Azecort 137 micrograms/50 micrograms per actuation nasal spray, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azelastine hydrochloride; Fluticasone propionate

Available from:

Mylan IRE Healthcare Limited

ATC code:

R01AD; R01AD58

INN (International Name):

Azelastine hydrochloride; Fluticasone propionate

Dosage:

137 µg/50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Therapeutic area:

Corticosteroids; fluticasone, combinations

Authorization status:

Not marketed

Authorization date:

2013-02-22

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZECORT
137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION
NASAL SPRAY, SUSPENSION
azelastine hydrochloride/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 Azecort is and what it is used for
2.
What you need to know before you use Azecort
3.
How to use Azecort
4.
Possible side effects
5.
How to store Azecort
6.
Contents of the pack and other information
1.
WHAT AZECORT IS AND WHAT IT IS USED FOR
Azecort contains two active substances: azelastine hydrochloride and
fluticasone propionate.
•
Azelastine hydrochloride belongs to a group of medicines called
antihistamines. Antihistamines
work by preventing the effects of substances such as histamine that
the body produces as part of
an allergic reaction – thus reducing symptoms of allergic rhinitis.
•
Fluticasone propionate belongs to a group of medicines called
corticosteroids which reduces
inflammation.
Azecort is used for the symptomatic treatment of severe hay fever
(seasonal allergic rhinitis) in adults.
Seasonal allergic rhinitis is an allergic reaction to substances such
as pollen (hayfever).
Azecort relieves the symptoms of seasonal allergies, for example:
runny nose, post nasal drip,
sneezing and itchy or blocked nose.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZECORT
DO NOT USE AZECORT:
•
if you are allergic to azelastine hydrochloride or fluticasone
propionate or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUT

Summary of Product characteristics

Health Products Regulatory Authority
02 March 2022
CRN00CDND
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azecort 137 micrograms/50 micrograms per actuation nasal spray,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of suspension contains 1000 micrograms azelastine hydrochloride
and 365 micrograms fluticasone propionate.
One actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (= 125 micrograms azelastine) and 50 micrograms
fluticasone propionate.
Excipient with known effect:
One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
White, homogeneous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For symptomatic treatment of severe seasonal allergic rhinitis in
adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
_ _
_Adults_
One actuation in each nostril twice daily (morning and evening).
_Paediatric population_
Azecort should not be used in children and adolescents under 18 years
of age.
_Elderly_
No dose adjustment is required in this population.
_Renal and hepatic impairment_
There are no data in patients with renal and hepatic impairment (see
section 4.4).
_ _
_Duration of treatment_
Azecort is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
Method of administration
Azecort is for nasal use only.
_INSTRUCTION FOR USE_
Preparing the spray:
Health Products Regulatory Authority
02 March 2022
CRN00CDND
Page 2 of 8
The bottle should be shaken gently before use for about 5 seconds by
tilting it upwards and downwards and the protective cap
be removed afterwards. Prior to first use Azecort must be primed by
pressing down and releasing the pump 6 times. If Azecort
has not been used for more than 7 days it must be reprimed once by
pressing down and releasing the pump.
Using