PROTOPIC

How should I use PROTOPIC Ointment?

• Use PROTOPIC Ointment exactly as prescribed.
• Use PROTOPIC Ointment only on areas of your skin that have eczema.
• Use PROTOPIC Ointment for short periods, and if needed, treatment may be repeated with breaks in between.
• Stop PROTOPIC Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
• Follow your doctor's advice if symptoms of eczema return after treatment with PROTOPIC Ointment.
• Call your doctor if :
• your symptoms get worse with PROTOPIC Ointment.
• you get an infection on your skin.
• your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

• Wash your hands before applying PROTOPIC.
• Apply a thin layer of PROTOPIC Ointment twice daily to the areas of skin affected by eczema.
• Use the smallest amount of PROTOPIC Ointment needed to control the signs and symptoms of eczema.
• If you are a caregiver applying PROTOPIC Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying PROTOPIC. This should remove any ointment left on the hands.
• Do not bathe, shower, or swim right after applying PROTOPIC. This could wash off the ointment.
• You can use moisturizers with PROTOPIC Ointment. Make sure you check with your doctor first about the products that are right for you. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after PROTOPIC Ointment.

Protopic Ointment is a prescription ointment used to treat moderate to severe eczema. Protopic is for use after other prescription medicines have not worked or when a doctor recommends that other prescription medicines should not be used. Protopic should be used for short periods, and, if needed, treatment may be repeated with breaks in between. Protopic is available in two strengths. Adults may use either Protopic Ointment 0.1% or 0.03%. Children 2 to 15 years of age should only use Protopic Ointment 0.03%. Protopic should not be used on children younger than 2 years of age.

WARNING: The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However, a link with Protopic has not been shown. Patients should avoid using Protopic continuously for a long time and apply Protopic only to areas with eczema. If the eczema does not improve within 6 weeks, patients should talk to their doctor.

Protopic should not be used by patients who are allergic to any of its ingredients. The most common side effects with the use of Protopic are stinging, burning, or itching.

Patients should avoid natural or artificial sunlight (sun lamps or tanning beds). Patients should not use Protopic if they have a skin infection on the area of skin to be treated. The skin being treated should not be covered with bandages, dressings, or wraps.

Only your doctor can weigh the risks and benefits and decide if Protopic is right for you. Please see the Medication Guide and talk to your doctor if you have any questions.

Get emergency medical help if you have any of these signs of an allergic reaction to Protopic: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Protopic and call your doctor at once if you have a serious side effect such as:

• severe stinging, burning, itching, or soreness where the medicine is applied;
• swollen glands;
• redness or crusting around your hair follicles; or
• signs of a skin infection (redness, swelling, itching, oozing).

Less serious Protopic side effects may include:

• mild burning, stinging, or itching;
• skin redness;
• acne;
• cold or flu symptoms such as stuffy nose, sneezing, sore throat;
• headache; or
• feeling more sensitive to hot or cold temperatures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.