Zeffix

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lamivudine 100mg;  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Lamivudine 100 mg

Dosage:

100 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Lamivudine 100mg   Excipient: Magnesium stearate Opadry butterscotch YS-1R-17307-A Powdered cellulose Sodium starch glycolate

Units in package:

Blister pack, 4x7, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Zeffix is indicated for the treatment of adults and children aged 2 years and older with chronic hepatitis B and evidence of hepatitis B viruse (HBV) replication.

Product summary:

Package - Contents - Shelf Life: Blister pack, 4x7 - 28 tablets - 36 months unopened stored at or below 30°C

Authorization date:

1997-07-10

Patient Information leaflet

ZEFFIX Tablets 1
ZEFFIX TABLETS
_Lamivudine 100 mg _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking ZEFFIX
tablets.
This leaflet answers some
common questions about ZEFFIX
tablets. It does not contain all of
the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
ZEFFIX against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
TABLETS.
You may need to read it again.
WHAT ZEFFIX TABLETS
ARE USED FOR
ZEFFIX tablets contain lamivudine
which belongs to a group of
medicines called antivirals.
ZEFFIX is used to treat patients
with long term (chronic) viral
infection of the liver caused by
hepatitis B and evidence of
hepatitis B virus replication.
Hepatitis B is a virus which
damages the liver. Treatment
with ZEFFIX can reduce the
amount of hepatitis B virus in your
body. This should lead to less
liver damage.
ZEFFIX does not reduce the risk
of passing hepatitis B to others.
You will still be able to pass on
the hepatitis virus by sexual
contact or through your blood.
You should use appropriate
precautions.
ZEFFIX tablets are not addictive.
Your doctor may have prescribed
ZEFFIX tablets for another
reason.
If you are already taking
medicines containing lamivudine
for HIV infection (3TC, Combivir),
your doctor will continue to treat
you with the higher dose for that
viral infection.
If you have any questions about
why ZEFFIX tablets have been
prescribed for you, ask your
doctor.
BEFORE YOU TAKE
ZEFFIX TABLETS
_WHEN YOU MUST NOT TAKE _
_ZEFFIX _
Do not take ZEFFIX tablets if you
have ever had an allergic reaction
to lamivudine or any of the
ingredients listed at the end of this
leaflet.
READ THE SIDE EFFECTS SECTION TO
FIND OUT ABOUT THE SYMPTOMS OF
ALLERGY.
Do not take ZEFFIX tablets if you
are pregnant,

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZEFFIX lamivudine 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 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Butterscotch coloured, film coated capsule shaped, biconvex and
engraved “GX
CG5” on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZEFFIX is indicated for the treatment of adults and children aged 2
years and older
with chronic hepatitis B and evidence of hepatitis B virus (HBV)
replication.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
_ADULTS AND ADOLESCENTS 12 YEARS AND OLDER: _the recommended dosage of
ZEFFIX
is 100 mg once daily.
_CHILDREN FROM TWO TO ELEVEN YEARS: _the recommended dose is 3 mg/kg
once daily
up to a maximum of 100 mg daily.
Treatment in this patient population should not be extended beyond one
year's
duration.
ZEFFIX oral solution is available for use in children and those
patients for whom the
tablets are inappropriate.
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 section 4.4 Special warnings and precautions
for use).
2
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.
Special 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 wi