Catephen 10 % ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Green tea dry extract

Available from:

Kora Corporation Limited trading as Kora Healthcare

ATC code:

D06BB; D06BB12

INN (International Name):

Green tea dry extract

Dosage:

10 percent

Pharmaceutical form:

Ointment

Administration route:

Cutaneous use

Units in package:

Tube contains 15 g or 30 g of ointmen

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Medigene AG

Therapeutic group:

Chemotherapeutics for topical use, antivirals

Therapeutic area:

Antivirals; sinecatechins

Therapeutic indications:

It is indicated for the cutaneous treatment of external genital and perianal warts (condylomataacuminata) in immunocompetent patients from the age of 18 years.

Authorization status:

Marketed

Authorization date:

2015-04-17

Patient Information leaflet

1
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 (
_Condylomataacuminata_
) 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
af

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Catephen 10 % ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
(-)-epigallocatechingallate.
First extraction solvent: water
Excipients with known effect:
1 g of ointment contains:
50 mg propylene glycol monopalmitostearate
350 mg isopropyl myristate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Brown, smooth ointment, free from gritty particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Catephen is indicated for the cutaneous treatment of external genital
and perianal warts (_condylomataacuminata_) in
immunocompetent patients from the age of 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology for adults
Up to 250 mg Catephen ointment as total single dose, corresponding to
about 0.5 cm of ointment strand to be applied
three times per day to all external genital and perianal warts (750 mg
total daily dose).
_Duration of use_
Treatment with Catephen should be continued until complete clearance
of all warts, however, no longer than 16 weeks
in total (max. duration), even if new warts develop during the
treatment period.
_Paediatric population_
The safety and efficacy of Catephen in children and adolescents below
the age of 18 years have not been investigated.
No data are available.
_Older people_
An insufficient number of older people were treated with Catephen
ointment to determine whether they respond
differently from younger subjects.
_Patients with hepatic impairment_
Patients with severe liver dysfunction(e.g. clinically relevant
elevation of liver enzymes, increase of bilirubin, increase
of INR) should not use Catephen due to insufficient safety data. (see
sections 4.4 and 4.8)
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