Amlexanox, Oral Patch

What are other names for this medicine?

Type of medicine: topical antiulcer

Generic and brand names: amlexanox, oral patch; OraDisc A

What is this medicine used for?

This medicine is a patch that is applied to the soft tissues of the mouth to treat canker sores (aphthous ulcers).

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• problems with your immune system

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not use more or less or use it longer than prescribed. Do not stop using this medicine without your healthcare provider's approval.

Apply the patch as soon as possible after you notice symptoms of a canker sore. Apply after you have brushed your teeth. Put the patch onto a sore (ulcer) in the mouth using gentle pressure. Use the patch daily until the ulcers heal.

Do not eat or drink for an hour after applying the patch. Apply the patch at least 80 minutes before bedtime, to make sure it has dissolved before you go to sleep. You may feel small particles in your mouth as the patch dissolves. These particles may be safely swallowed.

Wash your hands immediately after applying the patch. Keep the patch away from your eyes. If the patch gets into your eyes, rinse them with cool water.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

If the sores do not heal in 10 days or if you get a rash, contact your healthcare provider or dentist.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious: No serious side effects have been reported.

Other: Stinging, burning, irritation, or pain at the spot where patch is applied; nausea; diarrhea; sore throat; headache.

What products might interact with this medicine?

No significant interactions have been reported.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.