Nasonex 50 micrograms/actuation Nasal Spray, Suspension

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Mometasone furoate

Saadav alates:

LTT Pharma Limited

ATC kood:

R01AD; R01AD09

INN (Rahvusvaheline Nimetus):

Mometasone furoate

Annus:

50 microgram(s)

Ravimvorm:

Nasal spray, suspension

Retsepti tüüp:

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

Terapeutiline ala:

Corticosteroids; mometasone

Volitamisolek:

Authorised

Loa andmise kuupäev:

2016-09-02

Infovoldik

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
What Nasonex is and what it is used for
What you need to know before you use
Nasonex
How to use Nasonex
Possible side effects
How to store Nasonex
Contents of the pack and other information
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?
Hayfever 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 hayfever or perennial rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps in adults aged
18 and over.
Nasal polyps are small growths on the lining of the
nose and usually affect both nostrils. Nasonex
reduces the inflammation in the nose, ca

Toote omadused

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
White to off-white opaque suspension.
4 CLINICAL PARTICULARS
As per PA1286/038/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/038/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
dispersible cellulose (microcrystalline cellulose and sodium
carmellose)
glycerol
sodium citrate
citric acid monohydrate
polysorbate 80
benzalkonium chloride
purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
bottle and outer package of the product as marketed
in the country of origin.
Use within 2 months of first use.
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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 bottle, that contains 18 g
(140 actuations) of product formulation,
supplied with a metered-dose, manual spray pump actuator.