Azelastine hydrochloride /Fluticasone propionate Rowex 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:

Rowex Ltd

ATC code:

R01AD58

INN (International Name):

Azelastine hydrochloride; Fluticasone propionate

Pharmaceutical form:

Nasal spray, suspension

Therapeutic area:

fluticasone, combinations

Authorization status:

Not marketed

Authorization date:

2023-10-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
azelastine hydrochloride/fluticasone propionate
AZELASTINE HYDROCHLORIDE/FLUTICASONE
PROPIONATE ROWEX 137 MICROGRAMS/
50 MICROGRAMS PER ACTUATION,
NASAL SPRAY SUSPENSION
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 Azelastine hydrochloride/Fluticasone
propionate Rowex is and what it is used for
2.
What you need to know before you use Azelastine
hydrochloride/Fluticasone propionate Rowex
3.
How to use Azelastine hydrochloride/Fluticasone
propionate Rowex
4.
Possible side effects
5.
How to store Azelastine hydrochloride/Fluticasone
propionate Rowex
6.
Contents of the pack and other information
1
WHAT AZELASTINE HYDROCHLORIDE/
FLUTICASONE PROPIONATE ROWEX IS AND WHAT
IT IS USED FOR
Azelastine hydrochloride/Fluticasone propionate Rowex
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.
Azelastine hydrochloride/Fluticasone propionate Rowex
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 perennia

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2023
CRN00D0RH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azelastine hydrochloride/Fluticasone propionate Rowex 137
micrograms/50 micrograms per actuation, nasal spray suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 1000 micrograms azelastine
hydrochloride and 365 micrograms fluticasone propionate.
One actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (equivalent to 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
Azelastine hydrochloride/Fluticasone propionate Rowex 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_
Azelastine hydrochloride/Fluticasone propionate Rowex is suitable for
long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION_
Azelastine hydrochloride/Fluticasone propionate Rowex is for nasal use
only.
Health Products Regulatory Authority
27 October 2023
CRN00D0RH
Page 2 of 8
_INSTRUCTION FOR USE_
Prepar