Imiquimod is used to treat actinic keratoses (AK) which are precancerous growths on the skin. AK are caused by too much sun exposure. Treating this condition can decrease the risk of complications from them. It is also used to treat warts on the outside of the genitals/anus. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths.

This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

Read the Patient Information Leaflet if available from your pharmacist before you start using imiquimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication on the skin only. Apply this medication to the affected area as directed by your doctor, usually once a day. The number of times you apply this medication depends on the specific skin problem that is being treated. When treating actinic keratoses, apply once a day for 2 weeks. You will then rest the treated skin for the next two weeks by not applying any more imiquimod. After this rest period, you will resume applying this medication once a day for another 2 weeks. When treating warts, apply once a day until the warts clear or up to 8 weeks.

Do not apply this medication to broken skin (such as open wounds, infected areas, rash, burns). Also, do not apply this medication in the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, talk to your doctor right away.

If you are using the pump, prime the pump as directed before using it for the first time. If you are using the packet, use a new packet of cream for each use. Throw away any partly used packets of medication.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Before applying the medication, wash your hands and the area to be treated with soap and water, and dry thoroughly. Apply as directed by your doctor just before going to bed. Wash your hands with soap and water after each application. Do not cover the treated area with bandages or other waterproof coverings. Leave the cream on overnight, usually for about 8 hours. In the morning, wash the treated area with soap and water to remove the cream. Do not bathe or wet the treated area before the prescribed application time has passed. Do not use more imiquimod than prescribed or leave it on longer than prescribed by your doctor. Doing so may cause more severe skin reactions to occur.

Tell your doctor if your condition lasts or gets worse or if new growths appear during treatment.

Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal. Follow your doctor's directions.

Headache, loss of appetite, dizziness, diarrhea, nausea, or back pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• flu-like symptoms (such as fever, tiredness, muscle aches)
• swollen lymph nodes
• new unusual skin growths/changes
• chest pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using imiquimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• immune system problems

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Do not apply this medication onto sunburned skin. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.

To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, so they may not work as well to prevent pregnancy or spreading of HPV or HIV.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not apply this product on the same area of skin with other imiquimod-containing products.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Keep all medical appointments.

If you miss a dose, use it as soon as you remember. If you do not remember until the next day, skip the missed dose. Use your next dose at the regular time in the evening. Do not double the dose to catch up.

Store at room temperature. Do not freeze. Store the pump upright. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.