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

Allergan Limited Marlow International The Parkway Marlow Bucks SL7 1YL UK

Manufacturer

Allergan Pharmaceuticals Ireland Castlebar Road

ALLERGAN

nr

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.

5.    How to store FML

6.    Further information

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.

*_@ALLERCAN

© 2014 Allergan, Inc., Irvine CA 92612 ® Marks owned by Allergan, Inc.

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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 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.

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.

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.

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

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) Affecting the body

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 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.

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.

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.