Uses of Pimecrolimus:

• 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 Pimecrolimus?

For all patients taking this medicine (pimecrolimus):

• If you have an allergy to pimecrolimus or any other part of this medicine (pimecrolimus).
• If you are allergic to this medicine (pimecrolimus); any part of this medicine (pimecrolimus); 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 taking any drugs that suppress your immune system. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding or plan to breast-feed.

Children:

• If your child is younger than 2 years of age. Do not give this medicine (pimecrolimus) to a child younger than 2 years of age.

This is not a list of all drugs or health problems that interact with this medicine (pimecrolimus).

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 this medicine (pimecrolimus) 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 Pimecrolimus?

• Tell all of your health care providers that you take this medicine (pimecrolimus). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid sun, sunlamps, and tanning beds. If you need to be outside after putting this medicine (pimecrolimus) on, wear clothing that protects the treated area from the sun. Talk with your doctor to see if you need to do anything else to protect you from the sun.
• Do not have any kind of light therapy while you are using this medicine (pimecrolimus).
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before you use other drugs or products on your skin.
• You may need to have your skin checked while you take this medicine (pimecrolimus). Talk with your doctor.
• This medicine may cause harm if swallowed. If this medicine (pimecrolimus) 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 this medicine (pimecrolimus) while you are pregnant.

How is this medicine (Pimecrolimus) best taken?

Use this medicine (pimecrolimus) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take this medicine (pimecrolimus) as you have been told by your doctor. Do not use more than you were told to use.
• Do not take this medicine (pimecrolimus) by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get this medicine (pimecrolimus) in any of these areas, rinse well with water.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Put on clean, dry skin.
• Put a thin layer on the affected skin and rub in gently.
• Do not use on open wounds or infected skin.
• Avoid putting on healthy skin.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Do not bathe, shower, or swim right after putting on.
• Stop this medicine (pimecrolimus) when health problem is gone.
• Use this medicine (pimecrolimus) for short periods of time. If signs show up again, talk with the doctor.
• 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 infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Swollen gland.
• Night sweats.
• A big weight loss.
• Warts.
• Cold sores.
• Skin ulcers.
• A skin lump or growth.
• Change in color or size of a mole.

What are some other side effects of Pimecrolimus?

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:

• Irritation where this medicine (pimecrolimus) is used.
• Feeling of warmth.
• Headache.
• Signs of a common cold.
• Nose or throat irritation.
• Flu-like signs.
• It is common to have burning, stinging, soreness, or itching where this medicine (pimecrolimus) 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.

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 Pimecrolimus?

• Store at room temperature. Do not freeze.
• 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 this medicine (pimecrolimus) is refilled. If you have any questions about this medicine (pimecrolimus), 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.