Hepsera

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

adefovir dipivoxil

MAH:

Gilead Sciences Ireland UC

ATC_code:

J05AF08

INN:

adefovir dipivoxil

therapeutic_group:

Nucleoside and nucleotide reverse transcriptase inhibitors

therapeutic_area:

Hepatitis B, Chronic

therapeutic_indication:

Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

leaflet_short:

Revision: 27

authorization_status:

Withdrawn

authorization_date:

2003-03-06

PIL

23
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPSERA 10 MG TABLETS
adefovir dipivoxil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hepsera is and what it is used for
2.
What you need to know before you take Hepsera
3.
How to take Hepsera
4.
Possible side effects
5.
How to store Hepsera
6.
Contents of the pack and other information
1.
WHAT HEPSERA IS AND WHAT IT IS USED FOR
WHAT HEPSERA IS
Hepsera contains the active substance adefovir dipivoxil and belongs
to a group of medicines called
antiviral medicines.
WHAT IT IS USED FOR
Hepsera is used to treat chronic hepatitis B, an infection with
hepatitis B virus (HBV), in adults.
Infection with the hepatitis B virus leads to damage to the liver.
Hepsera reduces the amount of the
virus in your body, and has been shown to reduce liver damage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HEPSERA
DO NOT TAKE HEPSERA
•
IF YOU ARE ALLERGIC
to adefovir, adefovir dipivoxil or any of the other ingredients of
this
medicine (listed in section 6).
•
TELL YOUR DOCTOR AT ONCE
if you could be allergic to adefovir, adefovir dipivoxil or any of the
other ingredients of Hepsera.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Hepsera.
•
TELL YOUR DOCTOR IF YOU HAVE HAD KIDNEY DISEASE
, or if tests have shown problems with your
kidneys. Hepsera can affect the way your kidneys work. The risk of
this occurring is increased
with long-term use of Hepsera. Your doctor should run tests to check
your

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Hepsera 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of adefovir dipivoxil.
Excipient(s) with known effect
Each tablet contains 107.4 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in
diameter, debossed with
“GILEAD” and “10” on one side and a stylised shape of a liver
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepsera is indicated in adults for the treatment of chronic hepatitis
B with:
•
compensated liver disease with evidence of active viral replication,
persistently elevated serum
alanine aminotransferase (ALT) levels and histological evidence of
active liver inflammation
and fibrosis. Initiation of Hepsera treatment should only be
considered when the use of an
alternative antiviral agent with a higher genetic barrier to
resistance is not available or
appropriate (see section 5.1).
•
decompensated liver disease in combination with a second agent without
cross-resistance to
Hepsera.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B.
Posology
_Adults_
The recommended dose of Hepsera is 10 mg (one tablet) once daily taken
orally with or without food.
Higher doses must not be administered.
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.
In patients with decompensated liver disease, adefovir should always
be used in combination with a
second agent, without cross-resistance to adefovir, to reduce the risk
of resistance and to achieve rapid
viral suppression.
Medicinal Product no longer authorised
3
Patients should be monitored every six months for hepatitis B
biochemic