ALPHAGAN P 1.5 brimonidine tartrate 0.15% eye drop bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

brimonidine tartrate, Quantity: 1.5 mg/mL

Available from:

Abbvie Pty Ltd

INN (International Name):

brimonidine tartrate

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: magnesium chloride hexahydrate; boric acid; sodium chlorite; sodium chloride; carmellose sodium; borax; sodium hydroxide; purified water; hydrochloric acid; potassium chloride; calcium chloride dihydrate

Administration route:

Topical

Units in package:

5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ALPHAGAN P 1.5 eye drops are effective in lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension. ALPHAGAN P 1.5 eye drops can be used in the treatment of glaucoma as either monotherapy or in combination with topical beta blockers.

Product summary:

Visual Identification: Clear, green-yellow, isotonic sterile solutions; Container Type: Bottle; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-06-18

Patient Information leaflet

ALPHAGAN P
®
1.5 EYE DROPS CMI VERSION 2.0 - PI V3.0
1
ALPHAGAN
® P 1.5
_EYE DROPS _
_[brimonidine tartrate 1.5 mg/mL] _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALPHAGAN P 1.5
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 benefits and
risks. Your doctor has weighed the
risks of you using ALPHAGAN P
1.5 eye drops against the benefits
they expect it will have for you.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALPHAGAN
® P
1.5 EYE DROPS ARE USED
FOR
ALPHAGAN P 1.5 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.
Eye 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 P 1.5 eye drops lower
the pressure in the eye by decreasing
the fluid produced and helping the
flow of fluid out of

Summary of Product characteristics

ALPHAGAN
®
P 1.5 Eye Drops PI v4 - ccds v2.1
1
AUSTRALIAN PRODUCT INFORMATION ALPHAGAN
®
P 1.5 (BRIMONIDINE TARTRATE) EYE DROPS
1
NAME OF THE MEDICINE
Brimonidine tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of ALPHAGAN
®
P eye drops contains brimonidine tartrate 1.5 mg (equivalent to
0.99 mg as brimonidine free base).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
A
LPHAGAN

P 1.5 0.15% is a sterile ophthalmic solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALPHAGAN
®
P 1.5 eye drops are effective in lowering elevated intraocular
pressure in
patients with chronic open angle glaucoma or ocular hypertension.
ALPHAGAN
®
P 1.5 eye
drops can be used in the treatment of glaucoma as either monotherapy
or in combination with
topical beta-blockers.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of ALPHAGAN
®
P 1.5 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
®
P 1.5 eye drops.
In order to minimise systemic absorption of ALPHAGAN
®
P 1.5 eye drops, apply pressure to
the tear duct immediately following administration.
4.3
CONTRAINDICATIONS
A
LPHAGAN

P
1.5
eye
drops
are
contraindicated
in
patients
with
hypersensitivity
to
brimonidine tartrate or any component of this medication. This product
is also contraindicated
in patients receiving monoamine oxidase (MAO) inhibitor therapy.
ALPHAGAN
®
P 1.5 Eye Drops PI v4 - ccds v2.1
2
ALPHAGAN
®
P 1.5 eye drops are contraindicated in infants and children <2 years
of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
ALPHAGAN
®
P 1.5 eye drops should be used with caution in patients with
depression,
cerebral
or
coronary
insufficiency,
Raynaud's
phenomenon,
orthostatic
hypotension
or
thromboangiitis obliterans.
During the studies there was a loss of effect in some