Flixonase Aqueous Nasal Spray Suspension 50mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUTICASONE PROPIONATE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

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:

Authorised

Authorization date:

2006-03-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXONASE AQUEOUS NASAL SPRAY
fluticasone propionate 50 micrograms
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 Flixonase is and what it is used for
2.
What you need to know before you use Flixonase
3.
How to use Flixonase
4.
Possible side effects
5.
How to store Flixonase
6.
Contents of the pack and other information
1.
WHAT FLIXONASE IS AND WHAT IT IS USED FOR
Flixonase Aqueous Nasal Spray (called ‘Flixonase’ in this leaflet)
contains a medicine called
fluticasone propionate. This belongs to a group of medicines called
steroids (also called ‘cortico-
steroids’).
•
Steroids work by reducing inflammation.
•
They reduce swelling and irritation in your nose.
•
This helps to relieve itching, sneezing and your blocked or runny
nose.
Flixonase is used to prevent and treat:
•
Inflammation in the lining of your nose (rhinitis) due to seasonal
allergies, such as Hay fever.
•
Inflammation in the lining of your nose (rhinitis) due to year round
(perennial) allergies, such
as animal allergies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXONASE
DO NOT USE FLIXONASE 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 Flixonase:
•
If you have ever had an operation on your nose.
•
If you have an infection in your nose
Contact your doctor if you experience blurred vision or other visual
disturba

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
FLIXONASE AQUEOUS NASAL SPRAY
1.
NAME OF THE MEDICINAL PRODUCT
Flixonase Aqueous Nasal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aqueous suspension of 0.05% w/w micronised fluticasone propionate.
Each metered dose contains 50
micrograms of fluticasone propionate.
Excipient with known effect:benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Aqueous suspension for intranasal inhalation via metered dose
atomising pump.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prophylaxis and treatment of seasonal allergic rhinitis (including
hay fever) and perennial rhinitis.
Fluticasone propionate has potent anti-inflammatory activity but when
used topically on the nasal mucosa
has no detectable systemic activity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Flixonase Aqueous Nasal Spray is for administration by the intranasal
route only.
Contact with the eyes should be avoided.
Adults and children over 12 years of age:
For the prophylaxis and treatment of seasonal allergic rhinitis and
perennial rhinitis. Two sprays into each
nostril once a day, preferably in the morning. In some cases two
sprays into each nostril twice daily may be
required. Once symptoms are under control a maintenance dose of one
spray per nostril once a day may be
used. If symptoms recur the dosage may be increased accordingly. The
minimum dose should be used at
which effective control of symptoms is maintained. The maximum daily
dose should not exceed four sprays
into each nostril.
Elderly patients:
The normal adult dosage is applicable.
Children under 12 years of age:
For the prophylaxis and treatment of seasonal allergic rhinitis and
perennial rhinitis in children aged 4-11
years a dose of one spray into each nostril once daily preferably in
the morning is recommended. In some
cases one spray into each nostril twice daily may be required. The
maximum daily dose should not exceed
two sprays into each nostril. The minimum dose should be used at which
effective