Restasis eye drops contain cyclosporine which is an immunosuppressant. Cyclosporine can increase tear production that has been reduced by inflammation in the eye(s).

Restasis eye drops are used to treat chronic dry eye that may be caused by inflammation.

Restasis ophthalmic emulsion may also be used for treating eye disease not listed in this medication guide.

Do not touch the Restasis dropper on to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated (dirty), it could cause an infection in the eye(s).

Do not use this medicine while wearing contact lenses. Contact lenses may be reinserted 15 minutes following the administration of Restasis eye drops, unless otherwise directed by your doctor.

Before taking this medicine

You should not use Restasis if you are allergic to cyclosporine.

Restasis is likely safe in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Restasis passes into breast milk or if it could harm a nursing baby, although it is likely safe. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 16 years old.

Use Restasis eye drops exactly as directed by your doctor. Follow all directions on your prescription label. Do not use the eye drops in larger or smaller amounts or for longer than recommended.

The usual dose is 1 drop in each eye twice daily. Use Restasis eye drops every 12 hours (approximately).

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before using the eye drops.

To apply the eye drops:

• Turn the bottle upside down a few times to gently mix the medicine. Restasis eye drops should appear white in color.

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Wait at least 15 minutes before using artificial tears, or any other eye drops your doctor has prescribed.

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

Do not use the drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use bottle of Restasis is for one use only (in one or both eyes). Throw away the bottle after one use, even if there is still some medicine left in it.

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

1 drop 2 times a day in each eye approximately 12 hours apart

Restasis can be used concomitantly with artificial tears, allowing a 15 minute interval between products.

You should not use Restasis if you are allergic to cyclosporine.

Restasis is likely safe in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Restasis passes into breast milk or if it could harm a nursing baby, although it is likely safe. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 16 years old.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

An overdose of Restasis is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

You should not put Restasis in your eyes while wearing contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses. It may be best not to wear contact lenses if you have dry eyes. Talk with your doctor about your own risk.

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

Stop using this medicine and call your doctor at once if you have:

• eye pain; or

• eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection).

Common Restasis side effects may include:

• mild burning or stinging in the eyes;

• mild redness or itching;

• blurred vision; or

• feeling like something is in your eye.

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 FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on cyclosporine used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.