Veregen

Package Leaflet: Information for the User

Veregen, 100 mg/g, Ointment

Green tea leaf extract

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of Contents of the Leaflet:

• 1. What is Veregen and what is it used for
• 2. Important information before using Veregen
• 3. How to use Veregen
• 4. Possible side effects
• 5. How to store Veregen
• 6. Package contents and other information

1. What is Veregen and what is it used for

Veregen is a herbal medicinal product for cutaneous use only.
The active substance is green tea leaf extract. Veregen is used to treat genital warts (Condylomata acuminata) on the surface of the genital and anal areas. Veregen is used in adults with normal immune system function.
If after 4-6 weeks there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Veregen

Before starting to use Veregen, the patient should discuss it with their doctor.

When not to use Veregen

• if the patient is allergic (hypersensitive) to green tea leaf extract or any of the other ingredients of this medicine (listed in section "6. Package contents and other information").

Warnings and precautions

• The patient should consult a doctor if they have liver or immune system problems. Veregen should not be used in case of liver function disorders (e.g. if there is abnormal fluid accumulation in the abdomen, yellowing of the skin due to liver function disorders) or if the immune system is impaired (due to disease or other medications taken).
• Veregen should not be used until the area to be treated has healed completely after previous pharmacological or surgical treatment.
• Avoid contact with the eyes, nostrils, lips, and mouth. If the ointment accidentally gets into these areas, it should be wiped off and/or rinsed with water.
• Do not use on open wounds, damaged skin, or inflamed skin.
• Veregen should not be used on mucous membranes, i.e. it is not intended for the treatment of genital warts in the vagina, cervix, urethra, or inside the anus.
• Female patients with genital warts in the vulva area should use the ointment with caution, as treatment in this area may more frequently cause severe local side effects.
• Uncircumcised patients treating warts under the foreskin should retract the foreskin daily and wash the area to prevent foreskin narrowing (when the foreskin cannot be retracted over the glans penis). If early signs of narrowing are observed (e.g. open sores, skin hardening, or increasing difficulty in retracting the foreskin), treatment should be discontinued and a doctor consulted.
• Veregen does not eliminate the HPV virus or prevent the transmission of the disease, so caution should be exercised before sexual activity; see section "3. How to use Veregen" of this leaflet.
• If the sexual partner is infected with the HPV virus, their treatment is recommended. Treatment will help prevent re-infection. In case of doubts, consult a doctor.
• The treated area should not be exposed to sunlight and should not use sunlamps or tanning beds.
• Veregen stains clothing and bedding.
• Mild local skin reactions, such as redness, itching, irritation (mostly burning), pain, and swelling at the application site are very common and should not lead to discontinuation of treatment. These symptoms should subside 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.

Veregen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, or if they have recently undergone other treatments for genital warts or anal area. Veregen should not be used with other treatments in the area of the warts. Veregen should not be used if the skin has not healed after other treatments.

Veregen with food and drink

No interactions with food and drink.
As a precaution, to avoid interactions or side effects, Veregen should not be used at the same time as dietary supplements containing large amounts of green tea leaf extract.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor before using this medicine.
Pregnancy
There are no data or only limited data on the use of Veregen in pregnant women. Animal studies have shown a harmful effect on reproduction.
Therefore, for safety reasons, Veregen should be avoided during pregnancy, even though exposure to galusan epigallocatechin (the main component of green tea) after application to the skin appears to be small (see section "3. How to use Veregen").
Breastfeeding
It is not known whether Veregen or its metabolites pass into human milk. Therefore, it is not known whether there is a risk to the breastfed child. The risk to the breastfed child cannot be excluded.
However, after application to the skin in the mother, the risk of side effects in the breastfed child appears to be small.
Fertility
There is no evidence to suggest that Veregen affects fertility when used as recommended by the doctor.

Driving and using machines

No studies have been conducted on the effect of Veregen on the ability to drive and use machines. However, it is unlikely to affect the ability to drive and use machines.

Veregen contains isopropyl myristate and propylene glycol monopalmitostearate

Veregen contains, in addition to other ingredients, large amounts of isopropyl myristate, which may cause skin irritation and allergic reactions, and propylene glycol monopalmitostearate, which may cause skin irritation.

3. How to use Veregen

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The recommended dose is a maximum of 0.5 cm of ointment (corresponding to 250 mg) for all warts together, applied three times a day (morning, noon, and evening).

• Wash hands before and after applyingthe ointment.
• Apply a small amount of Veregen with the fingers to each wart, evenly covering all warts, leaving a thin layer of ointment on them.
• Do not use the ointment internally (do not insert into the anus, urethra, or vagina).
• After applying the ointment, do not bandage the treated area.
• It is not necessary to wash off the ointment from the treated area before the next application. When the patient has washed the treated area or taken a bath, they should apply the ointment.
• Veregen should be applied three times a day(morning, noon, and evening).
• During treatment, new warts may appear, which should be treated in the same way.
• Genital warts are a sexually transmitted disease; therefore, it is possible to infect the partner through sexual contact. Condoms should be used until all warts have completely disappeared. Using condoms prevents re-infection.
• Veregen may weaken condoms and diaphragms. Before sexual activity, the ointment should be thoroughly washed off with warm water and mild soap, and then a condom should be put on. The patient should ask their doctor about additional contraceptive methods.
• Female patients using tampons during menstruation: insert the tampon before applying the ointment. If it is necessary to change the tampon when the ointment is on the skin, care should be taken to avoid getting the ointment into the vagina. If the ointment accidentally gets into the vagina, it should be washed off immediately with warm water and mild soap.
• Treatment with Veregen should be continued until all warts have completely disappeared, but not longer than 16 weeks, even if new warts appear during treatment. If the warts do not disappear or the disease recurs, consult a 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

Data on the use of Veregen in the elderly are limited.

Impaired liver function

Veregen should not be used in case of liver function disorders (e.g. if there is abnormal fluid accumulation in the abdomen, yellowing of the skin due to liver function disorders).

Using more Veregen than recommended

More severe local reactions may occur (see sections "2. Important information before using Veregen" and "4. Possible side effects").
Wash off excess ointment with mild soap and water.
In case of accidental ingestion of the ointment, consult a doctor.

Missing a dose of Veregen

Continue with the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping treatment with Veregen

Treatment of warts may not be successful.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Veregen can cause side effects, although not everybody gets them.
Most side effects of Veregen are due to local effects on the skin and occur in the treated wart area or around it. Many patients experience redness, itching, irritation, pain, or swelling. Mild reactions can be expected, which should subside after the first few weeks of treatment. However, if the severity of local skin reactions has a negative impact on the patient's daily activities or if blisters occur, consult a doctor. It may be necessary to discontinue treatment.
Treatment can be resumed after the skin reaction has subsided. In case of local reaction, including blisters, consult a doctor.
In case of severe local reactions causing unacceptable discomfort, e.g. local inflammation/infection, ulcers, lymph node enlargement, or any other severe reaction (e.g. foreskin or urethral narrowing, difficulty urinating, or severe pain), discontinue treatment, wash off the ointment with warm water and mild soap, and consult a doctor immediately.
The following classification has been used for the frequency of side effects:

• local skin reactions in the area where Veregen was applied, including: redness, itching, irritation/burning, pain, swelling, ulcers, skin hardening, and blisters

Common:

• local skin reactions, such as flaking, discharge, bleeding, swelling
• lymph node swelling (in the groin)
• foreskin narrowing

Uncommon:

• local scarring, cracking, dryness, 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 virus infection, staphylococcal infection, vaginal fungal infection, urethritis or vulvovaginitis
• pain when urinating, frequent urination, or increased urge to urinate
• balanitis and glans penis pain, painful sexual intercourse
• rash, hypersensitivity

Side effects observed only with the use of a higher-strength ointment (Veregen 150 mg/g):

• bacterial skin infection (pyoderma), vulvitis
• urethral narrowing/difficulty urinating, discharge

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Veregen

The medicine should be stored out of 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 and carton after "Expiry date". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Veregen contains

The active substance of Veregen is green tea leaf extract. 1 g of ointment contains 100 mg of extract (in the form of a dry extract, purified) from Camellia sinensis(L.) O. Kuntze, folium (green tea leaves) (24-56:1), corresponding to: 55-72 mg of (-)-galusan epigallocatechin.
First extraction solvent: water
Other ingredients are:
white soft paraffin (contains all-rac-α-tocopherol),
white wax,
isopropyl myristate,
oleyl alcohol,
propylene glycol monopalmitostearate.

What Veregen looks like and contents of the pack

Veregen is a brown, smooth ointment, free of grainy particles, supplied in tubes of two sizes: 15 g and 30 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

ORNYX OÜ
Ida-Viru maakond
Jõhvi vald, Edise küla
Aiandi keskus 7, 41558
Estonia

Manufacturer

C.P.M. ContractPharma GmbH
Frühlingsstraße 7
83620 Feldkirchen-Westerham
Germany

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

Austria:
Veregen 10% Salbe
Belgium:
Veregen pommade
Bulgaria:
Вереген 10% маз
Croatia:
Veregen 100 mg/g mast
Cyprus:
Veregreen 10% Αλοιφή
Estonia:
Veregen
France:
VEREGEN 10%, pommade
Greece:
Veregreen 10% Αλοιφή
Spain
Veregen 100 mg/g pomada
Netherlands:
Veregen 10%, zalf
Ireland:
Catephen 10 % ointment
Lithuania:
Veregen 100 mg/g tepalas
Luxembourg:
Veregen 10 %
Latvia:
Veregen 100 mg/g ziede
Germany:
Veregen 10% Salbe
Poland:
Veregen
Portugal:
Veregen
Czech Republic:
Veregen
Slovakia:
Veregen 100 mg/g masť
Romania:
Veregen 100 mg/g unguent
Slovenia:
Veregen 100 mg/g mazilo
Hungary:
Veregen 10% kenőcs
United Kingdom (Northern Ireland):
Catephen 10 % ointment
Italy:
Veregen

Date of last revision of the leaflet: