Uses of Tacrolimus 0.03% Ointment:

• It is used to treat eczema.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Tacrolimus 0.03% Ointment?

• If you have an allergy to tacrolimus or any other part of tacrolimus 0.03% ointment.
• If you are allergic to tacrolimus 0.03% ointment; any part of tacrolimus 0.03% ointment; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Skin areas that have cancers or pre-cancers, a skin disease called Netherton's syndrome, other skin problems that may weaken the skin, a skin infection (including chicken pox or herpes), or a weak immune system.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with tacrolimus 0.03% ointment.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tacrolimus 0.03% ointment with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tacrolimus 0.03% Ointment?

• Tell all of your health care providers that you take tacrolimus 0.03% ointment. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told by the doctor.
• Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Do not have any kind of light therapy while you are using tacrolimus 0.03% ointment.
• Talk with your doctor before you drink alcohol.
• Talk with your doctor before you use other drugs or products on your skin.
• Have your skin checked as you have been told by your doctor.
• It is common to have burning, stinging, soreness, or itching where tacrolimus 0.03% ointment is put on. Most of the time, these happen during the first few days of treatment and go away as skin gets better. Call your doctor if any of these effects are very bad, bother you, or do not go away.
• This medicine may cause harm if swallowed. If tacrolimus 0.03% ointment is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tacrolimus 0.03% ointment while you are pregnant.

How is this medicine (Tacrolimus 0.03% Ointment) best taken?

Use tacrolimus 0.03% ointment as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take tacrolimus 0.03% ointment by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on healthy skin.
• If you are not treating the skin on your hands, wash your hands after use.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Do not bathe, shower, or swim right after putting on.
• Stop tacrolimus 0.03% ointment when health problem is gone.
• If your signs do not get better after 6 weeks of care, talk with your doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Fever.
• Ear pain.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• A skin lump or growth.
• Swollen gland.
• Muscle pain.

What are some other side effects of Tacrolimus 0.03% Ointment?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin tingling.
• Skin irritation.
• Not able to handle heat or cold.
• Headache.
• Cough.
• Stuffy nose.
• Flu-like signs.
• Pimples (acne).
• Hair bumps.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tacrolimus 0.03% Ointment?

• Store at room temperature.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time tacrolimus 0.03% ointment is refilled. If you have any questions about tacrolimus 0.03% ointment, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.