ZEFFIX TABLET 100MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LAMIVUDINE

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

LAMIVUDINE

Units in package:

28Tablet Tablets

Manufactured by:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Patient Information leaflet

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ZEFFIX TABLET
_ _
_ _
Lamivudine (100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZEFFIX is used for
2.
How ZEFFIX works
3.
Before you use ZEFFIX
4.
How to use ZEFFIX
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
ZEFFIX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZEFFIX IS USED FOR
Zeffix is used to treat hepatitis B
for individuals more than 16
years old.
HOW ZEFFIX WORKS
Zeffix is a type of medicine
known as an antiviral. It belongs
to a group of medicines called
nucleoside analogue reverse
transcriptase inhibitors (NRTIs).
Zeffix does not completely cure
hepatitis B infection; it reduces
the amount of virus in your
body, and keeps it at a low level.
However, this may stop your
hepatitis B disease progressing
and causing serious damage to
your liver.
Not everyone responds to
treatment with Zeffix in the
same way. Your doctor will
monitor the effectiveness of
your treatment.
BEFORE YOU USE ZEFFIX
-
_When you must not use it _
Do not take Zeffix
•
if you are allergic
(hypersensitive) to lamivudine
or any of the other ingredients
of Zeffix.
Check with your doctor
if you
think this applies to you.
-
_Before you start to use it _
Your doctor needs to know:
•
if you have ever had kidney
disease
•
if you are taking medications
for the treatment of HIV
infection
Check with your doctor
if you
think any of these may apply to
you. Your doctor may need to
adjust your dose, or Zeffix may
not be suitable for you.
_Pregnancy and breast-feeding _
If you are
pregnant or think you
could be, or if you are planning
to become pregnant:
•
Talk to your doctor about the
risks and benefits of taking
Zeffix
Zeffix can pass into breast milk.
If you are breast-feeding, you
must check with your doctor
before you take Zeffix.
-
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking any other
medicines, if you have taken any
recently, or if you start taking
new ones. This includes
medicin

Summary of Product characteristics

CONFIDENTIAL
1
[GSK LOGO]
ZEFFIX
LAMIVUDINE (HEPATITIS B)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamivudine 100 mg
_ZEFFIX _
tablets are butterscotch-coloured, film-coated, capsule-shaped,
biconvex with 'GX
CG5' engraved on the upper tablet face.
CLINICAL INFORMATION
INDICATIONS
_ _
_ZEFFIX _
is indicated for the treatment of patients
≥
16 years of age with chronic hepatitis B and
evidence of hepatitis B virus (HBV) replication.
DOSAGE AND ADMINISTRATION
Pharmaceutical Form
Film-coated tablets
The recommended dosage of
_ZEFFIX _
is 100 mg once daily.
_ZEFFIX _
can be taken with or
without food.
Patient compliance should be monitored while on
_ZEFFIX _
therapy.
Discontinuation of
_ZEFFIX _
may be considered in immunocompetent patients when HBeAg
and/or HBsAg seroconversion occurs. Discontinuation may also be
considered when loss of
efficacy occurs, as indicated by recurrent signs of hepatitis.
If
_ZEFFIX _
is discontinued, patients should be periodically monitored for
evidence of recurrent
hepatitis (
_see Warnings and Precautions_
).
Discontinuation of treatment is not recommended in patients with
decompensated liver disease.
There are limited data regarding the maintenance of seroconversion
long term after stopping
treatment with
_ZEFFIX_
.
_ZEFFIX _
should be used in accordance with available official recommendations.
CONFIDENTIAL
2
POPULATIONS
•
RENAL IMPAIRMENT
Lamivudine serum concentrations (AUC) are increased in patients with
moderate to severe renal
impairment due to decreased renal clearance. The dosage should
therefore be reduced for patients
with a creatinine clearance of less than 50 ml/min.
Data available in patients undergoing intermittent haemodialysis (less
than or equal to 4 hours
dialysis 2 to 3 times weekly), indicate that following the initial
dosage reduction of
_ZEFFIX _
to
correct for the patient's creatinine clearance, no further dosage
adjustments are required while
undergoing dialysis.
•
HEPATIC IMPAIRMENT
Data obtained in patients with hepatic impairment, including those
with en