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FML EYE DROPS

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FML® EYE DROPS
®
(Fluorometholone)

To keep the eye drops free from contamination, 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.

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

If you use more FML than you should

The name of your medicine is FML Eye Drops, throughout the remainder of this leaflet your
medicine will be referred to as FML.

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

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 or pharmacist.

4. Possible side effects
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 glaucoma (increased pressure inside the eye), thinning of or a hole
in the surface of the eye, cataracts, or the development of an eye infection. The pressure in
your eye will be regularly measured.
If you have a red eye this may be caused by herpes simplex virus, and FML may make the
inflammation worse. Talk to your doctor or pharmacist before using FML.
If your skin is thinning and fine red lines and enlarged blood vessels are appearing, especially
on your face.

Using other medicines
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.
FML Liquifilm Ophthalmic Suspension.

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.

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
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)

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

Abnormality of the surface of the eye

Excessive dilatation of the pupil

Excessive tear production

Affecting the body
Frequency not known:

Rash, abnormal sense of taste, headache, dizziness, raised blood pressure
If any of the side effects get serious, or if you notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.

5 How to store FML

Driving and using machines
FML can cause temporary blurred vision. Should this occur, wait for the blurring to clear before
driving or operating machinery.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25° C. Do not freeze.

Important information about some of the ingredients of FML

This product is sterile until seal is broken. Do not use the eye drops if the tamper-proof seal is
broken.

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.

Discard 28 days after first opening the bottle.

Ask your doctor or pharmacist for advice before taking any medicine.

If your doctor decides to stop treatment, return any remaining eye drops to your pharmacist for
safe disposal. Only keep them if your doctor tells you to.

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.

The product should not be used after the expiry date. This is shown on the label, carton and the
bottle.
If you notice signs of deterioration in your eye drops, ask the advise of your pharmacist who will
tell you what to do.
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.

Instructions for use

6 Further information

You must not use the bottle if the seal on the bottle neck is broken before you first use it.

What FML contains
Shake the bottle before use. Wash your hands before opening the bottle.

Each millilitre of ophthalmic suspension contains 1mg of the active ingredient fluorometholone.

Use your eye drops in the following way:

The other ingredients are polyvinyl alcohol, disodium edetate, polysorbate 80, dibasic sodium
phosphate, monobasic sodium phosphate, sodium chloride, sodium hydroxide, purified water
and benzalkonium chloride (as preservative).

What FML looks like and contents of the pack
FML is a white sterile aqueous suspension supplied in a tamper-proof plastic dropper bottle.
The bottle contains 5ml of the suspension.
1.

2.

3.

4.

1. Tilt your head back and look at the ceiling.
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.
5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.

Marketing Authorisation Holder and Manufacturer
Manufactured by Allergan Pharmaceuticals (Ireland) Limited, Westport, Co. Mayo, Republic of
Ireland and procured within the E.U. and repackaged by the Product Licence holder Stephar
(UK) Limited, 3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk NR31 0NN.
FML is the registered trademark of Allergan Limited.
PRODUCT LICENCE NUMBER:
FML Eye Drops: PL 10256/0414

POM

If a drop misses your eye, try again.

Leaflet Ref: FML/S
Revision Date: 14.06.2012-F
© STEPHAR (UK) LTD
Print Date: xx/xx/xxxx

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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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