FML FORTE

INDICATIONS

FML Forte suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

INSTRUCTIONS

Use FML Forte as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Shake well before each use.
To use FML Forte, 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 eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean 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 your eye. Keep the container tightly closed.
Do not wear soft contact lenses while you are using FML Forte. Sterilize contact lenses according to the manufacturer’s directions and check with your doctor before using them.
If your doctor prescribed more than 1 eye medicine, find out the best order for using each medicine.
If you miss a dose of FML Forte, 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 Forte.

DOSAGE

Instill one drop into the conjunctival sac two to four times daily. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The dosing of FML Forte suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

STORAGE

Store FML Forte between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep FML Forte out of the reach of children and away from pets.

SAFETY INFORMATION

Do NOT use FML Forte if:

• you are allergic to any ingredient in FML Forte
• 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.

Some medical conditions may interact with FML Forte. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, plan 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 Forte. Because little, if any, of FML Forte is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if FML Forte 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.

FML Forte may cause blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to FML Forte.
If your condition does not improve within 2 days or if it becomes worse, check with your doctor.
LAB TESTS, including eye pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use FML Forte with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using FML Forte during pregnancy. It is unknown if FML Forte is excreted in breast milk after use in the eye. If you are or will be breast-feeding while you are using FML Forte, check with your doctor or pharmacist to discuss the risks to your baby.

SIDE EFFECTS

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.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions (rash; hives; 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 Forte.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.