Emedastine Difumarate Ophthalmic drops, solution

What is this medicine?

EMEDASTINE (em e DAS teen) is an antihistamine for use in the eye. It is used to prevent itching of the eye caused by allergies.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• wear contact lenses

• an unusual or allergic reaction to emedastine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Wash hands before and after use. If you wear contact lenses, remove them before using this medicine. Tilt the head back slightly and pull down the lower lid with the index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops (usually 1 drop) into the pouch. Close the eye gently. Do not blink. Use your medicine at regular intervals. Do not use it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye products without telling your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better in 2 or 3 days or if they get worse.

Report any serious side effects right away. Stop using this medicine if your eyes get inflamed, painful, or have a discharge, and see your doctor or health care professional as soon as you can.

Be careful not to touch the tip of the dispensing container onto the eye, or any other surface. Serious eye infections can result from contamination of eye solutions.

If you wear contact lenses, do not wear them if your eyes are red. This eye drop should not be used to treat contact lens-related irritation. If you wear soft contact lenses, you should wait at least 10 minutes after instilling the eye drops before inserting your contact lenses.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• burning, stinging, or discomfort immediately after using the solution

• blurred vision

• dry or bad taste in mouth

• headache

• itching

• runny or stuffy nose

• tearing of the eyes

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Keep container tightly closed when not in use. Store between 4 and 30 degrees C (39 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.