Podofilox Topical

WHY is this medicine prescribed?

Podofilox is used to treat warts in the genital and anal area.Podofilox is in a class of medications called keratolytic agents. It works by slowly killing cells in the tissue that makes up the wart.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Podofilox comes as a gel and solution (liquid) to apply to the skin.Your doctor will prescribe the product that is best for your condition.Apply twice a day for 3 days in a row and then skip using it for 4 days.This week-long cycle may be repeated up to 4 times until the wart tissue is not able to be seen.Apply podofilox at around the same times every day (morning and night).If you can still see the warts after 4 weeks of use, contact your doctor.

Use podofilox exactly as directed. Ask your doctor or pharmacist to explain any part you do notunderstand. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not have sexual intercourse on the days that you are applying the gel or solution.

Apply the gel to the wart with the applicator tip or with your finger to the wart. Apply the solution to the wart with the applicator provided. If the wart is in a skin fold, spread the skin apart to reach the wart.Try to avoid getting the gel or solution on the surrounding skin.Allow the gel or solution to dry before returning the opposite skin surfaces to their normal position.Wash your hands after use.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using podofilox,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances.Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.Use birth control to avoid pregnancy while you are using podofilox.

• you should know to avoid contact of podofilox gel or solution with the eyes.If contact occurs, immediately flush the eyes with a large amounts of water and get medical care right away.

• you should know that podofilox gel is flammable. Keep it away from open flames.

• you should know that genital warts can be passed between sexual partners.Make sure your partner has also been checked for genital warts.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel or solution to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Podofilox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching, burning, stinging, redness, or pain at the site of application

Some side effects can be serious. If you experience any of these symptoms, stop using podofilox and call your doctor immediately:

• bleeding, swelling, or excessive pain, burning, itching

Podofilox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).Do not freeze the gel or solution.

Keep all medication out of sight and reach of children as many containers are not child resistant.Always lock safety caps. Place the medication in a safe location – one that is up andaway and out of their sight and reach.https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot takethem. Do not flush this medication down the toilet. Use a medicine take-back program. Talk toyour pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal ofMedicines website (https://goo.gl/c4Rm4p) for more information.

What should I do in case of OVERDOSE?

If someone swallows podofilox, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. If you use too much solution or gel on the skin, wash away the drug and call your doctor if you have any symptoms.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicinesvitamins, minerals, and dietary supplements you are taking. Bring this list with you each timeyou visit a doctor or if you are admitted to the hospital. You should carry the list with you incase of emergencies.