Veregen 100 mg/g pomada

Leaflet: information for the user

Veregen 100 mg/g cream

Green tea leaf extract

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

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

1. What Veregen is and what it is used for

2. What you need to know before you start using Veregen

3. How to use Veregen

4. Possible side effects

5. Storage of Veregen

6. Contents of the pack and additional information

Veregenis a plant-based medication for exclusive use onthe skin. Itsactive ingredient is an extract from green tea leaves. Veregen is used to treat genital warts(Condylomata acuminata)on the surface of the genitals (sexual organs) and around the anus. Veregen is used in adults with a normally functioning immune system.

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

Consult 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 medication (listed in the "6. Contents of the container and additional information" section).

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 damaged (e.g. abnormal fluid retention in the abdomen, yellowish skin due to liver dysfunction) or if 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 cream comes into contact with any of these areas without realizing it, it should be cleaned and/or rinsed with water.
• Do not apply it to open wounds, torn skin, or inflamed skin.
• Veregen should not be applied to mucous membranes, so it is not a treatment for genital warts on the vagina, cervix, urethra, or inside the anus.
• Patients with genital warts on the vulvar region should use the cream with caution as treatment in this area may cause severe local adverse reactions more frequently.
• Patients who are not circumcised and are 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 retracting the foreskin), treatment should be stopped and the doctor consulted.
• Veregendoes not eliminate the HPV virus orprevent the transmission of thedisease,so special care should be taken before sexual activity; seesection “3.How to use Veregen” of this leaflet.
• If your sexual partner is infected with genital warts, it is recommended that they be treated, which will help preventreinfection. You canask your doctor for advice.
• Do not expose treated areas to the sun or ultraviolet lamps (e.g. tanning beds).
• Veregenstains clothing and bedding.
• Mild local skin reactions are very common at the application site, such as redness, itching, irritation (usually burning), pain, and swelling, and should not lead to treatment interruption. 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 old.

Use of Veregen with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication or if you have recently undergone other treatments for warts around the genital or anal area. Veregen should not be used with other treatments in the area of the warts. Do not use Veregen until your skin has completely healed after previous treatments.

Use of Veregen with food and drinks

No interactions with food and drinks exist.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Therefore, as a precaution, although the exposure to epigallocatechin gallate (the main component of green tea) is expected to be low after application to the skin, 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 the risk to the infant is unknown.

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

Fertility

No evidence exists of any effect on fertility if you use Veregen as prescribed.

Driving and operating machinery

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

Veregen contains isopropyl myristate and propylene glycol monopalmitate.

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

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

The recommended dose is up to0.5 cmof cream (corresponding to 250 mg) for all warts together, applied three times a day (in the morning, atnoonand at night).

• Wash your hands before and after applyingthe cream.
• Apply a small amount of Veregen to each wart using your fingers, spreading it to ensure it is completely covered and leaving a small layer of cream on the wart. Do not apply the cream internally (inside the anus, urethra, or inside the vagina).
• Do not cover the treated area with bandages after applying the cream.
• No need to remove the cream from the treated area before the next application. When bathing or washing the treated area, apply the cream afterwards.
• Apply Veregenthree times a day(in the morning, atnoonand at night).
• New warts may develop during treatment, which should be treated in the same way.
• Genital warts are a sexually transmitted disease, so you may infect your partner through sexual activity. Use condoms until all warts have completely disappeared. Condom use also prevents re-infection.
• Veregen may weaken condoms and vaginal diaphragms. Before sexual activity, carefully remove the cream with warm water and mild soap and then place the condom. Consult your doctor for additional contraceptive information.
• Patients using tampons during menstruation: insert the tampon before applying the cream. If you need to change the tampon while having cream on your skin, avoid introducing cream into the vagina. In case of accidental application, immediately remove the cream by washing with warm water and mild soap.
• The duration of Veregen treatment should continue until all warts have completely disappeared, althoughit should not last more than 16 weeks, even if new warts develop during treatment. If warts do not disappear or return after treatment, consult your doctor.

Use in children and adolescents(under 18 years)

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

Older adults

There is limited experience with the use of Veregen in older adults.

Liver insufficiency

You should not use Veregen if your liver is damaged (e.g. abnormal fluid retention in the abdomen, yellowish 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 any excess cream with mild soap and water.

If you accidentally ingest the cream, contact your doctor.

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

If you forgot to use Veregen

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

If you interrupt Veregen treatment

You may not achieve wart removal.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The majority of side effects of Veregen are due to its local action on the skin and occur in the area of the wart being treated or in its surroundings. Many patients experience 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 cleared. 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, lymph node swelling, or any other severe reaction (e.g., penile or urethral constriction, difficulty urinating, or intense pain), you should stop treatment and remove the cream with warm water and mild soap, and consult your doctor immediately.

The following frequency of side effects was used for evaluation:

Very common:

• Local skin reactions in the area 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 peeling, suppurating, bleeding, and swelling.
• Lymph node inflammation (in the groin).
• Penile constriction.

Uncommon:

• Local scarring, fissuring, dry skin, discomfort, erosion, numbness, nodule, papules, skin inflammation, and skin color changes in the application area, local necrosis, eczema.
• Blisters in the application area, application area infections, genital herpes infection, staphylococcal infection, vaginal fungal infection, urethral or vulvar/vaginal inflammation.
• Pain, frequent or urgent urination.
• Prepuce and penile head inflammation, painful sex.
• Rash, hypersensitivity

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

• Skin bacterial infection (pyoderma), vulvar inflammation.
• Urethral constriction/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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

Do not store at a temperature above 25°C.

Use within the6weeks following the first opening of the tube.

Do not usethis medicationafter the expiration date that appears on the tube or on the box, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unusedmedicines atthe SIGREEcollection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

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) ofCamelia sinensis(L.) O. Kuntze folium (green tea leaf) (24-56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate

First solvent of extraction: water.

The other components are: white vaseline (contains all-rac-α tocopherol), white wax, isopropyl myristate, oleic alcohol, propylene glycol monopalmitostearate.

Appearance of the productand contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Exeltis Healthcare S.L.

Avda. de Miralcampo, 7

Industrial Estate Miralcampo

19200 Azuqueca de Henares

Spain

Responsible for Manufacturing:

C.P.M. ContractPharma GmbH

Frühlingsstraβe 7

83620 Feldkirchen-Westerham

Germany

This medicine is authorized in the member states of theEuropean Economic Areaand in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: 02/2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”