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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUTICASONE PROPIONATE; Azelastine hydrochloride

Available from:

Primecrown 2010 Limited

ATC code:

R01AD; R01AD58

INN (International Name):

FLUTICASONE PROPIONATE; Azelastine hydrochloride

Dosage:

137/50 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:

2018-02-09

Patient Information leaflet

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 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 (hay fever), house mites, moulds, dust or pets.
Dymista relieves the symptoms of allergies, for example: runny nose,
post
nasal drip, sneezing and itchy or blocked nose.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DYMISTA
DO NOT USE DYMISTA:
•
If you are allergic to azelastine hydrochloride o

Summary of Product characteristics

Health Products Regulatory Authority
05 August 2020
CRN009W4X
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 (0.14 g) delivers 137 micrograms azelastine
hydrochloride (= 125 micrograms azelastine) and 50 micrograms
fluticasone propionate.
Excipient(s) with known effect:
This medicinal product contain benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
_Product imported from the United Kingdom._
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 solution
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 onthe market in
the country oforigin.
In-use shelf life (after first use): 6 months
Health Products Regulatory Authority
05 August 2020
CRN009W4X
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle fitted with a spray pump, a nasal applicator
(actuator) and a dust cap, containing 23 g (at least 120
actuations) suspension.
Pack size: 1 bottle with 23 g suspension in 25 ml bottle (at least 120
actuations).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex
UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/067/001
9 DATE OF FIRST AUTHOR