When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to tacrolimus. Do not use this medicine on a child younger than 2 years of age.

How to Use This Medicine:
Ointment

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands before you apply this medicine. If you are not treating a skin rash on your hands, then you should also wash your hands with soap and water after you apply the medicine. However, do not wash your hands after if you are treating a rash on your hands. Do not bathe or swim immediately after applying this medicine. This could wash the medicine off.
• Apply a thin layer of the medicine to the affected area. Rub it in gently. Apply the medicine 2 times daily, at least 12 hours apart, unless your doctor tells you otherwise. Apply just enough to cover the area. Only apply this medicine to areas where eczema appears.
• You may apply a moisturizer to your skin after you apply the medicine, if your doctor approves it.
• Do not cover the treated area with a bandage unless directed by your doctor.
• This medicine is not for long-term use. Use the medicine only until your skin symptoms are gone. If the eczema comes back, you may start using the medicine again if your doctor approves. You must take breaks in between treatments.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), tacrolimus capsules (Prograf®), an antibiotic such as erythromycin (Ery-tab®), or an antifungal medicine such as fluconazole, ketoconazole, itraconazole, Diflucan®, Nizoral®, or Sporanox®. Tell your doctor if you are also using blood pressure medicines such as diltiazem, nifedipine, verapamil, Adalat®, Calan®, Cardizem®, Lotrel®, Plendil®, or Procardia®.
• Make sure your doctor knows if you are receiving any type of UV (ultraviolet) light treatment or phototherapy.
• Alcohol may cause flushing or redness in your face.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney problems, mononucleosis (mono), weakened immune system, or a history of an organ transplant. Tell your doctor if you have a skin infection, skin cancer, lymphoma, or skin absorption problems (such as lamellar ichthyosis, graft versus host disease, erythroderma, or Netherton syndrome).
• This medicine should not be used continuously for a long time. When the rash is gone, stop using the medicine. If your doctors says it is okay, you may start using the medicine again if the rash comes back, but you should allow time in between treatments.
• Call your doctor if your symptoms do not improve or if they get worse. Call your doctor if your symptoms do not improve within 6 weeks.
• Rarely, patients who have used the oral or topical forms of this medicine have developed skin cancer or lymphoma. It is not known if this was related to the medcine.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• This medicine may increase your chances of catching chicken pox, shingles, or herpes virus (including cold sores). Avoid people who have these infections. Call your doctor if you think you have been exposed to one of these illnesses.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Limit your time in the sun as much as possible. Cover the treated areas of your skin with loose clothing if you must be outside.
• This medicine may make you sick if it is not used correctly. Call a doctor or poison control center right away if you accidentally swallow this medicine.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Cold or flu symptoms such as fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• New skin problems, including chicken pox, shingles, or cold sores
• Swollen, painful, or tender glands in your neck, armpit, or groin

If you notice these less serious side effects, talk with your doctor:

• Acne
• Mild burning, stinging, tingling, redness, or itching when the medicine is applied
• Extra sensitive skin
• Headache
• Mild fever
• Swollen or infected hair follicles

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088