Sinecatechins (Topical application)

Sinecatechins is used to treat external warts around the genital and rectal areas known as condylomata acuminata. It is not used to treat warts that happen inside the vagina, penis, or rectum.

This medicine is available only with your doctor's prescription.

This medicine may make your skin more sensitive to sunlight. Do not expose the area being treated with this medicine to sunlight, sunlamps, or tanning beds.

Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the ointment off your skin before you engage in any sexual activity. Also, the medicine contains oils that can weaken latex (rubber) condoms, or diaphragms causing them not to work properly.

Sinecatechins will not keep you from spreading genital warts to other people. Talk with your doctor about safe sex practices.

This medicine is not a cure for genital or anal warts. You may still develop new warts during or after your treatment.

This medicine may stain your clothes and bedding.

Do not use cosmetics or any other skin care products on the same skin area on which you use this medicine, unless directed otherwise by your doctor.

If your condition does not improve within 16 weeks, or if it becomes worse, check with your doctor.

Many patients experience redness, swelling, sores or blisters, burning, or itching after using this medicine. If you experience a severe skin reaction, remove the ointment by washing the area with mild soap and water and contact your doctor right away.

In deciding to use a medicine, you and your doctor need to balance the risks of the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on the effects of sinecatechins in children have not been done. Safety and effectiveness have not been proven for this age group.

Geriatric

There is not enough information on how sinecatechins affect older patients. It is unclear if they work the same way in older adults as they do in younger adults or if they cause different side effects or issues.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In such cases, your doctor may adjust the dose or take other precautions. Let your healthcare provider know if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Inflamed, irritated, or infected skin—Use with caution. This medicine may worsen this condition.

• Weakened immune system—It is unclear if this medicine is safe to use with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blistering, peeling, or loosening of the skin
• breakdown of skin
• burning of skin
• cracking of skin
• flushing, redness of skin
• hardening or thickening of skin
• irritation of skin
• itching skin
• pain or discomfort in skin
• swelling of skin
• unusually warm skin

Less common

• Bleeding of skin
• blood in urine
• break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
• burning or itching around anus
• changes in skin coloring
• discharge from skin
• dryness of skin
• increased frequency of urination
• increased sensitivity to pain
• increased sensitivity to touch
• pain or burning during urination
• peeling of one area of skin
• pelvic pain
• problems with foreskin of penis
• rash with flat lesions or small raised lesions on the skin
• scarring of skin
• skin rash, encrusted, scaly and oozing
• skin rash on the face
• swollen, painful, or tender lymph glands in neck, armpit, or groin
• tingling in the hands and feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Veregen

Available Dosage Forms:

• Ointment

Therapeutic Class: Keratolytic

Use the medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it longer than directed.

Wash your hands with soap and water before and after using this medicine.

This medicine is for use on the skin only. Do not get it inside your eyes, nose, mouth, vagina, or anus. Do not use on open wounds or on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

Do not use this medicine on moles, birthmarks, or any other warts until you discuss it with your doctor.

Women using tampons should insert the tampon first before applying the ointment. If the tampon needs to be changed while the ointment is on the skin, avoid getting the ointment into the vagina.

Men who are not circumcised and treating genital warts under the foreskin should draw back the foreskin and clean the area daily.

Do not wash off the ointment from the treated area before you apply the next dose. When you wash the treatment area or bathe, apply the ointment afterwards.

Do not cover the treated area with a bandage unless your doctor has told you to. You may wear loose-fitting underwear after applying this medicine.

Keep using this medicine until all the warts have cleared up. However, you should not use this medicine for longer than 16 weeks.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (ointment):For warts on the genital or rectal areas: Adults—Apply a thin layer (about an 0.5 cm strand) to the affected area three times a day. Rub it in gently. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store in the refrigerator. Do not freeze.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.