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FML 0.1% EYE DROPS SUSPENSION

Active substance(s): FLUOROMETHOLONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FML® 0.1% EYE DROPS SUSPENSION /
FLUOROMETHOLONE 0.1% EYE DROPS SUSPENSION
(fluorometholone)

Your medicine is available using one of the above names, but will be referred to as FML
throughout this leaflet.
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.

In
1.
2.
3.
4.
5.
6.

this leaflet:
What FML is and what it is used for
Before you use FML
How to use FML
Possible side effects
How to store FML
Further information

1.

WHAT FML IS AND WHAT IT IS USED FOR

2.

BEFORE YOU USE FML

FML is an eye drop. It contains a steroid which is used to treat inflammation of the eye.

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 breast-feeding. Your doctor will decide if you should use FML during pregnancy or
whilst breast-feeding. Normally it is not recommended for use.

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.

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.

2.

3.

4.

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.

1.

Tilt your head back and look at the ceiling.

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.

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.

4.

Let go of the lower lid, and close your eye for 30 seconds.

If you have or have been previously treated for herpes simplex, use FML only under close
supervision of your doctor.

5.

Repeat steps 2 to 4 for the other eye, if it also needs treatment.

The use of the bottle by more than one person may spread infection.

If a drop misses your eye, try again.

Using other medicines

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.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, even those obtained without a prescription.
If you are using other eye drops, leave at least 5 minutes before putting in FML.

Children

The safety and effectiveness in children aged 2 years or less have not been shown.

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.
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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.

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 the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.

5.

HOW TO STORE FML

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.

Keep out of the sight and reach of children.
Throw the bottle away 28 days after opening, even if there is solution remaining.
The product should not be used after the expiry date. (This is printed on both the bottle and
carton label). The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Do not use the product if the tamper-proof seal on the bottle is broken.
If your doctor decides to stop treatment, return any leftover eye drops to the pharmacist. Only
keep them if your doctor tells you to.
If the eye drops appear discoloured or show any other signs of deterioration, take them to your
pharmacist who will advise you.
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.

Affecting the eye

6.

FURTHER INFORMATION

Frequency - Common (affecting up to 1 in 10 patients):
Increased pressure inside your eye

The active ingredient in FML is: fluorometholone. Each ml contains 1mg of fluorometholone.

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 or pharmacist.

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.

Frequency not known:
Cataract (a loss of transparency of the lens of the eye with partial or complete loss of vision)
Eye irritation
Eye inflammation
Redness of the eye
Itching of the eye
Eye pain
A feeling that something is in your eye
Difficulty in seeing clearly
Swelling of the eyelid or eye
Eye discharge
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.

What FML contains

It also contains: polyvinyl alcohol, edetate disodium, benzalkonium chloride, polysorbate 80,
sodium phosphate dibasic, sodium phosphate monobasic, sodium chloride, purified water and
sodium hydroxide to adjust pH.

What FML looks like and contents of the pack

Appearance – cardboard outer containing one white plastic bottle containing 5ml white sterile
ophthalmic suspension, with a tamper evident strip seal.
FML is a sterile eye drop suspension and each bottle contains 5ml of the medicine.

Manufacturer

FML is manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster,
DN3 1QR.
PL No: 04423/0585

POM

Leaflet revision and issue date (Ref): 26.11.15
FML® is a registered trademark of Allergan, Inc.
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302
365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name
FML 0.1% EYE DROPS SUSPENSION /
FLUOROMETHOLONE 0.1% EYE DROPS SUSPENSION
Reference number
04423/0585

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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.

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