Podofilox Topical Solution

What is this medication?

PODOFILOX (po do FIL ox) treats warts on and around the genital area caused by a virus. It does not kill the virus and it may still be possible to spread the virus to others. It will not treat infections caused by bacteria.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Condylox

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Large areas of burned or damaged skin
• An unusual or allergic reaction to podofilox, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only on the skin. Do not take by mouth. The solution may be used on the outside (external) areas of the skin around the vagina or penis to remove warts. The solution should not be used in the area between the rectum and the genitals. The solution should only be used on the outside skin. It should not be used to treat warts that are inside the rectum, vagina, or penis. Do not use this medication more often or for longer than directed. Do not use a larger dose than directed by your care team.

Wash hands before and after use. Read package directions carefully before using. Apply the medication to the specific wart as instructed by your care team. Apply the solution using the applicator provided or a cotton-tipped applicator. Applicators should not be re-used. Additionally, used applicators should not be dipped into the bottle to prevent contamination. After application, you should make sure that the medication is dry before normal, untreated skin comes into contact with the treated skin. This medication can cause severe irritation of normal skin. If contact with normal skin occurs, immediately flush the area thoroughly with water.

Talk to your care team about the use of this medication in children. Special care may be needed.

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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other medications on the affected area without talking to your care team.

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better within one week or if they get worse. This medication is not a cure. New warts may develop during or after treatment.

The weekly treatment course can be repeated up to 4 times. If the wart does not resolve in 4 weeks, a different treatment should be considered. If you are pregnant or think you might be pregnant, contact your care team.

Sexual (genital, oral, anal) contact should be avoided while the medication is on the skin.

The only way to prevent infecting others with the HPV virus (the virus that causes genital warts) is to avoid direct skin-to-skin contact. If warts are visible in the genital area, sexual contact should be avoided until the warts are treated. Experts advise that using latex condoms during sexual contact may reduce, but not entirely prevent, infecting others.

Avoid contact with the eyes. If eye contact occurs, immediately flush the eye with large quantities of water for 15 minutes and seek medical attention.

This medication contains alcohol and is flammable. Do not use near heat, open flame, or while smoking.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skin

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

• Dizziness
• Mild skin irritation, redness, or dryness
• Trouble sleeping
• Vomiting

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

This medication is flammable. Avoid exposure to heat, fire, flame, and smoking.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.