Lamivudine Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

lamivudine

Available from:

Teva B.V.

ATC code:

J05AF05

INN (International Name):

lamivudine

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

Hepatitis B, Chronic

Therapeutic indications:

Lamivudine Teva 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 in section 5.1).

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2009-10-23

Patient Information leaflet

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE TEVA 100 MG FILM-COATED TABLETS
lamivudine
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 Lamivudine Teva is and what it is used for
2.
What you need to know before you take Lamivudine Teva
3.
How to take Lamivudine Teva
4.
Possible side effects
5.
How to store Lamivudine Teva
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE TEVA IS AND WHAT IT IS USED FOR
The active ingredient in Lamivudine Teva is lamivudine.
LAMIVUDINE TEVA IS USED TO TREAT LONG TERM (CHRONIC) HEPATITIS B
INFECTION IN ADULTS.
Lamivudine Teva 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. Lamivudine Teva 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 Lamivudine Teva 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 Lamivudine Teva in the same way. Your doctor will
monitor the effectiveness of
your treatment with regular blood tests.
2.
WHAT YOU NEED TO KNO

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine Teva 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
Orange, capsule shaped, biconvex film-coated tablet – engraved with
“L 100” on one side and plain on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine Teva 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 Lamivudine Teva should be initiated by a physician
experienced in the management of
chronic hepatitis B.
Posology
_Adults_
The recommended dosage of Lamivudine Teva 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 tr