Nasonex

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MOMETASONE FUROATE

Available from:

Merck Sharp & Dohme Limited

ATC code:

R01AD09

INN (International Name):

MOMETASONE FUROATE

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

MOMETASONE FUROATE 50 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-09-15

Patient Information leaflet

17
PACKAGE LEAFLET: INFORMATION FOR THE USER
NASONEX 50 MICROGRAMS/ACTUATION NASAL SPRAY, SUSPENSION
_ _
Mometasone Furoate
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 signs of illness are the same as yours.
-
If you get any 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 Nasonex is and what it is used for
2.
What you need to know before you use Nasonex
3.
How to use Nasonex
4.
Possible side effects
5.
How to store Nasonex
6.
Contents of the pack and other 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. When mometasone furoate is sprayed into the nose, it
can help to relieve
inflammation (swelling and irritation of the nose), sneezing, itching
and a blocked up or runny nose.
WHAT IS NASONEX USED FOR?
Hay fever and perennial rhinitis
Nasonex is used to treat the symptoms of hayfever (also called
seasonal allergic rhinitis) and perennial
rhinitis in adults and children aged 3 and older.
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.
Nasonex reduces the swelling and
irritation in your nose and thereby relieving sneezing, itching and a
blocked-up or runny nose caused
by hay fever or perennial rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps in adults aged 18 an

Summary of Product characteristics

3
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Nasonex 50 micrograms/actuation Nasal Spray, Suspension
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Mometasone furoate (as the monohydrate) 50 micrograms/actuation.
Excipient with known effect
This medicinal product contains 0.02 mg of benzalkonium chloride per
actuation.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Nasal Spray, Suspension.
White to off-white opaque suspension.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
NASONEX Nasal Spray is indicated for use in adults and children 3
years of age and older to treat the
symptoms of seasonal allergic or perennial rhinitis.
NASONEX Nasal Spray is indicated for the treatment of nasal polyps in
adults 18 years of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
After initial priming of the NASONEX Nasal Spray pump, each actuation
delivers approximately 100 mg
of mometasone furoate suspension, containing mometasone furoate
monohydrate equivalent to
50 micrograms mometasone furoate.
POSOLOGY
Seasonal Allergic or Perennial Rhinitis
Adults (including older patients) and children 12 years of age and
older: The usual recommended dose is
two actuations (50 micrograms/actuation) in each nostril once daily
(total dose 200 micrograms). Once
symptoms are controlled, dose reduction to one actuation in each
nostril (total dose 100 micrograms) may
be effective for maintenance. If symptoms are inadequately controlled,
the dose may be increased to a
maximum daily dose of four actuations in each nostril once daily
(total dose 400 micrograms). Dose
reduction is recommended following control of symptoms.
Children between the ages of 3 and 11 years: The usual recommended
dose is one actuation
(50 micrograms/actuation) in each nostril once daily (total dose 100
micrograms).
NASONEX Nasal Spray demonstrated a clinically significant onset of
action within 12 hours after the
first dose in some patients with seasonal allergic rhinitis; however,
full benefit of treatment may not be
achieved in the first