Protopic Ointment

Protopic Ointment is used for:

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Treating moderate to severe atopic dermatitis.

Protopic Ointment is a topical immunosuppressant. How it works is not completely understood. It is thought to decrease the cell activity that causes atopic dermatitis.

Do NOT use Protopic Ointment if:

• you are allergic to any ingredient in Protopic Ointment

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

Before using Protopic Ointment:

Some medical conditions may interact with Protopic Ointment. 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 are receiving any form of light therapy on your skin
• if you have a skin infection (eg, chickenpox, herpes, shingles), a weakened immune system, mononucleosis, swollen lymph nodes, erythroderma, Netherton syndrome, skin cancer, or kidney problems

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

Ask your health care provider if Protopic Ointment 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 Protopic Ointment:

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

• Protopic Ointment comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Protopic Ointment refilled.
• Protopic Ointment is for external use only. Do not get Protopic Ointment in your eyes, nose, or mouth.
• Dry your skin completely after a bath or shower before applying Protopic Ointment.
• Apply a thin layer of Protopic Ointment to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Protopic Ointment (if hands are not an area of treatment).
• Do not bathe, shower, or swim right after applying Protopic Ointment. This could wash off the ointment.
• Do not cover the treated area with bandages or other dressings, unless otherwise directed by your doctor.
• Continue using Protopic Ointment for 1 week after signs and symptoms of the condition clear up.
• If you miss a dose of Protopic Ointment, 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 Protopic Ointment.

Important safety information:

• Protopic Ointment may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Protopic Ointment. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• If you develop a skin infection, your symptoms get worse, or your symptoms do not improve after 6 weeks of treatment, contact your doctor.
• Protopic Ointment 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.
• Protopic Ointment should not be used in CHILDREN younger than 2 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 Protopic Ointment while you are pregnant. Protopic Ointment is found in breast milk. Do not breast-feed while taking Protopic Ointment.

Possible side effects of Protopic Ointment:

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:

Acne; burning, stinging, soreness, itching, or redness of skin; flu-like symptoms; headache; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; increased sensitivity to pain or touch; indigestion; nasal congestion; muscle pain; painful menstrual periods; sensitivity to pain; skin infection; swollen glands; swollen or infected hair follicles; weakness.

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. Protopic Ointment may be harmful if swallowed.

Store Protopic Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Do not store in the bathroom. Keep Protopic Ointment out of the reach of children and away from pets.

General information:

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