Amlexanox (patient information)

Why this medication is prescribed

Amlexanox is used to treat ulcers of the mouth called aphthous ulcers or canker sores. It decreases the time ulcers take to heal. Because amlexanox decreases the healing time, it also decreases the pain you feel.

This medication is sometimes prescribed for other uses; ask your doctor, dentist, or pharmacist for more information.

How this medication should be used

Amlexanox comes as a beige-colored paste. Amlexanox should be used as soon as possible after noticing symptoms of an ulcer. Amlexanox is usually applied four times a day, following brushing and flossing after breakfast, lunch, dinner, and at bedtime. Squeeze 1/4 inch of the paste on your finger. With gentle pressure, dab amlexanox onto each ulcer in the mouth. Wash hands immediately after using amlexanox. Amlexanox is only used until the ulcer has healed, usually within 10 days. Contact your physician or dentist if significant healing has not occurred within 10 days.

Follow the directions on your prescription label carefully, and ask your doctor, dentist, or pharmacist to explain any part you do not understand. Use amlexanox exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or dentist.

Special Precautions

Before using amlexanox:

• tell your doctor or dentist and pharmacist if you are allergic to amlexanox or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins and herbal products.
• tell your doctor or dentist if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using amlexanox, call your doctor or dentist.

What to do if you forget a dose

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Amlexanox may cause side effects. Tell your doctor or dentist if any of these symptoms are severe or do not go away:

• slight pain, stinging, or burning of the skin that comes and goes
• nausea
• diarrhea

Severe Side Effects

If you experience the following symptom, call your doctor or dentist immediately:

• rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Other information

Keep all appointments with your doctor or dentist. Amlexanox is for external use only. Do not let amlexanox get into your eyes. If it does get into your eyes, rinse them promptly.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. Tell your doctor or dentist if your ulcers get worse or do not get better within 10 days.

Brand names

• Aphthasol®