پماد موضعی وارتاژن (سین کتچین) 15% 15 گرم

1. 1. Indication

Wartagen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

1. 1. Limitations of Use
   2. Theش safety and effectiveness of Wartagen have not been established for treatment beyond 16-weeks or for multiple treatment courses. The safety and effectiveness of Wartagen in immunosuppressed patients have not been established.

1. DOSAGE AND ADMINISTRATION

1. 1. General Dosing Information

Wartagen is to be applied three times per day to all external genital and perianal warts. Apply about an 0.5 cm strand of the Wartagen to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Wartagen. It is not necessary to wash off the ointment from the treated area prior to the next application. Wartagen is not for ophthalmic, oral, intravaginal, or intra-anal use.

1. 1. Treatment Period

Treatment with Wartagen should be continued until complete clearance of all warts, however no longer than 16 weeks. Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

1. DOSAGE FORMS AND STRENGTHS

Ointment, 15% w/w. Each gram of Wartagen Ointment, 15% contains 150 mg of                     sinecatechins in a brown ointment base.

1. CONTRAINDICATIONS

None

1. WARNINGS AND PRECAUTIONS

Wartagen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.

Use of Wartagen on open wounds should be avoided.

Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Wartagen has not been tested under these circumstances.

1. ADVERSE REACTIONS

The most common side effects with Wartagen Ointment are local skin and application site reactions including: • redness • swelling • sores or blisters • burning • itching • pain

Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Wartagen Ointment, stop treatment and call your doctor right away. You may experience other side effects of Wartagen Ointment which are not mentioned here. Ask your doctor or pharmacist for more information. Patients should be aware that new warts may develop during treatment as Wartagen Ointment is not a cure.

1. WHO SHOULD NOT USE Wartagen OINTMENT?

Do not use Wartagen Ointment if you are allergic to an ingredient in Wartagen Ointment. The list of ingredients is written on the box.

1. WHAT SHOULD I TELL MY DOCTOR BEFORE USING Wartagen OINTMENT?

Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals.

Be sure to tell your doctor if you are:

• pregnant or planning to become pregnant, as it is not known if Wartagen Ointment can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.

• breastfeeding, as it is not known if Wartagen Ointment can pass into your milk and if it can harm your baby.

• using any other type of skin product or have open wounds on the area to be treated. Wartagen Ointment should not be used until your skin has healed from other treatments applied to the same area.

• immunocompromised. This means that your immune system cannot fight infections as well as it should.

1. WHAT SHOULD I AVOID WHILE USING Wartagen OINTMENT?

• Do not apply Wartagen Ointment on open wounds or into the vagina or into the anus.
• Genital warts are a sexually transmitted disease, and you may infect your partner.
• Avoid sexual contact (genital, anal or oral) when Wartagen Ointment is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms. Talk to your doctor about safe sex practices.
• Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).
• Women using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina.
• Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily.

• Do not expose the genital area treated with Wartagen Ointment to sunlight, sunlamps or tanning beds.
• Do not cover the treated area. Loose-fitting undergarments can be worn after applying Wartagen Ointment.
• Wartagen Ointment may stain your light colored clothes and bedding.

1. HOW SHOULD I USE Wartagen OINTMENT?

• Use Wartagen Ointment only on the area affected exactly as prescribed by your doctor.
• Wash your hands before and after application of Wartagen Ointment. A small amount of the ointment should be applied to all warts using your finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts as directed by your doctor.
• Apply Wartagen Ointment three times per day in the morning, at noontime and in the evening. Do not wash off the ointment from the treated area before the next application. When you wash the treatment area or bathe, apply the ointment afterwards.
• Treatment with Wartagen Ointment should be continued until complete clearance of all warts, however no longer than 16 weeks. If your warts do not go away, or if they come back after treatment call your doctor.
• Wartagen Ointment is not a cure for warts on your genitals or around your anus with certainty. New warts may develop during or after treatment, and may need treatment.

1. HOW SHOULD I STORE Wartagen OINTMENT?

• Store Wartagen Ointment refrigerated (8-2°C).
• Do not freeze.
• Make sure the cap on the tube is tightly closed.
• Safely throw away Wartagen Ointment tubes that are out of date or are empty.
• Keep Wartagen Ointment and all medicines out of the reach of children.