Zeffix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

lamivudine

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J05AF05

INN (International Name):

lamivudine

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

Hepatitis B, Chronic

Therapeutic indications:

Zeffix 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 / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

Product summary:

Revision: 29

Authorization status:

Authorised

Authorization date:

1999-07-29

Patient Information leaflet

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZEFFIX 100 MG FILM-COATED TABLETS
lamivudine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have 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 Zeffix is and what it is used for
2.
What you need to know before you take Zeffix
3.
How to take Zeffix
4.
Possible side effects
5.
How to store Zeffix
6.
Contents of the pack and other information
1.
WHAT ZEFFIX IS AND WHAT IT IS USED FOR
The active ingredient in Zeffix is lamivudine.
ZEFFIX IS USED TO TREAT LONG TERM (CHRONIC) HEPATITIS B INFECTION IN
ADULTS.
Zeffix is an antiviral medicine that suppresses the hepatitis B virus
and belongs to a group of
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)_
.
Hepatitis B is a virus which infects the liver, causes long term
(chronic) infection, and can lead to liver
damage. Zeffix can be used in people whose liver is damaged, but still
functions normally
(compensated liver disease) and in combination with other medicines in
people whose liver is damaged
and does not function normally (decompensated liver disease).
Treatment with Zeffix can reduce the amount of hepatitis B virus in
your body. This should lead to a
reduction in liver damage and an improvement in your liver function.
Not everyone responds to
treatment with Zeffix in the same way. Your doctor will monitor the
effectiveness of your treatment
with regular blood tests.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEFFIX
Your healthcare provider should offer you counselling and testing for
HIV infection before you start
treatment with lamivudine for hepatiti

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zeffix 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg lamivudine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Butterscotch coloured, film-coated, capsule shaped, biconvex,
approximate dimensions 11mm x 5mm
and engraved “GX CG5” on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zeffix 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/or fibrosis. Initiation of lamivudine treatment should only be
considered when the use of an
alternative antiviral agent with a higher genetic barrier is not
available or appropriate (see section
5.1).

decompensated liver disease in combination with a second agent without
cross-resistance to
lamivudine (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with Zeffix should be initiated by a physician experienced in
the management of chronic
hepatitis B.
Posology
_Adults_
The recommended dosage of Zeffix is 100 mg once daily.
In patients with decompensated liver disease, lamivudine should always
be used in combination with a
second agent, without cross-resistance to lamivudine, to reduce the
risk of resistance and to achieve
rapid viral suppression.
_Duration of treatment_
The optimal duration of treatment is unknown.
•
In patients with HBeAg positive chronic hepatitis B (CHB) without
cirrhosis, treatment should
be administered for at least 6-12 months after HBeAg seroconversion
(HBeAg and HBV DNA
loss with HBeAb detection) is confirmed, to limit the risk of
virological relapse, or until HBsAg
seroconversion or there is loss of efficacy (see section 4.4). Serum
ALT and HBV DNA levels
3
should be followed regularly after treatment disco