Nasusaf 137 micrograms/50 micrograms per actuation nasal spray, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azelastine hydrochloride; Fluticasone propionate

Available from:

Teva B.V.

ATC code:

R01AD58

INN (International Name):

Azelastine hydrochloride; Fluticasone propionate

Pharmaceutical form:

Nasal spray, suspension

Therapeutic area:

fluticasone, combinations

Authorization status:

Not marketed

Authorization date:

2023-10-20

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NASUSAF 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 Nasusaf nasal spray is and what it is used for
2.
What you need to know before you use Nasusaf nasal spray
3.
How to use Nasusaf nasal spray
4.
Possible side effects
5.
How to store Nasusaf nasal spray
6.
Contents of the pack and other information
1.
WHAT NASUSAF NASAL SPRAY IS AND WHAT IT IS USED FOR
Nasusaf 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.
Nasusaf 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.
Nasusaf nasal spray relieves the symptoms of allergies, for example:
runny nose, post nasal drip,
sneezing and itchy or blocked nose.
2.
WHAT YOU

Summary of Product characteristics

Health Products Regulatory Authority
20 October 2023
CRN00CL7G
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasusaf 137 micrograms/50 micrograms per actuation nasal spray,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 1000 micrograms azelastine
hydrochloride and 365 micrograms fluticasone propionate.
One actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (equivalent to 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
Nasusaf 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.
Renal and hepatic impairment
There are no data in patients with renal and hepatic impairment.
_DURATION OF TREATMENT_
Nasusaf nasal spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION_
Nasusaf nasal spray is for nasal use only.
_INSTRUCTION FOR USE_
Preparing the spray:
Health Products Regulatory Authority
20 October 2023
CRN00CL7G
Page 2 of 8
The bottle should be shaken gently before use for about 5 seconds by
tilting it upwards and downwards and the protective cap
be remov