Active substance(s): FLUOROMETHOLONE / FLUOROMETHOLONE / FLUOROMETHOLONE
What FML looks like and contents of the pack
FML is a white suspension supplied in a plastic dropper bottle with
a screw cap.
The bottle contains 5 ml or 10 ml of suspension.
Marketing Authorisation Holder
INFORMATION FOR THE USER
OPHTHALMIC 1 mg/ml
EYE DROPS SUSPENSION
Allergan Pharmaceuticals Ireland
Read all of this leaflet carefully before you start using this medicine.
-- Keep this leaflet. You may need to read it again.
-- If you have further questions, please ask your doctor or your pharmacist.
-- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
-- If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet please tell your doctor or pharmacist.
This leaflet was last revised in February 2017.
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK only).
Please be ready to give the following
information: Fluorometholone 1 mg/ml
reference number PL 00426/0028.
This is a service provided by the
Royal National Institute of Blind People.
In this leaflet:
1. What FML is and what it is used for
2. Before you use FML
3. How to use FML
4. Possible side effects
5. How to store FML
6. Further information
1. WHAT FML IS AND WHAT IT IS USED FOR
FML is an eye drop. It contains a steroid which is used to treat inflammation
of the eye.
2. BEFORE YOU USE FML
Do not use FML
• if you are allergic (hypersensitive) to fluorometholone, benzalkonium
chloride, or any of the other ingredients of FML.
• if you have a bacterial, viral, or fungal infection of the eye.
Take special care with FML
You should not use FML for more than one week unless your doctor or eye
specialist advises it.
Prolonged use may cause the pressure inside your eye (intraocular pressure)
to increase, which could lead to glaucoma, rare damage to the optic nerve, lack
of clearness of vision, cataracts, delay in wound healing, or the development of
an eye infection. The pressure in your eye will be regularly measured.
If you have or have been previously treated for herpes simplex, use FML
only under close supervision of your doctor.
The use of the bottle by more than one person may spread infection.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of FML and your doctor may
wish to monitor you carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).
If you are using other eye drops, leave at least 5 minutes before putting in FML.
The safety and effectiveness in children aged 2 years or less have not
Pregnancy and breast feeding
Tell your doctor before you start using FML if you are pregnant or planning
to become pregnant or if you are breastfeeding. Your doctor will decide if
you should use FML during pregnancy or whilst breastfeeding. Normally it
is not recommended for use.
© 2017 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.
Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 72073MD011J
Drawing Number: 0106901
Driving and using machines
FML can cause temporary blurred vision. Should this occur, wait for the
blurring to clear before driving or operating machinery or taking part in any
activity where this could put yourself or others at risk.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FML can have side effects, although not everybody gets
them. The following side effects are known to occur but their frequency can
vary, as shown.
If you experience swallowing or breathing difficulties, swelling of your lips,
face, throat or tongue contact your doctor or go to the hospital immediately
as this could be a sign of a serious allergic reaction. The frequency of an
allergic reaction is not known.
Affecting the eye
Important information about some of the ingredients of FML
FML contains benzalkonium chloride as a preservative, which is known to
discolour soft contact lenses and can cause eye irritation. If you wear soft
contact lenses you must remove them before using FML eye drops and
wait at least 15 minutes before putting your lenses back in.
Ask your doctor or pharmacist for advice before taking any medicine.
3. HOW TO USE FML
Always use FML exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The usual dose is 1 or 2 drops of FML in each eye that needs treatment
2 to 4 times a day, or more frequently if your doctor advises it. During the
first 24 - 48 hours of treatment your doctor may advise you to apply 2 drops
at one hour intervals.
Treatment should not be withdrawn too early.
Instructions for use
You must not use the bottle if the seal on the bottle neck is broken before
you first use it.
Shake the bottle before use. Wash your hands before opening the bottle.
Use your eye drops in the following way:
1. Tilt your head back and look at the ceiling.
Frequency - Common (affecting up to 1 in 10 patients):
Increased pressure inside your eye
Frequency not known:
Cataract (a loss of transparency of the lens of the eye with partial or
complete loss of vision)
Redness of the eye
Itching of the eye
A feeling that something is in your eye
Difficulty in seeing clearly
Swelling of the eyelid or eye
Excessive dilatation of the pupil
Excessive tear production
Ulcer(s) on the surface of the eye
Small breaks in the surface of the eye
Visual field defects
Secondary infections (including bacterial, fungal, and viral infections)
Affecting the body
Frequency not known:
Rash, abnormal sense of taste, allergic reactions (hypersensitivity)
Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the clear layer
at the front of the eye (the cornea) have developed cloudy patches on the
cornea due to calcium build-up during treatment.
4. Let go of the lower lid, and close your eye for 30 seconds.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of
If a drop misses your eye, try again.
Keep out of the reach and sight of children.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and gently squeeze it to release 1 or 2 drops
into the eye.
5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.
5. HOW TO STORE FML
To keep the eye drops free from contamination and avoid eye injury, do not
let the tip of the bottle touch your eye or anything else. Put the cap back
on and close the bottle tightly straight after use. Wipe off any excess liquid
from your cheek with a clean tissue.
Do not use an unopened bottle of FML after the expiry date which is stated
on the bottle label and on the carton after “EXP”. The expiry date refers to
the last day of that month.
If you use more FML than you should
If you use more drops of FML than you should, it is unlikely to cause you
any harm. If you have placed too many drops in your eye(s), wash your
eyes with clean water. Put your next dose in at the usual time.
If you drink FML by accident
If anyone drinks FML by accident, it is unlikely to cause any harm. The affected
person should drink fluids to dilute.
If you forget to use FML
If you forget a dose, use FML as soon as you remember, unless it is almost
time for your next dose. Then use your next dose at the usual time. Do not
take a double dose to make up for a forgotten dose.
If you stop using FML
To work properly FML should be used as advised by your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor
Do not store above 25°C. Do not freeze.
You must throw away the bottle 28 days after you first opened it, even if
there are still some drops left. To help you remember, write down the date
you opened it in the space provided on the carton.
Keep the container tightly closed to prevent contamination.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What FML contains
The active substance is fluorometholone 1 mg/ml.
The other ingredients are polyvinyl alcohol, benzalkonium chloride, edetate
disodium, sodium chloride, disodium phosphate heptahydrate, sodium
dihydrogen phosphate monohydrate, polysorbate 80, sodium hydroxide
(for pH adjustment), and purified water.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.