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CATEPHEN 10% OINTMENT

Active substance(s): CAMELLIA SINENSIS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CATEPHEN® 10% OINTMENT
Extract from green tea leaves
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 further questions, ask your doctor.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Catephen is and what it is used for
2. What you need to know before you use Catephen
3. How to use Catephen
4. Possible side effects
5. How to store Catephen
6. Contents of the pack and other information

1. WHAT CATEPHEN IS AND WHAT IT
IS USED FOR
Catephen is a herbal medicinal product for skin use
only. Its active substance is an extract from green tea
leaves. Catephen is used to treat warts (Condylomata
acuminata) on the surface of the genitals (sexual
organs) and around the anus. Catephen is used in
adults with normal function of their immune system.
You should talk to a doctor if you feel worse, or do not
feel better after 4-6 weeks of treatment.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE CATEPHEN
Talk to your doctor before using Catephen.
Do not use Catephen
– 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 other information’).
Warnings and precautions
– Talk to your doctor if you have any problems with
your liver or immune system. Catephen should
not be used if your liver function is impaired (e.g.
abnormal accumulation of fluid in the abdomen,
yellow skin due to liver dysfunction) or when your
immune system is compromised (either due to
illness or due to other medicines you are taking).
– Do not use Catephen until the area to be treated
has completely healed after previous drug or
surgical treatment.
– Avoid contact with the eyes, nostrils, lips and
mouth. If the ointment gets on any of these areas
inadvertently, it should be wiped off and/or rinsed
off with water.
– Do not apply to open wounds, broken or inflamed
skin.
– Catephen must not be applied on 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 can cause severe local
adverse reactions more often.
– Uncircumcised male patients treating warts under
the foreskin should retract the foreskin and clean
the area daily to prevent phimosis (when the
foreskin cannot be pulled back over the head of
the penis). When early signs of stricture occur (e.g.
open sores, hardening of the skin or increasing
difficulty in retracting the foreskin), you should
stop the treatment and consult your doctor.
– Catephen does not eliminate the HPV-virus or
prevent transmission of the disease, therefore
special care should be taken before sexual activity;
see section ‘3. How to use Catephen’ of this leaflet.
– In case your sexual partner is infected with genital
warts his/her treatment is advisable and will help
to prevent reinfection. You can ask your doctor for
advice.
– Do not expose the treated area to sunlight and do
not use sunlamps and tanning beds.
– Catephen stains clothing and bedding.
– Mild local skin reactions such as redness, itching,
irritation (mostly burning), pain and swelling at
the site of application are very common and
should not lead to discontinuation. They should
decrease after the first weeks of treatment; see
section ‘4. ‘Possible side effects’.
Children and adolescents
Catephen is not recommended for use in children
and adolescents below the age of 18 years.
Other medicines and Catephen
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicine or if
you have recently had other treatments for warts
around the sexual organs or the anus. Catephen
should not be used together with other treatment at
the wart area. Catephen should not be used until
your skin has healed from other treatments.

Catephen with food and drink
There is no interaction with food and drink.
As a precaution to avoid interactions/side effects,
Catephen should not be used with with food
supplements containing high amounts of extract
from green tea leaves.
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 taking this medicine.
Pregnancy
There are no or limited data available on the use of
Catephen in pregnant women. Reproductive studies
in animals have shown toxic effects. Therefore, as a
precautionary measure, although exposure to
epigallocatechingallate (the main constituent of
green tea) is expected to be low following
application to the skin, the use of Catephen during
pregnancy should be avoided. (see section ‘3.
How to use Catephen’).
Breast-feeding
It is not known if Catephen or its metabolites are
excreted in breast milk and therefore it is not known
if there is a risk to a breast-fed baby.
However following application of the product to the
mother's skin, the risk of adverse effects in the breastfed baby are likely to be low.
Fertility
There is no evidence of an effect on fertility if you use
Catephen as prescribed.
Driving and using machines
No studies on the effect on the ability to drive and
use machines have been performed. However it is
unlikely that treatment will have an effect on the
ability to drive or use machines.
Catephen contains isopropyl myristate and
propylene glycol monopalmitostearate
Catephen contains, among other ingredients, high
amounts of isopropylmyristate (IPM), which can
cause irritation and sensitization of the skin, and
propylene glycol monopalmitostearate which may
cause skin irritations.

3. HOW TO USE CATEPHEN
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is up to 0.5 cm of ointment
strand (corresponding to 250 mg) for all warts
together, applied three times daily (in the morning,
at mid-day and in the evening).
– Wash hands before and after applying the
ointment.
– Apply a small amount of Catephen to each wart
using the fingers, dabbing it on to ensure complete
coverage and leaving a thin layer of the ointment
on the warts. Do not apply the ointment internally
(into the anus, urethra or into the vagina).
– Do not cover the treated area with bandages after
you have applied the ointment.
– It is not necessary to wash off the ointment from
the treated area prior to the next application.
When you wash the treatment area or bathe,
apply the ointment afterwards.
– Apply Catephen three times per day (in the
morning, at mid-day and in the evening).
– New warts may develop during treatment, which
need to be treated in the same way.
– Genital warts are a sexually transmitted disease;
therefore you may infect your partner by sexual
activity. Condoms should be used until complete
clearance of all warts. The use of condoms
prevents reinfection as well.
– Catephen may weaken condoms and vaginal
diaphragms. Before sexual activity, wash off the
ointment carefully with warm water and mild
soap and apply a condom thereafter. Ask your
doctor for additional methods of contraception.
– Female patients during menstruation using
tampons: insert the tampon before applying the
ointment. If you need to change your tampon
while the ointment is on your skin, avoid getting
the ointment into the vagina. In case of accidental
application immediately wash-off the ointment
with warm water and mild soap.

– Duration of treatment with Catephen should be
continued until complete clearance of all warts,
however no longer than 16 weeks, even if new
warts develop during the treatment period. If the
warts do not go away or if they come back after
treatment please consult your doctor.

Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

Use in children and adolescents (below the age of
18 years)
Catephen is not approved for use in children and
adolescents below the age of 18 years.

IReLAND
HPRA Pharmacovigilance,
earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Older people
There is limited experience for the use of Catephen
in older people.
Hepatic impairment
You should not use Catephen if your liver function is
impaired (e.g. abnormal accumulation of fluid in the
abdomen, yellow skin due to liver problems).
If you use more Catephen than you should
You may experience more intense local reactions
(see sections ‘2. What you need to know before you
use Catephen’ and ‘4. Possible side effects’).
Wash off the extra ointment with mild soap and
water.
If you have accidentally swallowed the ointment you
should contact your doctor.
If you forget to use Catephen
Continue next dose when it's due. Do not use a
double dose to make up for a forgotten dose.
If you stop using Catephen
Clearance of warts may not be achieved.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Most of the side effects of Catephen are due to its
local action on the skin and occur on or around the
treated wart area. Many patients experience redness,
itching, irritation, pain or swelling. Mild reactions are
expected and should ease after the first weeks of
treatment. If however, the intensity of local skin
reactions is affecting your daily activities or if blisters
occur, please consult your doctor. It may be necessary
to interrupt treatment. Treatment can be resumed
after the skin reaction has subsided. In case of
vesicular local reactions please consult your doctor.
If you experience severe local reaction causing
unacceptable discomfort e.g. local inflammation/
infection, open sore, swelling of lymph nodes or any
other serious reaction (e.g. constriction of foreskin or
urethra, difficulty passing urine or severe pain) you
should stop treatment, wash off the ointment with
warm water and mild soap and consult your doctor
straight away.
For the assessment of the side effects the following
frequency rating was used:
Very
common

may affect more than 1 in 10
people

Common

may affect up to 1 in 10 people

Uncommon

may affect up to 1 in 100
people

Very common:
– Local skin reactions at the wart site where you
have applied Catephen including: redness,
itching, irritation/burning, pain, swelling, open
sores, hardening of the skin, and blisters.
Common:
– Local skin reactions like flakiness, discharge,
bleeding, swelling
– Swelling of lymph nodes (in the groin)
– Constriction of the foreskin of the penis
Uncommon:
– Local scarring, fissure, skin dryness, discomfort,
erosion, increase or loss of sensation, nodule,
papules, inflammation of the skin, and changes in
skin colour at the application site, local necrosis,
eczema
– Pustules at the application site, infections at the
application site, genital herpes infection,
staphylococcal infection, fungal infection of the
vagina, inflammation of the urethra or of the vulva
and vagina
– Pain, high frequency or urgency in urinating
– Inflammation of the foreskin and head of the
penis, painful sexual intercourse
– Rash, hypersensitivity

You can also report side effects directly via

UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE CATEPHEN
Keep this medicine out of the sight and reach of
children
Do not store above 25°C
Use within 6 weeks after first opening of the tube
Do not use this medicine after the expiry date which
is stated on the tube and carton label after {eXP}. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Catephen contains
The active substance is an extract from green tea
leaves. 1 g of the ointment contains 100 mg of extract
(as dry extract, refined) 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 ingredients are:
White soft paraffin (contains all-rac-α-tocopherol),
white beeswax, isopropyl myristate, oleyl alcohol,
propylene glycol monopalmitostearate.
What Catephen looks like and contents of the pack
Catephen is a brown, smooth ointment, free from
gritty particles presented in 2 tube sizes: 15 g and
30 g. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Kora Corporation Ltd t/a Kora Healthcare
Swords Business Park, Swords, Co. Dublin, Ireland
Manufacturer:
Medigene AG
Lochhamer Strasse 11
D-82152 Planegg / Martinsried, Germany.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria:
Veregen 10% Salbe
Belgium:
Veregen pommade
Bulgaria:
Veregen 10% маз
Croatia:
Veregen 100 mg/g mast
Cyprus:
Veregreen 10% Αλοιφή
Czech Republic: Veregen 10% mast
Denmark:
Veregen, salve
estonia:
Veregen
Finland:
Veregen voide
France:
Veregen 10%, pommade
Germany:
Veregen 10% Salbe
Greece:
Veregreen 10%Αλοιφή
Hungary:
Veregen 10% kenőcs
Ireland:
Catephen
Italy:
Veregen
Latvia:
Veregen 100 mg/g ziede
Lithuania:
Veregen 100 mg/g tepalas
Luxembourg:
Veregreen 10 %
Netherlands:
Veregen 10%, zalf
Norway:
Veregen salve
Poland:
Veregen 100 mg/g maść
Portugal:
Veregen
Romania:
Veregen 100 mg/g unguent
Slovak Republic: Veregen 100 mg/g masť
Slovenia:
Veregen 100 mg/g mazilo
Spain:
Veregen 100 mg/g pomada
Sweden:
Veregen salva
United Kingdom: Catephen
This leaflet was last revised in 04/2016

Adverse reactions that were observed with a higher
strength (Catephen 15%) ointment only:
– Bacterial skin infections (pyoderma), inflammation of vulva
– Constriction of the urethra/difficulty passing
urine, vaginal discharge

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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