SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
02-11-2020
Summary of Product characteristics
(SPC)
02-11-2020
Public Assessment Report
(PAR)
18-10-2017
Active ingredient:
brimonidine tartrate, Quantity: 2 mg/mL; brinzolamide, Quantity: 10 mg/mL
Available from:
Novartis Pharmaceuticals Australia Pty Ltd
INN (International Name):
brimonidine tartrate,Brinzolamide
Pharmaceutical form:
Eye Drops, suspension
Composition:
Excipient Ingredients: propylene glycol; boric acid; mannitol; tyloxapol; sodium chloride; sodium hydroxide; purified water; carbomer 974P; hydrochloric acid; benzalkonium chloride
Administration route:
Ophthalmic
Units in package:
5 mL
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction
Product summary:
Visual Identification: SIMBRINZA is a white to off-white uniform suspension for multiple-dose topical ophthalmic use.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2014-11-20
Patient Information leaflet
SIMBRINZA
® 1%/0.2%
EYE DROPS
_brinzolamide 1% and brimonidine tartrate 0.2%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Simbrinza Eye Drops.
This leaflet answers some common
questions about Simbrinza Eye
Drops. It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
You can also download the most up
to date leaflet in Australia from
www.novartis.com.au and
www.medsafe.govt.nz in New
Zealand.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
Simbrinza Eye Drops against the
risks this medicine could have for
you.
The information in this leaflet applies
to Simbrinza only. This information
does not apply to similar products,
even if they contain the same
ingredients.
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 SIMBRINZA IS
USED FOR
Simbrinza is used to lower pressure
in the eye and to treat open-angle
glaucoma or ocular hypertension.
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
progres
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –
SIMBRINZA
® (BRINZOLAMIDE / BRIMONIDINE TARTRATE) EYE DROPS
1
NAME OF THE MEDICINE
Brinzolamide / brimonidine tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMBRINZA contains brinzolamide 1% (10 mg/mL) and brimonidine tartrate
0.2% (2 mg/mL) as the
active ingredients.
Excipient with known effect: benzalkonium chloride.
May contain potential allergen such as benzoates, sulfites and
hydroxybenzoates from the
manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, suspension.
SIMBRINZA is a white to off-white uniform suspension for multiple-dose
topical ophthalmic use. The
pH of SIMBRINZA is approximately 6.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dosage is one drop of SIMBRINZA in the conjunctival
sac of the affected eye(s)
twice daily. Shake the bottle well before use.
Nasolacrimal occlusion and gently closing the eyelid after
instillation are recommended. This may
reduce the systemic absorption of eye drops and result in a decrease
in systemic adverse reactions.
If more than one topical ophthalmic medicine is being used, the
medicines must be administered at
least 5 minutes apart.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should
not exceed one drop in the affected eye(s) twice daily.
When substituting another ophthalmic antiglaucoma agent with
SIMBRINZA, the other agent should
be discontinued and SIMBRINZA should be started the following day.
2
To prevent contamination of the dropper tip and solution, care must be
taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip of
the bottle. Instruct patients to
keep the bottle tightly closed when not in use. For individual patient
use
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