AZEP NASAL SPRAY 1 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AZELASTINE HCl

Available from:

MYLAN PHARMACEUTICALS PTE. LTD.

ATC code:

R01AC03

Dosage:

1 mg/ml

Pharmaceutical form:

SPRAY

Composition:

AZELASTINE HCl 1 mg/ml

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

MEDA Manufacturing GmbH

Authorization status:

ACTIVE

Authorization date:

1996-04-30

Patient Information leaflet

MEDA PHARMA GMBH & CO. KG
61352 Bad Homburg
Germany
PATIENT INFORMATION LEAFLET, PLEASE READ CAREFULLY!
AZEP
®
NASAL SPRAY
Active ingredient: azelastine hydrochloride
COMPOSITION
Active ingredient: Each spray puff (equivalent to 0.14 ml solution)
contains 0.14 mg of azelastine hydrochloride
Other ingredients: Hypromellose, disodium edetate dihydrate, citric acid, dibasic sodium phosphate dodeca-
hydrate, sodium chloride, purified water
INDICATIONS
For the symptomatic treatment of seasonal allergic rhinitis (hay fever) and non-seasonal (perennial) allergic
rhinitis.
CONTRAINDICATIONS
Azep Nasal Spray must not be used in patients with known
hypersensitivity to Azelastine hydrochloride,
           or EDTA, nor in children under 6 years of age.

PREGNANCY AND LACTATION
           Although doses far in excess of the therapeutic range
tested in laboratory animals failed to generate any evidence
           of a teratogenic effect of the drug, current medical
concepts discourage use of Azep Nasal Spray in the first  
                      trimester of pregnancy. 

  Nasal Spray should not be used by nursing mothers, because there is insufficient evidence of the safety of the 
                      drug during lactation.

SIDE EFFECTS 
                      In rare cases irritations of the
inflamed nasla mucosa can occur on spraying, e.g. stinging, itching
and sneezing.
                      In isolated cases patients can
experience nosebleeding. Improper administration (with head reclined
back; see
                      Dosage instruction and how to use)
may procduce a bitter taste which may lead occasionally to nausea.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
                     None known.

DOSAGE, METHOD O

Summary of Product characteristics

MEDA PHARMA GMBH & CO. KG
61352 Bad Homburg
Germany
PATIENT INFORMATION LEAFLET, PLEASE READ CAREFULLY!
AZEP
®
NASAL SPRAY
Active ingredient: azelastine hydrochloride
COMPOSITION
Active ingredient: Each spray puff (equivalent to 0.14 ml solution)
contains 0.14 mg of azelastine hydrochloride
Other ingredients: Hypromellose, disodium edetate dihydrate, citric
acid, dibasic sodium phosphate dodeca-
hydrate, sodium chloride, purified water
INDICATIONS
For the symptomatic treatment of seasonal allergic rhinitis (hay
fever) and non-seasonal (perennial) allergic
rhinitis.
CONTRAINDICATIONS
Azep Nasal Spray must not be used in patients with
known hypersensitivity to Azelastine hydrochloride,
or EDTA, nor in children under 6 years of age.
PREGNANCY AND LACTATION
Although doses far in excess of the therapeutic range tested in
laboratory animals failed to generate any evidence
of a teratogenic effect of the drug, current medical concepts
discourage use of Azep Nasal Spray in the first
trimester of pregnancy.
Nasal Spray should not be used by nursing mothers, because there is
insufficient evidence of the safety of the
drug during lactation.
SIDE EFFECTS
In rare cases irritations of the inflamed nasla mucosa can occur on
spraying, e.g. stinging, itching and sneezing.
In isolated cases patients can experience nosebleeding. Improper
administration (with head reclined back; see
Dosage instruction and how to use) may procduce a bitter taste which
may lead occasionally to nausea.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
DOSAGE, METHOD OF ADMINISTRATION AND DURATION OF TREATMENT
Unless otherwise prescribed, spray once into each nostril twice daily
(equivalent to a daily dose of
0.56 mg of azelastine hydrochloride).
Spray with head held upright (see How to use Azep Nasal Spray).
Azep Nasal Spray may be used until symptoms clear up, but treatment
should not be continued for more than 6
consecutive months.
AZEP NASENSPRAY
Tropon-Nr.: T5003226
EPE
TypoData: 56-54394-R Schriftgrösse: 8 pt
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