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:

Meda Health Sales Ireland Limited

ATC code:

R01AD; R01AD58

INN (International Name):

Azelastine hydrochloride; FLUTICASONE PROPIONATE

Dosage:

137/50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids; fluticasone, combinations

Authorization status:

Not marketed

Authorization date:

2013-02-22

Patient Information leaflet

palen-3356- renewal-nasal ulcers-tracked-180321.doc
1
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 to relieve the symptoms of moderate to severe seasonal
and perennial
allergic rhinitis if the use of either intranasal antihistamine or
corticosteroid alone is not
considered sufficient.
Seasonal and perennial allergic rhinitis are allergic reactions to
substances such as pollen
(hayfever), house mites, moulds, dust or pets.
Azecort relieves the symptoms of 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 AZEC

Summary of Product characteristics

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
Relief of symptoms of moderate to severe seasonal and perennial
allergic rhinitis if monotherapy with either intranasal
antihistamine or glucocorticoid is not considered sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
Adults and adolescents (12 years and older)
One actuation in each nostril twice daily (morning and evening).
Children below 12 years
Azecort is not recommended for use in children below 12 years of age
as safety and efficacy has not been established in
this age group.
Elderly
No dose adjustment is required in this population.
Renal and hepatic impairment
There are no data in patients with renal and hepatic impairment.
_DURATION OF TREATMENT_
Azecort is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_