FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, your pharmacist or your nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What FML is and what it is used for
2. What you need to know before you use FML
3. How to use FML
4. Possible side effects
5. How to store FML
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to fluorometholone or any of the other ingredients of this medicine (listed in section 6).
• if you have a bacterial, viral, or fungal infection of the eye.

Talk to your doctor, pharmacist or nurse before using FML.

You should not use FML for more than one week unless your doctor, pharmacist, nurse 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, pharmacist or nurse.

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

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

Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of FML and your doctor, pharmacist or nurse 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 been shown.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

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.

This medicine contains 0.046 mg benzalkonium chloride in each 1 ml

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor, pharmacist or nurse.

This medicine contains 1.91 mg phosphates in each 1 mL

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

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

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.

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 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 anyone drinks FML by accident, it is unlikely to cause any harm. The affected person should drink fluids to dilute.

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.

To work properly FML should be used as advised by your doctor, pharmacist or nurse.

Common (may affect up to 1 in 10 people)

Increased pressure inside your eye

Not known (frequency cannot be estimated from the available data)

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

Drooping eyelid(s)

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

Not known (frequency cannot be estimated from the available data):

Rash, abnormal sense of taste, allergic reactions (hypersensitivity)

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.

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.

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.

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. Not all pack sizes may be marketed.

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