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:

Imbat Limited

ATC code:

R01AD; R01AD58

INN (International Name):

Azelastine hydrochloride; FLUTICASONE PROPIONATE

Dosage:

137 µg/50 µg/actuation

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:

2017-10-27

Patient Information leaflet

Page 1 of 2
CP00009
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DYMISTA
® 137 MICROGRAMS/50 MICROGRAMS
PER ACTUATION NASAL SPRAY, SUSPENSION
(azelastine hydrochloride/fluticasone propionate)
Your medicine is available using the name Dymista 137 micrograms/50
micrograms per
actuation Nasal Spray, Suspension but will be referred to as Dymista
throughout this leaflet.
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 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DYMISTA
3.
HOW TO USE DYMISTA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DYMISTA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DYMISTA IS AND WHAT IT IS USED FOR
Dymista 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 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.
Dymista relieves the symptoms of allerg

Summary of Product characteristics

Health Products Regulatory Authority
27 November 2019
CRN0097Q8
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.
Each actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (equivalent to 125 micrograms azelastine) and 50
micrograms fluticasone propionate.
Excipient with known effect: Benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray Suspension
_Product imported from the UK._
White, homogenous suspension.
4 CLINICAL PARTICULARS
As per PA2010/059/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/059/001
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
bottle and outer carton of the product as marketed in the
country of origin.
In-use shelf life (after first use): 6 months
Health Products Regulatory Authority
27 November 2019
CRN0097Q8
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer carton containing an amber coloured glass bottle
fitted with a spray pump, applicator and a protective cap.
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
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/260/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27
th
October 2017
10 DATE OF REVISI