Dymista 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:

PCO Manufacturing Ltd.

ATC code:

R01AD; R01AD58

INN (International Name):

Azelastine hydrochloride; Fluticasone propionate

Dosage:

137 micrograms/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:

Authorised

Authorization date:

2016-12-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DYMISTA
® 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 Dymista Nasal Spray is and what it is used for
2.
What you need to know before you use Dymista Nasal Spray
3.
How to use Dymista Nasal Spray
4.
Possible side effects
5.
How to store Dymista Nasal Spray
6.
Contents of the pack and other information
1.
WHAT DYMISTA NASAL SPRAY IS AND WHAT IT IS USED FOR
Dymista 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.
Dymista Nasal Spray 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 (hay fever), house mites, moulds, dust or pets.
Dymista Nasal Spray relieves the symptoms of allergies, for example:
runny
nose, post nasal drip, sneezing and itchy or blocked nose.
2.
W

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2023
CRN00DV6L
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dymista 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 (0.14g) delivers 137 micrograms azelastine hydrochloride
(= 125 micrograms azelastine) and 50 micrograms
fluticasone propionate.
Excipient(s) with known effect:
Contains benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
_Product imported from Greece, France and Czech Republic:_
White homogeneous suspension
4 CLINICAL PARTICULARS
As per PA23355/010/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/010/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Glycerol
Microcrystalline cellulose
Carmellose sodium
Polysorbate 80
Benzalkonium chloride
Phenylethyl alcohol
Purified water
6.2 INCOMPATIBILITIES
Not applicable_._
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
In-use shelf life (after first use): 6 months
Health Products Regulatory Authority
22 September 2023
CRN00DV6L
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Glass bottle fitted with a spray pump, a nasal applicator (actuator)
and a dust cap, containing the suspension.
Pack size: 1 bottle with 23 g suspension in 25 ml bottles (at least
120 actuations).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/422/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first author