Azelastine Zentiva 1mg/ml nasal spray, solution

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

זמין מ:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

קוד ATC:

R01AC03

INN (שם בינלאומי):

AZELASTINE HYDROCHLORIDE 1 mg

טופס פרצבטיות:

NASAL SPRAY, SOLUTION

הרכב:

AZELASTINE HYDROCHLORIDE 1 mg

סוג מרשם:

POM

איזור תרפויטי:

NASAL PREPARATIONS

מצב אישור:

Authorised

תאריך אישור:

2017-10-18

עלון מידע

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZELASTINE ZENTIVA 1 MG/ML NASAL SPRAY SOLUTION
azelastine hydrochloride
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 Azelastine Zentiva is and what it is used for
2.
What you need to know before you use Azelastine Zentiva
3.
How to use Azelastine Zentiva
4.
Possible side effects
5.
How to store Azelastine Zentiva
6.
Contents of the pack and other information
1.
WHAT
AZELASTINE ZENTIVA
IS AND WHAT IT IS USED FOR
Azelastine Zentiva contains azelastine, which belongs to a group of
medicines that works by
preventing the effect of histamine (antihistamines) and other
substances that the body produces as
part of an allergic reaction, which usually affects you by causing a
runny nose, sneezing, itching or
blocked nose.
Azelastine Zentiva is used for the symptomatic treatment of seasonal
allergic rhinitis, and acute
exacerbations (attacks) of perennial allergic rhinitis.
Azelastine Zentiva nasal spray is intended for use by adults,
adolescents and children over 6 years of
age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
Azelastine Zentiva
_ _
DO NOT USE
Azelastine Zentiva
-
if you are allergic to azelastine or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
The spray should be used with the head held upright.
Talk to your doctor or pharmacist before using Azelastine Zentiva.
Page 2 of 5
CHILDREN AND ADOLESCENTS
This product should not be used for children under 6 years.
OTHER MEDICINES AND
Azelastine Z

מאפייני מוצר

Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Azelastine Zentiva 1mg/ml nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1mg azelastine (as hydrochloride).
One application (0.14 mL) contains 0.14 mg azelastine hydrochloride
equivalent to 0.13 mg
azelastine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray solution.
Clear colourless solution free from particles.
The pH of the solution is between 6.4 -7.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azelastine is indicated for the symptomatic treatment of seasonal
allergic rhinitis (e.g hayfever) and
acute exacerbations of perennial allergic rhinitis in adults,
adolescents and children from 6 years of
age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One application (0.14 ml) in each nostril twice daily (0.56 mg of
azelastine hydrochloride). 

Elderly:
There have been no specific studies in the elderly. 

Paediatric population:
For children aged 6 years and older, one application (0.14 ml) in each
nostril twice daily (0.56 mg of
azelastine hydrochloride).
Azelastine should not be used in children below 6 years of age due to
lack of data on safety and
efficacy.
Method of administration
Nasal use
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_Precautions to be taken before handling or administering the
medicinal product: _
Spray with head held upright.
Before the first use, press the pump several times until an even spray
emerges (3-4 times).
When azelastine has not been used for 6 or more days, the pump must be
reprimed by pressing down
and releasing the pump a sufficient number of times until a fine mist
emerges.
After administration, wipe the pump nozzle and replace the protective
cap.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The spray should be used with the head held upright, see section 4.8.
_ _
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No