FML®
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.
FML® eye drops contain the active ingredient fluorometholone. FML® is used to treat
inflammation (pain, swelling and redness) of the eye.
For more information, see Section 1. Why am I using FML®? in the full CMI.
Check the list of ingredients at the end of the CMI. Do not use FML® 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, use any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use FML®? in the full CMI.
Some medicines may interfere with FML® and affect how it works, or FML® may interfere
with other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will tell you the number of drops to use, when to use FML® and how long
to use it.
More instructions can be found in Section 4. How do I use FML®? in the full CMI.
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Things you should do
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Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using
FML®.
Follow all your doctor's instructions carefully.
Keep all your follow-up appointments so your condition can be closely checked.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not touch the dropper tip against your eye, eye lid or any surface.
Do not use FML® while you are wearing soft contact lenses.
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Driving or using machines
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Wait for your vision to clear after using FML® before you drive or use machines.
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Drinking alcohol
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There is no information on the effects of taking FML® with alcohol.
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Looking after your medicine
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Follow all instructions on the carton and bottle label.
Store it upright in a cool place, below 30°C away from heat, or sunlight. Do not freeze.
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For more information, see Section 5. What should I know while using FML®? in the full CMI.
Eye infection, increased pressure in the eye(s), blurred vision or other changes to
your vision, eye redness, swelling of the eye, eye lid or surrounding areas, itchy
eye(s), eye pain, irritation, dilation of the pupil, eye discharge, watery eye(s),
calcium deposit in the cornea the feeling of having something in the eye, droopy
eyelids, changes to taste, itchy, red skin rash, delayed wound healing, severe allergic
reaction.
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.
FML®
Active ingredient:
fluorometholone (floo-ro-meth-ol-lohn)
Consumer Medicine Information (CMI)
This leaflet provides important information about using FML® 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 FML®.
Where to find information in this leaflet:
FML® contains the active ingredient fluorometholone.
Fluorometholone acts by inhibiting the inflammation caused by certain irritations
in the eye.
FML® is used to treat inflammation (pain, swelling and redness) of the eye .
Do not use FML® if:
you have an eye infection caused by the Herpes simplex keratitis virus
you have any infection in or around the eye
you are allergic to fluorometholone, or any of the ingredients listed at the end of
this leaflet
you have tuberculosis of the eye
the seal around the cap is broken.
the bottle/packaging shows signs of tampering.
the product does not look quite right.
the expiry date on the bottle has passed
Check with your doctor if you:
have ever had an eye infection caused by the Herpes simplex virus
have increased pressure in your eye (glaucoma)
have had a recent eye infection
have or have had any other eye conditions
use any medicines for any other condition
have had an allergy to any other 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?
Eye drops containing a corticosteroid should not be used for more than 10 days except
under ophthalmic supervision with regular checks for increased pressure in the eye.
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant. Safety
of the use of topical steroids during pregnancy has not been established.
Make sure your doctor is aware that you are breastfeeding or intend to breastfeed.
It is not known whether your baby may absorb this medicine from breast milk and therefore
there is a possibility of harm to the baby.
Always tell your doctor or pharmacist about other medicines you are using. This includes
prescription and non-prescription medicines, vitamins or supplements . There are no
known interactions with FML® and other medicines. However, there's a small chance
that taking certain CYP3A inhibitor medicines, like some antibiotics, antifungal,
and antiretroviral drugs, could increase your risk of having side effects.
Check with your optical practitioner, doctor or pharmacist if you are not sure about
what medicines, vitamins or supplements you are taking and if these affect FML®.
How much to use
The usual dosage of FML® eye drops is one to two drops in the affected eye(s) two
to four times daily. During the first 24 to 48 hours, your doctor may advise to increase
the dosage to 2 drops every hour.
When to use FML®
Use FML® only as instructed by your doctor.
Make sure you understand how frequently you should use it and when to start using
it and when to finish using it.
In some instances, FML® needs 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.
How to use FML®
1. These eye drops are for topical use only.
2. Wash your hands well with soap and water.
3. If you wear soft contact lenses, remove them before using FML®.
4. Shake the bottle well.
5. Tear off the protective seal on any new bottle and throw the seal away. Remove the lid/cap.
6. Hold the bottle upside down in one hand between your thumb and index finger.
7. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
8. Tilt your head back and look up. This might be easier if you are sitting or lying down.
9. Put the tip of the bottle close to your lower eyelid. Do not let the tip touch your eye, eyelid or any other surface.
10. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
11. If a drop misses your eye, try again, and wipe off any excess that runs down your cheek.
12. Close your eye. Do not blink or rub your eye.
13. 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.
14. Replace the lid/cap, sealing it tightly.
15. Wash your hands again with soap and water.
16. If you wear soft contact lenses, wait 15 minutes before replacing your soft contact lenses.
If you forget to use FML®
It is important that you use FML® according to your doctor's instructions.
Use FML® 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 condition. It will also help you remember when to use the eye drops.
If you forget to use FML® and 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/taking
them 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 number of drops to make up for the dose you missed.
If you use too much FML®
Immediately rinse your eyes with water.
If FML® is accidentally swallowed, you should immediately:
phone the Poisons Information Centre
by calling 13 11 26 or
by calling 13 11 26 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.
Things you should do
If you wear soft contact lenses, remove them before using FML®, and wait at least
15 minutes before inserting them again. The preservative in FML® eye drops (benzalkonium
chloride) may be absorbed and cause discolouration of soft contact lenses.
Keep all your follow-up appointments with your doctor so your eye(s) can be checked.
Use all the medication prescribed to treat your eye condition
If you are about to start on any new medicine tell your doctor and pharmacist that
you are using FML® eye drops.
Call your doctor straight away if:
you develop an eye infection, receive an eye injury, or have eye surgery
you develop blurred vision or you notice any changes in your vision
you become pregnant while using FML®
your eye(s) seem(s) to be getting worse or is/are not improving.
Things you should not do
Do not to touch the dropper tip against your eye, eyelid, or anything else, to avoid
contaminating the eye drops.
Do not stop using this medicine without checking with your doctor
Do not give FML® to anyone else, even if they have the same condition as you.
Driving or using machines
Wait for your vision to clear after using FML® before you drive or use machines.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store FML® UPRIGHT.
Store it in a cool place below 30°C away from 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
Do not freeze the eye drops.
Keep it where young children cannot reach it.
Do not leave the top/lid off the bottle for any length of time to avoid contaminating
the eye drops.
When to discard your medicine
Write the date on the bottle when you open the eye drops and discard unused contents
4 weeks 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 open a new bottle to use it if the expiry date has passed.
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.
FML® eye drops help most people with inflammation of the eye, but they may have unwanted
side effects in a few people. The most common side effects are increased pressure
in the eye, which is seen with long term use of FML® eye drops.
Although side effects that affect the whole body are rare, they can happen. At rare
times, the body makes too much of a hormone called cortisol, which can cause weight
gain, swelling in the face, and muscle weakness.
See the information below and, if you need to, ask your optical practitioner, doctor
or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Effects on the eye:
swelling of the eye, eye lid or surrounding areas
itchy eye
eye redness
eye pain
eye irritation
the black circle in the center of the eye gets bigger
eye discharge
cloudy or white spot on the clear front part of the eye
the feeling of having something in the eye
droopy eyelids
watery eye(s)
Effects on the body as a whole:
changes to taste
itchy, red skin rash
takes longer for a cut or injury to heal
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Effects on the eye:
increased pressure in the eye
eye infection
blurred vision or other changes to your vision
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Call your doctor straight away, if you notice any of these serious side effects.
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Effects on the body as a whole:
severe allergic reaction, including swelling of the tongue, lips and throat, difficulty
breathing.
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Go straight to the Emergency Department at your nearest hospital if you notice any
of these serious side effects.
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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. 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
using any of your medicines.
This medicine is only available with a doctor's prescription.
What FML® contains
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Active ingredient
(main ingredient)
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fluorometholone
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Preservative
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benzalkonium chloride
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate heptahydrate
disodium edetate
monobasic sodium phosphate
polysorbate 80
polyvinyl alcohol
purified water
sodium chloride
sodium hydroxide
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Do not use this medicine if you are allergic to any of these ingredients.
