Aczone Gel

Aczone Gel is used for:

Treating acne.

Aczone Gel is a sulfone antibiotic. Exactly how Aczone Gel works to treat acne is not known.

Do NOT use Aczone Gel if:

• you are allergic to any ingredient in Aczone Gel
• you are taking an antimalarial medicine (eg, chloroquine) or oral dapsone

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

Before using Aczone Gel:

Some medical conditions may interact with Aczone 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 blood problems (eg, anemia) or a condition called glucose-6-phosphate dehydrogenase deficiency

Some MEDICINES MAY INTERACT with Aczone Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antimalarial medicines (eg, chloroquine) or oral dapsone because the risk of certain blood problems may be increased
• Trimethoprim/sulfamethoxazole because the risk of certain blood problems may be increased in certain patients
• Benzoyl peroxide because a temporary local yellow or orange discoloration of the skin or facial hair may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aczone 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 Aczone Gel:

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

• An extra patient leaflet is available with Aczone Gel. Talk to your pharmacist if you have questions about this information.
• Before applying Aczone Gel, gently wash and pat dry the area to be treated.
• Apply a pea-sized amount of Aczone Gel in a thin layer to the affected area. Rub in gently and completely.
• Wash your hands right away after using Aczone Gel.
• If you miss a dose of Aczone 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. If several applications are missed, contact your doctor or pharmacist.

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

Important safety information:

• Aczone Gel is for external use only. Do not get it in your eyes, mouth, or nose, or in the angles of your nose. Do not get it in your vagina. If you get it in any of these areas, rinse right away with cool water.
• Do not use other medicines or products on your skin while you are using Aczone Gel without first checking with your doctor.
• Aczone Gel may cause a temporary yellow or orange discoloration of skin and facial hair if used along with benzoyl peroxide.
• If your symptoms do not improve within 12 weeks or if they get worse, check with your doctor.
• Do not use Aczone Gel at a later time for other skin conditions without first checking with your doctor.
• Aczone 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.
• Aczone Gel should not be used in CHILDREN younger than 12 years old; 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 Aczone Gel while you are pregnant. Aczone Gel is found in breast milk. Do not breast-feed while taking Aczone Gel.

Possible side effects of Aczone 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:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Aczone Gel may be harmful if swallowed.

Store Aczone Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store with cap tightly closed away from heat, moisture, and light. Keep Aczone Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Aczone Gel, please talk with your doctor, pharmacist, or other health care provider.
• Aczone 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 Aczone 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.