DYLASTINE 125/50 azelastine (as hydrochloride) 125 microgram and fluticasone propionate 50 microgram nasal spray bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 50 microgram/actuation; azelastine hydrochloride, Quantity: 137 microgram/actuation (Equivalent: azelastine, Qty 125 microgram/actuation)

Available from:

Viatris Pty Ltd

INN (International Name):

Azelastine hydrochloride,fluticasone propionate

Pharmaceutical form:

Spray, nasal

Composition:

Excipient Ingredients: glycerol; disodium edetate; phenethyl alcohol; purified water; carmellose sodium; microcrystalline cellulose; polysorbate 80; benzalkonium chloride

Administration route:

Nasal

Units in package:

4 mL (commercial pack), 4 mL (starter pack), 17 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Product summary:

Visual Identification: White, homogeneous, redispersible suspension filled into Type I amber glass bottles fitted with a spray pump, nasal applicator and dust cap.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-01-14

Patient Information leaflet

Meda Pharmaceuticals Pty Ltd
Consumer Medicine Information v5
Page 1 of 5
DYLASTINE
® 125/50 NASAL SPRAY
_(DYE-LAS’-TEEN) _
_Azelastine hydrochloride and fluticasone propionate _
_(azel-as-teen hydro-klor-ide) and (flu-tic-a-sone pro-pi-o-nate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
DYLASTINE 125/50 Nasal
Spray.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
The information in this leaflet
was last updated on the date
listed on the final page. More
recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP
TO DATE INFORMATION ON THE
MEDICINE.
Those updates may contain
important information about the
medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
DYLASTINE 125/50 Nasal
Spray against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT
DYLASTINE 125/50
NASAL SPRAY IS USED
FOR
DYLASTINE 125/50 Nasal
Spray is sprayed into the nose
to treat allergic rhinitis
(hayfever and other allergies)
and rhinoconjunctivitis (allergy-
induced symptoms in the nose
and eyes) in adults and
children 12 years and older
where use of a combination
(intranasal antihistamine and
glucocorticoid) is appropriate.
DYLASTINE 125/50 Nasal
Spray relieves the symptoms of
allergies, for example:
symptoms relating to the nose -
runny nose, post nasal drip,
sneezing, itchy or blocked nose
and symptoms relating to the
eyes - itchy, watery and red
eyes.
Hayfever is an inflammation or
swelling of the nose lining
(which may cause blockage,
runny nose, itching and/ or
sneezing).
You may have symptoms only
during spring or summer. This
type of allergy is generally due
to various pollens. Some
people may ex

Summary of Product characteristics

Product Information v5
Meda Pharmaceuticals Pty Ltd
Page 1 of 16
DYLASTINE
® 125/50
NASAL SPRAY
PRODUCT INFORMATION
NAME OF THE MEDICINE
Azelastine hydrochloride and fluticasone propionate
The chemical name for azelastine hydrochloride is
(_R,S_)-4[(4-Chlorophenyl)methyl]-2-
(hexahydro-1-methyl-1_H_-azepin-4-yl)-phthalazin-1(2_H_)-one
hydrochloride. Azelastine
hydrochloride has the following chemical structure:
C
22
H
24
ClN
3
O
.
HCl
Molecular weight: 418.37 g mol
-1
CAS Registry No: 79307-93-0
The chemical name for fluticasone propionate is
6α,9-Difluoro-17-[[(fluoromethyl)
sulphanyl]carbonyl]-11β-hydroxy-16α-methyl-3-oxoandrosta-1,4-dien-17α-yl
propanoate.
Fluticasone propionate has the following chemical structure:
C
25
H
31
F
3
O
5
S
Molecular weight: 500.6 g mol
-1
CAS Registry No: 80474-14-2
DESCRIPTION
DYLASTINE
125/50
is formulated as a white, homogeneous and redispersible suspension.
It is available as a metered-spray suspension for intranasal
administration.
Product Information v5
Meda Pharmaceuticals Pty Ltd
Page 2 of 16
DYLASTINE
125/50
nasal spray is a fixed combination product containing the following
active ingredients: azelastine hydrochloride and fluticasone
propionate. Each g of
suspension contains 1 mg azelastine hydrochloride and 0.365 mg
fluticasone propionate.
One spray (137 mg) contains 125 µg of azelastine (as the base) and 50
µg of fluticasone
propionate.
DYLASTINE
125/50
nasal spray contains the following inactive ingredients: disodium
edetate, glycerol, microcrystalline cellulose, carmellose sodium,
polysorbate 80,
benzalkonium chloride, phenethyl alcohol and purified water.
PHYSICAL AND CHEMICAL PROPERTIES
Azelastine hydrochloride occurs as a white, odourless, crystalline
powder with a bitter taste.
It is sparingly soluble in water, and soluble in ethanol and
dichloromethane. Azelastine
hydrochloride is slightly hygroscopic.
Fluticasone propionate is a white or almost white powder. It is
practically insoluble in water,
sparingly soluble in dichloromethane and slightly soluble i