Podofilox Topical gel

What is this medicine?

PODOFILOX (po do FIL ox) is used to remove genital or perianal warts.

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

What should I tell my health care provider before I take this medicine?

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

• an unusual or allergic reaction to podofilox, podophyllum resin, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. This medicine may be used to remove warts on areas of the skin around the vagina or penis and between the rectum and the genitals. It should not be used to treat warts that are inside the rectum, vagina, or penis. Follow the directions on the prescription label. Wash hands before and after use. Apply the gel to the specific wart as instructed by your doctor or health care professional. Use the applicator provided or a cotton-tipped applicator. Applicators should not be re-used. Make sure that the gel is dry before normal, untreated skin comes into contact with the treated skin. This medicine can cause severe irritation of normal skin. If contact with normal skin occurs, immediately flush the area thoroughly with water. 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. Do not use this medicine more often or for longer than directed.

Talk to your pediatrician regarding the use of this medicine 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, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products on the same area of skin without asking your doctor or health care professional.

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine is not a cure. New warts may develop during or after treatment.

Tell your doctor or health care professional if your symptoms do not start to get better within one week. The weekly treatment course can be repeated up to 4 times. If the wart does not go away in 4 weeks, a different treatment should be considered. If you are pregnant or think you might be pregnant, contact your doctor or health care professional.

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.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bleeding, blistering, burning, crusting, or scabbing of treated skin

• blood in the urine

• dizziness

• vomiting (may indicate excessive dosage)

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

• dryness, flaking or peeling of the skin

• headache

• mild redness, itching or stinging of the skin

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep container tightly closed. This medicine contains alcohol and is flammable. Do not store near heat or open flame. Throw away any unused medicine after the expiration date.

Podofilox Topical solution

What is this medicine?

PODOFILOX (po do FIL ox) is a medication used to remove genital warts. The topical solution should only be used to treat genital warts located on the outside skin of the genitals (i.e., penis or vagina). The solution should not be used to treat warts near the rectal area.

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

What should I tell my health care provider before I take this medicine?

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

• an unusual or allergic reaction to podofilox, podophyllum resin, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine 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 medicine more often or for longer than directed. Do not use a larger dose than directed by your health care professional.

Wash hands before and after use. Read package directions carefully before using. Apply the medication to the specific wart as instructed by your physician. 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 medicine can cause severe irritation of normal skin. If contact with normal skin occurs, immediately flush the area thoroughly with water.

Talk to your pediatrician regarding the use of this medicine 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 medicine?

Interactions are not expected. Do not use any other medicines on the affected area without asking your doctor or health care professional.

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine is not a cure. New warts may develop during or after treatment.

Tell your doctor or health care professional if your symptoms do not start to get better within one week. 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 doctor or health care professional.

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, patients should immediately flush the eye with large quantities of water for 15 minutes and seek medical attention.

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• bleeding, blistering, burning, crusting, or scabbing of treated skin

• blood in the urine

• dizziness

• severe skin rash or swelling

• vomiting (may indicate excessive dosage)

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

• dryness, flaking or peeling of the skin

• headache

• mild redness, itching or stinging of the skin

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 to 30 degrees C (59 to 86 degrees F). Do not freeze. Keep container tightly closed. This medicine contains alcohol and is flammable. Do not store near heat or open flame. Throw away any unused medicine after the expiration date.