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NASONEX 50 MICROGRAMS AQUEOUS NASAL SPRAY

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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.
4. Possible side effects
5. How to store Nasonex
6. Further information

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

PROOF HISTORY:
v.1 - waymade - 29/09/13

Leaflet Flat Size = 180 x 429

In this leaflet:
1. What Nasonex is and what it is used for
2. Before you use Nasonex
3. How to use Nasonex

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.

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

DATE:

CUSTOMER
APPROVED:

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.

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.

DATE:


TVT CHECKED

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.

REPORTING SIDE EFFECTS

Once your symptoms are controlled your doctor may advise you to reduce the dose to two sprays into each nostril once daily.
UK PIL DATED NOVEMBER 2011

DATE OF PROOF:

20/09/13

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.

6464/2519 F

DT

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.

CODE:

PRE-PRESS NO.:

ARTWORKER:
Nasonex Aqueous spray

CUSTOMER: Waymade

PRODUCT:

04-1957

Q.A.
APPROVED:

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.

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 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.

WARNING!

This product is known as the above name but will be referred to as Nasonex throughout this leaflet.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

WARNING!

Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

NASONEX® 50 MICROGRAMS AQUEOUS NASAL SPRAY
(mometasone furoate monohydrate)

2. Gently blow your nose.
27mm

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
fine mist into your nose by pressing down ONCE with your fingers.

Figure 2

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).

Figure 3

ARIAL REGULAR FONT SIZE 8
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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.
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.

PROOF HISTORY:
v.1 - waymade - 29/09/13

Leaflet Flat Size = 180 x 429

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

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.

WARNING!

Figure 1

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

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.

20/09/13

By reporting side effects you can help provide more information on the safety of this medicine.

REPORTING SIDE EFFECTS

UK PIL DATED NOVEMBER 2011

TVT CHECKED

DATE OF PROOF:

6464/2519 F
CODE:

04-1957

DT
Nasonex Aqueous spray

PRE-PRESS NO.:

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.

PRODUCT:

CUSTOMER: Waymade

ARTWORKER:

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
• Nasonex 50 micrograms Aqueous nasal spray should be stored below 30°C. Do not freeze.
• Do not use after the expiry date printed on the carton or bottle label. The expiry date refers to the last day of that month.
• The spray should be used within 2 months of first use.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the spray, please take it back to the pharmacist for safe disposal. Only keep the spray if your
doctor tells you to.
• If your spray fails to work properly or you notice any other signs of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
• 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
Your medicine is called Nasonex 50 micrograms Aqueous nasal spray. It contains the active ingredient Mometasone furoate 50
micrograms as monohydrate per metered actuation in a white aqueous suspension.
Nasonex 50 micrograms Aqueous nasal spray also contains the following:
microcrystalline cellulose, sodium carboxymethylcellulose, glycerol, sodium citrate dihydrate, citric acid monohydrate, polysorbate
80, benzalkonium chloride, phenylethanol and purified water.
What Nasonex looks like and contents of the pack
Nasonex 50 micrograms Aqueous Nasal Spray comes in a white plastic bottle with a blue/green elongated cap. Each bottle
contains 140 metered actuations.
Marketing Authorisation Holder and Manufacturer
POM

PL No: 6464/2519

This product is manufactured by Schering-Plough Labo N.V., Heist-op-den-Berg, Belgium and is procured from within the EU and
repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 20.09.2013
NASONEX is a registered trademark of SCHERING CORPORATION

WARNING!

DATE:

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.

DATE:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

Expand Transcript

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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