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MOMETASONE FUROATE 50 MICROGRAMS/DOSE NASAL SPRAY SUSPENSION

Active substance(s): MOMETASONE FUROATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mometasone Furoate 50 microgram/dose
Nasal Spray, suspension.
Read all of this leaflet carefully before you start taking 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 only. Do not pass it
onto others. It may harm them, even if their signs of illness are
the same as yours.
If you get any of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet.

What is in this leaflet:
1. What Mometasone Furoate Nasal Spray is and what it is used
for
2. What you need to know before you use Mometasone Furoate
Nasal Spray
3. How to use Mometasone Furoate Nasal Spray
4. Possible side effects
5. How to store Mometasone Furoate Nasal Spray
6. Contents of the pack and other information

1. What Mometasone Furoate Nasal Spray is and what it
is used for
Mometasone Furoate Nasal Spray contains mometasone furoate,
one of a group of medicines called corticosteroids. It should not be
confused with ‘anabolic’ steroids misused by some athletes and
taken as tablets or injections.
This medicine is used to treat symptoms of allergic rhinitis caused
by allergy to pollen from grass or trees (seasonal allergic rhinitis,
also called hayfever) or caused by allergy, for example, to animals,
house-dust mites or moulds (perennial allergic rhinitis). When tiny
amounts of active substance are sprayed into the nose, it can help
to relieve inflammation, sneezing, itching and a blocked or runny
nose.
In case of allergic rhinitis Mometasone Furoate nasal spray is for
use in adults and children aged 6 years and over.
This medicine is also used for symptomatic treatment of nasal
polyps (small growths inside the nose) in adults 18 years of age
and older. By reducing inflammation it causes nasal polyps to
shrink gradually.
2. What you need to know before you use Mometasone
Furoate Nasal spray
Do not use Mometasone Furoate if you:




are allergic to mometasone furoate or any of the other
ingredients of this medicine.
have an infection in your nose. You should wait until the
infection is resolved before you start using the nasal spray.
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.

Warnings and precautions
Talk to your doctor or pharmacist before using Mometasone
Furoate if you:





have or have ever had tuberculosis
have herpes simplex (virus) infection of the eye
have any other type of infection
are taking other corticosteroid medicines, either by mouth or by
injection
• have cystic fibrosis.
While using this medicine, 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 has these infections.
The use of this nasal spray may produce positive results in doping
tests.
Children and adolescents
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.
Other medicines and Mometasone Furoate
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 when you begin using this medicine. A few people may find
that when they discontinue oral or injected corticosteroids they
have some side 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
develop other allergies, such as itchy, watering eyes or patches of
red and itchy skin. If this happens and you are worried, you should
see your doctor.
Pregnancy and breast-feeding
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.
You should not use this medicine if you are pregnant unless your
doctor has told you to. You should not breast feed when you are
using this medicine.
Driving and using machines
Mometasone Furoate is unlikely to affect your ability to drive and
use machines.
Mometasone Furoate contains benzalkonium chloride
This medicine contains preservative benzalkonium chloride,
which may be an irritant and may cause skin reactions. If used for
a longer period, benzalkonium chloride may cause nasal mucosa
swelling.

3. How to use Mometasone Furoate Nasal Spray
Mometasone Furoate is intended for nasal use only.
Always use this medicine exactly as your doctor has told you.
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
The usual dose is 2 sprays into each nostril once a day. Once
your symptoms are under control, your doctor may advise you to
spray once only into each nostril once a day.
If you do not start to feel any better, you should see your doctor
who may tell you to increase the dose to the maximum daily
amount of 4 sprays into each nostril once a day. Once your
symptoms are controlled your doctor may advise you to reduce the
dose to 2 sprays into each nostril once daily.
Use in children and adolescents
Children over 12 years of age
The usual dose is 2 sprays into each nostril once a day. Once
symptoms are under control, a doctor may advise to spray once
only into each nostril once a day.
Children aged 6 to 11 years
The usual dose is one spray into each nostril once daily.
Severe hayfever
If you suffer badly from hayfever, your doctor may tell you to start
using Mometasone Furoate 2 to 4 weeks before the start of the
pollen season, as this will help to prevent your hayfever
symptoms. Your doctor may recommend that you use other
treatments with this medicine, particularly if your eyes are itching
or irritated. At the end of the pollen season your hayfever
symptoms should improve and treatment may no longer be
needed.
Nasal Polyps
The usual starting dose is 2 sprays into each nostril once daily.
If symptoms are not controlled after 5 to 6 weeks, the dose may be
increased to 2 sprays in each nostril twice daily. Once symptoms
are under control, your doctor will reduce your dose.
If no improvement in symptoms is seen after 5 to 6 weeks of twice
daily use, you should contact your doctor to discuss different
treatments.
Preparing your nasal spray for use
Your Mometasone Furoate Nasal Spray has a dust cap which
protects the nozzle and keeps it clean. Take this off before using
the spray and 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. Shake the bottle well.
2. Put your forefinger and middle finger on either side of the
nozzle and your thumb underneath the bottle (Figure 1).
3. Point the nozzle away from you and then press down with your
fingers to pump the spray (Figure 1).

If you have not used the spray for 14 days or more, you need to
‘re-prime’ the bottle by pumping the spray twice until a fine mist is
produced.

At the usual dose of 2 sprays into each nostril once daily, this
medicine should provide enough doses for 30 days (120 sprays) or
35 days (140 sprays).
How to use your nasal spray
1. Shake the bottle well and remove the dust cap. (Figure 2)

Very rare side effects (may affect up to 1 in 10,000 people):
• an increase in pressure in the eye (glaucoma), causing visual
disturbances and damage to the partition in the nose which
separates the nostrils
• alterations in taste and smell
Additional side effects in children and adolescents
When used at high doses for long periods of time in children,
corticosteroid nasal sprays may cause growth reduction. Your
child’s height may be monitored regularly. If you get any side
effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

2.
3.
4.
5.

Gently blow your nose.
Close one nostril and put the nozzle into the other nostril.
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 (Figure 3).

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
your mouth.
8. Repeat steps 3 to 7 for the other nostril.
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 that you 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. 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 Mometasone Furoate than you should
It is important that you take your dose as stated in this Package
Leaflet or as advised by your doctor. Using more or less may
make your symptoms worse.
Tell your doctor if you accidentally use more than you should.
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 Mometasone Furoate
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 Mometasone Furoate
In some patients this medicine should begin to relieve symptoms
12 hours after the first dose; however, the full benefit of treatment
may not be seen for up to 2 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 medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
STOP taking this medicine and seek medical help immediately
if you have any of the following which may be signs of a rare
severe allergic reaction:
• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
The following side effects can also occur during treatment:
Common side effects (may affect up to 1 in 10 people):
• headache
• nose bleeds
• sore nose or throat
Rare side effects (may affect up to 1 in 1,000 people):
• immediate hypersensitivity (allergic) reactions.

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.

5. How to store Mometasone Furoate Nasal Spray
Keep out of the sight and reach of children.
Do not use Mometasone Furoate after the expiry date which is
stated on the label after EXP. The expiry date refers to the last
day of the month.
Do not freeze.
Once opened use within 2 months.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measurements will help to protect the
environment.

6. Contents of the pack and other information
What Mometasone Furoate contains




The active substance is mometasone furoate. Each actuation
of the pump delivers a metered dose of 50 micrograms of
mometasone furoate (as mometasone furoate monohydrate).
The other ingredients are microcrystalline cellulose, carmellose
sodium, glycerol, citric acid monohydrate, sodium citrate
dihydrate, polysorbate 80, benzalkonium chloride solution and
purified water.

What Mometasone Furoate looks like and contents of the
pack
Mometasone Furoate is a white nasal spray, suspension packed in
a white plastic bottle filled with a spray pump.
1 bottle containing 18.0 g nasal spray suspension, corresponding
to 140 delivered doses.
Manufacturer
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana,
Slovenia
Or
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Or
S.C. Sandoz S.R.L, Str. Livezeni nr 7A, RO-540472 Targu-Mures,
Romania
Procured from within the EU
Product licence holder: Ecosse Pharmaceuticals Limited, 3
Young Place, East Kilbride, G75 0TD, UK
Re-packaged by: Munro Wholesale Medical Supplies Limited, 3
Young Place, East Kilbride, G75 0TD, UK
PL 19065/0470
This leaflet was last revised 11.12.2014
E0470-1

POM

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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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