Epiduo Forte (Topical application)

Adapalene and benzoyl peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep using it.

This medicine may make your skin more sensitive to sunlight, wind, and cold weather. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, like a hat.

Skin reactions such as dryness, redness, scaling, burning, or stinging can happen when you use this medicine. Use a moisturizer as needed to reduce these skin issues.

Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, hair removal products, soaps or cosmetics that cause dryness, or products that contain alcohol, astringents, spices, or lime.

Do not use "waxing" as a hair removal method on skin areas treated with this medicine.

Allow this medicine to dry completely before getting dressed. This medicine may cause bleaching of clothes or hair.

In deciding to use a medicine, you must consider the risks against the benefits. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Epiduo® affects children younger than 9 years of age. Safety and effectiveness have not been established.

There have not been appropriate studies on how Epiduo® Forte affects children younger than 12 years of age. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of the adapalene and benzoyl peroxide combination.

Breast Feeding

There are no adequate studies in women to determine the risk to the infant when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Eczema (skin disorder) or
• Sunburn—This medicine should not be used by patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Dryness and peeling of the skin
• Flushing or redness of the skin
• Unusually warm skin

Less common

• Blistering, burning, crusting, or flaking of the skin
• Burning, itching, redness, skin rash, swelling, or soreness at the application site
• Scaling, severe redness, or swelling of the skin

Incidence not known

• Skin pain
• Sunburn

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Burning, dry, or itching eyes
• Change in the color of the treated skin
• Discharge or excessive tearing
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• Skin rash, encrusted, scaly, and oozing
• Swelling of the face

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Epiduo
• Epiduo Forte

Available Dosage Forms:

• Gel/Jelly
• Pad

Therapeutic Class: Antiacne

Chemical Class: Retinoid

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash the affected area of your skin with water and a mild soap. Rinse well and pat dry.
• Apply a small amount of the medicine to each affected area of the skin (eg, forehead, chin, cheeks, chest, shoulders, back), and gently rub it in.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (gel):For acne: Epiduo®: Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day. Children younger than 9 years of age—Use and dose must be determined by your doctor. Epiduo® Forte: Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.