VEREGEN 100 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Veregen 100 mg/g Ointment

Extract of green tea leaves

Read the package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Veregen and what is it used for
2. What you need to know before using Veregen
3. How to use Veregen
4. Possible side effects
5. Storage of Veregen
6. Contents of the pack and further information

1. What is Veregen and what is it used for

Veregen is a herbal medicine for exclusive use on the skin. Its active ingredient is an extract from green tea leaves. Veregen is used to treat genital warts (Condylomata acuminata) on the surface of the genitals (sex organs) and around the anus. Veregen is used in adults with a normally functioning immune system.

You should consult your doctor if your condition worsens or does not improve after 4-6 weeks of treatment.

2. What you need to know before using Veregen

Talk to your doctor before using Veregen.

Do not use Veregen

• If you are allergic (hypersensitive) to green tea extract or any of the other ingredients of this medicine (listed in section “6. Contents of the pack and further information").

Warnings and precautions

• If you have any problems with your immune system or liver, talk to your doctor. Veregen should not be used if your liver function is impaired (e.g., abnormal fluid retention in the abdomen, yellow skin due to liver dysfunction) or when your immune system is compromised (either due to a disease or due to other medications you are taking).
• Do not use Veregen until the area to be treated is completely healed after previous treatments with medications or surgery.
• Avoid contact with the eyes, nostrils, lips, and mouth. If the ointment accidentally reaches any of these areas, it should be washed and/or rinsed with water.
• Do not apply it to open wounds, lacerated skin, or inflamed skin.
• Veregen should not be applied to mucous membranes, so it is not a treatment for warts in the vagina, cervix, urethra, or inside the anus.
• Patients with genital warts in the vulvar region should use the ointment with caution, as treatment in this area can cause severe local adverse reactions more frequently.
• Uncircumcised patients receiving treatment for warts located under the foreskin should retract it and wash the area daily to prevent phimosis (when the foreskin cannot be retracted from the glans). If early signs of constriction appear (e.g., open sores, skin hardening, or increased difficulty in retracting the foreskin), treatment should be stopped, and a doctor consulted.
• Veregen does not eliminate the HPV virus nor prevent the transmission of the disease; therefore, special care should be taken before sexual activity; see section “3. How to use Veregen” of this package leaflet.
• In case your sexual partner is infected with genital warts, their treatment is recommended, which will help prevent reinfection. You can ask your doctor for advice.
• Do not expose the treated areas to the sun or ultraviolet lamps (e.g., tanning beds).
• Veregen stains clothing and bed linen.
• Mild local skin reactions at the application site, such as redness, itching, irritation (generally burning), pain, and swelling, are very common and should not lead to the interruption of treatment. These should decrease after the first few weeks of treatment; see section “4. Possible side effects”.

Children and adolescents

Veregen is not recommended for use in children and adolescents under 18 years of age.

Using Veregen with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines or if you have recently undergone other treatments for warts around the sex organs or anus. Veregen should not be used together with another treatment in the area of the warts. Veregen should not be used until your skin has completely healed after previous treatments.

Using Veregen with food and drinks

There are no interactions with food and drinks.

As a precaution to avoid interactions/adverse effects, Veregen should not be used with dietary supplements containing large amounts of green tea leaf extract.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

There are limited data on the use of Veregen in pregnant women. Reproductive studies in animals have shown toxic effects.

Therefore, as a precautionary measure, although exposure to epigallocatechin gallate (the main component of green tea) is expected to be low after skin application, the use of Veregen should be avoided during pregnancy (see section “3. How to use Veregen”).

Breastfeeding

It is unknown whether Veregen or its metabolites are excreted in breast milk, and therefore, it is unknown whether there is a risk to breastfed infants.

However, after applying the product to the skin of breastfeeding mothers, the risk of adverse effects in the breastfed infant is likely to be low.

Fertility

There is no evidence of any effect on fertility if you use Veregen as prescribed.

Driving and using machines

There are no available studies that demonstrate the effects on the ability to drive and use machines. However, it is unlikely that the treatment will have effects on the ability to drive or use machines.

Veregen contains isopropyl myristate and propylene glycol monopalmitostearate.

Veregen contains, among other ingredients, high amounts of isopropyl myristate (IPM), which may cause skin irritation and sensitization, and propylene glycol monopalmitostearate, which may cause skin irritation.

3. How to use Veregen

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

The recommended dose is up to 0.5 cm of ointment (corresponding to 250 mg) for all warts together, applied three times a day (morning, noon, and night).

• Wash your hands before and after applyingthe ointment.
• Apply a small amount of Veregen to each wart using your fingers, spreading it to ensure that it is completely covered, and leaving a thin layer of ointment on the wart. Do not apply the ointment internally (inside the anus, urethra, or vagina).
• Do not cover the treated area with bandages after applying the ointment.
• It is not necessary to remove the ointment from the treated area before the next application. When bathing or washing the treated area, apply the ointment afterward.
• Apply Veregen three times a day(morning, noon, and night).
• New warts may develop during treatment and should be treated in the same way.
• Genital warts are a sexually transmitted disease; therefore, you can infect your partner through sexual activity. Condoms should be used until all warts have disappeared completely. The use of condoms also prevents reinfection.
• Veregen may weaken condoms and diaphragms. Before sexual activity, carefully remove the ointment by washing with warm water and mild soap, and then put on the condom. Consult your doctor for information on additional contraceptive methods.
• Patients using tampons during menstruation: insert the tampon before applying the ointment. If you need to change the tampon while you have ointment on your skin, avoid introducing ointment into the vagina. In case of accidental application, immediately remove the ointment by washing with warm water and mild soap.
• The duration of treatment with Veregen should continue until the complete disappearance of all warts, although it should not last more than 16 weeks, even if new warts develop during the treatment period. If the warts do not disappear or if they recur after treatment, consult your doctor.

Use in children and adolescents(under 18 years of age)

Veregen is not approved for use in children and adolescents under 18 years of age.

Elderly

There is limited experience with the use of Veregen in elderly people.

Liver impairment

You should not use Veregen if your liver function is impaired (e.g., abnormal fluid retention in the abdomen, yellow skin due to liver problems).

If you use more Veregen than you should

You may experience more intense local adverse reactions (see sections “2. What you need to know before using Veregen” and “4. Possible side effects”).

Remove excess ointment with mild soap and water.

If you accidentally ingest the ointment, contact your doctor.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915 620 420.

If you forget to use Veregen

Continue with the next dose when it is due. Do not apply a double dose to make up for forgotten doses.

If you stop using Veregen

It is possible that the warts will not be eliminated.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects of Veregen are due to its local action on the skin and occur at the site of the treated wart or in its surroundings. Many patients suffer from redness, itching, irritation, pain, or swelling. Mild reactions are normal and should decrease after the first few weeks of treatment. However, if the intensity of local skin reactions affects your daily activities or if blisters appear, consult your doctor. It may be necessary to interrupt treatment. Treatment can be resumed after the skin reaction has disappeared. In the case of local vesicular reactions, please consult your doctor.

If you experience severe local reactions that cause unacceptable discomfort, such as local inflammation/infection, open ulcer, swelling of the lymph nodes, or any other severe reaction (e.g., constriction of the foreskin or urethra, difficulty urinating, or intense pain), you should stop treatment and remove the ointment with warm water and mild soap, and consult your doctor immediately.

For the assessment of side effects, the following frequency convention was used:

Very common:

• Local skin reactions at the site of the wart where Veregen has been applied, including: redness, itching, irritation/burning, pain, swelling, open ulcers, skin hardening, and blisters.

Common:

• Local skin reactions such as scaling, suppuration, bleeding, and swelling.
• Inflammation of the lymph nodes (in the groin).
• Constriction of the foreskin of the penis.

Uncommon:

• Local scarring, fissure, dry skin, discomfort, erosion, increased or decreased sensation, nodule, papules, skin inflammation, and changes in skin color at the application site, local necrosis, eczema.
• Pustules at the application site, infections at the application site, genital herpes infection, staphylococcal infection, vaginal fungal infection, inflammation of the urethra or vulva and vagina.
• Pain, increased frequency or urgency of urination.
• Inflammation of the foreskin and head of the penis, painful sexual intercourse.
• Rash, hypersensitivity

Adverse reactions that were observed only with a higher dose ointment (Veregen 15%):

• Bacterial skin infection (pyoderma), vulvar inflammation.
• Constriction of the urethra/difficulty urinating, vaginal discharge.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Veregen

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Use within 6 weeks of first opening the tube.

Do not use this medicine after the expiry date which is stated on the tube or carton, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Veregen

The active ingredient is a green tea leaf extract. 1 g of ointment contains 100 mg of extract (as dry, refined extract) of Camellia sinensis(L.) O. Kuntze folium (green tea leaf) (24-56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate

First extraction solvent: water.

The other ingredients are: white petrolatum (contains all-rac-α-tocopherol), white wax, isopropyl myristate, oleic acid, propylene glycol monopalmitostearate.

Appearance of the product and contents of the pack

Veregen is a smooth, brown ointment, free of sandy particles, available in 2 tube sizes: 15 g and 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Exeltis Healthcare S.L.

Avda. de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares

Spain

Manufacturer:

C.P.M. ContractPharma GmbH

Frühlingsstraße 7

83620 Feldkirchen-Westerham

Germany

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this package leaflet: 02/2022

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"