Elidel: Patient Product Information

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What is Elidel?
Elidel is a prescription medicine you put on your skin (topical) to treat atopic dermatitis, also known as eczema. ELIDEL is for use on the skin only. ELIDEL is for adults and children age 2 years and older. You can use ELIDEL for short or intermittent long periods of treatment. Intermittent means starting and stopping repeatedly, as directed by your doctor.

You can use it on all affected areas of your skin, including your face and neck.

Who should not use ELIDEL?
If you are pregnant or a nursing mother, you should use ELIDEL only if your doctor determines that it is clearly necessary. It is not known if the medicine in ELIDEL will pass through your milk to the baby.

If you have a skin condition called Netherton’s syndrome, ask your doctor before you start using ELIDEL.

If you are allergic to ELIDEL or any of its ingredients. The active ingredient is pimecrolimus. If you need to know the inactive ingredients, ask your doctor or pharmacist.

If you think you have a viral infection of your skin, like chicken pox or herpes, do not apply ELIDEL on these areas. Check with your doctor about what to do. Before you start using ELIDEL, tell your doctor if you are:

• using any other prescription medicines, non-prescription (over-the-counter) medicines, supplements or herbal medicines. Some medicines should be used carefully if you use ELIDEL.
  
• receiving any form of light therapy (phototherapy, UVA or UVB) on your skin.
  
• using any other type of skin product.
  
• pregnant or planning to become pregnant.

ELIDEL may not be right for you.

How should I use ELIDEL?
Use ELIDEL only to treat eczema that has been diagnosed by a doctor. Wash your hands before using ELIDEL.

Use ELIDEL only on your skin. Apply a thin layer of ELIDEL to the affected skin twice daily as directed by your doctor. You can apply ELIDEL Cream on affected areas on all skin surfaces, including your face, head, and neck. Avoid contact with your eyes.

You can use moisturizers with ELIDEL. Because the skin of patients with eczema can be very dry, you should discuss good skin care practices with your doctor to keep your skin healthy and moisturized. If you use moisturizers, apply them after ELIDEL.

If you are a caregiver applying ELIDEL Cream to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying ELIDEL. This should remove any cream left on the hands.

Do not cover the skin being treated with bandages, dressings or wraps. However, you can wear normal clothing. Do not bathe, shower or swim right after applying ELIDEL. This could wash off the cream.

Do not use this medication for any disorder other than that for which it was prescribed. Do not use ELIDEL in the eyes. Do not swallow ELIDEL. If your condition gets worse at any time or you see no improvement after 6 weeks of treatment, contact your doctor.

What should I avoid while using ELIDEL?
Avoid sunlight and sun lamps, tanning beds, and treatment with UVA or UVB light. If you need to be outdoors after applying ELIDEL, wear loose fitting clothing that protects the treated area from the sun. In addition, ask your doctor what other type of protection from the sun you should use.

Check with your doctor or pharmacist before you

• start taking any new medicines while using ELIDEL.
  
• start using any other ointment, lotions, or creams on your skin.

What are the possible side effects of ELIDEL?
The most common side effect at the site of application is burning or a feeling of warmth. The burning feeling is usually mild or moderate, occurring in the first 5 days of treatment, and the burning usually clears up in a few days. See your doctor if an application site reaction is severe or persists for more than 1 week.

Other common side effects include headache, and with long-term intermittent use, nasopharyngitis (common cold/stuffy nose), influenza, pharyngitis (sore throat), fever, viral infection, and cough. Some people may get herpes skin infections (like cold sores, chicken pox, or shingles), warts, or swollen lymph nodes (glands).

See your doctor if side effects continue or become a problem.

How should I store ELIDEL?
Store ELIDEL at room temperature (59°F to 86°F). Do not freeze. For instance, never leave ELIDEL in your car in cold or hot weather. Make sure the cap on the tube is tightly closed. Keep ELIDEL out of the reach of children.

General advice about ELIDEL
Do not use ELIDEL for a condition for which it was not prescribed. If you have any concerns about ELIDEL, ask your doctor. Your doctor or pharmacist can give you information about ELIDEL that was written for health care professionals. For more information, you can also call the ELIDEL help line at 877-4 ELIDEL (877-435-4335).

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