Protopic contains tacrolimus monohydrate, which is a macrolide immunosuppressant. It is formulated as an ointment for topical dermatologic use, available in strengths of 0.03% or 0.1% tacrolimus by weight. The ointment includes key inactive ingredients such as mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your hands, only wash your hands before use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop. Apply a thin film of the medication to the affected area. Before applying this medication, the affected area should be patted dry. Do not cover the area with a dressing (bandage). You can wear normal clothing to cover the affected area. Do not bathe, shower, or swim right after applying this medication as it may wash off. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Burning, itching, crusting, or peeling of treated skin -Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue -Infection—fever, chills, cough, or sore throat -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Skin infection—skin redness, swelling, warmth, or pain -Swollen lymph nodes in the neck, groin, chest, or underarm area Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Acne -Headache -Muscle pain -Sensitivity to light -Small, red, pus-filled bumps on skin around hair follicles

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cutaneous T-cell lymphoma -Immune system problems -Infection, especially a viral infection such as chickenpox, cold sores, or herpes -Large areas of burned or damaged skin -Netherton syndrome -Recent or ongoing radiation -An unusual or allergic reaction to tacrolimus, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Alcoholic beverages or medications containing high percentages of alcohol -Calcium channel blockers, such as diltiazem, nifedipine, nimodipine, nisoldipine -Certain medications used to treat fungal infections, such as itraconazole, ketoconazole, and fluconazole -Cimetidine -Erythromycin -Vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. This medication may increase your risk of melanoma or skin cancer. Check your skin for changes to moles or for new growths while taking this medication. Call your care team if you notice any of these skin changes. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths. While you are using this medication, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Let your care team know if you notice such reactions. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What are the most serious risks of this medication?

This medicine may increase the risk of cancer. Do not use this medicine on infants or children younger than 2 years old. Children age 2 to 15 should only use the 0.03% medicine. The medicine comes in one other strength for anyone 16 and older.