Brinzolamide
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before you start to use Azopt Eye Drops.
This leaflet answers some common questions about Azopt. 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 Azopt against the risks this medicine could have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Azopt is used for
Azopt Eye Drops contain the active ingredient brinzolamide, which belongs to a class
of medicines known as "carbonic anhydrase inhibitors".
Azopt Eye Drops are used, either alone or in combination with other eye drops/medicines,
to lower high pressure inside the eye(s) and to treat open-angle glaucoma or hypertension
(high pressure) in the eye.
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 the 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.
Azopt Eye Drops lower the pressure within the eye by reducing the production of fluid.
Although Azopt Eye Drops help to control your glaucoma, they do not cure it.
For more information about glaucoma, contact Glaucoma Australia Inc. (PO BOX 420,
Crows Nest 1585 telephone 1800 500 880).
Ask your doctor if you have any questions about why Azopt has been prescribed for
you.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription.
Azopt Eye Drops are not addictive.
Use in Children
Azopt Eye Drops are not recommended for use in children. The safety and effectiveness
of Azopt Eye Drops in children has not been established.
Before you use Azopt
When you must not use it
Do not use Azopt if:
You have an allergy to AZOPT Eye Drops or other medicines containing brinzolamide,
other carbonic anhydrase inhibitors or any ingredients in Azopt Eye Drops that are
listed at the end of this leaflet.
If you think you may be allergic, ask your doctor or healthcare provider for advice.
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.
You have severe kidney disease
You have high levels of chloride in your blood (hyperchloraemia).
Do not take this medicine if the expiry date has passed, the packaging is torn or
the safety seal around the closure and neck area is broken.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using Azopt, talk to your doctor.
Before you start to take it
Tell your doctor if:
You have an allergy to sulfonamide medicines
The active ingredient of Azopt Eye Drops, brinzolamide, is a sulfur-containing medicine
(a sulfonamide). If you are allergic to sulfur medicines, such as some antibiotics,
medicines used to treat diabetes and also diuretics (water tablets), you may be allergic
to Azopt Eye Drops. Check with your doctor or pharmacist if you are not sure whether
you are allergic to sulfonamides.
You are pregnant, or intend to become pregnant
Your doctor will discuss the possible risks and benefits of using Azopt during pregnancy.
You are breast-feeding or intend to breast-feed
Your doctor will discuss the possible risks and benefits of using Azopt when you are
breast-feeding.
You have or have had any medical conditions such as problems with your liver or kidneys.
You have impaired corneas which can occur in diabetes mellitus, low endothelial cell
counts or in a condition called corneal dystrophies
If you are unsure if you have any of these conditions ask your doctor.
You have an allergy to any other medicines or any other substances, such as foods,
preservatives or dyes.
If you have or have had any severe skin reactions like skin rash, skin peeling, blistering
of the lips, eyes or mouth.
If you have not told your doctor about any of the above, tell them before you use
Azopt Eye Drops.
Do not put Azopt Eye Drops into your eye(s) while you are wearing contact lenses.
The preservative in Azopt Eye Drops, benzalkonium chloride, may cause eye irritation
and is also known to discolour soft contact lenses.
You can put your contact lenses back into your eyes 15 minutes after you have used
Azopt Eye Drops.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.
Some medicines and Azopt Eye Drops may interfere with each other.
These include:
Aspirin, in high doses
High dose of salicylate-containing medicines which are used to relieve pain
Other medicines known as "carbonic anhydrase inhibitors" that you take to treat glaucoma.
These medicines may be affected by Azopt Eye Drops or may affect how well it works.
You may need different amounts of your medicines or you may need to take different
medicines.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide)
or medicines that are nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates,
talk to your doctor or healthcare provider.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take Azopt
Use Azopt Eye Drops only as prescribed by your doctor.
Follow all directions given to you by your doctor or healthcare provider carefully.
They may differ from the information contained in this leaflet.
Use Azopt Eye Drops only when prescribed by your doctor.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to use
The usual dose of Azopt Eye Drops is ONE DROP in the affected eye(s) TWICE A DAY.
This will normally be in the morning and at night. Your doctor will tell you how many
drops you need to use each day.
After using Azopt Eye Drops wait at least 5 minutes before putting any other eye drops
in your eye(s). Eye ointment should be administered last.
If you are being changed from one eye drop to another, follow your doctor's instructions
carefully as to when to stop the old drops and when to start the new drops.
If you are unsure about when, or how, to stop using Azopt Eye Drops you should talk
to your doctor.
How to use Azopt
You may find it easier to use your eye drops if you are sitting or lying down.
If you are wearing contact lenses, remove them before putting the drops in your eye.
Follow these steps to use AZOPT Eye Drops:
1. Wash your hands thoroughly with soap and water.
2. Immediately before using a bottle for the first time, break the safety seal around
the neck area and throw the loose plastic ring away.
3. Mix the contents of the bottle by inverting 5 to 10 times.
4. Remove the cap from the bottle.
5. Hold the bottle upside down in one hand between your thumb and middle finger (see
Diagram 1).
Diagram 1
6. While tilting your head back, gently pull down the lower eyelid of your eye to form
a pouch/pocket.
7. Place the tip of the bottle close to your eye. Do not let it touch your eye.
8. 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
9. 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 Azopt 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.
After using Azopt Eye Drops, 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 Azopt Eye Drops at about the same time every day unless your doctor tells you
otherwise.
Using your eye drops at the same time 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
Azopt Eye Drops help control your condition but will not cure it. Therefore Azopt
Eye Drops must be used every day.
Continue using Azopt Eye Drops for as long as your doctor prescribes.
If you forget to take 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 the medicines
as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
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 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 Azopt Eye Drops, immediately telephone your doctor or Poisons Information
Centre on 131126 or go to Accident and Emergency at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using Azopt
Things you must do
To make sure that Azopt is working properly, have your eye pressure checked regularly.
Keep all your doctor’s appointments so that your progress can be checked.
If you develop an eye infection, receive an eye injury or have eye surgery tell your
doctor.
If you notice signs of serious reactions or hypersensitivity including severe skin
reaction such as skin rash, red skin, blistering of the lips, eyes or mouth, skin
peeling and fever (signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
discontinue the use of this medication and seek medical attention immediately.
Your doctor may tell you to use a new container of Azopt Eye Drops because of possible
contamination of the old one, or may advise you to stop your treatment with Azopt
Eye Drops.
If you become pregnant while using Azopt Eye Drops tell your doctor immediately.
If you are about to be started on any new medicine tell your doctor and pharmacist
that you are using Azopt Eye Drops.
Tell all your doctors and pharmacists that you are using Azopt.
Things you must not do
Do not use Azopt Eye Drops to treat other complaints unless your doctor or pharmacist
tells you to.
Do not give Azopt Eye Drops to anyone else, even if they appear to have the same condition
as you.
Do not stop using Azopt Eye Drops 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 let children handle Azopt Eye Drops. If a child accidentally swallows any of
the drops read the instructions under "If you use too much (overdose)"
Things to be careful of
Be careful of driving or operating machinery until you know how Azopt Eye Drops affect
you and your vision.
As with any eye medicines, temporary blurred vision or other visual disturbances may
affect the ability to drive and 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 Azopt Eye Drops.
Azopt Eye Drops help 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following effects in the eye(s)
and the eye area and they worry you:
Blurred or abnormal vision
Discomfort, irritation or feeling of something in the eye(s)
Redness of the eye(s)
Dry eye(s)
Eye pain
Discharge from the eye(s)
Itchy eye(s)
Watering of the eye(s).
Additional side effects that can occur rarely include:
Swelling of the clear front part of the eye(s)
Red, itchy, irritated, crusty, swollen eyelid(s)
Swelling of the skin around the eye(s)
Crusty eyelashes
Sticky sensation in the eye(s)
Tired eye(s)
Sensitivity to bright lights
Double vision
Seeing flashes or sparks of light
Eye numbness.
Occasionally some people notice unwanted effects in the rest of their body as a result
of using Azopt Eye Drops. These effects may include:
Headache
Chest pain, shortness of breath
Unusual tiredness or weakness
Dry mouth and/or nose
Blocked or running nose
Bleeding nose
Sore throat, irritation and/or coughing
Mucous in the chest
Nausea, indigestion, diarrhoea and/or upset stomach
Tingling, numbness and/or dizziness
Depression
Abnormal dreams
Muscle stiffness
Agitation
Change in sensation of taste
Loss of memory
Nervousness
Rash, itchy skin
Hair loss
Persistent noises in the ear(s)
Impotence
Kidney pain.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if any of the following happen:
Generalised itchiness
Chest pain
Shortness of breath
Severe and sudden onset of pinkish, itchy swellings on the skin, also called hives
or nettle rash.
Skin rash, red skin, skin peeling, blistering of the lips, eyes or mouth, fever or
any combination of these (Stevens-Johnson syndrome / toxic epidermal necrolysis)
These are hypersensitivity reactions and can be very serious side effects. You may
need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor if you notice any other effects.
Other side effects not listed above may also occur in some patients.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
After using Azopt
Storage
Keep your eye drops in a cool place where the temperature stays below 25°C. Do not
freeze the eye drops.
Do not store Azopt Eye Drops or any other medicine in the car, in the bathroom or
in other warm, damp places.
Heat and dampness can destroy some medicines.
A locked cupboard at least one and a half meters above the ground is a good place
to store medicines.
Keep it where children cannot reach it.
Put the top back on the bottle right away after use to avoid contaminating the eye
drops. Do not leave the top off the bottle for any length of time.
Disposal
Write the date on the bottle when you open the eye drops and throw out any remaining
solution after four weeks.
Open a new bottle every 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.
If your doctor tells you to stop using the eye drops or they have passed their expiry
date, ask your pharmacist what to do with any remaining solution.
Product description
What it looks like
Azopt Eye Drops is a sterile suspension that comes in a 5mL dropper bottle (DROP-TAINER®) with screw cap.
The safety seal must be removed before use.
Ingredients
The active ingredient in Azopt is brinzolamide 10 mg/mL (1.0%).
It also contains the inactive ingredients:
mannitol
carbomer 974P
sodium chloride
tyloxapol
disodium edetate
sodium hydroxide and/or hydrochloric acid (to adjust pH)
purified water
benzalkonium chloride 0.1 mg/mL (as a preservative),
Supplier
Azopt is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1-800-671-203.
Web site: www.novartis.com.au
Australian registration number
AUST R 72750.
Date of preparation
This leaflet was prepared in November 2022.
® Registered Trademark
© Novartis Pharmaceuticals Australia Pty Limited 2022.
Internal document code
(azo021122c) based on PI (azo021122i)