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NASONEX 50 MICROGRAM NASAL SPRAY

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Patient Information Leaflet

Nasonex® 50 microgram Nasal Spray
(mometasone furoate)
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.
The name of your medicine is Nasonex 50 microgram Nasal Spray, but
will be referred to as Nasonex throughout the remainder of the leaflet.
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 Nasal Spray 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 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. If you are using the spray for the first time you need
to ‘prime’ the bottle by pumping the spray
10 times until a fi ne 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 “reprime” the bottle by pumping the spray 2 times until a fi ne 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 15 days.
How to use your nasal spray
1. Shake the bottle gently and remove the dust
cap. (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.
4. Start to breathe in gently or slowly through
your nose and whilst you are breathing in squirt
a spray of fi ne 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.
6. Remove the nozzle from this nostril and
breathe out through the mouth.
7. Repeat steps 3 to 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 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.
PP1/1314/V1

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, 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.

6. Further Information
The active substance is mometasone furoate. Each spray contains 50
micrograms of mometasone furoate, as the monohydrate.
Also contains: dispersible cellulose, glycerol, sodium citrate, citric acid
monohydrate, polysorbate 80, benzalkonium chloride, purified water.
Nasonex is available in a white suspension spray in a white plastic bottle
with green push on/off dust cap.
Each bottle contains 120 metered actuations
Bottles containing 120 metered actuations are supplied in single packs.
PL 20774/1314 Nasonex 50 microgram Nasal Spray

POM

Manufactured by: Schering-Plough Labo N.V. Industriepark, 30-B-2220
Heist-op-den-Berg, Belgium. Procured from within the EU. Product
Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd,
Bolton, BL6 4SA.
Nasonex is a registered trademark of Schering Corporation
th

Leaflet revision Date: 16 July 2012

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.
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.
If any of these side-effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Nasonex
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use Nasonex 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.
This product should be used within 2 months of first use.
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.

PP1/1314/V1

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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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