Azecort Nasal Spray, 137 micrograms/50 micrograms per actuation, Nasal Spray, Suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Available from:

Meda Pharmaceuticals Limited

ATC code:

R01AD58

INN (International Name):

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

AZELASTINE HYDROCHLORIDE 137 µg; FLUTICASONE PROPIONATE 50 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2013-02-21

Patient Information leaflet

 
Page 1 of 8

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

AZECORT NASAL SPRAY 
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 Nasal Spray is and what it is used for 
2.  What you need to
know before you use Azecort Nasal Spray 
3.  How to use Azecort Nasal Spray 
4.  Possible side effects 
5.  How to store Azecort Nasal Spray 
6.  Contents of the pack and other information 

1. WHAT AZECORT NASAL SPRAY IS AND WHAT IT IS USED FOR 

Azecort Nasal Spray 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 Nasal Spray
 is used to relieve the symptoms of moderate to severe seasonal and perennial 
allergic rhinitis if the use of either intranasal
a

Summary of Product characteristics

.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AZECORT NASAL SPRAY
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 glucocortocoid 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 Nasal Spray 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 Nasal Spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION _
Azecort Nasal Spray is for nasal use only.
_INSTRUCTION FOR USE _
Preparing the spray:
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
Nasal Spray must be primed by pressing
down and releasing the pump 6 times. If Azecort