Veregen 100 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Veregen 100 mg/g ointment

Green tea leaf extract

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Veregen is and what it is used for

Veregen is a plant-based medicinal product intended for topical use only. Its active ingredient is an extract derived from green tea leaves. Veregen is used to treat warts (Condylomata acuminata) on the genital skin (sex organs) and around the anus. Veregen is used in adults with normally functioning immune systems.

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 to any of the other components of this medicine (listed in section “6. Contents of the pack and other information”).

Warnings and precautions

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

Children and adolescents

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

Using Veregen with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you might need to take any other medicine, or if you have recently undergone other treatments for warts around the genital organs or anus. Veregen must 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 drink

There are no interactions with food and drink.

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

There is 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 following skin application, the use of Veregen should be avoided during pregnancy (see section “3. How to use Veregen”).

Breast-feeding

It is unknown whether Veregen or its metabolites are excreted in human milk, and therefore it is unknown whether there is a risk to the nursing infant.

However, following application of the product to the skin of nursing mothers, the risk of adverse effects in the infant is likely to be low.

Fertility

There is no evidence of any effect on fertility when using Veregen as prescribed.

Driving and using machines

No studies are available demonstrating effects on the ability to drive and use machines. However, it is unlikely that the treatment will affect 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 instructions given by your doctor for administering this medicine. If you have any 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 combined, applied three times daily (in the morning, at midday, and in the evening).

• Wash your hands before and after applying the ointment.
• Apply a small amount of Veregen to each wart using your fingers, spreading it to ensure complete coverage and leaving a thin layer of ointment on the wart. Do not apply the ointment internally (inside the anus, urethra, or inside the 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 afterwards.
• Apply Veregen three times a day (in the morning, at midday, and in the evening).
• New warts may develop during treatment, which should be treated in the same way.
• Genital warts are a sexually transmitted disease; therefore, you may infect your partner through sexual activity. Condoms should be used until all warts have completely disappeared. The use of condoms also helps prevent reinfection.
• Veregen may weaken condoms and vaginal diaphragms. Before sexual activity, carefully remove the ointment by washing with lukewarm water and mild soap, then put on the condom. Consult your doctor for advice on additional contraceptive methods.
• Patients who use tampons during menstruation: insert the tampon before applying the ointment. If you need to change the tampon while ointment is still on your skin, avoid introducing ointment into the vagina. In case of accidental application, immediately remove the ointment by washing with lukewarm water and mild soap.
• Treatment with Veregen should continue until all warts have completely disappeared, but should not last longer than 16 weeks, even if new warts develop during the treatment period. If the warts do not disappear or if they reappear 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 patients

Experience with the use of Veregen in elderly patients is limited.

Hepatic impairment

You should not use Veregen if your liver function is impaired (e.g., abnormal fluid retention in the abdomen, yellowing of the 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 starting to use 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, contact the Toxicology Information Service. Telephone: 915 620 420.

If you forget to use Veregen

Continue with the next dose as scheduled. Do not apply a double dose to make up for missed doses.

If you stop using Veregen

It is possible that the warts will not be eliminated.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Most adverse effects of Veregen are due to its local action on the skin and occur at the treated wart area or in the surrounding skin. Many patients experience redness, itching, irritation, pain, or swelling. Mild reactions are common 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 may be resumed once the skin reaction has disappeared. In the case of local vesicular reactions, please consult your doctor.

If you experience severe local reactions causing 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 severe pain), you must stop treatment, wash off the ointment with warm water and mild soap, and consult your doctor immediately.

For the assessment of adverse effects, the following frequency classification was used:

Very common:

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

Common:

• Local skin reactions such as flaking, oozing, bleeding, and swelling.
• Swelling of 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 skin color changes at the application site, local necrosis, eczema.
• Pustules at the application site, infections at the application site, genital herpes infection, staphylococcal infection, fungal vaginal infection, urethritis or vulvovaginitis.
• Pain, increased frequency or urgency to urinate.
• Inflammation of the foreskin and glans penis, painful sexual intercourse.
• Rash, hypersensitivity.

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

• Bacterial skin infection (pyoderma), vulvitis.
• Urethral stricture/difficulty urinating, vaginal discharge.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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 stated on the tube or carton, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Veregen

The active substance is a green tea leaf extract. 1 g of ointment contains 100 mg of extract (as dried, refined extract) from 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 components are: white petrolatum (contains all-rac-α-tocopherol), white wax, isopropyl myristate, oleyl alcohol, propylene glycol monopalmitostearate.

Appearance of the product and contents of the pack

Veregen is a soft brown ointment, free from sandy particles, available in two tube sizes: 15 g and 30 g.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: 02/2022

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”