Alphagan 0.2% w/v (2 mg/ml) eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Brimonidine tartrate

Available from:

PCO Manufacturing Ltd.

ATC code:

S01EA05

INN (International Name):

Brimonidine tartrate

Dosage:

0.2 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Administration route:

Eye instillation

Units in package:

5 ml bottle

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

PCO Manufacturing

Therapeutic group:

Sympathomimetics in glaucoma therapy

Therapeutic area:

brimonidine

Therapeutic indications:

Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension

Authorization status:

Authorised

Authorization date:

2015-07-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPHAGAN
® 0.2% W/V (2 MG/ML)
EYE DROPS, SOLUTION
brimonidine tartrate
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 ALPHAGAN is and what it is used for
2.
What you need to know before you use ALPHAGAN
3.
How to use ALPHAGAN
4.
Possible side effects
5.
How to store ALPHAGAN
6.
Contents of the pack and other information
1.
WHAT ALPHAGAN IS AND WHAT IT IS USED FOR
ALPHAGAN is used to reduce pressure within the eye. The active
ingredient in ALPHAGAN is brimonidine tartrate which belongs to a
group of medicines called alpha-2 adrenergic receptor agonists and
works by reducing pressure within the eyeball.
It can be used either alone, when beta-blocker eye drops are
contraindicated, or with another eye drop, when a single medicine is
not enough to lower the increased pressure in the eye, in the
treatment of open angle glaucoma or ocular hypertension
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALPHAGAN
DO NOT USE ALPHAGAN
•
If you are allergic (hypersensitive) to brimonidine tartrate or any
of the other ingredients of this medicine (listed in section 6).
•
If you are taking monoamine oxidase (MAO) inhibitors or
certain other antidepressants. You must inform your doctor if
you are taking any antidepressant drug.
•
If you are breast-feeding.
•
In infants/babies (from birth until 2 years).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using ALPHAGAN
•
If you suffer or have suffered from depression, reduced mental
capacity, reduced blood suppl

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2022
CRN00D9HP
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alphagan 0.2% w/v (2 mg/ml) eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 2.0 mg brimonidine tartrate, equivalent to
1.3 mg of brimonidine.
Excipient(s) with known effect:
Contains benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from the Czech Republic, Netherlands and Poland:_
Clear, greenish-yellow to light greenish-yellow solution.
4 CLINICAL PARTICULARS
As per PA1824/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1824/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Benzalkonium chloride
Poly(vinyl alcohol)
Sodium chloride
Sodium citrate
Citric acid monohydrate
Purified water
Hydrochloric acid (for pH-adjustment) or Sodium hydroxide for
(pH-adjustment)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer carton of the product as marketed
in the country of origin.
After first opening: Use within 28 days.
Health Products Regulatory Authority
23 December 2022
CRN00D9HP
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
White dropper bottles with a tip. The cap is either a conventional
polystyrene screw cap or a Compliance Cap (C-Cap). One 5
ml bottle in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/413/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1
st
July 2015
10 DATE OF REVISION OF THE TEXT
December 2022