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FML

Active substance(s): FLUOROMETHOLONE

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Insert - FML® LIQUIFILM® - Great Britain - MoH Submission

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.
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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

FML® LIQUIFILM®
OPHTHALMIC 1 mg/ml
EYE DROPS SUSPENSION
Fluorometholone

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.

Marketing Authorisation Holder
Allergan Limited
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK

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

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland

1. WHAT FML IS AND WHAT IT IS USED FOR

This leaflet was last revised in September 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.

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.
Contact your doctor if you experience blurred vision or other
visual disturbances.

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

© 2017 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.

Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 72073MD201J
Drawing Number: 0106901

72073MD201J

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.

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.

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.

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.
If a drop misses your eye, try again.

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.

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 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
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)
Blurred vision
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.

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
this medicine.

5. HOW TO STORE FML

Keep out of the reach and sight of children.

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.
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.

+ Expand Transcript

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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