Catephen 10% Ointment

Country: United Kingdom

Bahasa: Inggeris

Sumber: myHealthbox

Bahan aktif:

extract (as dry extract, refined) from Camellia sinensis (L.) O. Kuntze, folium (green tea leaf)

Boleh didapati daripada:

Kora Corporation Ltd t/a Kora Healthcare

Kod ATC:

D06BB12

INN (Nama Antarabangsa):

extract (as dry extract, refined) from Camellia sinensis (L.) O. Kuntze, folium (green tea leaf)

Dos:

100mg

Borang farmaseutikal:

Ointment

Laluan pentadbiran:

cutaneous use

Unit dalam pakej:

One tube contains 15 g or 30 g of ointment

Jenis preskripsi:

POM - Prescription Only Medicine

Dikeluarkan oleh:

Medigene AG

Kumpulan terapeutik:

Chemotherapeutics for topical use, antivirals

Tanda-tanda terapeutik:

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

Status kebenaran:

Authorised

Tarikh kebenaran:

2015-03-24

Risalah maklumat

_Origination:_
16/07/2014
Rev.1: 22/07/2014
Rev.2: 23/07/2014
Rev.3: 18/02/2015
Rev.4: 19/02/2015
_Pharma Code:_
KORA
HEALTHCARE
_Registration:_
_Date:_
_Client:_
_Product:_
CATEPHEN 10% OINTMENT
_Spec Code:_
????
_Dimensions:_
148X420MM
_Typefont: _MYRIAD 9 POINT
PACKAGE LEAFLET: INFORMATION FOR THE USER
CATEPHEN
®
10% OINTMENT
EXTRACT FROM GREEN TEA LEAVES
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 an herbal medicinal product for skin use
only. Its active substance is an extract from green tea
leaves.  Catephen  is  used  to  locally  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 do not feel better
or if you feel worse 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.
abdominal  dropsy,  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 Ca

Ciri produk

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(s) with known effect: 
1 g of ointment contains: 
50 mg Propylene glycol monopalmitostearate 
350 mgIsopropyl 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) sho