Patient information: uses, side effects, how to take - Veregen
What is Veregen Ointment?
Veregen Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.
Who should not use Veregen Ointment?
Do not use Veregen Ointment if you are allergic to an ingredient in Veregen Ointment. The list of ingredients is at the end of this leaflet.
What should I tell my doctor before using Veregen 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 Veregen Ointment can harm your unborn baby. Your doctor will determine whether the benefit outweighs the risk.
- breastfeeding, as it is not known if Veregen 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. Veregen 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.
How should I use Veregen Ointment?
- Use Veregen Ointment only on the area affected exactly as prescribed by your doctor.
- Wash your hands before and after application of Veregen 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 Veregen 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 Veregen 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.
- Veregen 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.
What should I avoid while using Veregen Ointment?
- Do not apply Veregen 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 Veregen 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 Veregen Ointment to sunlight, sunlamps or tanning beds.
- Do not cover the treated area. Loose-fitting undergarments can be worn after applying Veregen Ointment.
- Veregen Ointment may stain your light colored clothes and bedding.
What are the possible side effects of Veregen Ointment?
The most common side effects with Veregen 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 Veregen Ointment, stop treatment and call your doctor right away.
You may experience other side effects of Veregen 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 Veregen Ointment is not a cure.
How should I store Veregen Ointment?
- Store Veregen Ointment refrigerated or up to 77°F (25°C).
- Do not freeze.
- Make sure the cap on the tube is tightly closed.
- Safely throw away Veregen Ointment tubes that are out of date or are empty.
Keep Veregen Ointment and all medicines out of the reach of children.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen Ointment for a condition for which it was not prescribed. Do not give Veregen Ointment to other people, even if they have the same symptoms you have. It may harm them.
Do not use Veregen Ointment after the expiration date on the tube.
This leaflet summarizes the most important information about Veregen Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen Ointment that is written for the doctor.
For more information, go to www.anipharmaceuticals.com or call 1-800-308-6755.
What are the ingredients in Veregen Ointment?
Active ingredient:
A defined green tea extract named sinecatechins.
Inactive ingredients:
Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.
Manufactured by:
C.P.M. ContractPharma GmbH.
Frühlingstrasse 7 D-83620
Feldkirchen-Westerham, Germany
Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
U.S. Patent Nos. 5795911 and 5968973
0-20720-00 Rev 01/22
This Patient Information has been approved by the U.S. Food and Drug Administration.