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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

R01AD58

INN (International Name):

AZELASTINE HYDROCHLORIDE 137 µg/spray FLUTICASONE PROPIONATE 50 µg/spray

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

AZELASTINE HYDROCHLORIDE 137 µg/spray FLUTICASONE PROPIONATE 50 µg/spray

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2013-02-21

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DYMISTA NASAL SPRAY
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
(hayfever), 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 nos

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DYMISTA NASAL SPRAY
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 with known effect:
One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension.
White, homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of symptoms of moderate to severe seasonal and perennial
allergic rhinitis if monotherapy
with either intranasal antihistamine or glucocorticoid is not
considered sufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
_ _
Adults and adolescents (12 years and older)
One actuation in each nostril twice daily (morning and evening).
Children below 12 years
Dymista 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.
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Renal and hepatic impairment
There are no data in patients with renal and hepatic impairment.
_ _
_ _
_DURATION OF TREATMENT _
Dymista Nasal Spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION _
Dymista Nasal Spray is for nasal use only.
_INSTRUCTION FOR USE _
Preparing the spray:
The bottle should be shaken gently before use for about 5 seconds by
tilting it upwards and
downwards and the protective cap be removed afterwards. Prior to first
use Dymista Nasal Spray
must be primed by pressing down and releasing the