Azelaic Acid Gel

Azelaic Acid Gel is used for:

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Treating lesions due to mild to moderate rosacea.

Azelaic Acid Gel is a topical antibacterial. Exactly how Azelaic Acid Gel works to treat rosacea is unknown.

Do NOT use Azelaic Acid Gel if:

• you are allergic to any ingredient in Azelaic Acid Gel, including propylene glycol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Azelaic Acid Gel:

Some medical conditions may interact with Azelaic Acid Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of asthma or cold sores

Some MEDICINES MAY INTERACT with Azelaic Acid Gel. Because little, if any, of Azelaic Acid Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Azelaic Acid Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Azelaic Acid Gel:

Use Azelaic Acid Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Azelaic Acid Gel is only to be used on the skin. Before using Azelaic Acid Gel, wash the affected area with warm water and mild soap or a soap-free cleanser, rinse, and pat dry. Cover the affected area with a thin film of medicine. Gently rub the medicine into your skin.
• Wash your hands immediately before and after using Azelaic Acid Gel.
• Do not cover the affected area with gauze or a bandage unless your doctor tells you to do so.
• Continue to use Azelaic Acid Gel for the full course of treatment even if your condition improves. Do not miss any doses.
• If you miss a dose of Azelaic Acid Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azelaic Acid Gel.

Important safety information:

• It may take several weeks for Azelaic Acid Gel to work. If your symptoms do not get better within 12 weeks or if they get worse, check with your doctor.
• Azelaic Acid Gel is for external use only. Avoid getting Azelaic Acid Gel in your vagina, eyes, nose, or mouth. If Azelaic Acid Gel does get into your eyes, wash your eyes immediately with plenty of water. If eye irritation continues, contact your doctor.
• If you use topical products too often, your condition may become worse.
• Azelaic Acid Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Makeup may be applied over the affected area after the medicine dries.
• Avoid any food or liquids that may bring on redness, flushing, and blushing of the skin (eg, spicy foods, alcohol, hot drinks).
• Azelaic Acid Gel should be used with extreme caution in CHILDREN; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azelaic Acid Gel while you are pregnant. It is not known if Azelaic Acid Gel is found in breast milk. If you are or will be breast-feeding while you use Azelaic Acid Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azelaic Acid Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; temporary burning, itching, redness, stinging, or tingling at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in skin color; peeling, irritation, or inflammation of skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Azelaic Acid Gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Azelaic Acid Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Azelaic Acid Gel, please talk with your doctor, pharmacist, or other health care provider.
• Azelaic Acid Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Azelaic Acid Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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