NASONEX 50 micrograms/actuation Nasal Spray, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

R01AD; R01AD09

INN (International Name):

Mometasone furoate

Dosage:

50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids; mometasone

Authorization status:

Marketed

Authorization date:

1998-01-23

Patient Information leaflet

1
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 and o

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2020
CRN009F64
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NASONEX 50 micrograms/actuation Nasal Spray, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
White to off-white opaque suspension.
4 CLINICAL PARTICULARS
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 seas