Nasofan Aqueous 50 microgram Nasal Spray Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluticasone propionate

Available from:

Teva B.V.

ATC code:

R01AD; R01AD08

INN (International Name):

Fluticasone propionate

Dosage:

50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids; fluticasone

Authorization status:

Marketed

Authorization date:

2005-11-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NASOFAN
TM AQUEOUS 50 MICROGRAM NASAL SPRAY SUSPENSION
fluticasone propionate
READ ALL OF 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 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 Nasofan Nasal Spray is and what it is used for
2.
What you need to know before you use Nasofan Nasal Spray
3.
How to use Nasofan Nasal Spray
4.
Possible side effects
5.
How to store Nasofan Nasal Spray
6.
Contents of the pack and other information
1.
WHAT NASOFAN NASAL SPRAY IS AND WHAT IT IS USED FOR
Your medicine is called Nasofan Aqueous 50 microgram Nasal Spray
Suspension (described as ‘Nasofan
Nasal Spray’ throughout this leaflet) and contains 50 micrograms of
the active ingredient, fluticasone
propionate, in each spray. Fluticasone propionate is one of a group of
medicines known as corticosteroids.
Nasofan Nasal Spray has anti-inflammatory properties. When sprayed
into your nose it will reduce swelling
and irritation. It is used to prevent and treat seasonal allergic
rhinitis (e.g. hay fever) and perennial rhinitis
(e.g. blocked or runny nose and sneezing and itching caused by house
dust mites or animals such as cats and
dogs). It can be used by adults and children aged 4 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASOFAN NASAL SPRAY
DO NOT USE NASOFAN NASAL SPRAY
-
if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Nasofan Nasal Spray:
•
if you have ever had an opera

Summary of Product characteristics

Health Products Regulatory Authority
16 September 2022
CRN00CWNY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasofan Aqueous 50 microgram Nasal Spray Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 microlitre metered spray contains 50 micrograms of
fluticasone propionate.
Excipient(s) with known effect:
Each metered spray contains 40 micrograms of benzalkonium chloride
solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, Suspension.
The medicinal product consists of a white, opaque aqueous suspension
contained within an amber glass multidose bottle fitted
with a metering pump.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nasofan Aqueous 50 microgram Nasal Spray is indicated in adults and
children aged 4 years and older for the prophylaxis and
treatment of seasonal allergic rhinitis (including hay fever) and
perennial rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population:_
The safety and efficacy of Nasofan Aqueous 50 micrograms Nasal Spray
in children aged less than 4 years has not been
established.
ADULTS AND CHILDREN OF 12 YEARS OF AGE AND OVER:
Two sprays into each nostril once a day (200 mcg), preferably in the
morning, is recommended. In some cases two sprays into
each nostril twice a day (400 mcg) may be required. Once symptoms are
under control a maintenance dose of one spray per
nostril once a day (100 mcg) may be used. If symptoms recur the dosage
may be increased accordingly. The maximum daily
dose should not exceed four sprays into each nostril (400 mcg). The
minimum dose at which the effective control of symptoms
is maintained should be used.
ELDERLY PATIENTS:
The normal adult dosage is applicable.
CHILDREN BETWEEN AGES OF 4 AND 11:
One spray into each nostril once a day (100 mcg), preferably in the
morning, is recommended. In some cases one spray into
each nostril twice a day (200 mcg) may be required. The maximum daily
dose should not exceed two sprays into each nostril
(20