Azecort Nasal Spray, 137 micrograms/50 micrograms per actuation

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

R01AD58

INN (International Name):

AZELASTINE HYDROCHLORIDE 137 µg FLUTICASONE PROPIONATE 50 µg

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

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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 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 Nasal Spray 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 NASAL SPRAY
DO NOT USE AZECORT NASAL SPRAY:
•
if you are allergic to azelastine hydr

Summary of Product characteristics

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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
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 Nasal Spray should not be used in children and adolescents
under 18 years of age.
_Elderly _
No dose adjustment is required in this population.
_ _
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_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 Nasal Spray has not
been used for more than 7 days it must be reprimed once by pressing
down and releasing the pump.
Using the spray:
The bottle should be shaken gently