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Medication Guide

ELIDEL®
[EL-ee-del]
(pimecrolimus) Cream 1%

Important Note: ELIDEL (pimecrolimus cream) Cream is for use on the skin only (topical). Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum.

Read the Medication Guide that comes with ELIDEL (pimecrolimus cream) Cream before you or a family member start using it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about ELIDEL (pimecrolimus cream) Cream, ask your doctor or pharmacist.

What is the most important information I should know about ELIDEL (pimecrolimus cream) Cream?

It is not known if ELIDEL (pimecrolimus cream) Cream is safe to use for a long period of time. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But a link that ELIDEL (pimecrolimus cream) Cream caused these cancers use has not been shown. Because of this concern:

• Do not use ELIDEL (pimecrolimus cream) Cream continuously for a long time.
• Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
• Do not use ELIDEL (pimecrolimus cream) Cream on a child under 2 years old.

What is ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL (pimecrolimus cream) Cream is in a class of medicines called topical calcineurin inhibitors. ELIDEL (pimecrolimus cream) Cream is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL (pimecrolimus cream) Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL (pimecrolimus cream) Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.

It is not known if ELIDEL (pimecrolimus cream) Cream is safe and effective in people who have a weakened immune system.

ELIDEL (pimecrolimus cream) Cream is not for use in children under 2 years of age.

Who should not use ELIDEL (pimecrolimus cream) Cream?

Do not use ELIDEL (pimecrolimus cream) Cream:

• if you are allergic to ELIDEL (pimecrolimus cream) Cream or anything in it. See the end of this Medication Guide for a complete list of ingredients in ELIDEL (pimecrolimus cream) Cream.

What should I tell my doctor before starting ELIDEL (pimecrolimus cream) Cream?

Before you start using ELIDEL (pimecrolimus cream) Cream, tell your doctor about all of your medical conditions, including if you:

• have a skin disease called Netherton's syndrome (a rare inherited condition)
• have any infection on your skin including chicken pox or herpes
• have been told you have a weakened immune system
• are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I use ELIDEL (pimecrolimus cream) Cream?

• Use ELIDEL (pimecrolimus cream) Cream exactly as prescribed.
• Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
• Use ELIDEL (pimecrolimus cream) Cream for short periods, and if needed, treatment may be repeated with breaks in between.
• Stop ELIDEL (pimecrolimus cream) Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
• Follow your doctor's advice if symptoms of eczema return after a treatment with ELIDEL (pimecrolimus cream) Cream.
• Call your doctor if:
  • your symptoms get worse with ELIDEL (pimecrolimus cream) Cream
  • you get an infection on your skin
  • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply ELIDEL (pimecrolimus cream) Cream:

Read and carefully follow the directions below.

• Wash your hands before using ELIDEL (pimecrolimus cream) Cream. If you apply ELIDEL (pimecrolimus cream) Cream after a bath or shower, make sure your skin is dry.
• Apply a thin layer of ELIDEL (pimecrolimus cream) Cream only to the affected skin areas, two times each day, as directed by your doctor.
• Use the smallest amount of ELIDEL (pimecrolimus cream) Cream needed to control the signs and symptoms of eczema.
• If you apply ELIDEL (pimecrolimus cream) Cream to another person, or if you have eczema and are not treating your hands, it is important for you to wash your hands with soap and water after applying ELIDEL (pimecrolimus cream) Cream. This should remove any cream left on your hands.
• Do not bathe, shower or swim right after applying ELIDEL (pimecrolimus cream) Cream. This could wash off the cream.
• You can use moisturizers with ELIDEL (pimecrolimus cream) Cream. Make sure you check with your doctor first about the products that are right for you. People with eczema can have very dry skin, so it is important to keep up good skin care practices. If you use moisturizers, apply them after ELIDEL (pimecrolimus cream) Cream.

What should I avoid while using ELIDEL (pimecrolimus cream) Cream?

• You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL (pimecrolimus cream) Cream.
• Limit your time in the sun during treatment with ELIDEL (pimecrolimus cream) Cream even when the medicine is not on your skin. If you need to be outdoors after applying ELIDEL (pimecrolimus cream) Cream, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how ELIDEL (pimecrolimus cream) Cream may affect your skin with exposure to ultraviolet light.
• Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
• ELIDEL (pimecrolimus cream) Cream is for use on the skin only. Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL (pimecrolimus cream) Cream in any of these areas, burning or irritation can happen. Wipe off any ELIDEL (pimecrolimus cream) Cream from the affected area and then rinse the area well with cold water.
• Do not swallow ELIDEL (pimecrolimus cream) Cream. If you do, call your doctor.
• Avoid using ELIDEL (pimecrolimus cream) Cream on skin areas that have cancers or pre-cancers.

What are the possible side effects of ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream may cause serious side effects. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But, a link that ELIDEL (pimecrolimus cream) Cream caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with ELIDEL (pimecrolimus cream) Cream. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store ELIDEL (pimecrolimus cream) Cream?

• Store ELIDEL (pimecrolimus cream) Cream at room temperature between 59° to 86°F (15° to 30°C).
• Keep ELIDEL (pimecrolimus cream) Cream and all medicines out of the reach of children.

General advice about ELIDEL (pimecrolimus cream) Cream

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ELIDEL (pimecrolimus cream) Cream only for the condition for which it was prescribed. Do not give ELIDEL (pimecrolimus cream) Cream to other people even if they have the same symptoms you have, as it may not be right for them.

This Medication Guide summarizes the most important information about ELIDEL (pimecrolimus cream) Cream. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about ELIDEL (pimecrolimus cream) Cream that is written for health care professionals. For more information, you can also visit the Novartis Internet site at www.elidel (pimecrolimus cream) .com or call the ELIDEL (pimecrolimus cream) Cream help line at 877-4 ELIDEL (pimecrolimus cream) (877-435-4335).

What are the ingredients in ELIDEL Cream?

Active ingredient: pimecrolimus

Inactive ingredients: benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.