Package leaflet: Information for the user

Veregen 10% Ointment

Green tea leaf extract
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor. See section 4.

Contents of this leaflet:

What Veregen is and what it is used for
Before you use Veregen
How to use Veregen
Possible side effects
How to store Veregen
Contents of the pack and other information

1. What Veregen is and what it is used for

Veregen is a plant-derived medicinal product intended for topical use. Its active ingredient is an extract from green tea leaves. Veregen is used to treat genital warts (Condyloma acuminata) in the external genital and perianal areas. Veregen is used in adults who have normal immune system function.
If there are signs of worsening or no signs of improvement after 4–6 weeks of treatment, consult your doctor.

2. Before using Veregen

Talk to your doctor before using Veregen.
Do not use Veregen

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

Warnings and precautions

Consult your doctor if you have liver or immune system problems. Veregen must not be used if liver function is impaired (e.g. abnormal fluid accumulation in the abdomen, yellowing of the skin due to liver dysfunction) or when the immune system is compromised (due to disease or other medications you are taking).
Do not use Veregen until the area to be treated has completely healed following previous treatment with another medicine or following surgical treatment.
Avoid contact with eyes, nostrils, lips, and mouth. If the ointment comes into contact with any of these areas accidentally, it must be removed and/or rinsed off with water.
Do not apply on open wounds, damaged or inflamed skin.
Veregen must not be applied to mucous membranes; therefore, it is not a treatment for warts in the vagina, cervix, urethra, or inside the anus.
Female patients with genital warts in the vulvar area should use the ointment with caution, as treatment in this area may more frequently cause severe local adverse reactions.
Uncircumcised male patients treating warts under the foreskin must retract the foreskin and clean the area daily to avoid phimosis (when the foreskin cannot be pulled back over the head of the penis). If early signs of stenosis occur (e.g. open sores, hardened skin, or increasing difficulty in retracting the foreskin), treatment should be stopped and a doctor consulted.
Veregen does not eliminate the HPV virus and does not prevent disease transmission; therefore, special precautions must be taken before sexual activity; see section 3 “How to use Veregen”.
If the patient’s sexual partner is infected, treatment of the partner is recommended to prevent reinfection of the patient.
Do not expose the treated area to sunlight and do not use sunlamps or sunbeds.
Veregen may stain clothing and bed linen.
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 should decrease after the first few weeks of treatment; see section 4 “Possible side effects”.

Children and adolescents
Veregen is not recommended for children and adolescents under 18 years of age.
Interaction of Veregen with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, or if you have recently undergone other treatments for genital or anal warts. Veregen must not be used concurrently with other local treatments in the area of the warts. Veregen must not be used until the skin has completely healed following other treatments.
Interaction with food and drink
There is no interaction with food and drink.
As a precaution to avoid interactions/side effects, Veregen must not be used concurrently 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 have a baby, ask your doctor for advice before using this medicine.
Pregnancy
There is limited clinical data available on the use of Veregen in pregnant women. Reproductive studies in animals have shown toxic effects. Therefore, as a precautionary measure, even though exposure to epigallocatechin gallate (the main constituent of green tea) should be low following topical application of Veregen, the use of Veregen during pregnancy should be avoided (see section “3. How to use Veregen”).
Breast-feeding
It is not known whether Veregen or its metabolites are excreted in human milk, and therefore the risks to the breastfed infant are unknown.
However, following application of the product on the skin of mothers, it is likely that the risk of adverse effects in the breastfed infant is low.
Fertility
There is no evidence of an effect on fertility when Veregen is used as directed.
Driving and using machines
No studies on the ability to drive and use machines have been conducted.
However, it is unlikely that treatment with Veregen would have any effect on the ability to drive or use machines.
Veregen contains isopropyl myristate and polyglyceryl-6 polyricinoleate
Veregen contains, among other ingredients, high amounts of isopropyl myristate (IPM), which may cause skin irritation and sensitization, and polyglyceryl-6 polyricinoleate, which may cause skin irritation.

3. How to use Veregen

Always use this medicine exactly as prescribed by your doctor. If you have any doubts about how to use Veregen, consult your doctor or pharmacist.
The recommended dose is up to 0.5 cm of ointment layer (equivalent to 250 mg) for all warts, 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, gently patting to ensure complete coverage and leaving a thin layer of ointment on the warts. Do not apply the ointment internally (in the anus, urethra, or vagina).
Do not cover the treated area with bandages after applying the ointment.
It is not necessary to wash off the ointment from the treated area before the next application. When washing the treated area or bathing, reapply the ointment afterwards.
Apply Veregen three times daily (in the morning, at midday, and in the evening).
New warts may develop during treatment; these should be treated in the same way.
Genital warts are a sexually transmitted disease, so you may infect your partner through sexual activity. Therefore, the use of condoms is recommended during sexual intercourse until all warts have completely disappeared. Using a condom also helps prevent reinfection.
Veregen may damage condoms and vaginal diaphragms. Before sexual activity, thoroughly wash off the ointment with lukewarm water and mild soap before using a condom. Ask your doctor for advice regarding alternative contraceptive methods.
Women who use tampons during menstruation are advised to insert the tampon before applying the ointment. If you need to change the tampon while the ointment is applied to the skin, avoid contact of the ointment with the vagina. If this occurs accidentally, immediately remove the ointment with warm water and mild soap.
Treatment with Veregen should continue until all warts have completely disappeared, but not for longer than 16 weeks, even if new warts develop during the treatment period. If the warts do not disappear or if they recur after treatment, please consult your doctor.

Children/adolescents (under 18 years)
The use of Veregen is not authorized in children and adolescents under 18 years of age.
Elderly patients
Experience with the use of Veregen in elderly patients is limited.
Hepatic impairment
Do not take Veregen if you have impaired liver function (e.g., abnormal fluid accumulation in the abdomen, yellowing of the skin due to liver problems).
If you use more Veregen than you should:
Severe skin reactions may occur (see sections 2. Before using Veregen and 4. Possible side effects).
Remove the excess amount with water and mild soap.
In case of accidental ingestion of the ointment, contact your doctor immediately.
If you forget to use Veregen
Continue with the next dose as scheduled. Do not apply a double amount to make up for the missed dose.
If you stop using Veregen
Genital warts may not heal completely.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Veregen can cause adverse reactions, although not everyone experiences them.
Most of Veregen's side effects are related to its local irritant effect on the skin and occur at or around the site of application.
Many patients report redness, itching, skin irritation, pain, or swelling. Mild skin reactions are likely and should disappear within the first weeks of treatment.
If local skin reactions become severe enough to interfere with daily life, or if blisters develop, consult your doctor. It may be necessary to discontinue treatment.
Treatment may be resumed once the skin reactions have resolved. In case of vesicular local reactions, consult your doctor.
If severe skin reactions occur with particularly troublesome symptoms, such as local inflammation/infection, ulcers, swollen lymph nodes, or other serious side effects (e.g. phimosis or urethral meatus narrowing, difficulty urinating, or severe pain), stop treatment immediately, wash off the ointment with water and a mild soap, and contact your doctor immediately.

For the assessment of adverse reactions, the following frequency categories have been used:

Very common	May affect more than 1 in 10 patients
Common	May affect up to 1 in 10 patients
Uncommon	May affect up to 1 in 100 patients

Very common:

Local skin reactions at the site of application on the warts, such as redness, itching, skin irritation/burning, pain, swelling, ulceration, hardening or blistering

Common:

Local skin reactions such as peeling, oozing, bleeding and swelling
Swollen lymph nodes (in the groin)
Phimosis (tightening of the foreskin)

Uncommon:

Local scarring, skin fissures, dry skin, discomfort, skin abrasions, increased or reduced sensitivity, nodules, papules, inflammation, skin discoloration at the application site, local necrosis, eczema
Pustules at the application site, infections at the application site, genital herpes, staphylococcal infections, fungal vaginal infections, inflammation of the urethra, vulva or vagina
Pain, urgent need to urinate
Inflammation of the foreskin and glans, pain during sexual intercourse
Skin rash, hypersensitivity

Adverse reactions observed only with the higher strength ointment (Veregen 15%):

Bacterial skin infection (pyoderma), inflammation of the vulva
Urethral stricture/difficulty urinating, vaginal discharge

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Veregen

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Use within 6 weeks after first opening the tube.
Do not use this medicine after the expiry date which is stated on the tube and outer packaging after
{Exp}. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Veregen contains
The active substance is an extract from green tea leaves. 1 g of ointment contains 100 mg of extract (as
dried, refined extract) from Camellia sinensis (L.) O. Kuntze, folium (green tea leaves) (24-56:1),
corresponding to: 55-72 mg of (-)-epigallocatechin gallate.
First extraction solvent: water
The other components are:
White soft paraffin (containing racemic α-tocopherol),
White beeswax,
Isopropyl myristate,
Oleic alcohol,
Propylene glycol monopalmitostearate.
Description of the appearance of Veregen and package contents
Veregen is a smooth, brown ointment free from lumps, available in two pack sizes: 15 g and 30 g.
Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (VA)
Manufacturer:
Medigene AG
Lochhamer Strasse 11
D-82152 Planegg / Martinsried
Germany
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Austria: Veregen 10% Salbe Italy: Veregen
Belgium: Veregen pommade Latvia: Veregen 100 mg/g ziede
Bulgaria: Veregen 10% маз Lithuania: Veregen 100 mg/g tepalas
Croatia: Veregen 100 mg/g mast Luxembourg: Veregreen 10 %
Cyprus: Veregreen 10% Αλοιφή Netherlands: Veregen 10%, zalf
Czech Republic: Veregen 10% mast Norway: Veregen salve
Denmark: Veregen, salve Poland: Veregen 100 mg/g maść
Estonia: Veregen Portugal: Veregen
Finland: Veregen voide Romania: Veregen 100 mg/g unguent
France: Veregen 10%, pommade Slovakia: Veregen 100 mg/g masť
Germany: Veregen 10% Salbe Slovenia: Veregen 100 mg/g mazilo
Greece: Veregreen 10%Αλοιφή Spain: Veregen 100 mg/g pomada
Hungary: Veregen 10% kenőcs Sweden: Veregen salva
Ireland: Catephen United Kingdom: Catephen
This patient information leaflet was last approved in {MM/YYYY}.