Details for: VEREGEN
Company: PALADIN LABS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02411849 | VEREGEN | SINECATECHINS | 10 % / W/W | OINTMENT | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
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.
Proper treatment can clear visible warts, relieving discomfort and helping prevent the spreading of external genital warts to others.
What it does
It has not yet been proven precisely how VEREGEN® works to treat external genital warts but it may inhibit the production of growth factors that stimulate growth of the warts..
When it should not be used
Do not use VEREGEN® Ointment if you are allergic to sinecatechins or any other ingredient in this product (See What the important nonmedicinal ingredients are).
What the medicinal ingredient is
Sinecatechins ointment 10 % w/w (from green tea leaf extract)
What the non-medicinal ingredients are
Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.
What dosage form it comes in
Ointment in tubes of 15 g and 30 g.
Warnings and precautions
BEFORE you use VEREGEN® (sinecatechins) Ointment talk to your doctor or pharmacist 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.
What should I avoid while using VEREGEN® Ointment:
- Do not apply VEREGEN® Ointment on open wounds, broken or inflamed skin or into the vagina or anus.
- Genital warts are a sexually transmitted disease, and you may infect your partner. If your sexual partner is infected, your partner should also be treated to avoid reinfection.
- 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). In case of accidental contact, wipe off and rinse with water for the eyes or soap and water for other sensitive areas.
- 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 with dressings or a bandage. Loose-fitting undergarments can be worn after applying VEREGEN® Ointment.
- VEREGEN® Ointment may stain your light colored clothes and bedding. It is recommended to wear darker colored undergarments while using VEREGEN® Ointment.
Interactions with this medication
Tell your doctor or pharmacist about all the medicines you take or have taken, including prescription and non-prescription medicines, vitamins, and herbal supplements. Drug interaction studies have not been done with VEREGEN® Ointment. It is not known if VEREGEN® Ointment and other medicines can affect each other.
Proper use of this medication
Usual Adult Dose
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 (a maximum of 250 mg, about 0.5 cm strand) 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.
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.
VEREGEN® Ointment 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.
Patients should be aware that new warts may develop during treatment with VEREGEN® Ointment and these should also be treated.
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.
External genital warts can recur and it is also possible to become reinfected. If you choose to be sexually active, limit the number of partners you have and always practice safe sex. Your doctor can advise you about safe sex practices.
Overdose
Missed Dose
If you forget to apply VEREGEN® Ointment, continue on your regular schedule and do not make up the missed dose(s). Do not double dose(s).
Side effects and what to do about them
The most common side effects with VEREGEN® Ointment are local skin and application site reactions including:
- redness
- swelling
- sores or blisters
- burning
- itching
- pain
These reactions should decrease over time but if they become bothersome, contact your doctor.
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 develop 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.
How to store
- Store between 5°C and 25°C. Do not store VEREGEN® Ointment above 25 ºC (77ºF).
- Use within 6 weeks after first opening the tube.
- 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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours. This leaflet does not contain the complete information about your medicine. If any questions remain unanswered or you are not sure about something, you should ask your doctor or pharmacist.
You may want to read this leaflet again. Please Do Not Throw It Away until you have finished your medicine.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.paladinlabs.com or by contacting the sponsor, Paladin Labs Inc., at: 1-888-867-7426.
This leaflet was prepared by Paladin Labs Inc.
VEREGEN® is a registered trademark of Medigen AG.
Last revised: March 22, 2016