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

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Brimonidine tartrate

MAH:

Allergan Pharmaceuticals Ireland

ATC_code:

S01EA; S01EA05

INN:

Brimonidine tartrate

dosage:

0.2 percent weight/volume

pharmaceutical_form:

Eye drops, solution

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Sympathomimetics in glaucoma therapy1); brimonidine

authorization_status:

Marketed

authorization_date:

1997-11-14

PIL

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 supply to
the

SPC

Health Products Regulatory Authority
07 September 2020
CRN009T9G
Page 1 of 8
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 with known effect
Contains benzalkonium chloride 0.05 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, greenish-yellow to light greenish-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma or ocular hypertension.

As monotherapy in patients in whom topical beta-blocker therapy is
contraindicated.

As adjunctive therapy to other intraocular pressure lowering
medications when the target IOP is not achieved with
a single agent (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including the elderly)_
The recommended dose is one drop of Alphagan in the affected eye(s)
twice daily, approximately 12 hours apart. No dosage
adjustment is required for the use in elderly patients.
_Use in renal and hepatic impairment_
Alphagan has not been studied in patients with hepatic or renal
impairment (see section 4.4).
_Paediatric population_
No clinical studies have been performed in adolescents (12 to 17
years).
Alphagan is not recommended for use in children below 12 years and is
contraindicated in neonates and infants (less than 2
years of age) (see sections 4.3, 4.4 and 4.9). It is known that severe
adverse reactions can occur in neonates. The safety and
efficacy of Alphagan have not been established in children aged 2 to
12 years.
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be compressed at the
medial canthus (punctal occlusion) for one minute. This should be
performed immediately following the instil