Azelastine Eye Drops, 0.5 mg/ml, Eye Drops, solution

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Azelastine hydrochloride

MAH:

Mylan IRE Healthcare Limited

ATC_code:

S01GX; S01GX07

INN:

Azelastine hydrochloride

dosage:

0.5 milligram(s)/millilitre

pharmaceutical_form:

Eye drops, solution

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Other antiallergics; azelastine

authorization_status:

Not marketed

authorization_date:

1998-08-28

PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZELASTINE EYE DROPS 0.5 MG/ML EYE DROPS, 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.
•
In this leaflet Azelastine 0.5 mg/ml Eye Drops, Solution is called
Azelastine.
WHAT IS IN THIS LEAFLET
1.
What Azelastine is and what it is used for
2.
What you need to know before you use Azelastine
3.
How to use Azelastine
4.
Possible side effects
5.
How to store Azelastine
6.
Contents of the pack and other information.
1.
WHAT AZELASTINE IS AND WHAT IT IS USED FOR
Azelastine contains the active substance azelastine hydrochloride,
which belongs to a group
of medicines called antiallergics (antihistamines). Antihistamines
work by preventing the
effects of substances such as histamine that the body produces as part
of an allergic reaction.
Azelastine has been shown to reduce inflammation of the eye.
Azelastine can be used to treat and prevent eye disorders which you
get with hayfever
(seasonal allergic conjunctivitis) in adults and children aged 4 years
and above.
Azelastine can be used for eye disorders caused by an allergy to
substances such as house
dust mites or animal hair (perennial allergic conjunctivitis) in
adults and children aged 12
years and above.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
AZELASTINE IS NOT SUITABLE FOR TREATING EYE INFECTIONS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZELASTINE
DO NOT USE AZELASTINE:
•
if you are allergic to azelastine hydrochloride or any of the other
ing

SPC

Health Products Regulatory Authority
30 November 2020
CRN00C216
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azelastine Eye Drops, 0.5 mg/ml, Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015
mg azelastine hydrochloride.
Excipient with known effect: 1 ml contains 0.125 mg benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of the symptoms of seasonal allergic
conjunctivitis in adults and children 4 years and older.
Treatment of the symptoms of non-seasonal (perennial) allergic
conjunctivitis in adults and children 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Seasonal allergic conjunctivitis: The usual dosage in adults and
children 4 years and older is one drop in each eye twice daily
that can be increased, if necessary, to four times daily. If allergen
exposure is anticipated Azelastine eye drops should be
administered prophylactically, prior to the exposure.
Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in
adults and children 12 years and older is one drop in each
eye twice daily that can be increased, if necessary, to four times
daily.
As safety and efficacy have been demonstrated in clinical trials for a
period of up to 6 weeks, the duration of any course should
be limited to a maximum of 6 weeks.
Patients should be advised to contact their doctor if symptoms worsen
or do not approve after 48 hours.
Health Products Regulatory Authority
30 November 2020
CRN00C216
Page 2 of 5
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
Azelastine eye drops is not intended for treatment of eye infections.
Azelastine eye drops contains the preservative benzalkonium chloride
which may cause eye irritati