Vyloma (Imiquimod) cream belongs to a group of medications called immune response modifiers. It works by stimulating the body's defenses to fight certain types of skin conditions. Vyloma (Imiquimod) cream is used to treat adults with external genital and perianal Warts caused by the human papillomavirus (HPV). The external genital area includes skin surfaces on and around the vagina or penis. The perianal area includes skin surfaces surrounding the anus (the opening through which fecal matter is passed).

Vyloma (Imiquimod) may be available under multiple brand names and/or in several different forms. Any specific brand name of Vyloma (Imiquimod) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Vyloma (Imiquimod) may not be used for all of the conditions discussed here.

Your doctor may have suggested Vyloma (Imiquimod) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Vyloma (Imiquimod), speak to your doctor. Do not stop using Vyloma (Imiquimod) without consulting your doctor.

Do not give Vyloma (Imiquimod) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Vyloma (Imiquimod) if their doctor has not prescribed it.

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Vyloma (Imiquimod) is used by applying it to the affected area, once daily. You may apply up to 1 full actuation of the pump to the treatment area.

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 Vyloma (Imiquimod) cream to the affected skin area once a day just before going to bed. Apply a thin layer of Vyloma (Imiquimod) onto the clean, dry wart area and rub gently into skin until the cream is absorbed. Wash your hands after using the medication. Do not apply an occlusive dressing (made of airtight material) over Vyloma (Imiquimod).

Women using Vyloma (Imiquimod) to treat genital warts should be careful when applying Vyloma (Imiquimod) around the vaginal opening. Do not apply this mediation inside the vagina. If Vyloma (Imiquimod) is being used to treat perianal warts it should not be applied inside the anus.

Leave the medication on the skin area for 8 hours, and then remove it by washing the treated area with mild soap and water. Continue to use Vyloma (Imiquimod) until the warts have completely cleared, but do not use it for longer than 8 weeks. A rest period from the medication for several days may be taken depending on your discomfort and the severity of skin reactions as directed by your doctor. Treatment should not last longer than 8 weeks even if a rest period is taken.

Before using a new pump container, the pump must be primed. Remove the cap and press down on the pump one or more times until cream is dispensed. Discard this cream and then press down on the pump to get a full dose of cream.

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 taking the medication without consulting your doctor.

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

It is important to use Vyloma (Imiquimod) 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 take 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 Vyloma (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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Vyloma (Imiquimod). If you are concerned about side effects, discuss the risks and benefits of Vyloma (Imiquimod) with your doctor.

The following side effects have been reported by at least 1% of people taking Vyloma (Imiquimod). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back or joint pain
• blistering on skin
• burning or stinging of skin (mild)
• Diarrhea
• fatigue
• flaking or peeling of skin
• hardening of skin
• headache
• lightened or darkened skin colour where skin is treated
• nausea
• pain or irritation at the site of application
• redness of skin (mild)
• scabbing, crusted skin
• skin itching
• swelling of skin (mild)
• vaginal infection (symptoms may include itching, burning, or discharge)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• any sign or symptom in the treatment area that makes daily activity difficult or impossible
• any sign or symptom that makes it difficult to continue applying the medication
• difficulty urinating
• flu-like symptoms (e.g., Fever or chills, headache, muscle aches, nausea)
• open sores or scabs on skin
• rash
• skin bleeding
• symptoms of an infection (e.g., coughing, sore throat, muscle or joint pain, swollen glands, fatigue)

Stop using the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Vyloma (Imiquimod).

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Each gram of off-white to faintly yellow cream contains Vyloma (Imiquimod) 37.5 mg (3.75%). Nonmedicinal ingredients: isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben. Supplied as a pump container which delivers 235 mg of cream with each actuation.

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

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There may be an interaction between Vyloma (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 Vyloma (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 Vyloma (Imiquimod).

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

New genital and perianal warts: During treatment with Vyloma (Imiquimod) cream, new warts may develop, but may clear with treatment. Even though initial warts disappear with treatment, new warts may develop in the future and will require further treatment. It should be kept in mind that genital and perianal warts are considered to be a chronic condition, and Vyloma (Imiquimod) cream is not a cure.

Sexual contact: Avoid sexual contact while the cream is on your skin. The effect of Vyloma (Imiquimod) on the transmission of genital warts is unknown. Wash the medication off before sexual contact and reapply afterwards. Vyloma (Imiquimod) may weaken condoms and vaginal diaphragms; therefore, wash off Vyloma (Imiquimod) prior to using these barrier methods of birth control or use an alternate form of birth control.

Skin colour changes: Some people using Vyloma (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 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.

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

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

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

Children: The safety and effectiveness of using Vyloma (Imiquimod) have not been established for children under 18 years of age.

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