Alphagan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Brimonidine tartrate 2 mg/mL;  

Available from:

AbbVie Limited

INN (International Name):

Brimonidine tartrate 2 mg/mL

Dosage:

0.2 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Brimonidine tartrate 2 mg/mL   Excipient: Benzalkonium chloride Citric acid monohydrate Hydrochloric acid Polyvinyl alcohol Purified water Sodium chloride Sodium citrate dihydrate Sodium hydroxide

Units in package:

Bottle, dropper, 2.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Piramal Enterprises Limited

Therapeutic indications:

ALPHAGAN® eye drops are effective for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, - 2.5 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 5 mL - 30 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 10 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1996-07-08

Patient Information leaflet

ALPHAGAN
®
Eye Drops-CMI Version 3.0 – PIv7.0
Page 1 of 4
A
LPHAGAN

EYE DROPS
[brimonidine tartrate]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ALPHAGAN
®
eye drops, including
how to use the eye drops. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
ALPHAGAN
®
eye drops against
the benefits they expect it will
have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read
it again.
WHAT ALPHAGAN
 EYE
DROPS ARE USED FOR
ALPHAGAN
®
eye drops are used
to lower raised pressure in the eye
and to treat glaucoma. Glaucoma
is a condition in which the
pressure of fluid in the eye may be
high. However, some people with
glaucoma may have normal eye
pressure. Glaucoma is usually
caused by a build up of the fluid
which flows through the eye. This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in. Since
new fluid continues to enter the
eye, joining the fluid already there,
the pressure continues to rise.
This raised pressure may damage
the back of the eye resulting in
gradual loss of sight. Damage can
progress so slowly that the person
is not aware of this gradual loss of
sight. Sometimes even normal
eye pressure is associated with
damage to the back of the eye.
There are usually no symptoms of
glaucoma. The only way of
knowing that you have glaucoma
is to have your eye pressure, optic
nerve and visual field checked by
an eye specialist or optometrist. If
glaucoma is not treated it can lead
to serious problems, including total
blindness. In fact, untreated
glaucoma is one of the most
common causes of blindness.
ALPHAGAN
®
eye drops are used,
either alone or in combination with
other eye drops/medicines, to
lower raised pressure within your
eye(s).
Mechanism

Summary of Product characteristics

ALPHAGAN
®
brimonidine tartrate Datasheet Version 7.0-CCDS v2.1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ALPHAGAN
®
0.2% eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of ALPHAGAN
®
eye drops contains 2.0 mg brimonidine tartrate, equivalent
to 1.32 mg as brimonidine free base.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Sterile ophthalmic solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALPHAGAN
®
eye drops are effective for lowering intraocular pressure in patients
with
chronic open-angle glaucoma or ocular hypertension.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of ALPHAGAN
®
eye drops in the affected eye(s)
twice daily, approximately 12 hours apart.
If more than one topical ophthalmic medicine is to be used, other eye
drops should
not be used within five to ten minutes of using ALPHAGAN
®
eye drops.
In order to minimise systemic absorption of ALPHAGAN
®
eye drops, apply pressure
to the tear duct immediately following administration.
PAEDIATRIC USE
Symptoms of bradycardia, coma hypotension, lethargy, pallor,
respiratory,
depression, somnolence, hypothermia, hypotonia and apnea have been
reported) in
neonates, infants and children receiving brimonidine either for
congenital glaucoma
or by accidental oral ingestion. Also see 4.3 Contraindications
section.
ALPHAGAN
®
brimonidine tartrate Datasheet Version 7.0-CCDS v2.1
4.3 CONTRAINDICATIONS
ALPHAGAN
®
eye drops are contraindicated in patients with hypersensitivity to
brimonidine tartrate or any of the excipients listed in section 6.1.
ALPHAGAN
®
is also
contraindicated in patients receiving monoamine oxidase (MAO)
inhibitor therapy.
ALPHAGAN
®
eye drops are also contraindicated in neonates and infants (children
under the age of 2 years)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Children 2 years of age and above, especially those weighing ≤ 20
kg, should be
treated with caution and closely monitored due to the high incidence
and severity of
somnolence (see Paediatri