Flixonase Allergy & Hayfever 24 Hour

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluticasone propionate 0.05%{relative};  

Available from:

Haleon New Zealand ULC

INN (International Name):

Fluticasone propionate 0.05% w/w

Dosage:

0.05% w/w

Pharmaceutical form:

Nasal spray suspension

Composition:

Active: Fluticasone propionate 0.05%{relative}   Excipient: Benzalkonium chloride Dispersible cellulose Glucose Hydrochloric acid Phenethyl alcohol Polysorbate 80 Purified water

Units in package:

Spray bottle, glass, metered, Type 1 amber glass, 60 dose units

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Glaxo Wellcome Manufacturing Pte Ltd

Therapeutic indications:

Flixonase Allergy & Hayfever 24 Hour is indicated for the prophylaxis and treatment of allergic rhinitis including hay fever and that caused by other airborne allergens such as house dust mite, mould spores and animal dander. During treatment Flixonase Allergy & Hayfever 24 Hour provides symptomatic relief of sneezing, itchy and runny nose, congestion including associated sinus discomfort and pressure around the nose and eyes. Flixonase Allergy & Hayfever 24 Hour also provides relief of ocular symptoms associated with allergic rhinitis.

Product summary:

Package - Contents - Shelf Life: Spray bottle, glass, metered, Type 1 amber glass - 60 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze. - Spray bottle, glass, metered, Type 1 amber glass - 120 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze. - Spray bottle, plastic, metered, Polyproplene - 60 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze - Spray bottle, plastic, metered, Polyproplene - 120 dose units - 24 months from date of manufacture stored at or below 30°C protect from light. Do not freeze

Authorization date:

1989-07-11

Patient Information leaflet

FLIXONASE ALLERGY & HAYFEVER 24 HOUR
1
FLIXONASE
® ALLERGY & HAYFEVER 24
HOUR
_Fluticasone propionate, 50 mcg per spray _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use FLIXONASE
ALLERGY & HAYFEVER 24 HOUR.
This leaflet answers some common
questions about FLIXONASE
ALLERGY & HAYFEVER 24 HOUR. It
does not contain all of the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLIXONASE
ALLERGY &
HAYFEVER 24 HOUR
IS USED FOR
FLIXONASE ALLERGY & HAYFEVER
24 HOUR contains a corticosteroid
called fluticasone propionate, which
treats inflamed tissue. The tiny
amounts sprayed into your nose help
to reduce swelling and irritation.
FLIXONASE ALLERGY & HAYFEVER
24 HOUR is used to prevent and treat
seasonal allergic rhinitis (e.g.
hayfever) and perennial rhinitis in
adults aged 18 years and over.
Use only on medical advice in
adolescents aged 12 – 17 years.
Do not use in children under 12 years
of age.
When you have rhinitis, the inside of
your nose becomes swollen and
itchy. This usually occurs during
spring and summer when it is caused
by breathing pollens from grasses or
trees. This condition is called
hayfever. Some people get problems
all the year round and this is called
perennial rhinitis. It is often due to
house dust mites or animals such as
cats or dogs.
When you spray FLIXONASE
ALLERGY 24 HOUR into your nose it
helps to relieve the itching, sneezing
and blocked or runny nose.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS OR IF YOU
AREN’T SURE WHY FLIXONASE
ALLERGY & HAYFEVER 24 HOUR
HAS BEEN RECOMMENDED FOR YOU.
FLIXONASE ALLERGY & HAYFEVER
24 HOUR is not addictive.
BEFORE YOU USE
FLIXONASE ALLERGY
& HAYFEVER 24
HOUR
_ _
_WHEN YOU MUST NOT USE IT _
•
Do not use FLIXONASE ALLERGY
& HAYFEVER 24 HOUR if you
have

Summary of Product characteristics

Page 1 of 9
FLIXONASE NASAL SPRAY -Data Sheet
1
PRODUCT NAME
NEW ZEALAND DATA SHEET
Fluticasone propionate (50 mcg per actuation) Aqueous Nasal Spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _Fluticasone propionate 50 mcg per actuation. CAS:
80474-14-2
Flixonase MW 500.57
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Aqueous suspension of microfine fluticasone propionate. Each 100 mg of
spray contains 50 micrograms
of fluticasone propionate. Nasal spray, suspension.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Flixonase Allergy & Hayfever 24 Hour is indicated for the prophylaxis
and treatment of allergic
rhinitis including hay fever and that caused by other airborne
allergens such as house dust mite,
mould spores and animal dander.
During treatment Flixonase Allergy & Hayfever 24 Hour provides
symptomatic relief of sneezing,
itchy and runny nose, congestion including associated sinus discomfort
and pressure around the
nose and eyes. Flixonase Allergy & Hayfever 24 Hour also provides
relief of ocular symptoms
associated with allergic rhinitis.
4.2
Dose and method of administration
Flixonase Allergy & Hayfever 24 Hour is for administration by the
intranasal route only.
Page 2 of 9
FLIXONASE NASAL SPRAY -Data Sheet
ADULTS 18 YEARS AND OVER: FOR THE PROPHYLAXIS AND TREATMENT OF
ALLERGIC RHINITIS:-
The recommended dose is two sprays into each nostril once a day,
preferably in the morning.
Once control is achieved the dose should be titrated down to one spray
in each nostril once a
day (100 micrograms per day).
In some cases two sprays into each nostril twice daily may be required
for short periods to
achieve control of symptoms, after which the dose should be titrated
down.
_THE MAXIMUM DAILY DOSE SHOULD NOT EXCEED FOUR SPRAYS INTO EACH
NOSTRIL. _
_ _
Onset of action in the treatment of allergic rhinitis has been
observed in some patients as early
as 2-4 hours after use, with most users achieving symptomatic relief
within 12 hours of
treatment.
Prophylaxis of aller