NASONEX® Aqueous Nasal Spray 0.05%
Mometasone Furoate Monohydrate
Consumer Medicine Information
NASONEX® Aqueous Nasal Spray 0.05%
Published by MIMS April 2021 1
What is in this leaflet
This leaflet answers some common questions
about NASONEX. It does not contain all the
available information.
It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you using
this medicine against the benefits they expect
it will have for you.
If you have any concerns about taking this
medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What NASONEX is used for
NASONEX contains the active ingredient
mometasone furoate. This belongs to a
family of medicines called corticosteroids,
which are used to help reduce inflammation.
Allergic Rhinitis (hayfever):
NASONEX is sprayed into the nose to help
relieve symptoms that may occur with
hayfever or other year-round allergies,
including stuffiness (congestion) in the nose,
discharge, itching and sneezing. Your doctor
may also prescribe this medicine to help
prevent these symptoms two to four weeks
before the beginning of the pollen season.
Nasal Polyps:
Swollen tissue in the nose can cause grape-
like swellings called 'polyps'. Polyps can
cause nasal stuffiness, discomfort and loss of
smell.
NASONEX can be used for the treatment of
nasal polyps in patients over 18 years of age.
Acute Rhinosinusitis:
Rhinosinusitis is the swelling of the sinuses
resulting in stuffiness of the nose, large
quantities of mucus from the nose, cough,
face pain and/or fever. These symptoms
usually last for less than 4 weeks.
NASONEX is used to treat the symptoms of
rhinosinusitis in adults and children 12 years
of age and older, who do not have the signs
or symptoms of a severe bacterial infection.
Your doctor may have prescribed it for
another reason. Ask your doctor if you
have any questions about why this
medicine has been prescribed for you.
There is no evidence that this medicine is
addictive.
This medicine is available only with a
doctor's prescription.
Before you use NASONEX
When you must not use it
Do not use the medicine if:
1.
You have an allergy to:
•
any medicine containing mometasone
furoate
•
any of the ingredients listed at the end of
this leaflet.
2. You have a tendency to bleed or
recurrent nose bleeding
3.
You have severe nose infection,
especially fungal infection.
4. You have had recent nose injury or
nose surgery; check with your doctor,
because you may be told to wait until
healing has occurred before using this
medicine.
Do not use it after the expiry date (EXP)
printed on the pack or if the packaging is
torn or shows sign of tampering.
If you are not sure whether you should
start taking this medicine, contact your
doctor.
Before you start to use it
Tell your doctor or pharmacist if you have
or have had any medical conditions,
especially the following:
•
a history of tuberculosis, or active
tuberculosis
•
infection of the nose, sinus, mouth,
throat, lungs or eye
•
sores in the nose
•
recent injury or surgery to your nose
•
open sores in your nose
Tell your doctor or pharmacist if you are
taking other corticosteroid medicines,
either by mouth, as eye drops, as an
asthma inhaler or by injection.
Tell your doctor or pharmacist if you have
allergies to:
•
any other medicines
•
any other substances, such as foods,
preservatives or dyes
Tell your doctor if you are pregnant or
intend to become pregnant
Your doctor will discuss the possible risks
and benefits of using this medicine during
pregnancy.
Tell your doctor if you are breastfeeding
or plan to breastfeed.
Breastfeeding is not recommended during
treatment with this medicine.
If you have not told your doctor about any
of the above, tell them before you use this
medicine.
Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from your
pharmacy, supermarket or health food
shop.
Some medicines and NASONEX may
interfere with each other. These include:
•
Certain antifungals such as ketoconazole
and itraconazole
•
Some antibiotics such as clarithromycin
•
Some medicines used to treat HIV
infection such as ritonavir and cobcistat-
containing products.
How to use NASONEX
Follow all directions given to you by your
doctor or pharmacist carefully and do not
use more than the recommended dose.
These directions may differ from the
information contained in this leaflet.
If you do not understand the instructions, ask
your doctor or pharmacist for help
How much to use
Hayfever and allergies in adults (including
the elderly) and children 12 years of age
and older:
Two sprays into each nostril once daily.
Children 3 to 11 years of age:
One spray into each nostril once daily.
Each actuation of the spray pump delivers
the equivalent of 50 microgram of
mometasone furoate. The volume of the
containers are sufficient to deliver the
labelled 65 sprays, or 140 sprays.
When your symptoms have been controlled,
your doctor may recommend one spray into
each nostril once daily to keep your
symptoms under control.
Your doctor may change this dosage,
depending on your response to this medicine.
Nasal Polyps in patients (including the
elderly) 18 years of age and older:
Two sprays into each nostril once daily. If
your symptoms are not controlled, your
doctor may increase your dose to two sprays
into each nostril twice daily.
When your symptoms have been controlled,
your doctor may reduce your dose.
Acute rhinosinusitis in adults and children
12 years of age and older:
Two sprays in each nostril two times a day.
If symptoms worsen during treatment, see
your doctor immediately.
About your nasal spray
Your 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.
Do not pierce the nasal applicator.
If you are using the spray for the first time,
prime the pump by pumping the spray 10
times until a fine mist is produced. If you
have not used the pump for 14 days or more
reprime by pumping 2 times.
It is important to clean the nozzle 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 nozzle to dry. Push the nozzle
back onto the bottle and replace the dust cap.
The pump will need to be reprimed when
first used after cleaning.
How to use it
1.
Shake the bottle gently and remove the
dust cap.
2.
Gently blow your nose.
3.
Close one nostril and put the nozzle into
the other nostril.
4.
Tilt your head forward slightly, keeping
the bottle upright.
5.
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.
6.
Breathe out through your mouth. Repeat
step 5 to inhale a second spray in the
same nostril.
7.
Remove the nozzle from this nostril and
breathe out through the mouth.
8.
Repeat steps 3 to 7 for the other nostril.
After using the spray, wipe the nozzle
NASONEX® Aqueous Nasal Spray 0.05%
Published by MIMS April 2021 2
carefully with a clean tissue and replace
the dust cap.
When to use it
As instructed by your doctor. Do not use
more frequently than instructed.
How long to use it
Your doctor will determine the length of
treatment.
If you forget to use it
If it is almost time for your next dose, skip
the dose you missed and use your next
dose when you are meant to.
Otherwise, use it as soon as you
remember, and then go back to use your
medicines as you would normally.
Do not use a double dose to make up for
the dose you missed.
If you are not sure what to do, ask your
doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the
Australian Poisons Information Centre on
13 11 26 if you think you or anyone else
may have used too much of this medicine.
Do this even if there are no signs of
discomfort or poisoning.
Keep telephone numbers for these places
handy.
While you are using NASONEX
Things you must do
If you become pregnant while you are
using this medicine tell your doctor.
Tell any other doctors, dentists and
pharmacists who are treating you that you
are using this medicine.
If you are about to be started on any new
medicine, tell your doctor, dentist or
pharmacist that you are using this
medicine.
If you are going to have surgery, tell the
surgeon or anaesthetist that you are using
this medicine.
See your doctor immediately if you notice
the symptoms of severe bacterial infection.
These symptoms may include fever,
persistent face/tooth pain on one side of the
face, swelling around the eye area, or
worsening of symptoms after an initial
improvement.
Things you must not do
Do not give this medicine to anyone else,
even if they have the same condition as
you.
Do not use it to treat any other complaints
unless your doctor tells you to.
Things to be careful of
This medicine generally does not cause any
problems with your ability to drive a car or
operate machinery.
If you have a lower resistance to infection,
avoid coming into contact with anyone
who has measles or chickenpox especially
while you are using cortisone-type
medicines. Tell your doctor if you do.
Side effects
Tell your doctor or pharmacist as soon as
possible if you do not feel well while you
are using this medicine.
The doctor will decide whether any change
in your treatment is needed.
This medicine helps most people, but it
may have unwanted side effects in a few
people.
All medicines can have side effects.
Sometimes they are serious, most of the
time they are not. You may need medical
treatment if you get some of the side
effects. If you are over 65 years of age, you
may have an increased chance of getting
side effects.
Ask your doctor or pharmacist to answer
any questions you may have.
Most people do not have any problems after
using the nasal spray. However, a few people
may find that they suffer from one or more of
the following:
•
headache
•
sneezing
•
nosebleeds or blood-tinged mucus
•
sore throat or burning or irritation inside
the nose after using this medicine. These
symptoms are consistent with the use of
corticosteroid nasal sprays.
•
visual disturbances or blurred vision
•
cataracts have been reported with the use
of corticosteroid nasal sprays
If you develop a rash, wheezing or
breathlessness, stop using the nasal spray,
as you may be allergic to it and contact
your doctor immediately.
Other side effects not listed above may
also occur in some patients. Tell your
doctor if you notice anything that is
making you feel unwell.
Long-term use of corticosteroid sprays
may be associated with other side effects.
Your doctor will monitor your health if
you are using NASONEX for extended
periods of time.
Do not be alarmed by this list of possible
side effects.
You may not experience any of them.
After using NASONEX
Storage
Keep the nasal spray in a cool dry place
where the temperature stays below 25°C.
Do not freeze. Store it away from heat.
Do not store it or any other medicine in
the bathroom or near a sink. Do not leave
it in the car or on windowsills.
Heat and dampness can destroy some
medicines.
Keep it where children cannot reach.
Disposal
If your doctor tells you to stop using this
medicine or it has passed the expiry date,
ask your pharmacist what to do with any
that is left over.
Further information
Drug testing for sport events:
This product is a corticosteroid for intranasal
administration; it is not a restricted drug for
sports.
Corticosteroid may be detected in blood
and in the urine during drug testing; thus
prior written permission for its use may be
required by some sport agencies.
Product description
What it looks like
The nasal spray is a white to off-white
suspension contained in a plastic bottle with
a metered-dose, manual spray pump for
intranasal administration.
Ingredients
Active ingredient:
Mometasone furoate monohydrate
Inactive ingredients:
Dispersible cellulose, glycerol, citric acid
monohydrate (or anhydrous citric acid),
sodium citrate, polysorbate 80 and purified
water
Preservatives:
Benzalkonium chloride
Sponsor
Organon Pharma Pty Ltd
Building A, 26 Talavera Road
Macquarie Park NSW 2113
AUSTRALIA
Australian Registration Number
2 x 140 metered dose bottles per pack
140 metered doses per pack
65 metered doses per pack (Junior Pack)
NASONEX: AUST R 77112
Date of Preparation
16 February 2021
S-CCDS-MK0887-NS-082017
