Skip to Content

MOMETASONE FUROATE 50 MICROGRAMS/DOSE NASAL SPRAY SUSPENSION

Active substance(s): MOMETASONE FUROATE MONOHYDRATE / MOMETASONE FUROATE MONOHYDRATE / MOMETASONE FUROATE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Mometasone Furoate 50 micrograms/dose
Nasal Spray, suspension

mometasone furoate

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 on to 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. See section 4.
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

Driving and using machines
Mometasone Furoate is unlikely to affect
your ability to drive and use machines.

What Mometasone Furoate
Nasal Spray is and what it is
used for

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.

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.

3

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.

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.

In case of allergic rhinitis Mometasone
Furoate nasal spray is for use in adults
and children aged 6 years and over.

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.

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

How to use Mometasone
Furoate Nasal Spray

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.

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.

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.

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.

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.

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.

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.

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
childʼs height at intervals during treatment
and reduce the dose if any effects are
seen.

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 ʻprimeʼ the bottle by pumping
the spray 10 times until a fine mist is
produced:

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.

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).

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.

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.

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.

Continued on the next page >>

Artwork Proof Box
draft: 44032634
laetus code: 0000
mat.no.: 00000000

Ref: V015: SPC update in line with PAR for paediatric studies & QRD
Proof no.
005.0

Date prepared:
03/03/2015

Colours:
Black
Dimensions: 130 x 540 mm

Font size:
8pt
Fonts:
Helvetica

Reporting of side effects
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 via the Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

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)

5

Keep out of the reach and sight of
children.

Figure 2.

2. Gently blow your nose.
3. Close one nostril and put the nozzle
into the other nostril.
4. Tilt your head forward slightly, keeping
the bottle upright.
5. 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).

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 that 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 measures will
help to protect the environment.

6

Figure 3.

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 (E460),
carmellose sodium (E468), glycerol
(E442), citric acid monohydrate (E330),
sodium citrate dihydrate (E331),
polysorbate 80 (E433), benzalkonium
chloride and water for injection.

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.

What Mometasone Furoate looks like
and contents of the pack
Mometasone Furoate is a white nasal
spray, suspension packed in white plastic
bottle fitted with a spray pump.
1 bottle containing 10.0 g nasal spray
suspension, corresponding to 60
delivered doses.
1 bottle containing 17.0 g nasal spray
suspension, corresponding to 120
delivered doses.
1 bottle containing 18.0 g nasal spray
suspension, corresponding to 140
delivered doses.
3 bottles containing 18.0 g nasal spray
suspension, corresponding to 140
delivered doses.

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.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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.

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
or

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.

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

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

4

How to store Mometasone
Furoate Nasal Spray

This leaflet was last revised in 03/2015.

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.

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
childʼs height may be monitored regularly.

00000000
SZ00000LT000

Artwork Proof Box
draft: 44032634
laetus code: 0000
mat.no.: 00000000

Ref: V015: SPC update in line with PAR for paediatric studies & QRD
Proof no.
005.0

Date prepared:
03/03/2015

Colours:
Black
Dimensions: 130 x 540 mm

Font size:
8pt
Fonts:
Helvetica

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.

Hide