Hepsera

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Adefovir dipivoxil 10mg;  

Available from:

Gilead Sciences (NZ)

INN (International Name):

Adefovir dipivoxil 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Adefovir dipivoxil 10mg   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Purified talc Starch

Units in package:

Bottle, plastic, HDPE x 30 tablets, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

ZaCh System, S.A.

Therapeutic indications:

HEPSERA is indicated for the treatment of patients 12 years and older with chronic hepatitis B infection and evidence of hepatitis B viral replication. For adult patients this indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg-/HBVDNA+ chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. For adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus with compensated liver function.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE x 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2003-09-30

Patient Information leaflet

HEPSERA Consumer Medicine Information (23 April 2019) Page 1 of 4
HEPSERA
 TABLETS
_10 mg adefovir dipivoxil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about HEPSERA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist about your medical
condition or treatment.
If you have further questions, please
ask your doctor or your pharmacist.
Keep this leaflet with your
HEPSERA medicine. You may need
to read it again.
This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
WHAT HEPSERA
TABLETS ARE USED FOR
HEPSERA is used to treat chronic
hepatitis B in patients 12 years of age
or older.
Hepatitis B is caused by infection
with the hepatitis B virus (HBV)
which can damage the liver.
_HOW HEPSERA WORKS _
HEPSERA belongs to a group of
medicines called antiviral medicines.
HEPSERA reduces the amount of the
virus in your body, by lowering the
ability of the virus to multiply and
infect new liver cells and can
improve the inflammation and scar
tissue caused by the hepatitis B virus
in your liver. Lowering the amount
of virus in your body may reduce the
chance of developing cirrhosis, liver
failure and liver cancer.
We do not know how long
HEPSERA may help treat your
hepatitis. Sometimes viruses change
in your body and medicines no
longer work. This is called drug
resistance.
_USE IN CHILDREN _
HEPSERA is not recommended for
use in children under 12 years of age
as its safety and effectiveness in that
age group have not been established.
BEFORE YOU TAKE
HEPSERA
_WHO MUST NOT TAKE IT _
DO NOT TAKE HEPSERA IF YOU ARE
ALLERGIC TO:
•
adefovir dipivoxil or
•
any of the other ingredients of
HEPSERA.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
rash, itching or hives on the skin
•
swelling of the face, lips, tongue
or other

Summary of Product characteristics

Hepsera Data Sheet v13.0 – (19 May 2020)
1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Hepsera
®
(adefovir dipivoxil 10 mg) Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adefovir dipivoxil 10 mg.
For full list of excipients, see Section 6.1.
HEPSERA are white, flat-faced tablets debossed with “10” and
“GILEAD” on one side and the
stylised figure of a liver on the other side.
3 PHARMACEUTICAL FORM
Tablet.
Adefovir dipivoxil is a white to off-white crystalline powder with an
intrinsic aqueous solubility
of 19 mg/mL at pH 2 and 0.4 mg/mL at pH 7.2. It has an octanol/aqueous
phosphate buffer (pH
7) partition coefficient (
_log p_
) of 1.91.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HEPSERA is indicated for the treatment of patients 12 years and older
with chronic hepatitis B
infection and evidence of hepatitis B viral replication.
For adult patients this indication is based on histological,
virological, biochemical, and
serological responses in adult patients with HBeAg+ and HBeAg-/HBVDNA+
chronic hepatitis
B with compensated liver function, and in adult patients with clinical
evidence of lamivudine-
resistant hepatitis B virus with either compensated or decompensated
liver function.
For adolescent patients (12 to <18 years of age), the indication is
based on virological and
biochemical responses in patients with HBeAg+ chronic hepatitis B
virus with compensated liver
function.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dose of HEPSERA is one tablet, once daily taken
orally, without
regard to food. Doses higher than those recommended must not be
administered. The optimum
duration of treatment is unknown.
CHILDREN AND ADOLESCENTS:
The recommended dose of HEPSERA in chronic hepatitis B patients
≥12 years of age with adequate renal function is one tablet, once
daily taken orally, without
regard to food. HEPSERA is not recommended for use in children below
12 years of age.
Hepsera Data Sheet v13.0 – (19 May 2020)
2
ELDERLY:
No data are available to support a dose recommendation f