FML S.O.P.

FML S.O.P. (for the eyes) is a steroid medicine that helps treat eye inflammation due to surgery, injury, or other conditions.

FML S.O.P. may also be used for reasons not mentioned in this medication guide.

You should not use FML S.O.P. if you have any type of bacterial, fungal, or viral infection of the eye (including herpes).

You should not use fluorometholone if you are allergic to it, or if you have any type of bacterial, fungal, or viral infection of the eye (including herpes).

Tell your doctor if you have ever had:

• glaucoma; or
• cataracts.

It is not known if FML S.O.P. will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

FML S.O.P. should not be given to a child younger than 2 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

FML S.O.P. may cause serious side effects. Call your doctor immediately if you experience:

• pain behind your eyes, sudden changes in vision;
• slow healing after your eye surgery;
• eye pain, tunnel vision, or seeing halos around lights; or
• signs of a new eye infection, such as swelling, discharge, or crusting of your eyes.

Common side effects of FML S.O.P. may include:

• mild stinging or burning in your eyes;
• feeling like there is something in your eye;
• red or swollen eyelids;
• blurred vision; or
• drooping eyelids.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Wash your hands before using eye medication.

Shake the eye drops well just before each use.

To use the eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the number of drops your doctor has prescribed.

Do not the eye drops use while wearing soft contact lenses. A preservative in FML S.O.P. could permanently stain the lenses. Use the medicine at least 15 minutes before inserting your contact lenses.

To apply the ointment: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Squeeze a ribbon of ointment from the tube into this pocket. Blink your eye gently and then keep it closed for 1 or 2 minutes. Wipe excess ointment from your eyelashes using a clean tissue.

Do not touch the tip of the eye dropper or ointment tube or place it directly on your eye. A contaminated tube tip can infect your eye, which could lead to serious vision problems.

Call your doctor if your symptoms do not improve after 2 days of treatment.

If you use this medicine for longer than 10 days, you may need frequent vision tests to check the pressure inside your eyes.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

You should not stop using this medicine suddenly. Follow your doctor's instructions about tapering your dose.

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at once.

An overdose of FML S.O.P. is not expected to be dangerous. Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if someone has accidentally swallowed the medication.

Avoid driving or doing anything that needs clear vision. You may experience blurred vision for a short time.

Do not share FML S.O.P. with anyone else, even if they have the same symptoms as you.

Medicine used in the eyes is not likely to be affected by other drugs you use. However, many drugs can interact with each other. Inform all your healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products.