. How to store Nasonex
• Keep this medicine out of the sight
and reach of children.
• Do not store the bottle above
25°C. Do not freeze.
• Do not use this medicine after the
expiry date which is stated on the
bottle and carton after EXP. The
expiry date refers to the last day of
that month.
• The bottle should be used within
2  months of first opening. Only
open one bottle at a time.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What Nasonex contains

The
active
substance
is
mometasone
furoate.
Each
spray contains 50  micrograms
of mometasone furoate, as the
monohydrate.

The
other
ingredients
are
dispersible cellulose, glycerol,
sodium
citrate,
citric
acid
monohydrate, polysorbate 80,
benzalkonium chloride, purified
water.
What Nasonex looks like and
contents of the pack
Nasonex is a nasal spray suspension.
Each bottle contains 60  sprays or
140 sprays.
Bottles containing 60  sprays are
supplied in single packs.
Bottles containing 140  sprays are
supplied in packs of 1, 2 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
The
Marketing
Authorisation
Holder in the UK and Malta is Merck
Sharp & Dohme Limited, Hertford
Road, Hoddesdon, Hertfordshire,
EN11 9BU, UK.
The
Marketing
Authorisation
Holder in Ireland is Merck Sharp &
Dohme Ireland (Human Health) Limited,
Red Oak North, South County Business
Park, Leopardstown, Dublin 18, Ireland.
The manufacturer is:
Schering-Plough Labo NV, Heist-op-den
Berg, Belgium
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria: Nasonex aquosum – Nasenspray
Belgium, Croatia, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Slovenia, Sweden, UK: Nasonex
Bulgaria, Czech Republic, Romania, Slovak Republic: NASONEX
Latvia: Nasonex 50 mikrogrami/deva deguna aerosols,suspensija
Portugal: Nasomet
Spain: NASONEX 50 microgramos suspensión para pulverización nasal

This leaflet was last approved in
December 2015
© Merck Sharp & Dohme Limited
2015. All rights reserved.
PIL.NSX.15.UK.4622-II-065

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Nasonex® 50 micrograms/actuation
Nasal Spray, Suspension

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Technical Info

Mometasone Furoate

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DISCLAIMER: Schawk Australia has quality checked this artwork and
information for complete accuracy. Ownership of the final approval
for content, layout, text and spelling is the client’s responsibility.
Please review all areas for inaccuracies, omissions or errors before
committing to final approval.

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Please read 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. 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 Nasonex is and what it is
used for
2. What you need to know before you
use Nasonex
3. How to use Nasonex
4. Possible side effects
5. How to store Nasonex
6. Contents of the pack and other
information
1. What Nasonex is and what it is
used for
What is Nasonex?
Nasonex Nasal Spray contains
mometasone furoate, one of a group
of medicines called corticosteroids.
When mometasone furoate is sprayed
into the nose, it can help to relieve
inflammation (swelling and irritation
of the nose), sneezing, itching and a
blocked up or runny nose.
What is Nasonex used for?
Hayfever and perennial rhinitis
Nasonex is used to treat the symptoms
of hayfever (also called seasonal
allergic rhinitis) and perennial rhinitis
in adults and children aged 3  and
older.
Hayfever, which occurs at certain
times of the year, is an allergic
reaction caused by breathing in pollen
from trees, grasses, weeds and also
moulds and fungal spores. Perennial
rhinitis occurs throughout the year
and symptoms can be caused by
a sensitivity to a variety of things
including house dust mite, animal
hair (or dander), feathers and certain
foods. Nasonex reduces the swelling
and irritation in your nose and thereby
relieving sneezing, itching and a
blocked-up or runny nose caused by
hayfever or perennial rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps
in adults aged 18 and over.
Nasal polyps are small growths on the
lining of the nose and usually affect
both nostrils. Nasonex reduces the
inflammation in the nose, causing the
polyps to gradually shrink, thereby
relieving a blocked feeling in the nose
which may affect breathing through
the nose.
2. What you need to know before
you use Nasonex
Do not use Nasonex
• if you are allergic (hypersensitive)
to mometasone furoate or any
of the other ingredients of this
medicine (listed in section 6).
• if you have an untreated infection in
your nose. Use of Nasonex during
an untreated infection in your nose,
such as herpes, can worsen the
infection. You should wait until the
infection is resolved before you
start using the nasal spray.
• if you have recently had an
operation on your nose or you have
injured your nose. You should not
use the nasal spray until your nose
has healed.
Warnings and precautions
Talk to your doctor or pharmacist
before using Nasonex
• if you have or have ever had
tuberculosis.
• if you have any other infection.
• if you are taking other corticosteroid
medicines, either by mouth or by
injection.
• if you have cystic fibrosis.
While you are using Nasonex, talk to
your doctor
• if your immune system is not
functioning well (if you have
difficulty in fighting infection) and
you come into contact with anyone
with measles or chickenpox. You
should avoid coming into contact
with anyone who has these
infections.
• if you have an infection of the nose
or throat.
• if you are using the medicine for
several months or longer.
• if you have persistent irritation to
the nose or throat.

When corticosteroid nasal sprays are
used at high doses for long periods of
time, side effects may occur due to
the drug being absorbed in the body.
If your eyes are itching or irritated,
your doctor may recommend that you
use other treatments with Nasonex.
Children
When used at high doses for long
periods of time, corticosteroid nasal
sprays may cause certain side-effects,
such as slowed growth rate in children.
It is recommended that the height
of children receiving long-term
treatment with nasal corticosteroids
is regularly monitored and if any
changes are noted, their doctor
should be notified.
Other medicines and Nasonex
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
If you are taking other corticosteroid
medicines for allergy, either by mouth
or injection, your doctor may advise
you to stop taking them once you
begin using Nasonex. A few people
may find that once they discontinue
oral or injected corticosteroids
they suffer from some undesirable
effects, such as joint or muscular
pain, weakness and depression. You
may also seem to develop other
allergies, such as itchy, watering
eyes or patches of red and itchy skin.
If you develop any of these effects,
you should contact your doctor.
Pregnancy and breast-feeding
There is little or no information on the
use of Nasonex in pregnant women. It
is not known if mometasone furoate is
found in breast milk.
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
There is no known information on the
effect of Nasonex on the ability to
drive or use machinery.
Nasonex contains benzalkonium
chloride
Nasonex contains benzalkonium
chloride which may cause nasal
irritation.
3. How to use Nasonex
Always use Nasonex exactly as your
doctor has told you. You should
check with your doctor or pharmacist
if you are not sure. Do not use a
larger dose or use the spray more
often or for longer than your doctor
tells you to.
Treatment of Hayfever and Perennial
Rhinitis
Use in adults and children over
12 years old
The usual dose is two sprays into
each nostril once a day.
• Once your symptoms are under
control, your doctor may advise
you to decrease the dose.
• If you do not start to feel any
better, you should see your doctor
and he or she may tell you to
increase the dose; the maximum
daily dose is four sprays into each
nostril once a day.
Use in children aged 3 to 11 years
The usual dose is one spray into
each nostril once daily.
In some patients Nasonex begins to
relieve symptoms within 12 hours after
the first dose; however full benefit of
treatment may not be seen in the
first two days. Therefore, you should
continue regular use to achieve full
benefit of treatment.
If you or your child suffer badly from
hayfever, your doctor may tell you to
start using Nasonex some days before
the start of the pollen season, as this
will help to prevent your hayfever
symptoms from occurring.
Nasal Polyps
Use in adults over 18 years old
The usual starting dose is two
sprays into each nostril once daily.
• If symptoms are not controlled
after 5 to 6 weeks, the dose may
be increased to two sprays in each
nostril twice daily. Once symptoms
are under control, your doctor may
advise you to decrease your dose.
• If no improvement in symptoms
is  seen after 5  to 6  weeks of
twice  daily administration, you
should contact your doctor.
Preparing your nasal spray for
use
Your Nasonex Nasal Spray has a dust
cap which protects the nozzle and
keeps it clean. Remember to take

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Number

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123

N/A
11-DEC-15-v01
123 (Sample)
126138A01
N/A

Printer:

Black

Profile:
Folded Size:
Open Size:
Folding:

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Yellow

Magenta

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Technical Info

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SIN-LFLD-32.5x130_520x130
32.5x130mm
520x130mm
Pharmacode visible after folding

DISCLAIMER: Schawk Australia has quality checked this artwork and
information for complete accuracy. Ownership of the final approval
for content, layout, text and spelling is the client’s responsibility.
Please review all areas for inaccuracies, omissions or errors before
committing to final approval.

Pr

Proprietary

this off before using the spray and to
replace it after use.
If you are using the spray for the first
time you need to ‘prime’ the bottle by
pumping the spray 10  times until a
fine mist is produced:
1. Gently shake the bottle.
2. Put your forefinger and middle
finger either side of the nozzle and
your thumb underneath the bottle.
Do Not pierce the nasal applicator.
3. Point the nozzle away from you and
then press down with your fingers
to pump the spray 10 times until a
fine mist is produced.
If you have not used the spray
for  14  days or more, you need to
“re-prime” the bottle by pumping
the spray 2 times until a fine mist is
produced.
How to use your nasal spray
1. Shake the bottle Figure 1
gently and remove
the dust cap.
(Figure 1)
2. Gently blow your
nose.
3. Close one nostril Figure 2
and put the nozzle
into the other
nostril as shown.
(Figure 2) Tilt
your head forward
slightly, keeping the bottle upright.
4. Start to breathe in gently or slowly
through your nose and whilst you
are breathing in squirt a spray of
fine mist into your nose by pressing
down ONCE with your fingers.
5. Breathe out through your mouth.
Repeat step 4  to inhale a second
spray in the same nostril if
applicable.
6. Remove the nozzle from this nostril
and breathe out through the mouth.
7. Repeat steps 3 to Figure 3
6  for the other
nostril (Figure 3).
After using the spray,
wipe the nozzle
carefully with a clean
handkerchief
or tissue and replace the dust cap.
Cleaning your nasal spray
• It is important to clean your nasal
spray regularly, otherwise it may
not work properly.
• Remove the dust cap and gently
pull off the nozzle.
• Wash the nozzle and dust cap in
warm water and then rinse under a
running tap.
• Do not try to unblock the nasal
applicator by inserting a pin or
other sharp object as this will
damage the applicator and
cause you not to get the right
dose of medicine.
• Allow the dust cap and nozzle to
dry in a warm place.
• Push the nozzle back onto the
bottle and replace the dust cap.
• The spray will need to be primed
again with 2 sprays when first used
after cleaning.
If you use more Nasonex than you
should
Tell your doctor if you accidentally use
more than you were told.
If you use steroids for a long time or
in large amounts they may, rarely,
affect some of your hormones. In
children this may affect growth and
development.
If you forget to use Nasonex
If you forget to use your nasal spray
at the right time, use it as soon as you
remember, then carry on as before.
Do not take a double dose to make up
for a forgotten dose.
If you stop using Nasonex
In some patients Nasonex should
begin to relieve symptoms 12  hours
after the first dose; however full
benefit of treatment may not be seen
for up to two days. It is very important
that you use your nasal spray
regularly. Do not stop your treatment
even if you feel better unless told to
do so by your doctor.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Immediate hypersensitivity (allergic)
reactions may occur after use of this
product. These reactions may be
severe. You should stop taking Nasonex
and get immediate medical help if you
experience symptoms such as:
• swollen face, tongue or pharynx
• trouble swallowing
• hives
• wheezing or trouble breathing
When corticosteroid nasal sprays are
used at high doses for long periods of
time, side effects may occur due to
the drug being absorbed in the body.
Other side effects
Most people do not have any problems
after using the nasal spray. However,
some people, after using Nasonex

or other corticosteroid nasal sprays,
may find that they suffer from:
Common side effects (may affect up
to 1 in 10 people):
• headache
• sneezing

nose bleeds [occurred very
commonly (may affect more
than 1 in 10 people) in people with
nasal polyps receiving Nasonex two
sprays in each nostril twice a day]
• sore nose or throat
• ulcers in the nose
• respiratory tract infection
Not known (frequency cannot be
estimated from the available data):
• increase in pressure in the eye
(glaucoma)
and/or
cataracts
causing visual disturbances,
• damage to the partition in the nose
which separates the nostrils
• changes in taste and smell

difficulty in breathing and/or
wheezing
Reporting of side effects
If you get any 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 (see details below). By
reporting side effects you can help
provide more information on the
safety of this medicine.
United Kingdom: Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
Malta: ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal
5. How to store Nasonex
• Keep this medicine out of the sight
and reach of children.
• Do not store the bottle above
25°C. Do not freeze.
• Do not use this medicine after the
expiry date which is stated on the
bottle and carton after EXP. The
expiry date refers to the last day of
that month.
• The bottle should be used within
2  months of first opening. Only
open one bottle at a time.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6.
Contents of the pack and
other information
What Nasonex contains
• The active substance is mometasone
furoate. Each spray contains
50  micrograms of mometasone
furoate, as the monohydrate.
• The other ingredients are dispersible
cellulose,
glycerol,
sodium
citrate, citric acid monohydrate,
polysorbate 80, benzalkonium
chloride, purified water.
What Nasonex looks like and
contents of the pack
Nasonex is a nasal spray suspension.
Each bottle contains 60  sprays or
140 sprays.
Bottles containing 60  sprays are
supplied in single packs.
Bottles containing 140  sprays are
supplied in packs of 1, 2 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
The
Marketing
Authorisation
Holder in the UK and Malta is Merck
Sharp & Dohme Limited, Hertford
Road, Hoddesdon, Hertfordshire,
EN11 9BU, UK.
The
Marketing
Authorisation
Holder in Ireland is Merck Sharp &
Dohme Ireland (Human Health) Limited,
Red Oak North, South County Business
Park, Leopardstown, Dublin 18, Ireland.
The manufacturer is:
Schering-Plough Labo NV, Heist-op-den
Berg, Belgium
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria: Nasonex aquosum – Nasenspray
Belgium, Croatia, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Slovenia, Sweden, UK: Nasonex
Bulgaria, Czech Republic, Romania, Slovak Republic: NASONEX
Latvia: Nasonex 50 mikrogrami/deva deguna aerosols,suspensija
Portugal: Nasomet
Spain: NASONEX 50 microgramos suspensión para pulverización nasal

This leaflet was last approved in
December 2015
©  Merck Sharp & Dohme Limited
2015. All rights reserved.
PIL.NSX.15.UK.4622-II-065

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Barcodes
Type

Number

CODE 128

123

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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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