Uses

Sinecatechins are used to treat warts on and around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural substances found in certain green tea leaves. It is not known how this medication works.

This medication does not cure warts, but it may help the infection clear faster. New warts may occur during or after treatment. This medication does not prevent the spread of warts through sexual contact, and it may weaken condoms and diaphragms. Talk to your doctor about safer sex practices.

How To Use

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

Use this medication on the skin only. Wash your hands before and after applying. Apply the ointment to all warts as directed by your doctor, usually 3 times a day. Use your finger to apply a small amount, about 0.2 inches (0.5 centimeters), to completely cover each wart with a thin layer. Do not wash off the ointment from the previous treatment before re-applying. Always re-apply the ointment after taking your usual baths/showers. Do not cover the treated area with bandages or other waterproof dressings. You may cover the area with cotton gauze or cotton underwear. Do not use more often or for longer than prescribed.

Male patients who are not circumcised and who are treating warts under the foreskin should pull the foreskin back and clean the area daily, then apply this medication.

Women using tampons should insert the tampon before applying the ointment. If you need to change the tampon while the ointment is on the skin, avoid getting the ointment inside the vagina.

Do not use this medication inside the vagina or anus or on an open sore. Avoid touching your eyes, nose, or mouth while the ointment is on your finger. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor right away.

Avoid sexual contact while using this product. This product may weaken condoms and vaginal diaphragms. This effect increases the risk of pregnancy and passing sexually transmitted disease (including genital warts) to others. Wash the product off before sexual activity. Ask your doctor about safer sex practices.

Use this medication regularly to get the most benefit from it. Continue treatment until the warts are gone. Do not use for longer than 16 weeks unless directed by your doctor. Tell your doctor if your condition does not improve or if new warts appear.

Side Effects

Mild skin reactions such as itching/burning/pain/swelling/reddening of the treated area may occur. If any of these effects last or get worse, 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.

Tell your doctor right away if you have any serious side effects, including:

• blistering/oozing/peeling skin in treated area
• open sore in treated area (skin ulcer)

If you are an uncircumcised male who is using this drug to treat warts on the penis, narrowing of the foreskin (phimosis) may rarely occur. If you notice tightening/pain in your foreskin, tell your doctor right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 this product, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to green tea; 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:

• open sores in the area being treated
• recent/unhealed treatment or wound on the wart area (such as podophyllin, liquid nitrogen, surgery)
• immune system problem

This product may stain clothing and bedding.

Do not expose the treated area to sunlight, tanning booths, or sunlamps.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). This product does not destroy the virus but only helps to get rid of the wart. New warts may form even while you are being treated.

You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV. To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During treatment of genital/anal warts, avoid all sexual contact while the ointment is on the skin. Condoms, dental dams, and diaphragms may be weakened by the ointment. They may not work as well to prevent pregnancy or the spread of HPV or other sexually transmitted diseases (such as HIV).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. 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.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Be sure to keep all medical appointments. HPV can increase the risk of cancer of the cervix. It is very important that women exposed to HPV have regular PAP tests to check for cancer.

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 this product in the refrigerator or at room temperature. Different brands of this medication may have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not freeze. Keep all medications 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.