COZDOL 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dorzolamide hydrochloride,timolol maleate

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

Dorzolamide hydrochloride,Timolol maleate

Authorization status:

Registered

Patient Information leaflet

_Cozdol 20/5 eye drops – Consumer Medicine Information _
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_Cozdol 20/5 CMI v 2.0 _
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_Page 1 _
COZDOL 20/5
_Dorzolamide (as hydrochloride)/timolol (as maleate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cozdol 20/5. 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 Cozdol 20/5
against the benefits it is expected to
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 COZDOL 20/5 IS
USED FOR
Cozdol 20/5 is 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. You may have
no symptoms but eventually
glaucoma can lead to total
blindness. In fact, untreated
glaucoma is one of the most
common causes of blindness.
Although Cozdol 20/5 helps control
your glaucoma it does not cure it.
So you must keep using it until
your doctor tells you

Summary of Product characteristics

Product Information - Australia
Cozdol 20/5 PI v2.0
Page 1
COZDOL 20/5
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_(DORZOLAMIDE (AS HYDROCHLORIDE) AND TIMOLOL (AS MALEATE) EYE DROPS) _
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PRODUCT INFORMATION
1 NAME OF THE MEDICINE
Cozdol 20/5
contains dorzolamide (as hydrochloride) and timolol (as maleate).
2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM
Dorzolamide hydrochloride has a molecular weight of 360.91. It is a
white to off-white, free
flowing crystalline powder, which is soluble in water and slightly
soluble in methanol and
ethanol.
Timolol maleate has a molecular weight of 432.50. It is a white,
odourless, crystalline powder
which is soluble in water, methanol, and alcohol.
Cozdol 20/5 is supplied as a sterile, isotonic, buffered, slightly
viscous, aqueous solution. Each
millilitre of Cozdol 20/5 contains 20 mg dorzolamide (22.26 mg of
dorzolamide hydrochloride)
and 5 mg timolol (6.83 mg of timolol maleate) as the active
ingredients.
Cozdol 20/5 contains the following inactive ingredients: sodium
citrate dihydrate, hyetellose,
sodium hydroxide, mannitol, and water for injections. Benzalkonium
chloride (0.0075%) is
added as preservative.
Each bottle contains 5 mL of a slightly opalescent, nearly colourless,
slightly viscous solution
of 2.0% w/v dorzolamide (as hydrochloride) and 0.5% w/v timolol (as
maleate).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of elevated intraocular pressure (IOP) in patients with
ocular hypertension or
open-angle glaucoma when concomitant therapy is appropriate.
4.2 DOSAGE AND ADMINISTRATION
For individual patient use only.
The dose is one drop of Cozdol 20/5 in the affected eye(s) two times
daily.
When substituting Cozdol 20/5 for another ophthalmic antiglaucoma
agent(s), discontinue
the other agent(s) after proper dosing on one day, and start Cozdol
20/5 on the next day.
If another topical ophthalmic agent is being used, Cozdol 20/5 and the
other agent should
be administered at least ten minutes apart.
Efficacy in paediatric patients has not been established. Safety