Mometasone 50 microgram/dose, Nasal spray, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Rowex Ltd

ATC code:

R01AD; R01AD09

INN (International Name):

Mometasone furoate

Dosage:

50 microgram(s)/dose

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:

2013-02-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOMETASONE 50 MICROGRAM/DOSE, NASAL SPRAY, SUSPENSION
mometasone furoate
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 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 is and what it is used for
2.
What you need to know before you use Mometasone
3.
How to use Mometasone
4.
Possible side effects
5.
How to store Mometasone
6.
Contents of the pack and other information
1. WHAT MOMETASONE IS AND WHAT IT IS USED FOR
WHAT IS MOMETASONE?
Mometasone 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 MOMETASONE USED FOR?
Hay fever and perennial rhinitis
Mometasone is used to treat the symptoms of hay fever (also called
seasonal allergic rhinitis)
and perennial rhinitis in adults and children aged 3 and older.
Hay fever, 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. Mometasone
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
Mometasone is used to t

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2020
CRN009FT5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone 50 microgram/dose, Nasal spray, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation of the pump delivers a metered dose of 50 micrograms of
mometasone furoate (as mometasone furoate
monohydrate).
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, homogenous suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mometasone 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.
Mometasone 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 Mometasone 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).
Mometasone nasal spray demonstrated a clinically significant onset of
a