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MOMETASONE FUROATE 0.05% W/W NASAL SPRAY

Active substance(s): MOMETASONE FUROATE

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Nasonex® Aqueous Nasal Spray /
Mometasone Furoate 0.05% w/w Aqueous Nasal Spray
(mometasone furoate)
This medicine is known by above names but will be referred to as Nasonex
throughout this leaflet.
Package Leaflet: Information for the User
Please read this leaflet carefully before you start using this medicine.
• 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 symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Nasonex is and what it is used for
2. Before you use Nasonex
3. How to use Nasonex
4. Possible side effects
5. How to store Nasonex
6. Further information

1. WHAT NASONEX IS AND WHAT IT IS USED FOR
What is Nasonex?
Nasonex contains mometasone furoate, one of a group of medicines called
corticosteroids. Mometasone furoate should not be confused with “anabolic”
steroids misused by some athletes and taken as tablets or injections. When
tiny amounts of mometasone furoate are sprayed into the nose, it can help to
relieve inflammation, sneezing, itching and a blocked up or runny nose.
What is Nasonex used for?
Nasonex is used in adults and children aged 6 and older to treat the
symptoms of hayfever (also called seasonal allergic rhinitis) and perennial
rhinitis.
In adults aged 18 and over, Nasonex is also used to treat nasal polyps.
What is hayfever and perennial rhinitis?
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. These
allergies cause a runny nose and sneezing and make the lining of the nose
swell, causing a stuffy blocked-up feeling. Nasonex reduces the swelling and
irritation in your nose and so relieves sneezing, itching and a blocked-up or
runny nose.
What are nasal polyps?
Nasal polyps are small growths on the lining of the nose and usually affect
both nostrils. The main symptom is a blocked feeling in the nose which may
affect breathing through the nose. Watering from the nose, a feeling of
something running down the back of the throat and loss of taste and smell
may also occur. Nasonex reduces the inflammation in the nose, causing the
polyps to gradually shrink.

2. BEFORE YOU USE NASONEX
Do not use Nasonex
• if you are allergic (hypersensitive) to mometasone furoate or any of the
other ingredients of Nasonex.
• if you have an infection in your nose. 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 wait until it has healed before you start using the
nasal spray.
Take special care with Nasonex
• if you have or have ever had tuberculosis
• if you have herpes simplex (virus) infection of the eye
• if you have any other type of infection
• if you are taking other corticosteroid medicines, either by mouth or by
injection
• if you have cystic fibrosis
While using Nasonex, avoid coming into contact with anyone who has
measles or chickenpox. You should tell your doctor if you do come into
contact with anyone who is suffering from these infections.

Using 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. If these occur you should
inform your doctor who will advise about continuing use of your nasal spray.
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 and you
are worried, you should see your doctor.
Pregnancy and breast-feeding
You should not use Nasonex if you are pregnant unless your doctor has told
you to. Tell your doctor if you are pregnant before you start using this
medicine. You should not breast feed when you are using this medicine
unless your doctor has told you to.

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.
• Hayfever and perennial rhinitis

Adults and children over 12 years old
The usual dose is two sprays into each nostril once a day for adults
(including the elderly) and children over the age of 12 years.
• Once your symptoms are under control, your doctor may advise you to
only spray once into each nostril once a day.
• If you do not start to feel any better, you should see your doctor and he
may tell you to increase the dose to the maximum daily dose of four sprays
into each nostril once a day. Once your symptoms are controlled your
doctor may advise you to reduce the dose to two sprays into each nostril
once daily.
Children aged 6 to 11 years
The usual dose is one spray into each nostril once daily.
Long term use of nasal steroids at high doses may cause slowing of growth
in children. Your doctor may check your child’s height at intervals during
treatment and reduce the dose if any effects are seen.
If you suffer badly from hayfever, your doctor may tell you to start using
Nasonex two to four weeks before the start of the pollen season, as this will
help to prevent your hayfever symptoms from occurring. Your doctor may
recommend that you use other treatments with Nasonex, particularly if your
eyes are itching or irritated.
At the end of the pollen season your hayfever symptoms should get better
and treatment may then not be needed.
• Nasal Polyps

The usual starting dose for adults aged 18 and over 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 should ask you to reduce your dose to the
lowest amount where symptoms are still controlled.
• If no improvement in symptoms is seen after 5 to 6 weeks of twice daily
administration, you should contact your doctor to discuss other treatments
to replace Nasonex.
Preparing your nasal spray for use
Your Nasonex 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.
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.
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.
At normal dose of two sprays into each nostril once daily for the treatment of
hayfever and perennial rhinitis and nasal polyps, this product should provide
enough doses for 35 days.

How to use your nasal spray
1. Shake the bottle gently and remove the dust cap.
(Figure 1)

Figure 1

2. Gently blow your nose.
3. Close one nostril and put the nozzle into the other nostril
as shown. (Figure 2).
Tilt your head forward slightly, keeping the bottle upright.

Figure 2

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.

Figure 3

6. Remove the nozzle from this nostril and breathe out
through the mouth.

Children
When used at high doses for long periods of time, corticosteroid nasal sprays
may cause certain side effects, such as growth reduction 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.
Nasonex contains benzalkonium chloride which may cause nasal irritation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
By reporting side effects, you can help provide more information on the
safety of this medicine.

7. Repeat steps 3 to 6 for the other nostril (Figure 3).

5. HOW TO STORE NASONEX
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 to dry in a warm place. Push the nozzle back
onto the bottle and replace the dust cap. The spray will need to be re-primed
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.

Keep out of the sight and reach of children.
Do not store your Nasonex above 30°C. Do not freeze the spray.
Do not use after the expiry date shown on the carton or nasal spray labels.
The expiry date refers to the last day of that month.
The spray should be used within 2 months of first use.
If your doctor tells you to stop using this nasal spray, please return it to the
pharmacist for safe disposal. Only keep this nasal spray if your doctor tells
you to.
If the nasal spray shows any signs of deterioration, you should seek the
advice of your pharmacist.
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.

6. FURTHER INFORMATION
What Nasonex contains
Nasonex contains 50 micrograms mometasone furoate as monohydrate in
each spray.
Nasonex also contains the following inactive ingredients: dispersible
cellulose, glycerol, sodium citrate dihydrate, citric acid monohydrate,
polysorbate 80, benzalkonium chloride, phenyl ethyl alcohol, purified water.

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.

What Nasonex looks like and contents of the pack
Nasonex is available in a white high-density polyethylene bottle, supplied
with a metered dose manual polypropylene spray actuator.

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

Nasonex is manufactured by Schering Plough Labo N.V., Industriepark 30,
Heist-op-den-Berg, Belgium and is procured from within the EU by the
Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance
Road, London W3 0RB and repackaged by OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nasonex can cause side effects, although not everybody
gets them.
Rarely, immediate hypersensitivity (allergic) reactions may occur after use of
this product. Very rarely, these reactions may be severe. If you have any
wheezing or have trouble breathing, get immediate medical help.
In rare cases, treatment with corticosteroid nasal sprays like Nasonex has led
to an increase in pressure in the eye (glaucoma) and/or cataracts, causing
visual disturbances and damage to the partition in the nose which separates
the nostrils. Contact your doctor if you notice any of these side effects.
When corticosteroid nasal sprays are used at high doses for long periods of
time, side effects may occur very rarely 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,
a few people after using Nasonex or other corticosteroid nasal sprays may
find that they suffer from:
• headache
• sneezing
• nose bleeds
• sore nose or throat
• alterations in taste or smell which may occur very rarely.

Each bottle contains 140 metered sprays.

PL 13826/0337

POM

Nasonex
Leaflet revision date (ref):19/02/2015
‘Nasonex’ is a registered trademark of Schering Corporation.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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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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