ENIDIN brimonidine tartrate 2mg/mL eye drop bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

brimonidine tartrate, Quantity: 2 mg/mL

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: polyvinyl alcohol; benzalkonium chloride; citric acid; hydrochloric acid; sodium citrate dihydrate; sodium chloride; sodium hydroxide; purified water

Administration route:

Ophthalmic

Units in package:

2.5mL (sample pack) shelf life is 24 months below 25 deg, 5mL. Shelf life is 30 months below 30 deg

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS:ENIDIN eye drops are effective as monotherapy for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension in whom (Beta symbol)-blockers are not tolerated or are contraindicated. INDICATIONS AS AT 7 DECEMBER 1999: ENIDIN eye drops are effective in lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension.ENIDIN eye drops can be used in the treatment of glaucoma either as monotherapy or in combination with topical beta-blockers.

Product summary:

Visual Identification: Clear, greenish-yellow solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-04-24

Patient Information leaflet

ENIDIN
®
Eye Drops-CMI Version 2.0-PIv5.0
Page 1 of 4
ENIDIN
®
EYE DROPS
_ _
[brimonidine tartrate]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about ENIDIN
®
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 ENIDIN
®
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 ENIDIN
® EYE DROPS
ARE USED FOR
ENIDIN
®
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.
Although ENIDIN
®
eye drops help
control your glaucoma, it does not
cure it.
For more information about
glaucoma, contact the Glaucoma
Australia Inc. (telephone 180

Summary of Product characteristics

ENIDIN
®
Eye Drops PI v6-CCDS v2.1
1
AUSTRALIAN PRODUCT INFORMATION – ENIDIN
®
(BRIMONIDINE TARTRATE) EYE DROPS
1
NAME OF THE MEDICINE
Brimonidine tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of ENIDIN
®
0.2% 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 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
ENIDIN
®
0.2% is a sterile ophthalmic solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ENIDIN
®
eye drops are effective in lowering elevated intraocular pressure in
patients with
chronic open angle glaucoma or ocular hypertension. ENIDIN
®
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
MONOTHERAPY:
The recommended dose is one drop of ENIDIN
®
eye drops in the affected
eye(s) twice daily, approximately 12 hours apart.
COMBINATION THERAPY:
The recommended dose is one drop of ENIDIN
®
eye drops in the
affected eye(s) twice daily, approximately 12 hours apart.
In order to minimise systemic absorption of ENIDIN
®
eye drops, apply pressure to the tear
duct immediately following administration of the drug.
As with all eye drops containing benzalkonium chloride as a
preservative, there is potential for
incompatibility with other topical ophthalmic medications. If more
than one topical ophthalmic
drug is to be used, other eye drops should not be used within five to
ten minutes of using
ENIDIN
®
eye drops.
ENIDIN
®
Eye Drops PI v6-CCDS v2.1
2
4.3
CONTRAINDICATIONS
ENIDIN
®
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.
ENIDIN
®
eye drops are also contraindicated in neonates and infants (children
under the age of
2 years)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS