Uses

Podofilox solution is used to treat warts on the outside of the genitals. It stops the growth of the wart and the wart eventually falls off. Podofilox belongs to a group of drugs called antimitotics.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for a skin infection called molluscum contagiosum.

How To Use

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

This medication is for use on the skin only. Only apply this medication to the genital warts that your doctor has identified for you. Do not use this medication on warts around the anus or on the mucous membranes (such as in the urethra, rectum, and vagina), inside your body, or on any other skin growths.

Use this medication usually twice daily (once in the morning and once in the evening, every 12 hours), for 3 days in a row, followed by no treatment for the next 4 days. If the warts do not go away, you may repeat this 7-day cycle up to a total of 4 treatment weeks in a row. Follow your doctor's directions exactly.

First wash the area to be treated with soap and water, and dry thoroughly. Use an applicator that comes with this product, dip it into the solution just enough to wet it, but not so much that solution is dripping from the tip. Apply this medication only to the warts your doctor has directed you to treat. Do not apply it to the area surrounding the warts. It may help to use a hand mirror.

For warts within skin folds, pull the skin fold open and apply the medication. Let the medication dry before allowing the skin folds around the warts to return to their normal position.

Only use the applicator once. Do not dip it into the solution again. Throw it away in a safe place after use. Wash your hands with soap and water after each application.

Do not cover the treated area with bandages or other waterproof dressings. Covering the area with cotton gauze, or cotton underwear for the genital area, is permitted.

Use this medication regularly 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.

Avoid getting this medication in the eyes/nose/mouth, on healthy skin, or on other areas as mentioned above. If the medication gets on healthy skin, wipe it off right away and wash the area thoroughly with soap and water and rinse off. If the medication gets in your eyes, nose, or mouth, flush the area with plenty of water for 15 minutes and contact your doctor.

Do not apply a large amount of this medication or apply it to a large area. Ask your doctor or pharmacist for details. Do not use it more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition persists after 4 weeks of treatment, or if it worsens, or if new growths appear during treatment. Genital warts often return after treatment.

Side Effects

Redness, itching, burning, and pain may occur in the treated area. If any of these effects persist or worsen, or if you have bleeding, severe swelling, or severe pain, wash the medication off with soap and water. Stop using this medication and 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.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

Precautions

Before using podofilox, 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:

• injured/irritated/inflamed skin around the treated area
• recent surgery on the treated area

This medication is not a cure for genital warts. These warts are caused by a virus called human papillomavirus (HPV). Podofilox does not destroy the virus. It only helps to remove the warts, but new warts may form or old warts may return, during and after treatment.

Do not have sexual intercourse on the days you have applied this medication.

Genital warts are spread by sexual contact. Condoms (such as latex or polyurethane types) may help prevent the spread of genital warts to your partner. Consult your doctor or pharmacist for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

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

Drug Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

Overdose

This product may be harmful if swallowed. If too much of this medication is applied to the skin, wash it off with plenty of soap and water. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, diarrhea, fever, coma, trouble breathing, seizures.

Notes

Do not share this medication with others.

Keep all medical appointments.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from high heat and open flame. Do not freeze. Keep the container cap tightly closed. Keep all medicines 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 for more details about how to safely discard your product.