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ELIDEL DRUG INFORMATION

GENERIC ELIDEL®: Pimecrolimus

ELIDEL USES

Elidel (Pimecrolimus) is used to control the symptoms of atopic dermatitis (a skin disease also called eczema). Elidel is only used to treat patients who cannot take other medications for atopic dermatitis, or whose symptoms have not been controlled by other medications. Elidel (Pimecrolimus) is in a class of medications called immunosuppressants. It works by stopping your immune system from producing the substances that cause eczema.

OTHER ELIDEL USES

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW TO USE ELIDEL

Elidel (Pimecrolimus) comes as a cream to be apply to the skin. It is usually applied twice daily for up to 6 weeks at a time. Carefully follow the directions on the prescription label. Ask your physician or pharmacist to explain any part you do not understand. Apply Elidel cream exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your physician.

Elidel should not be used regularly for a long time. You should only apply Elidel cream when you have symptoms of atopic dermatitis (eczema). Call your physician when your symptoms go away to find out if you should stop using Elidel. Also call your physician as soon as you notice that your symptoms have come back to find out if you should start using Elidel again.

It may take two weeks or longer before you feel the full benefit of Elidel, but your symptoms should improve within six weeks. Call your physician if your symptoms become worse at any time during treatment or if they do not improve after six weeks of treatment.

To use the Elidel cream, follow these steps:

• Wash your hands with soap and water.
  
  
• Apply a thin layer of Elidel cream to all affected areas of your skin. You can apply Elidel to all affected skin surfaces including your face, head and neck. Be careful to avoid getting the cream in your eyes or mouth.
  
  
• Rub the Elidel cream into your skin gently and completely.
  
  
• Wash your hands with soap and water to remove any leftover Elidel cream. But if you are treating your hands with Elidel, do not wash them.
  
  
• The treated area can be covered with normal clothes, but do not use any bandages, dressings or wraps.
  
  
• Be careful not to wash the cream off affected areas of your skin. Do not shower, bathe or swim immediately after applying Elidel cream.

ELIDEL DRUG INTERACTIONS and PRECAUTIONS

Before you buy Elidel cream,

Tell your physician and pharmacist if you are allergic to pimecrolimus or any other medications.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, especially the following. Your physician may need to change the doses of your medications or monitor you carefully for any side effects.

• antifungals such as:
  • ketoconazole (Nizoral)
  • fluconazole (Diflucan)
  • itraconazole (Sporanox)
• calcium channel blockers such as
  • verapamil (Calan, Isoptin, Verelan)
  • diltiazem (Cardizem, Dilacor, Tiazac, others)
• clarithromycin (Biaxin)
• cimetidine (Tagamet)
• cyclosporine (Neoral, Sandimmune)

IMPORTANT NOTE: This information is supplemental only, not a substitute for, the expertise and judgment of your physician, pharmacist or other healthcare provider. It should not be construed to indicate that use of this medication is appropriate, effective or safe for you. Consult your doctor or healthcare professional before this medicine is used

• delavirdine (Rescriptor)
• danazol (Danocrine)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fluvoxamine (Luvox)
• fluoxetine (Prozac, Sarafem)
• HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir)
• isoniazid (INH, Nydrazid)
• metronidazole (Flagyl)
• nefazodone (Serzone)
• oral contraceptives (birth control pills)
• troleandomycin (TAO)
• zafirlukast (Accolate).
• other ointments, creams, or lotions
• tell your physician if you have or have ever had
• any disease which affects your immune system such as
  • acquired immunodeficiency syndrome (AIDS)
  • cancer
  • severe combined immunodeficiency syndrome (SCID)
• Netherton's syndrome (a type of skin disease), or any kind of skin infection, especially:
  • chicken pox
  • eczema herpeticum
  • herpes
  • shingles

Tell your doctor if you are currently being treated with any form of light therapy such as phototherapy, UVA, or UVB

Avoid unnecessary or prolonged exposure to sunlight and wear protective clothing, sunscreen and sunglasses. Also avoid exposure to artificial sunlight such as tanning beds. Elidel (Pimecrolimus) cream may increase your risk of developing skin cancer if your skin is exposed to sunlight.

Avoid exposure to shingles, chicken pox and other viruses. If you are exposed to one of these while using Elidel, call your doctor immediately.

Talk to your doctor about the moisturizers you should use. Good skin care and moisturizers may help relieve your symptoms. Be sure to always apply them after applying Elidel cream.

ELIDEL and PREGNANCY

Tell your doctor if you are pregnant or trying to get pregnant.

ELIDEL and BREAST FEEDING

Tell your doctor if you are breast feeding.

ELIDEL DIETARY PRECAUTIONS

Talk to your physician about drinking grapefruit juice while taking Elidel.

ELIDEL AND CANCER

While using Elidel, skin cancer or lymph node cancer has developed in some patients. Although there is an Elidel cancer link, it is not known if Elidel cream caused the cancer to develop or if the patients would have developed cancer even if they had not used Elidel cream. If you are concerned about the cancer risk with Elidel, talk to your doctor.

ELIDEL OVERDOSE

If someone swallows Elidel (Pimecrolimus) cream, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

ELIDEL SIDE EFFECTS

Tell your physician if any of these Elidel side effects are severe or do not go away:

• burning warmth or redness in the areas where you applied Elidel which lasts more than 1 week
• cough
• headache
• red, runny or stuffy nose

The following Elidel side effects are uncommon, but if you experience any of them, call your physician immediately:

• bumps, warts, or other growths on your skin
• fever
• flu-like symptoms
• ear infection symptoms (pain, discharge or other signs)
• red or sore throat
• swollen glands in your neck

Elidel (Pimecrolimus) may cause other side effects. Call your physician if you have any unusual problems while taking this medication.

OTHER ELIDEL INFORMATION

Keep all appointments with your physician.

Do not let anyone else take your Elidel. Do not use Elidel cream to treat a skin condition other than the one for which it was prescribed. Ask your pharmacist any questions you have about a prescription refill.

ELIDEL MISSED DOSES

Apply the missed dose of Elidel as soon as you remember it. However, if it is almost time for your next dose, skip the missed one and continue your regular dosing schedule. Do not apply extra Elidel cream to make up for a missed dose.

ELIDEL STORAGE

Keep ELIDEL in its original container, tightly closed, and out of reach of children. Store it at room temperature and away from excessive heat and moisture. Do not store in the bathroom. Throw away any outdated or unused medicine. Talk to your pharmacist about the proper disposal of Elidel.

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