HEPSERA TABLET 10 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ADEFOVIR DIPIVOXIL

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J05AF08

Dosage:

10 mg

Pharmaceutical form:

TABLET

Composition:

ADEFOVIR DIPIVOXIL 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PATHEON INC

Authorization status:

ACTIVE

Authorization date:

2003-06-28

Patient Information leaflet

Singapore proposed PI_clean 

1 

HEPSERA
TM

(ADEFOVIR DIPIVOXIL) 
1.  NAME OF THE MEDICINAL PRODUCT 
Adefovir dipivoxil 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet for oral use contains 10 mg adefovir dipivoxil. For 
excipients
, see 6.1 List of Excipients. 

3.  PHARMACEUTICAL FORM 
_HEPSERA_ tablets, 10 mg are white to off-white, round, flat-faced
tablets with a beveled edge and 
debossed with “GSK KNU” on one side, and blank on the other
side. 
4.  CLINICAL PARTICULARS 
4.1  THERAPEUTIC INDICATIONS 
_HEPSERA_ is indicated for the treatment of chronic hepatitis B in
adults with evidence of hepatitis B 
viral replication _AND EITHER EVIDENCE OF PERSISTENT ELEVATIONS IN
SERUM AMINOTRANSFERASES (ALT OR _
_AST) OR HISTOLOGICALLY ACTIVE DISEASE._  
Reductions in viral replication and improvements in liver
function have also been demonstrated in 
supportive studies in a limited number of chronic hepatitis B
patients with genotypic evidence of 
lamivudine-resistance, including patients with compensated or
decompensated liver disease and 
patients co-infected with HIV
_ _
(see section 4.4 Special Warnings and Special Precautions for Use). 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
ADULTS (18-65 YEARS): 
The recommended dose of _HEPSERA_ is 10 mg (one tablet) once daily
taken orally with or without 
food.  
The indication has been obtained primarily based on clinical trials of
48 weeks duration.  The optimum 
duration of treatment is unknown. 

The relationship between treatment response and long-term outcomes
such as hepatocellular carcinoma or 
decompensated cirrhosis is not known.

CHILDREN AND ADOLESCENTS (< 18 YEARS): 
The safety and efficacy of _HEPSERA_ in patients under the age of
18 years have not been established 
(see section 4.4 Special Warnings and Special Precautions for use). 
ELDERLY (
> 65 YEARS): 
The safety and efficacy of adevovir dipivoxil in patients over
the age of

Summary of Product characteristics

1
HEPSERA
TM
(ADEFOVIR DIPIVOXIL)
1.
NAME OF THE MEDICINAL PRODUCT
Adefovir dipivoxil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet for oral use contains 10 mg adefovir dipivoxil. For
excipients
, see 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
_HEPSERA_
tablets, 10 mg are white to off-white, round, flat-faced tablets with
a beveled edge and
debossed on one side, and blank on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HEPSERA_
is indicated for the treatment of chronic hepatitis B in adults with
evidence of hepatitis B
viral replication
_AND EITHER EVIDENCE OF PERSISTENT ELEVATIONS IN SERUM
AMINOTRANSFERASES (ALT OR _
_AST) OR HISTOLOGICALLY ACTIVE DISEASE._
Reductions in viral replication and improvements in liver function
have also been demonstrated in
supportive studies in a limited number of chronic hepatitis B patients
with genotypic evidence of
lamivudine-resistance, including patients with compensated or
decompensated liver disease and
patients co-infected with HIV
_ _
(see section 4.4 Special Warnings and Special Precautions for Use).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (18-65 YEARS):
The recommended dose of
_HEPSERA_
is 10 mg (one tablet) once daily taken orally with or without
food.
The indication has been obtained primarily based on clinical trials of
48 weeks duration. The optimum
duration of treatment is unknown.
The relationship between treatment response and long-term outcomes
such as hepatocellular carcinoma or
decompensated cirrhosis is not known.
CHILDREN AND ADOLESCENTS (< 18 YEARS):
The safety and efficacy of
_HEPSERA_
in patients under the age of 18 years have not been established
(see section 4.4 Special Warnings and Special Precautions for use).
ELDERLY (
> 65 YEARS):
The
safety and efficacy of adevovir dipivoxil in patients over the age of
65 years have not been
established (see section 4.4 Special Warnings and Special Precautions
for use).
Caution should be
exercised when prescribing
_HEPSERA_
to the elderly, keeping in mind the greater f