COMBIGAN brimonidine tartrate 2.0mg/mL and timolol 5.0mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

brimonidine tartrate, Quantity: 2 mg/mL; timolol maleate, Quantity: 6.8 mg/mL

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: benzalkonium chloride; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; purified water; hydrochloric acid

Administration route:

Ophthalmic

Units in package:

5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COMBIGAN eye drops are indicated for the reduction of elevated intraocular pressure for treatment of open angle glaucoma and/or ocular hypertension, in patients not adequately responding to monotherapy

Product summary:

Visual Identification: Clear, greenish-yellow sterile isotonic solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-01-07

Patient Information leaflet

COMBIGAN
®
Eye Drops-CMI Version 2.0 – PIv5.0
1
COMBIGAN
® EYE DROPS
(BRIMONIDINE TARTRATE 2.0 MG PER ML AND TIMOLOL (AS MALEATE) 5.0 MG
PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COMBIGAN
®
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 COMBIGAN
®
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 COMBIGAN
® EYE DROPS ARE
USED FOR
COMBIGAN
®
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.
COMBIGAN
®
eye drops
lower
the pressure in the eye by
decreasing the fluid produced and
helping the flow of fluid out
of the eye chamber.
Although
COMBI

Summary of Product characteristics

COMBIGAN
®
Eye Drops PI v6 – CCDS v3.1
1
AUSTRALIAN PRODUCT INFORMATION – COMBIGAN
®
(BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) EYE DROPS
1
NAME OF THE MEDICINE
Brimonidine tartrate and timolol maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
mL
of
COMBIGAN
®
Eye
Drops
solution
contains
brimonidine
tartrate
2.0
mg
(equivalent to 1.32 mg as brimonidine free base) and 6.8 mg of timolol
maleate (equivalent to
5.0 mg of timolol).
COMBIGAN
®
is a combination eye drop containing brimonidine tartrate and timolol
maleate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops, solution.
COMBIGAN
®
is a sterile ophthalmic solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMBIGAN
®
eye drops are indicated for the reduction of elevated intraocular
pressure for
treatment of open angle glaucoma and/or ocular hypertension, in
patients not adequately
responding to monotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of COMBIGAN
®
in the affected eye(s) twice daily,
approximately 12 hours apart.
In order to minimise systemic absorption of COMBIGAN
®
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
COMBIGAN
®
eye drops.
COMBIGAN
®
Eye Drops PI v6 – CCDS v3.1
2
4.3
CONTRAINDICATIONS
COMBIGAN
®
eye
drops
are
contraindicated
in
patients
with
hypersensitivity
to
any
component of this medication, in patients receiving monoamine oxidase
(MAO) inhibitor
therapy, in patients with bronchospasm, bronchial asthma or patients
with a history of bronchial
asthma, or severe chronic obstructive pulmonary disease, in patients
with sinus bradycardia,
sick sinus syndrome, sino-atrial nodal block, second or third deg