Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using GANFORT® 0.3/5 eye drops?
GANFORT® 0.3/5 eye drops contains the active ingredients bimatoprost and timolol (as
maleate). GANFORT® 0.3/5 eye drops are used to lower raised pressure in the eye and
to treat glaucoma.
2. What should I know before I use GANFORT® 0.3/5 eye drops?
Check the list of ingredients at the end of the CMI. Do not use GANFORT® 0.3/5 eye
drops if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not aware that you have
any other medical conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with GANFORT® 0.3/5 eye drops and affect how it works,
or GANFORT® 0.3/5 eye drops may interfere with other medicines and affect how they
work.
4. How do I use GANFORT® 0.3/5 eye drops?
Use one drop in your affected eye(s), according to your doctor's instructions.
Use the drops each morning.
5. What should I know while using GANFORT® 0.3/5 eye drops?
Things you should do
|
Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
GANFORT® 0.3/5 eye drops.
Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor tells you to
stop. GANFORT® 0.3/5 eye drops helps to control your condition but does not cure it.
Keep all your appointments so your condition can be checked.
|
Things you should not do
|
Do not touch the dropper tip against your eye, eye lid or any surface
Do not stop using GANFORT® 0.3/5 eye drops without checking with your doctor.
Do not use GANFORT® 0.3/5 eye drops while you are wearing contact lenses.
|
Driving or using machines
|
Wait until your vision clears after using GANFORT® 0.3/5 eye drops before driving
or using machines.
|
Drinking alcohol
|
There is no information on the effects of using GANFORT® 0.3/5 eye drops with alcohol.
|
Looking after your medicine
|
Follow all instructions on the carton
Store it in a cool dry place, below 25°C, away from moisture, heat, or sunlight.
|
6. Are there any side effects?
The most common side effects include red, congested eyes, or growth of eyelashes.
Note that side effects can occur in other parts of the body, including serious effects
on the heart or, blood vessels, decreased blood flow to the brain, serious allergic
reaction (anaphylaxis).For more information, including what to do if you have any
side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredients:
bimatoprost & timolol (bim-at-oh-prost & tim-oh-lol)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using GANFORT® 0.3/5 eye drops.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using GANFORT® 0.3/5 eye drops.
Where to find information in this leaflet:
1. Why am I using GANFORT® 0.3/5 eye drops?
1. Why am I using GANFORT® 0.3/5 eye drops?
GANFORT® 0.3/5 eye drops contain the active ingredients bimatoprost and timolol (as
maleate).
GANFORT® 0.3/5 eye drops are used to lower raised pressure in the eye and to treat
glaucoma. It works by decreasing the production of fluid in the eye and by helping
the flow of fluid out of 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 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.
Although GANFORT® 0.3/5 eye drops help control your condition, they will not cure
it.
Your doctor may have prescribed this medication for another reason. Ask your doctor
if you have any questions about why GANFORT® 0.3/5 eye drops have been prescribed
for you.
2. What should I know before I use GANFORT® 0.3/5 eye drops?
Warnings
Do not use GANFORT® 0.3/5 eye drops if:
you are allergic to bimatoprost or timolol, or any of the ingredients listed at the
end of this leaflet.
you have or have had any problems with your lungs, such as asthma, bronchospasm, or
a condition called chronic obstructive pulmonary disease (COPD).
you have or have had a heart condition, such as a slow heartbeat, irregular heartbeat,
or heart failure.
The seal around the cap is broken, the bottle/packaging shows signs of tampering,
or the product does not look quite right.
Check with your doctor if:
your eye(s) is/are inflamed
you have fluid build-up in the light-sensitive layer at the back of the eye, known
as the macula
you have had eye surgery
you have a diabetes-related eye condition, such as diabetic retinopathy or blockage
of a retinal vein
your eye does not have a lens or your eye has an artificial lens, following cataract
surgery
the capsule ("bag") that normally holds the eye's lens in place is torn, or ruptured
you have had severe allergic reactions (anaphylaxis) to such things as medicines,
foods, dyes
you have angina or other problems with your heart or blood vessels
you have low blood pressure
you have or have had problems with your liver or kidneys
you have an overactive thyroid
you have diabetes
you are about to have surgery under general anaesthetic
you have muscle weakness
you have problems with your circulation, such as Raynaud's syndrome
you have any disease that affects the surface of the eye (cornea)
you take any medicines for any other condition.
you have had an allergy to any medicines or any other substances, such as foods, preservatives
or dyes
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant or
are breastfeeding or intend to breastfeed.
Cosmetic effects
Before you start using GANFORT® 0.3/5 eye drops your doctor should tell you that some
changes to your eyes may occur which may be permanent.
During treatment, GANFORT® 0.3/5 eye drops may cause a loss of fat around the eye,
which may cause your eyelid crease to deepen, your eye to appear sunken, your upper
eyelid to droop, the skin around your eye to tighten and the lower white part of your
eye to become more visible. The changes are typically mild, but if pronounced, they
can affect your field of vision. The changes may disappear if you stop using GANFORT®
0.3/5 eye drops.
Eyelashes may also grow longer and thicker, and eyelashes, the skin around the eye
and the coloured part of the eye (iris) may become darker. If only one eye is being
treated the cosmetic differences between the eyes may be noticeable. None of these
changes affect vision. If you have any concerns, ask your doctor or pharmacist.
Hair may grow where GANFORT® 0.3/5 eye drops contact the skin. It is important to
use as directed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with GANFORT® 0.3/5 eye drops and affect how it works,
while GANFORT® 0.3/5 eye drops may affect how other medicines work.
Medicines where GANFORT® 0.3/5 eye drops may
increase
their effect include:
medicines for high blood pressure
some medicines used to treat diabetes
some medicines used to treat heart conditions, such as for irregular heart beats
medicines used to expand blood vessels (vasodilator drugs).
medicines to treat depression
These medicines may be affected by GANFORT® 0.3/5 eye drops, or affect how well it
works. You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect GANFORT® 0.3/5 eye drops.
4. How do I use GANFORT® 0.3/5 eye drops?
Follow all directions given to you by your doctor carefully. The directions may differ
from the information contained in this leaflet.
How much to use
Your doctor will tell you how many drops you need to use each day. Use GANFORT® 0.3/5
eye drops only as prescribed by your doctor.
The usual dose of GANFORT® 0.3/5 is one drop in your affected eye(s), according to
your doctor's instructions.
When to use GANFORT® 0.3/5 eye drops
Use the drops each morning.
Use GANFORT® 0.3/5 eye drops every day, at about the same time each 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.
In some instances, GANFORT® 0.3/5 eye drops need to be used with other eye drops.
Your doctor will let you know which drops, how to use them, and how long to use them.
Wait at least 5 to 10 minutes after using GANFORT® 0.3/5 eye drops before using other
eye drops. If you are also using an eye ointment, instill the eye ointment 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.
How to use GANFORT® 0.3/5 eye drops
Do not put the eye drops into your eye(s) while you are wearing soft contact lenses.
The preservative in GANFORT® eye drops (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 GANFORT® eye drops.
These drops are for use in your eyes only.
You may find it easier to put drops in your eye while you are sitting or lying down.
To open a new bottle of GANFORT® 0.3/5 eye drops first tear off the protective seal
from the bottle. The contents are sterile if the seal is intact.
The seal will break and you can pull it off and then throw it away.
1. Wash your hands well with soap and water.
2. 2. Remove the lid/cap.
3. Hold the bottle upside down in one hand between your thumb and forefinger or index
finger.
4. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
5. Tilt your head back and look up.
6. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
7. Release one drop into the pouch or pocket formed between your eye and eyelid by gently
squeezing the bottle.
8. Close your eye. Do not blink or rub your eye.
9. 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. Ask your doctor for more specific instructions
on this technique.
10. Replace the lid/cap, sealing it tightly.
11. Wash your hands again with soap and water to remove any residue.
If a drop misses your eye, try again. Wipe off any excess that runs down the cheek.
Wait 15 minutes before replacing your contact lenses.
Be careful not to touch the dropper tip against your eye, eyelid or anything else
to avoid contaminating the eye drops.
If you forget to use GANFORT® 0.3/5 eye drops
It is important that you use GANFORT® 0.3/5 eye drops at the same time each day.
If you miss using your drops and it is almost time for your next dose, use GANFORT® 0.3/5 eye drops at the usual time the next day.
If you miss using your drops and remember during the day, use the drops as soon as you remember and go back to using them at your usual time
the next day.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not use double the number of drops to make up for the dose you missed
.
If you use too much GANFORT® 0.3/5 eye drops
Immediately rinse your eyes with warm water.
If GANFORT® 0.3/5 eye drops are accidentally swallowed
You should immediately:
phone the Poisons Information Centre
(13 11 26 in Australia or
0800 POISON (0800 764 766) in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.
5. What should I know while using GANFORT® 0.3/5 eye drops?
Things you should do
Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor tells you to
stop. GANFORT® 0.3/5 eye drops help to control your condition but does not cure it.
Keep all your doctor's appointments so that your condition can be monitored, and your
eye pressure can be checked.
Tell your doctor if you think your condition is not improving while using GANFORT®
0.3/5 eye drops.
Call your doctor straight away if you:
develop any problems with your eye(s), such as, trauma, change of vision, infection
in the eye or eyelid, or have eye surgery.
become pregnant while using GANFORT® 0.3/5 eye drops.
Remind any doctor, dentist, pharmacist or optometrist you visit that you are using
GANFORT® 0.3/5 eye drops.
Things you should not do
Do not touch the dropper tip against your eye, eyelid or anything else, to avoid contaminating
the eye drops.
Do not stop using GANFORT® 0.3/5 eye drops without checking with your doctor. Your
eye pressure can rise again and may cause damage to your eye.
Do not give GANFORT® 0.3/5 eye drops to anyone else, even if they have the same condition
as you.
Driving or using machines
Your vision may be blurred after using GANFORT® 0.3/5 eye drops. Wait until your
vision clears before driving or using machines.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Ensure the lid is closed tightly after each use.
Keep it where young children cannot reach it.
When to discard your medicine
Discard the bottle 28 days after first opening it.
Getting rid of any unwanted medicine
If your doctor advises that you no longer need to use this medicine or it is out of
date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date has passed.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most
of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Less serious side effects
|
What to do
|
Effects on the eye(s):
red, congested eyes
growth of eyelashes
darkening of eyelash colour
burning and/or stinging in the eye
itching or irritation of the eyes
small lesions on the eye surface
eye dryness
the feeling of having something in the eye or discomfort in the eye
watery eyes
redness or swelling in the eye or area around the eye
excessive sensitivity to bright light
red, swollen, itching eyelids
inflamed eyelids
darkening of the coloured part of the eye (iris)
darkening of skin around the eye
abnormal hair growth
misdirected upper or lower eyelashes that turn inward towards the eye
loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken
eye, drooping eyelid, tightening of the skin around your eye, and the lower white
part of your eye to become more visible.
decreased sensation to the front of the eye
Effects on the body as a whole
headache
ringing in the ear
symptoms of a cold such as runny nose or nasal congestion
cough
increased colour or pigment on the face around the eye
feeling tired
reduced interest in sex or sexual dysfunction
allergic skin reaction (rash, itching, hives) and eye allergy
changes in your taste sensation
dry mouth
inability to sleep, nightmares, anxiety, confusion, hallucinations or memory loss.
loss of appetite
muscle pain
excessive or abnormal hair growth in areas where the product repeatedly comes into
contact with the skin
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Serious side effects
|
What to do
|
Effects on the eye(s):
eye pain
discharge from the eye
small spots on the eye surface
changes to vision, double vision
macular edema (build-up of fluid at the back of the eye, which causes vision to become
blurry)
spasm of the eyelids where there is uncontrolled blinking and squeezing of the eyelid
Effects on the body as a whole:
slow heartbeat
shortness of breath
asthma or worsening of asthma
high blood pressure
feeling weak and tired, nauseous, dizzy
depression (low mood, feelings of worthlessness)
low blood sugar
diarrhoea, stomach pain, vomiting, indigestion
red, scaly patches on the skin, rash or hair loss.
|
Call your doctor straight away, if you notice any of these serious side effects.
|
Effects on the body as a whole:
severe allergic reaction, including swelling of the eye, tongue, lips and throat,
difficulty breathing
symptoms suggestive of decreased blood flow to the brain, such as symptoms of a stroke,
fainting, tingling or numbness, muscle weakness
severe chest pain, heart beating slowly or irregularly, low blood pressure
swelling or coldness in your hands or feet, pain or tiredness in the legs.
|
Go straight to the Emergency Department at your nearest hospital if you notice any
of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems in Australia or to
https://nzphvc.otago.ac.nz/reporting/ in New Zealand. By reporting side effects, you can help provide more information
on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What GANFORT® 0.3/5 eye drops contains
Active ingredients
(main ingredients)
|
bimatoprost 0.3 mg/mL
timolol (as maleate) 5.0 mg/mL
|
Other ingredients
(inactive ingredients)
|
benzalkonium chloride
citric acid monohydrate
dibasic sodium phosphate heptahydrate
hydrochloric acid
sodium chloride
sodium hydroxide
purified water
|
Do not take this medicine if you are allergic to any of these ingredients.
What GANFORT® 0.3/5 eye drops look like
GANFORT® 0.3/5 eye drops are a sterile, clear to slightly yellow solution. It is
supplied in a 3mL bottle which is packed inside a carton. (AUST R 147830).
Who distributes GANFORT® 0.3/5 eye drops?
GANFORT® 0.3/5 eye drops are distributed in Australia by:
AbbVie Pty Ltd
241 O’Riordan Street
Mascot NSW 2020
Australia
GANFORT® 0.3/5 eye drops are distributed in New Zealand by:
AbbVie Limited
6th Floor, 156-158 Victoria St
Wellington, 6011
New Zealand
This leaflet was prepared in Aug 2023.
© 2023 AbbVie. All rights reserved.
GANFORT and its design are trademarks of Allergan, Inc., an AbbVie company.