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MOMETASONE FUROATE 0.05% AQUEOUS NASAL SPRAY

Active substance(s): MOMETASONE FUROATE MONOHYDRATE

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Children

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

NASONEX® AQUEOUS NASAL SPRAY /
MOMETASONE FUROATE 0.05%
AQUEOUS NASAL SPRAY
(mometasone furoate)

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.

This product is available using the name Nasonex Aqueous Nasal Spray but will be referred to as
Nasonex throughout this leaflet.
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.

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.

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.

Other medicines and Nasonex

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.

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.

3.

What is Nasonex used for?
Hayfever and perennial rhinitis

Treatment of Hayfever and Perennial Rhinitis
Use in adults and children over 12 years old

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.




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.

Nasal Polyps

WHAT YOU NEED TO KNOW BEFORE YOU USE NASONEX

Use in adults over 18 years old

Do not use Nasonex


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.

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 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.

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.

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.

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.

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.

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.

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.

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.

Page 1 of 2

How to use your nasal spray

1.
2.

Reporting of side effects

Shake the bottle gently and remove the dust cap. (Figure 1)
Gently blow your nose.

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.
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

3.
4.
5.
6.
7.

5.

Close one nostril and put the nozzle into the other nostril as shown.
(Figure 2) Tilt your head forward slightly, keeping the bottle upright.
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.
Breathe out through your mouth. Repeat step 4 to inhale a second
spray in the same nostril if applicable.
Remove the nozzle from this nostril and breathe out through the
mouth.
Repeat steps 3 to 6 for the other nostril (Figure 3).








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.

After using the spray, wipe the nozzle carefully with a clean handkerchief
or tissue and replace the dust cap.

6.

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.




Nasonex is a high density polyethylene bottle, supplied with a metered-dose,
manual polypropylene spray pump actuator. The bottle is white with a green lid.
Nasonex is a nasal spray suspension. Each bottle contains 120 actuations

Manufacturer

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.

Nasonex is made by:
Schering-Plough Labo N.V. - Industriepark, Heist-op-den-Berg, Belgium.

If you forget to use Nasonex

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

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.

Product Licence holder:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

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.

PL No: 04423/0559

Nasonex® is a registered trademark of the Schering Corporation.

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):





POM

Leaflet revision and issue date (Ref): 19.04.16

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





The active substance in Nasonex is mometasone furoate. Each actuation delivers
50 micrograms of mometasone furoate (as the monohydrate).
The following inactive ingredients are also contained in the nasal spray: dispersible cellulose,
glycerol, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80,
benzalkonium chloride, phenylethyl alcohol and purified water.

What Nasonex looks like and contents of the pack

Tell your doctor if you accidentally use more than you were told.





CONTENTS OF THE PACK AND OTHER INFORMATION

What Nasonex contains

If you use more Nasonex than you should

4.

HOW TO STORE NASONEX

Do not use after the date, which is printed on the carton label. The expiry date refers to the
last day of that month.
Do not store above 30°C. Do not freeze.
Discard unused spray within 2 months of first opening.
Keep out of the sight and reach of children.
If your medicine shows any signs of deterioration, take it to your pharmacist who will advise
you what to do.
If you are told to stop taking this medicine, take the nasal spray which you haven’t finished
back to your pharmacist for safe disposal.

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

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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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