Pimecrolimus Topical cream

What is this medicine?

PIMECROLIMUS (pim e KROW li mus) is used on the skin to treat eczema.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cold sores or shingles
• decreased immune function
• Netherton's syndrome
• receiving any form of light therapy (phototherapy, UVA, or UVB) to your skin
• skin infection
• an unusual or allergic reaction to pimecrolimus, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is applied to the skin. Follow the directions on the prescription label. Wash your hands before and after use. If treating a hand infection, wash hands before use only. Apply a thin layer to the affected areas. Rub in gently and completely. Usually, you will continue using the cream until the areas heal. Do not cover the treated skin with bandages or other dressings. Do not use your medicine more often than directed or for other types of skin conditions unless directed by your health care provider.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• alcoholic beverages or medicines containing high percentages of alcohol
• calcium channel blockers like diltiazem, nifedipine, nimodipine, nisoldipine
• certain medicines used to treat fungal infections like itraconazole, ketoconazole, and fluconazole
• cimetidine
• erythromycin
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Improvements to your skin may occur after the first few weeks of treatment. Even though your skin looks better, it is important to keep using the cream as instructed by your health care provider. If you do not notice an improvement in your condition within 6 weeks or if your condition gets worse, tell your health care professional.

Avoid sunlight, sun lamps, tanning beds and treatment with UVA or UVB light while using this medicine. If you need to be outdoors after applying the cream, wear loose fitting clothing that protects the treated area from the sun. Ask your health care provider what other type of sun protection you should use.

Do not cover the skin being treated with bandages, dressings, or wraps. Unless otherwise instructed by your health care provider, do not apply another type of skin product on top of this medicine. However, you can wear normal clothing over the treated areas.

Do not bathe, shower, or swim right after applying this medicine. This could wash off the cream.

While you are using this medicine, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Let your doctor or health care professional know if you notice such reactions.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• chickenpox infection
• cold sores or shingles
• extreme tiredness
• hives
• infection at site of application
• skin bleeding or change in your skin's appearance (color, change in a mole or freckle, new growth)
• swollen glands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• irritation at the site or sites where you apply pimecrolimus including stinging, feeling of warmth or burning
• runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.