Alphagan 0.2% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Brimonidine tartrate

Available from:

Waymade Healthcare Plc

ATC code:

S01EA05

INN (International Name):

Brimonidine tartrate

Dosage:

2mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPHAGAN
® EYE DROPS
BRIMONIDINE TARTRATE 0.2% EYE DROPS
(brimonidine tartrate)
Your medicine is avaliable using one of the above names but will
be referred to as Alphagan throughout the leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Alphagan is and what it is used for
2.
Before you use Alphagan
3.
How to use Alphagan
4.
Possible side effects
5.
How to store Alphagan
6.
Further information
1.
WHAT ALPHAGAN IS AND WHAT IT IS USED FOR
Alphagan is used to reduce pressure within the eye.
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. The
active ingredient in Alphagan is brimonidine tartrate, which works
by reducing pressure within the eyeball.
2.
BEFORE YOU USE ALPHAGAN
DO NOT USE ALPHAGAN

If you are allergic (hypersensitive) to brimonidine tartrate or
any of the other ingredients of Alphagan.

If you are taking monoamine oxidase (MAO) inhibitors or
certain 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).
TAKE SPECIAL CARE WITH ALPHAGAN
Before you take this medicine, tell your doctor:

If you suffer or have suffered from depression, reduced
mental capacity, reduced blood supply to the brain, heart
problems, a disturbed blood supply of the limbs or a blood
pressure disorder.
�

Summary of Product characteristics

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): Contains benzalkonium chloride 0.05 mg/ml. For a 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
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.
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.
If more than one topical ophthalmic drug is to be used, the different
drugs
should be instilled 5-15 minutes apart.
_Use in renal and hepatic impairment _
Alphagan has not been studied in patients with hepatic or renal
impairment
(see section 4.4).
_Use in paediatric subjects _
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.
4.