Azelastine/Fluticasonpropionaat Win Medica 137 microgram / 50 microgram per verstuiving, neusspray, suspensie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AZELASTINEHYDROCHLORIDE 1000 mg/g SAMENSTELLING overeenkomend met ; AZELASTINE 0,913 mg/g ; FLUTICASONPROPIONAAT 0,365 mg/g

INN (Algemene Internationale Benaming):

AZELASTINEHYDROCHLORIDE 1000 mg/g SAMENSTELLING overeenkomend met ; AZELASTINE 0,913 mg/g ; FLUTICASONPROPIONAAT 0,365 mg/g

farmaceutische vorm:

Neusspray, suspensie

Samenstelling:

BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; DINATRIUMEDETAAT 2-WATER ; FENYLETHYLALCOHOL ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; WATER, GEZUIVERD, BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; DINATRIUMEDETAAT 2-WATER ; FENYLETHYLALCOHOL ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; WATER, GEZUIVERD

Toedieningsweg:

Nasaal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZELASTINE/FLUTICASONPROPIONAAT WIN MEDICA 137 MICROGRAM / 50
MICROGRAM PER VERSTUIVING,
NEUSSPRAY, SUSPENSIE
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 Nasal Spray is and what it is used for
2.
What you need to know before you use Nasal Spray
3.
How to use Nasal Spray
4.
Possible side effects
5.
How to store Nasal Spray
6.
Contents of the pack and other information
1.
WHAT NASAL SPRAY IS AND WHAT IT IS USED FOR
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.
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.
Nasal Spray relieves the symptoms of allergies,

Productkenmerken

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Azelastine/Fluticasonpropionaat Win Medica 137 microgram / 50
microgram per verstuiving,
neusspray, suspensie
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
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 _
Nasal Spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION _
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
Nasal Spray must be primed by pressing down and