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

Country: Մալթա

language: անգլերեն

source: Medicines Authority

MAH:

Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland

ATC_code:

S01EA05

INN:

BRIMONIDINE TARTRATE 2 mg/ml

pharmaceutical_form:

EYE DROPS, SOLUTION

composition:

BRIMONIDINE TARTRATE 2 mg/ml

prescription_type:

POM

therapeutic_area:

OPHTHALMOLOGICALS

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

authorization_status:

Authorised

authorization_date:

2022-04-19

PIL

Page 1 of 6
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 s

SPC

1
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
Page 2 of 8
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 instillation of each drop. This may result
in a decrease o