SIMBRINZA

Main information

  • Trade name:
  • SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219839
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219839

SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

20/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle

Product Type

Single Medicine Product

Effective date

11/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides

insufficient IOP reduction

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

12 Months

Store below 25

degrees Celsius

Not recorded

Discard 4 weeks after

opening

Pack Size/Poison information

Pack Size

Poison Schedule

5 mL

(S4) Prescription Only Medicine

2.5 mL Sample Pack

(S4) Prescription Only Medicine

Components

1. SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle

Dosage Form

Eye Drops, suspension

Route of Administration

Ophthalmic

Visual Identification

SIMBRINZA is a white to off-white uniform suspension for multiple-dose

topical ophthalmic use.

Active Ingredients

brimonidine tartrate

2 mg/mL

Brinzolamide

10 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 19.10.2017 at 02:04:12 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

SIMBRINZA

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 from

www.novartis.com.au.

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

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. 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.

Simbrinza is not suitable for use in

acute angle-closure glaucoma.

Simbrinza combines two ingredients,

brinzolamide and brimonidine

tartrate. Brinzolamide is a carbonic

anhydrase inhibitor and brimonidine

tartrate is an alpha-2 adrenergic

agonist. Both brinzolamide and

brimonidine tartrate work by

reducing the production of fluid

within the eye.

For more information about

glaucoma, contact Glaucoma

Australia (telephone 1800 500 880).

Your doctor may have prescribed

Simbrinza for another reason. Ask

your doctor if you have any questions

about why Simbrinza has been

prescribed for you.

This medicine is available only with

a doctor's prescription.

There is no evidence that Simbrinza

is addictive.

Use in Children

Simbrinza Eye Drops are not

recommended in children and young

adults aged between 2 to 17 years as

the safety and efficacy in children

has not been established.

Simbrinza Eye Drops should not be

used in children under 2 year of age.

Before you use

SIMBRINZA

When you must not use it

Do not use Simbrinza if you have an

allergy to:

brinzolamide

SIMBRINZA

brimonidine tartrate

any other carbonic anhydrase

inhibitor or alpha-2 adrenergic

agonist

any of the ingredients listed at the

end of this leaflet.

If you are unsure if you are taking

or using any of these medicines ask

your doctor.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not use Simbrinza if:

you have severe kidney problems

you have too much acidity in

your blood (a condition called

hyperchloraemic acidosis).

Do not use Simbrinza if:

you are taking any antidepressant

medicines.

These include medicines called

monoamine oxidase (MAO)

inhibitors or other types of

antidepressants.

Do not use this medicine after the

expiry date printed on the pack or

bottle, if the seal around the pack

is broken or shows signs of

tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you use this medicine after the

expiry date has passed, it may not

work.

If you are not sure whether you

should start using Simbrinza, talk

to your doctor.

Before you start to use it

Tell your doctor if you have had an

allergy to any other medicines or

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have an

allergy to sulphonamide medicines.

Brinzolamide, one of the active

ingredients in Simbrinza, is a sulfur-

containing medicine. If you are

allergic to sulfur medicines, such as

some antibiotics, you may be allergic

to Simbrinza Eye Drops. Check with

your doctor or pharmacist if you are

not sure whether you are allergic to

sulphonamides.

Tell your doctor if you have or

have had any medical conditions,

in particular the following:

heart conditions.

These include coronary heart

disease (symptoms can include

chest pain or tightness,

breathlessness or choking), heart

failure, high or low blood

pressure

circulation conditions.

These include Raynaud's disease,

thromboangiitis obliterans

(Buerger disease) where there is

inflammation and clotting of the

small and medium arteries and

veins of the hands and feet and

poor circulation of blood in the

brain.

kidney problems

liver problems

compromised cornea and/or

corneal disease

depression.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor will discuss the possible

risks and benefits of using Simbrinza

during pregnancy.

Tell your doctor if you are

breastfeeding.

Your doctor will discuss the possible

risks and benefits of using Simbrinza

when you are breast-feeding.

If you have not told your doctor

about any of the above, tell

him/her before you use Simbrinza.

Taking or using other

medicines

Tell your doctor if you are taking or

using any other medicines, including

other eye drops or ointments, and any

other medicines that you buy without

a prescription from your pharmacy,

supermarket or health food shop.

Some medicines and Simbrinza may

interfere with each other or add to the

effects of Simbrinza. These include:

medicines to lower blood

pressure

digoxin, a medicine used to treat

heart failure

other medicines or eye drops for

glaucoma

carbonic anhydrase inhibitors

such as acetazolamide,

dorzolamide

antiviral or antibiotic medicines

chlorpromazine, methylphenidate,

reserpine

isoprenaline, prazosin

salicylates such as aspirin

monoamine oxidates (MAO)

inhibitors, or other

antidepressants including

amitriptyline, nortriptyline,

clomipramine and mianserin.

CNS depressants such as alcohol,

barbiturates, opiates, sedatives or

anaesthetics

These medicines may be affected by

Simbrinza, or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while using

Simbrinza.

How to use

SIMBRINZA

Carefully follow all directions

given to you by your doctor and

pharmacist.

SIMBRINZA

They may differ from the

information contained in this leaflet.

If you are being changed from one

medicine to another, follow your

doctor's instructions carefully as to

when to stop the medicine and when

to start the new eye drops.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for

help.

How much to use

Use Simbrinza only when prescribed

by your doctor.

The usual dose of Simbrinza is one

drop in the affected eye(s) twice

daily. Usually, this means one drop

in the affected eye(s) first thing in the

morning, and one drop in the

evening.

Your doctor will tell you how many

drops you need to use each day.

These dosing instructions will be

printed on the label your pharmacist

adds.

How to use it

It is important to use Simbrinza

exactly as your doctor or pharmacist

has told you. If you use the drops less

often than prescribed, they may not

work as well and the eye problem

may not improve. Using the drops

more often than prescribed may not

improve the eye problem any faster

and may cause increased side effects.

If you are wearing soft contact

lenses, remove them before putting

the drops in your eye.

Follow these steps to use the eye

drops:

Wash your hands thoroughly with

soap and water.

Immediately before using a bottle

for the first time, break the safety

seal around the neck area and

throw the loose plastic ring away.

Shake the bottle.

Remove the cap from the bottle.

Hold the bottle upside down in

one hand between your thumb

and middle finger (see Diagram

Diagram1

While tilting your head back,

gently pull down the lower eyelid

of your eye to form a

pouch/pocket.

Place the tip of the bottle close to

your eye. Do not let it touch your

eye.

Release one drop into the

pouch/pocket formed between

your eye and eyelid by gently

tapping or pressing the base of

the bottle with your forefinger

(see Diagrams 2 and 3).

Diagram 2

Diagram 3

Close your eye. Do not blink or

rub your eye.

10. While your eye is closed, place

your index finger against the

inside corner of your eye and

press against your nose for about

two minutes. This will help to

stop the medicine from draining

through the tear duct to the nose

and throat, from where it can be

absorbed into other parts of your

body. This will also reduce the

unpleasant taste sensation that

some people experience when

using these drops.

11. If necessary, repeat the above

steps for the other eye.

12. Your eyelids can only hold less

than one drop at a time, so it is

normal for a small amount of the

eye drop to spill onto your cheek.

You should wipe away any

spillage with a tissue.

13. Replace the cap on the bottle,

closing it tightly.

14. Wash your hands again with soap

and water to remove any residue.

You may feel a slight burning

sensation in the eye shortly after

using the eye drops. If this persists,

or is very uncomfortable, contact

your doctor or pharmacist.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else.

This will help prevent the drops

becoming dirty or contaminated.

If you have trouble knowing whether

you have placed your drops correctly,

you may want to store them in the

fridge. Some people find it easier to

feel the drops in the eye if they are

cold.

After using Simbrinza, wait at least 5

minutes before putting any other eye

drops in your eye(s).

Wait 15 minutes before replacing

your contact lenses.

When to use it

Use Simbrinza every day, at about

the same times each day, unless your

doctor tells you otherwise. Using

your eye drops at the same times

each day will have the best effect on

your eye pressure. It will also help

you remember when to use the eye

drops.

How long to use it

Simbrinza helps control your

condition but does not cure it.

Simbrinza must be used every day.

Continue using SIMBRINZA for as

long as your doctor prescribes.

SIMBRINZA

If you are unsure about when or how

to stop using Simbrinza, you should

talk to your doctor or pharmacist.

If you forget to use it

If it is almost time for your next

dose, skip the dose you missed and

use your next dose when you are

meant to.

Otherwise, use the drops as soon as

you remember, and then go back

to using them as you would

normally.

Do not use double the amount to

make up for the dose that you

missed.

Using multiple doses may cause

unwanted side effects.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

If you have trouble remembering

to use your eye drops, ask your

pharmacist for some hints.

If you use too much

(overdose)

If you accidentally put several drops

in your eye(s), immediately rinse

your eye(s) with warm water.

If you think that you or anyone

else may have swallowed any or all

of the contents of a bottle of

Simbrinza, immediately telephone

your doctor or the Poisons

Information Centre on 13 1126 for

advice, or go to Accident and

Emergency at your nearest

hospital. Do this even if there are

no signs of discomfort or

poisoning.

While you are using

SIMBRINZA

Things you must do

Have your eye pressure checked

when your eye specialist says, to

make sure Simbrinza is working.

If you are about to start taking or

using any new medicine, tell your

doctor and pharmacist that you

are using Simbrinza.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are using Simbrinza.

Tell your doctor if, for any reason,

you have not used Simbrinza

exactly as prescribed. Otherwise

your doctor may think that the eye

drops were not effective and

change the treatment

unnecessarily.

If you become pregnant or decide

to breastfeed while using

Simbrinza, tell your doctor

immediately.

Things you must not do

Do not use Simbrinza to treat other

complaints unless your doctor tells

you to.

Do not give Simbrinza to anyone

else, even if they have the same

condition as you.

Do not stop using Simbrinza

without first talking to your

doctor. If you stop using your eye

drops, your eye pressure may rise

again and damage to your eye may

occur.

Do not put the Simbrinza eye

drops into your eye(s) while you

are wearing soft contact lenses.

The preservative in Simbrinza

(benzalkonium chloride) may be

deposited in soft contact lenses. You

can put your soft contact lenses back

into your eyes 15 minutes after you

have used Simbrinza.

Things to be careful of

Be careful driving, operating

machinery or performing tasks

requiring mental alertness and/or

physical coordination until you

know how Simbrinza affects you

and your vision. As with any eye

medicine, temporary blurred

vision or other visual disturbances

may affect the ability to drive or

use machinery in some people. If

blurred vision occurs when you use

your drops, wait until your vision

is clear before driving or operating

machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Simbrinza.

Simbrinza helps most people with

high eye pressure and glaucoma, but

it may have unwanted side effects in

a few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by the following

list of possible side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following effects in the eye(s)

and the eye area, and they worry

you:

blurred vision

eye allergy

eye discomfort

eye pain

eye redness

eye surface inflammation

feeling of having something in

the eye.

These are the more common side

effects of your medicine. They are

usually mild and short-lived.

Additional side effects that are

noticed less often include:

eye surface inflammation with

surface damage

sensitivity to bright light

excessive tearing

dry eye

eye discharge

SIMBRINZA

redness of the eyelids

tired eyes

inflammation of the eyelids

deposits on the eye surface

eye and eyelid swelling.

Occasionally some people notice

unwanted effects in the rest of their

body as a result of using Simbrinza.

These effects may include:

difficulty sleeping

drowsiness

bad taste in the mouth

headache

dizziness

decreased blood pressure

dry throat

stuffy nose

dry nose

postnasal drip

dry mouth

indigestion

abdominal pain

abnormal sensation in mouth

skin inflammation, redness or

itching

medication residue.

If any of the following happen, stop

using Simbrinza and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

skin rash

swelling of the face, hands or feet

wheezing, difficulty in breathing

shortness of breath (dyspnoea,

heart failure)

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

These hypersensitivity reactions can

be very serious side effects. You may

need urgent medical attention or

hospitalisation. These side effects are

very rare.

Other side effects not listed above

may also occur in some people.

After using

SIMBRINZA

Storage

Store Simbrinza in a cool dry place

where the temperature stays below

25°C. It is not necessary to store

Simbrinza in the refrigerator, but it is

acceptable if you prefer to instil cold

drops.

Do not store Simbrinza or any

other medicine in the car, in the

bathroom or in other warm, damp

places.

Heat and dampness can destroy some

medicines.

Do not leave the top off the bottle

for any length of time, to avoid

contaminating the eye drops.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Write the date on the bottle when

you open the eye drops and throw

out any remaining solution after

four weeks.

Eye drops contain a preservative

which helps prevent germs growing

in the solution for the first four

weeks after opening the bottle. After

this time there is a greater risk that

the drops may become contaminated

and cause an eye infection. A new

bottle should then be used.

If your doctor tells you to stop

using Simbrinza or they have

passed their expiry date, ask your

pharmacist what to do with any

remaining solution.

Product description

What it looks like

Simbrinza is a liquid (white to off-

white uniform suspension) supplied

in a pack containing 5 mL in an 8 mL

dropper bottle (DROP-TAINER)

with screw cap.

Tamper evidence is provided with a

safety seal around the neck area of

the bottle.

Ingredients

Simbrinza contains the active

ingredient(s):

brinzolamide 10 mg/mL

brimonidine tartrate 2 mg/mL.

Simbrinz also contains the inactive

ingredients:

benzalkonium chloride (used as a

preservative)

propylene glycol

carbomer 974P

boric acid

mannitol

sodium chloride

tyloxapol

purified water

hydrochloric acid and/or sodium

hydroxide are added to adjust pH.

Supplier

Simbrinza is supplied in Australia

Novartis Pharmaceuticals Australia

Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone No. 1800 671 203

www.novartis.com.au

Date of preparation

This leaflet was prepared in August

2017

Australian Register Number

AUST R 219839

© Novartis Pharmaceuticals

Australia Pty Limited 2017

® Registered Trademark

SIMBRINZA

Internal document code:

(sib030717c) based on PI

(sib030717i)

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