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

Administration route:

Nasal

Units in package:

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

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

DYMISTA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DYMISTA 125/50 NASAL SPRAY?
DYMISTA 125/50 Nasal Spray contains the active ingredient azelastine
(as hydrochloride) and fluticasone propionate. DYMISTA
125/50 Nasal Spray is used to relieve the symptoms of allergies, for
example: symptoms relating to the nose - runny nose, sneezing,
itchy or blocked nose and symptoms relating to the eyes - itchy,
watery and red eyes.
For more information, see Section 1. Why am I using DYMISTA 125/50
Nasal Spray? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DYMISTA 125/50 NASAL SPRAY?
Do not use if you have ever had an allergic reaction to azelastine (as
hydrochloride) or fluticasone propionate or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
DYMISTA 125/50 Nasal Spray? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DYMISTA 125/50 Nasal Spray and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DYMISTA 125/50 NASAL SPRAY?
•
Spray one spray into each nostril in the morning and evening. This
medicine is not recommended for children under 12 years of
age.
More instructions can be found in Section 4. How do I use DYMISTA
125/50 Nasal Spray?4. How do I use DYMISTA 125/50 Nasal
Spray?4. How do I use DYMISTA 125/50 Nasal Spray? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DYMISTA 125/50 NASAL SPRAY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DYMISTA 125/50 Nasal Spray.
•
DYMISTA 125/50 Nasal Spray is su

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DYMISTA
® 125/50
_azelastine (as hydrochloride) and fluticasone propionate nasal spray
_
1
NAME OF THE MEDICINE
Azelastine (as hydrochloride) and fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DYMISTA 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.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DYMISTA 125/50
a white, homogeneous and redispersible suspension.
It is available as a metered-spray suspension for intranasal
administration.
4
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DURATION OF TREATMENT
DYMISTA 125/50 nasal spray is suitable for long-term use. There is no
restriction regarding duration of use.
DOSAGE
Adults and adolescents (e.g. 12 years and older)
One spray in each nostril twice daily (morning and evening).
Children below 12 years
DYMISTA 125/50 nasal spray 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 (see Sections 5.2
PHARMACOKINETIC PROPERTIES under
Special Populations –
_Age_
and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Use in the
Elderly).
Renal and hepatic impairment
No dose adjustment is required in patients with renal impairment or
mild to moderate hepatic impairment (see
Sections
5.2 PHARMACOKINETIC
PROPERTIES
under
Special
Populations
–
_Renal _
_Impairment _
and
4.4 SPECIAL WARNINGS AND PRECAUTI