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What is Aldara?
INDICATIONS:

Aldara (imiquimod) is an immune response modifier. Aldara is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Aldara (for the skin) is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Aldara also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts. Imiquimod may be used in adults and children who are at least 12 years.

Aldara may also be used for purposes not listed in this medication guide.

INSTRUCTIONS

Use Aldara as directed by your doctor.

Before applying Aldara, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use Aldara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Aldara.
Aldara is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating. Follow your doctor's instructions.
If you miss a dose, skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.
STORAGE

Store Aldara at room temperature away from moisture and heat. Do not freeze. Keep each packet unopened until you are ready to use it.

SAFETY INFORMATION

Do NOT use Aldara if you have any of these or other conditions:

sunburn or other skin problems;

a weak immune system or autoimmune disorder;

graft-versus-host disease;

if you have recently been treated for actinic keratosis or genital warts with surgery or other medications; or

if you have recently received a bone marrow transplant or cord blood transplant.

Avoid getting Aldara in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water. Do not use Aldara on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with Aldara unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Aldara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid having unprotected sex. Imiquimod is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission during sex.

SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction to Aldara: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.

Stop using Aldara and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands. When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using Aldara and call your doctor right away.
Uses
This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. 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.

How to use Aldara Cream In Packet
Read the Patient Information Leaflet provided by your pharmacist before you start using imiquimod and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Use this medication on the skin only. Apply this medication to the affected area once a day as directed by your doctor. The number of times and the length of time you apply this medication depend on the specific skin problem that is being treated. When treating actinic keratoses, apply twice a week for a full 16 weeks. When treating superficial basal cell carcinoma, apply 5 times a week for a full 6 weeks. When treating warts, apply 3 times a week for up to 16 weeks. If you have any questions about which days to apply this medication or how often or how long to use this medication, talk to your doctor or pharmacist.

Do not apply this medication into the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor right away.

Use this medication regularly in order to get the most benefit from it. To help you remember, use a calendar to mark the days you will be applying the medication each week. Before applying the medication, wash the area to be treated with soap and water, and dry thoroughly. Use a new packet of cream for each use. 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. Covering the area with cotton gauze, or cotton underwear if treating the genital area, is permitted. Leave the cream on overnight, usually for about 8 hours if treating actinic keratoses or basal cell carcinoma, or 6-10 hours for warts or as directed. 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 leave imiquimod cream on longer than prescribed by your doctor. Throw away any partly used packets of medication.

Tell your doctor if your condition persists or worsens or if new growths appear during treatment.
Side Effects
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 persist or worsen, 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.

Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.
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