Aczone

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet if available from your pharmacist before you start using dapsone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Wash your hands before and after applying this medication. Gently clean the affected skin with a mild/soapless cleanser and pat dry. Apply a small amount of medication (about the size of a pea) in a thin layer to the affected areas of skin as directed by your doctor. Depending on your brand, this medication is usually used once or twice a day. Rub in gently. Be careful to avoid the eyes and lip area.

Use this medication on the skin only. Do not apply to the inside of the mouth/nose or in or around the groin/vaginal area.

Avoid getting this medication in your eyes. If this occurs, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

Use this product regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not use a larger amount or use it more often than directed. Your skin will not improve any faster and you may have a greater risk of side effects.

Tell your doctor if your condition does not get better or if it gets worse after 12 weeks.

Skin redness, peeling, oiliness, or dryness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, agitation), unusual tiredness/weakness, dark urine, shortness of breath.

Get medical help right away if you have any very serious side effects, including: blue/grey lips or nails.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to dapsone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme deficiency (G6PD deficiency), a certain blood disorder (methemoglobinemia).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Dapsone passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: dapsone taken by mouth, drugs to treat malaria (such as chloroquine), trimethoprim/sulfamethoxazole, other medications applied to the skin.

Benzoyl peroxide is a commonly used medication for acne. Using benzoyl peroxide at the same time as dapsone gel may cause your skin to temporarily change color (yellow/orange). Talk with your doctor or pharmacist and ask if you should be using prescription or non-prescription benzoyl peroxide products and how to use them safely.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers, or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

If you forget to use this medication, use it as soon as you remember if it is the same day. If you don't remember until the next day, apply your next dose at the regular time.