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|FML-S Suspension FML-S

FML-S Suspension

FML-S Suspension is used for:

Treating inflammation (swelling, warmth, redness, pain) of the eyes and eyelids when infection or risk of infection is present.

FML-S Suspension is a combination corticosteroid and antibiotic. The corticosteroid decreases inflammation and the antibiotic treats or prevents infection.

Do NOT use FML-S Suspension if:

• you are allergic to any ingredient in FML-S Suspension, to sulfonamides (eg, sulfamethoxazole), or to other corticosteroids (eg, prednisone)
• you have a viral infection of the eye (eg, herpes), a fungal or tuberculosis infection of the eye, certain untreated eye infections (eg, infections producing pus or discharge), or vaccinia or chickenpox infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using FML-S Suspension:

Some medical conditions may interact with FML-S Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have thinning of the eye tissues (eg, cornea, sclera), other eye problems (eg, glaucoma, cataracts, nerve damage), or diabetes
• if you have recently had cataract surgery

Some MEDICINES MAY INTERACT with FML-S Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Silver-containing medicines (eg, silver nitrate) because they may decrease FML-S Suspension"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if FML-S Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use FML-S Suspension:

Use FML-S Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• To use FML-S Suspension in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using FML-S Suspension. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Do not use FML-S Suspension if it is dark brown.
• If your doctor prescribed more than 1 eye medicine, find out the best order for using each medicine.
• To clear up your infection completely, use FML-S Suspension for the full course of treatment. Keep taking/using it even if you feel better in a few days.
• FML-S Suspension works best if it is taken at the same time each day.
• Continue to use FML-S Suspension even if you feel well. Do not miss any doses.
• If you miss a dose of FML-S Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use FML-S Suspension.

Important safety information:

• FML-S Suspension may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use FML-S Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• FML-S Suspension only works against bacteria; it does not treat viral infections
• Be sure to use FML-S Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of FML-S Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If your symptoms do not get better within 2 days or if they get worse, check with your doctor.
• Lab tests, including eye pressure, may be performed while you use FML-S Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• FML-S Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using FML-S Suspension while you are pregnant. It is not known if FML-S Suspension is found in breast milk after use in the eye. Do not breast-feed while using FML-S Suspension.

Possible side effects of FML-S Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; taste changes; temporary burning or stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continuing blurred vision; discharge from eyes; eye pain, itching, redness, swelling, irritation, or sores not present when you began using FML-S Suspension; fever, chills, or sore throat; red, swollen, or blistered skin; unusual tiredness or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store FML-S Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep FML-S Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about FML-S Suspension, please talk with your doctor, pharmacist, or other health care provider.
• FML-S Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about FML-S Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.