Aldara P

External genital and perianal warts: Before applying the cream, wash your hands with soap and water, and gently wash the treatment area with mild soap and water and allow the skin to dry thoroughly. Apply Aldara P (Imiquimod) cream to the affected skin area 3 times a week just before going to bed. (Examples of a 3-times weekly schedule include Monday/Wednesday/Friday and Tuesday/Thursday/Saturday.) Apply a thin layer of Aldara P (Imiquimod) onto the clean, dry wart area and rub gently into the skin until the cream is absorbed. Do not use the cream in your vagina. Wash your hands after using the medication. Do not apply an occlusive dressing (made of airtight material) over Aldara P (Imiquimod).

Leave the medication on the skin area for 6 to 10 hours, and then remove it by washing the treated area with mild soap and water. Continue to use Aldara P (Imiquimod) until the warts have completely cleared, but do not use it for longer than 16 weeks. A rest period from medication for several days may be taken depending on your discomfort and the severity of skin reactions, as directed by your doctor.

Actinic keratosis (AK): Before applying the cream, wash your hands with soap and water, and gently wash the treatment area with mild soap and water and allow the skin to dry thoroughly. Apply Aldara P (Imiquimod) cream to the affected skin area 2 times a week just before going to bed. (Examples of a 2-times weekly schedule include Monday/Thursday and Tuesday/Friday.) Apply a thin layer of Aldara P (Imiquimod) onto the clean, dry AK lesion and rub gently into the skin until the cream is absorbed. Avoid contact with eyes, lips, and nostrils. If the cream gets in your eyes, rinse them with large amounts of water. Wash your hands after using the medication. Do not apply an occlusive dressing (made of airtight material) over Aldara P (Imiquimod).

Leave the medication on the skin area for approximately 8 hours, and then remove it by washing the treated area with mild soap and water. Continue to use Aldara P (Imiquimod) for a total of 16 weeks, or as directed by your doctor. A rest period from medication for several days may be taken depending on your discomfort and the severity of skin reactions, as directed by your doctor.

Superficial basal cell carcinoma (sBCC): Before applying the cream, wash your hands with soap and water, gently wash the treatment area with mild soap and water and allow the skin to dry thoroughly. Apply the cream to the affected area 5 times a week just before going to bed. Apply a thin layer of Aldara P (Imiquimod) onto the affected area, making sure that the cream covers the entire area and at least 1 cm beyond the edges of the affected area. Gently rub the cream into the skin until the cream is absorbed. Wash your hands after using the medication. Do not apply an occlusive dressing (made of airtight material) over Aldara P (Imiquimod). Leave the medication on the skin area for approximately 8 hours, and then remove it by washing the treated area with mild soap and water. Treatment usually continues for 6 weeks. You should expect some skin irritation, but contact your physician if symptoms affect your ability to perform daily tasks. A rest period from medication for several days may be taken depending on your discomfort and the severity of skin reactions, as directed by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Use a new packet for each application. Your doctor will tell you the amount of cream you need to use. It may not be a full packet or the full amount of cream delivered by one actuation of the pump. Throw away the remainder of an opened packet each time. Remaining cream from one full actuation of the pump should also be discarded if you are using a smaller amount.

Aldara P (Imiquimod) is for external use only. Do not take it by mouth.

It is important that Aldara P (Imiquimod) be used exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and apply the cream at bedtime the next night. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Aldara P (Imiquimod) at room temperature, prevent it from freezing, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: occasionally, it may cause stinging and/or itching; it may cause tissues to break down at the site where the medication is used; it could cause water retention and swelling; it may cause local redness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each gram of off-white, oil-in-water cream contains Aldara P (Imiquimod) 50 mg (5%). Nonmedicinal ingredients: benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Supplied as single-use packets containing 250 mg of cream or a pump container which delivers 235 mg of cream with each actuation.

Do not use Aldara P (Imiquimod) cream if you are allergic to Aldara P (Imiquimod) or any ingredients of the medication.

There may be an interaction between Aldara P (Imiquimod) and any of the following:

• corticosteroids (e.g., Prednisone)
• echinacea
• medications that suppress the immune system (such as medications for cancer or organ transplants, e.g., Tacrolimus, Cyclosporine, Methotrexate)
• Pimecrolimus
• other medications applied to the skin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Aldara P (Imiquimod). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Aldara P (Imiquimod).

Exposure to sunlight: You should avoid or minimize any exposure to sunlight (including sunlamps) and use protective clothing (such as long sleeves and a hat) during treatment with Aldara P (Imiquimod) cream due to an increased risk of Sunburn. If you get a sunburn, stop using the medication until you are fully recovered.

Immunosuppressed individuals: The safety and effectiveness of Aldara P (Imiquimod) cream has not been determined for people with medical conditions that affect the immune system (e.g., HIV/AIDS, Lupus, psoriasis) or for people who take medications that reduce the effectiveness of the immune system. If you have any condition affecting the immune system, discuss with your doctor how Aldara P (Imiquimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aldara P (Imiquimod), and whether any special monitoring is needed.

New genital warts or actinic keratosis (AK) lesions: During treatment with Aldara P (Imiquimod) cream, new genital warts or AK lesions may develop, but may clear with treatment. Even though initial genital warts or AK lesions disappear with treatment, new lesions may develop in the future and will require further treatment. Keep in mind that genital warts and AK are considered chronic conditions, and Aldara P (Imiquimod) cream is not a cure.

Sexual contact: If you are applying Aldara P (Imiquimod) to the external genital area, avoid sexual contact while the cream is on your skin. The effect of Aldara P (Imiquimod) on the transmission of genital warts is unknown. Wash the medication off before sexual contact and reapply afterwards. Aldara P (Imiquimod) may weaken condoms and vaginal diaphragms; therefore, wash off Aldara P (Imiquimod) prior to using these barrier methods of birth control.

Skin colour changes: Some people using Aldara P (Imiquimod) cream notice that the area where the cream was applied has become lighter or darker. Sometimes the change in skin colour is permanent.

Skin conditions: Aldara P (Imiquimod) may worsen inflammatory skin conditions including a condition called chronic graft versus host disease.

Skin reactions: If you experience a severe skin reaction to this cream, wash the area with mild soap and water. Once the reaction has cleared, start using the cream again, unless your doctor has told you to stop using it.

Superficial basal cell skin cancer: The safety and effectiveness of Aldara P (Imiquimod) have not been established for basal cell skin cancer of the face, head, hands, feet, or anal and genital areas.

Uncircumcised men: If you use Aldara P (Imiquimod) to treat warts under the penis foreskin, you should pull back the foreskin and clean the area each morning.

Pregnancy: Aldara P (Imiquimod) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Aldara P (Imiquimod), contact your doctor immediately.

Breast-feeding: It is not known if Aldara P (Imiquimod) passes into breast milk. If you are a breast-feeding mother and are taking Aldara P (Imiquimod), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aldara P (Imiquimod) have not been established for children less than 18 years of age.

During treatment, avoid exposure to UV rays as much as possible and protect yourself when out in the sun. This medication is typically used 3 times a week. However, your pharmacist may have suggested a different schedule that is more appropriate for you.