DYMISTA NASAL SPRAY

Nazione: Sudafrica

Lingua: inglese

Fonte: South African Health Products Regulatory Authority (SAHPRA)

Commercializzato da:

Viatris Healthcare (Pty) Ltd

Dosaggio:

1,0 mg 0,365 mg

Forma farmaceutica:

NASAL SPRAY

Composizione:

EACH 1,0 g SUSPENSION CONTAINS AZELASTINE HYDROCHLORIDE 1,0 mg FLUTICASONE PROPIONATE 0,365 mg

Stato dell'autorizzazione:

Registered

Foglio illustrativo

Viatris Healthcare (Pty) Ltd
Dymista Nasal Spray
Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg
fluticasone propionate
APPROVED: 31 OCTOBER 2023
Page 1 of 12 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S2 DYMISTA NASAL SPRAY
137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION
NASAL SPRAY, SUSPENSION
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DYMISTA
NASAL SPRAY
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
Dymista Nasal Spray has been prescribed for you personally and
you should not share your medicine with other people. It may harm
them, even if their symptoms are the same as yours. _ _
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 take Dymista Nasal Spray
3.
How to take 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
Viatris Healthcare (Pty) Ltd
Dymista Nasal Spray
Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg
fluticasone propionate
APPROVED: 31 OCTOBER 2023
Page 2 of 12
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.
Dymista Nasal Spray is also used t

Scheda tecnica

Viatris Healthcare (Pty) Ltd
Dymista Nasal Spray
Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg
fluticasone propionate
APPROVED: 31 OCTOBER 2023
Page 1 of 22
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1
NAME OF THE MEDICINE
DYMISTA NASAL SPRAY
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg
fluticasone propionate.
Each actuation (0,14 g) delivers 137 micrograms azelastine
hydrochloride (= 125
micrograms azelastine) and 50 micrograms fluticasone propionate.
Preservatives: Benzalkonium chloride 0,01 % m/m (0,014 mg per
actuation) and
Phenylethyl alcohol 0,25 % m/m (0,343 mg per actuation).
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Nasal spray, suspension.
White, homogeneous, redispersible suspension free from visible foreign
matter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dymista Nasal Spray is indicated for the treatment of seasonal and
perennial
allergic rhinitis (including hay fever) and rhino-conjunctivitis in
adults if the use of
either intranasal antihistamine or corticosteroid alone is not
sufficient.
Dymista Nasal Spray is also indicated for short term treatment of
seasonal allergic
rhinitis in children above the age of 6 years if the use of either
intranasal
Viatris Healthcare (Pty) Ltd
Dymista Nasal Spray
Each g suspension contains 1 mg azelastine hydrochloride and 0,365 mg
fluticasone propionate
APPROVED: 31 OCTOBER 2023
Page 2 of 22
antihistamine or corticosteroid alone is not 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 CHILDREN (6 YEARS AND OLDER) _
One actuation in each nostril twice daily (morning and evening).
_CHILDREN BELOW 6 YEARS _
Dymista Nasal Spray is not recommended for use in children below 6
years of age
as safety and efficacy has not been established in this age group.
_ELDERLY _
No dose adjustment is required in this population.
_RENAL