NASONEX 50 micrograms/actuation Nasal Spray, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

IMED Healthcare Ltd.

ATC code:

R01AD09

INN (International Name):

Mometasone furoate

Dosage:

50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Administration route:

Nasal

Units in package:

18g bottle

Prescription type:

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

Manufactured by:

Schering-Plough Labo NV

Therapeutic group:

Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids

Therapeutic area:

mometasone

Therapeutic indications:

It is indicated for use in adults and children 12 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.

Authorization status:

Authorised

Authorization date:

2015-05-22

Patient Information leaflet

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 ov

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2023
CRN00DGKS
Page 1 of 2
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 benzalkonium chloride
_For the full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
_Product imported from Greece and Romania._
White to off-white opaque suspension.
4 CLINICAL PARTICULARS
As per PA23198/011/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/011/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Greece:_
dispersible cellulose 65 cps (microcrystalline cellulose and
carmellose sodium)
glycerol
sodium citrate
citric acid monohydrate
polysorbate 80
benzalkonium chloride
purified water
_Product imported from Romania:_
Dispersable cellulose (microcrystalline cellulose and sodium
carmellose)
Glycerol
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 80
Benzalkonium chloride
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
28 March 2023
CRN00DGKS
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the market in
the country of origin.
Use within 2 months of first use.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
NASONEX Nasal Spray is contained in a white, high density polyethylene
bottle, that contains 18 g (140 actuations) of product
formulation, supplied with a metered-dose, manual polypropylene spray
pump actuator.
Pack sizes: 18g: 1 bottle
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane