Azelastine Galenicum 1mg/ml Nasal Spray Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELASTINE HYDROCHLORIDE

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

R01AC03

INN (International Name):

AZELASTINE HYDROCHLORIDE 1 mg

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

AZELASTINE HYDROCHLORIDE 1 mg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2017-10-18

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZELASTINE GALENICUM 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 Galenicum is and what it is used for
2.
What you need to know before you use Azelastine Galenicum
3.
How to use Azelastine Galenicum
4.
Possible side effects
5.
How to store Azelastine Galenicum
6.
Contents of the pack and other information
1.
WHAT AZELASTINE GALENICUM IS AND WHAT IT IS USED FOR
Azelastine Galenicum 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 Galenicum is used for the symptomatic treatment of seasonal
allergic rhinitis, and
acute exacerbations (attacks) of perennial allergic rhinitis.
Azelastine Galenicum
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 GALENICUM
_ _
DO NOT USE AZELASTINE GALENICUM:
-
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.
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Talk to your doctor or pharmacist before using Azelastine Galenicum.
CHILDREN AND ADOLESCENTS
This product should not be used for children under 6 years.
OTHER M

Summary of Product characteristics

Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Azelastine Galenicum 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.
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Method of administration
Nasal use
_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 inter