Sinecatechins 15 % Topical Ointment

Sinecatechins are used to treat warts located on or around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural antioxidants found in certain green tea leaves. While it is not known how this medication works, research has found that Sinecatechins inhibit cell signaling, which prevents the reproduction of diseased cells and helps to contain wart outbreaks. This medication does not cure warts, but it may help the infection clear up 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 medical provider about safe sex practices.

• This medicine comes with a Patient Information Leaflet. Read it carefully. Request a callback from your medical provider if you have any questions about this medication.
• Only use this medication on the skin. Wash your hands before and after applying. Apply the ointment to all warts as prescribed, usually 3 times a day or as directed by your medical provider.
• Use your finger to apply a small amount, covering 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 before applying this medication.
• Women who use 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 fingers. If you get this medication in those areas, flush with plenty of water. If irritation occurs, request a callback from your medical provider 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 medical provider about safe sex practices.
• Use this medication regularly to get the most benefit from it.
• Continue treatment until the warts are gone. Do not use it for longer than 16 weeks unless directed by your medical provider. Tell your medical provider if your condition does not improve or if new warts appear.

• Mild skin reactions such as itching/burning/pain/swelling/reddening of the treated area frequently occur. If any of these effects last or continue to worsen, wash off the ointment with soap and water, discontinue using the medication immediately and request a callback from your medical provider promptly.
• Remember that this medication has been prescribed because your medical provider 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 medical provider right away if any of these unlikely but serious side effects occur: blistering/oozing/peeling skin or open sores in the treated area (skin ulcers).
• If you are an uncircumcised male who is using this drug to treat warts on the penis, a narrowing of the foreskin (phimosis) may occur in rare cases. If you notice tightening/pain in your foreskin, request a callback from your medical provider right away. Should the pain become severe, the foreskin cannot be pulled forward or urinating becomes difficult, seek immediate medical attention.
• In extremely rare cases, there have been reports of blood stream infection from Staph and necrosis (death) of the skin.

• 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, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

• Before using this product, tell your medical provider 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. Request a callback from your medical provider for more details.
• Before using this medication, tell your medical provider if you have a history of: open sores in the area being treated, recent/unhealed treatment or wound on the wart area (such as podophyllin, liquid nitrogen, surgery) or problems with your immune system.
• 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, it only helps to get rid of the warts. New warts may form even while you are being treated.
• You may be able to infect any sexual partner who comes into contact with the affected skin areas infected with HPV. To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms or dental dams) during all sexual activity. Request a callback from your medical provider 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 OB-GYN.
• It is not known whether this drug passes into breast milk. Consult your OB-GYN before breastfeeding.
• Some strains of HPV can cause cervical cancer. This treatment does not eliminate that risk or  remove any abnormal cervical cells that may be precancerous or cancerous. Let your OB-GYN know you are taking this medication and request a PAP smear to screen for abnormal cells that need to be treated to prevent cervical cancer.

• 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 medical provider. Do not start, stop or change the dosage of any medicines without your medical provider's approval.
• Some products that may interact with this drug include: drugs that may affect the immune system (including chemotherapy and corticosteroids such as Hydrocortisone/Prednisone).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. If symptoms from using this medication are less severe, call your local poison control center at 1-800-222-1222 right away.

• 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 medical provider tells you to.
• Be sure to keep all medical appointments. HPV can increase the risk of cervical cancer. It’s very important that women exposed to HPV have regular PAP smear tests to check for cancer.

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

• Store this product in the refrigerator or at room temperature or below 77 degrees F (25 degrees C) away from moisture. 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.
• Close the container tightly after each use.
• 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.