3TC TABLETS 150MG

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:

60Tablet Tablets

Manufactured by:

GLAXOSMITHKLINE PHARMACEUTICALS SA

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
3TC TABLETS / 3TC ORAL SOLUTION
Lamivudine (150 mg, 10 mg/ml)
WHAT IS IN THIS LEAFLET
1.
What 3TC is used for
2.
How 3TC works
3.
Before you use 3TC
4.
How to use 3TC
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of 3TC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT 3TC IS USED FOR
3TC is used to treat HIV (human
immunodeficiency virus)
infection in adults and children.
HOW 3TC WORKS
3TC is a type of medicine
known as an anti-retroviral. It
belongs to a group of medicines
called
_nucleoside analogue _
_reverse transcriptase inhibitors _
(NRTIs).
3TC does not cure HIV
infection; it reduces the amount
of virus in your body, and keeps
it at a low level. It also increases
the CD4 cell count in your
blood. CD4 cells are a type of
white blood cell that are
important in helping your body
to fight infection.
Not everyone responds to
treatment with 3TC in the same
way. Your doctor will monitor
the effectiveness of your
treatment.
BEFORE YOU USE 3TC
-
_When you must not use it _
Do not take 3TC
•
if you are allergic
(hypersensitive) to lamivudine
or any of the other ingredients
of 3TC.
Check with your doctor if you
think this applies to you.
_Pregnancy and breast-feeding _
If you are pregnant or think you
could be, or if you are planning
to become pregnant do not take
3TC without checking with your
doctor. Your doctor will
consider the benefit to you and
the risk to your baby of taking
3TC while you are pregnant.
Babies whose mothers took
NRTIs (medicines like 3TC)
during pregnancy had a reduced
risk of being infected with HIV.
Where possible, women who are
HIV-positive should not breast-
feed. This is because HIV
infection can be passed on to the
baby in breast milk. If formula
feeding is not possible, you
should get advice from your
doctor. A small amount of the
ingredients in 3TC can also pass
into your breast-milk.
Talk to your doctor immediately
if you are breast-feeding, or
thinking about breas

Summary of Product characteristics

CONFIDENTIAL
[ViiV logo]
3TC
LAMIVUDINE (HIV)
QUALITATIVE AND QUANTITATIVE COMPOSITION
_3TC _
oral solution contains 10 mg/ml lamivudine in a solution containing
20% (w/v)
sucrose. It is a clear, colourless to pale yellow solution.
_3TC _
film-coated tablets contain 150 mg lamivudine.
–
150 mg tablets are white, diamond shaped, scored and engraved with the
code
“GX CJ7” on both faces.
CLINICAL INFORMATION
INDICATIONS
_ _
_3TC, _
in combination with other anti-retroviral agents, is indicated for the
treatment of HIV
infected adults and children.
DOSAGE AND ADMINISTRATION
Oral Solution.
Film-coated tablets.
_ _
_3TC _
therapy should be initiated by a physician experienced in the
management of HIV
infection.
_3TC _
can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed
without crushing. For patients who are unable to swallow tablets,
lamivudine is available
as an oral solution. Alternatively, the tablets may be crushed and
added to a small
amount of semi-solid food or liquid, all of which should be consumed
immediately (
_see _
_Pharmacokinetics_
).
•
ADULTS, ADOLESCENTS AND CHILDREN WEIGHING AT LEAST 25 KG
The recommended dose of
_3TC _
is 300 mg daily. This may be administered as 150 mg
(15 ml oral solution, 1 x 150 mg tablet) twice daily or 300 mg (30 ml
oral solution, 2 x
150 mg tablet) once daily
_(see Warnings and Precautions). _
CONFIDENTIAL
•
CHILDREN AGED ≥ THREE MONTHS AND WEIGHING LESS THAN 25 KG
ORAL SOLUTION
The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily or 1 mL/kg (10
mg/kg) once
daily
_(see Warnings and Precautions)_
.
150 MG SCORED TABLETS
CHILDREN WEIGHING 14 TO < 20 KG:-
The recommended oral dose of
_3TC _
is either one half tablet taken twice daily or one
whole tablet taken once daily.
FOR CHILDREN WEIGHING ≥ 20 KG TO < 25 KG:-
The recommended oral dose of
_3TC _
is either one-half tablet taken in the morning and one
whole tablet taken in the evening, or one and a half tablets taken
once daily.
CHILDREN WEIGH