Alcaftadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as itchy or watery eyes.

Alcaftadine ophthalmic (for the eyes) is used to prevent itching in the eyes caused by allergies.

Alcaftadine ophthalmic should not be used to treat eye irritation caused by contact lenses.

Alcaftadine ophthalmic may also be used for purposes not listed in this medication guide.

To make sure you can safely use alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.

Alcaftadine ophthalmic should not be used to treat eye irritation caused by contact lenses.

Do not use this medication while wearing contact lenses. Alcaftadine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using alcaftadine ophthalmic before putting your contact lenses in.

Alcaftadine ophthalmic should not be used in a child younger than 2 years old.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using alcaftadine ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the eye drops.

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

Do not use this medication while wearing contact lenses. Alcaftadine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using alcaftadine ophthalmic before putting your contact lenses in.

Wash your hands before using eye medication.

To apply 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 with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Use only the number of drops your doctor has prescribed.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

• Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

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

Usual Adult Dose for Allergic Conjunctivitis:

1 drop instilled into each eye once a day

Comments:
-Contacts should be removed before administration, and may be reinserted after 15 minutes.
-When additional ophthalmic medications are used, an interval of at least 5 minutes between each application is recommended.

Use: Prevention of itching associated with allergic conjunctivitis

Usual Pediatric Dose for Allergic Conjunctivitis:

2 years and older: 1 drop instilled into each eye once a day

Comments:
-Contacts should be removed before administration, and may be reinserted after 15 minutes.
-When additional ophthalmic medications are used, an interval of at least 5 minutes between each application is recommended.

Use: Prevention of itching associated with allergic conjunctivitis

You should not use this medication if you are allergic to alcaftadine.

To make sure you can safely use alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.

Alcaftadine ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether alcaftadine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Alcaftadine ophthalmic should not be used in a child younger than 2 years old.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not use other eye medications during treatment with alcaftadine ophthalmic unless your doctor tells you to.

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

Stop using alcaftadine ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the eye drops.

Less serious side effects may include:

• mild burning, stinging, or irritation;

• eye redness or itching;

• runny or stuffy nose, sore throat, flu symptoms; or

• headache.

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.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.