Nasofan Aqueous Nasal Spray Suspension 50mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUTICASONE PROPIONATE

Available from:

Norton Healthcare Limited Ridings Point, Whistler Driver, Castlleford, West Yorkshire, WF10 5HX, United Kingdom

ATC code:

R01AD08

INN (International Name):

FLUTICASONE PROPIONATE 50 µg

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

FLUTICASONE PROPIONATE 50 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2016-07-13

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
(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. hayfever) 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 operation to you

Summary of Product characteristics

Page 1 of 8
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:
Contains 40 micrograms of benzalkonium chloride solution per metered
spray.
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.
_ _
Page 2 of 8
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 (200 mcg). The
minimum dose at which the
effe