Imiquimod Topical cream

What is this medicine?

IMIQUIMOD (i mi KWI mod) cream is used to treat external genital or anal warts. It is also used to treat other skin conditions such as actinic keratosis and certain types of skin cancer.

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:

• decreased immune function
• an unusual or allergic reaction to imiquimod, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Apply just before bedtime. Wash your hands before and after use. Apply a thin layer of cream and massage gently into the affected areas until no longer visible. Do not use in the mouth, eyes or the vagina. Use this medicine only on the affected area as directed by your health care provider. Do not use for longer than prescribed. It is important not to use more medicine than prescribed. To do so may increase the chance of side effects.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 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?

Interactions are not expected. Do not use any other medicines on the treated area without asking your doctor or health care professional.

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?

Visit your health care professional for regular checks on your progress.

Do not use this medicine until the skin has healed from any other drug (example: podofilox or podophyllin resin) or surgical skin treatment.

Females should receive regular pelvic exams while being treated for genital warts. Most patients see improvement within 4 weeks. It may take up to 16 weeks to see a full clearing of the warts. This medicine is not a cure. New warts may develop during or after treatment. Avoid sexual (genital, anal, oral) contact while the cream is on the skin. If warts are visible in the genital area, sexual contact should be avoided until the warts are treated. The use of latex condoms during sexual contact may reduce, but not entirely prevent, infecting others. This medicine may weaken condoms, diaphragms, cervical caps or other barrier devices and make them less effective as birth control. Do not cover the treated area with an airtight bandage. Cotton gauze dressings can be used. Cotton underwear can be worn after using this medicine on the genital or anal area.

Actinic keratoses that were not seen before may appear during treatment and may later go away. The treatment area and surrounding area may lighten or darken after treatment with this medicine. These skin color changes may be permanent in some patients.

If you experience a skin reaction at the treatment site that interferes or prevents you from doing any daily activity, contact your health care provider. You may need a rest period from treatment. Treatment may be restarted once the reaction has gotten better as recommended by your doctor or health care professional.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

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:

• open sores with or without drainage
• skin infection
• skin rash
• unusual or severe skin reaction

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

• burning or itching
• redness of the skin (very common but is usually not painful or harmful)
• scabbing, crusting, or peeling skin
• skin that becomes hard or thickened
• swelling of the skin

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 the reach of children.

Store between 4 and 25 degrees C (39 and 77 degrees F). Do not freeze. Throw away any unused medicine after the expiration date. Discard packet after applying to affected area. Partial packets should not be saved or reused.

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.