ABACAVIR/LAMIVUDINE 600/300 SUN abacavir 600 mg / lamivudine 300 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

abacavir sulfate,lamivudine

Available from:

Sun Pharma ANZ Pty Ltd

Authorization status:

Registered

Patient Information leaflet

1
ABACAVIR/LAMIVUDINE SUN 600/300 Tablets v1.1
ABACAVIR/LAMIVUDINE SUN
600/300
TABLETS
_abacavir (as sulfate) and lamivudine_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
Please read this leaflet carefully
before you start
ABACAVIR/LAMIVUDINE SUN
600/300 tablets.
This leaflet answers some
common questions about
ABACAVIR/LAMIVUDINE
SUN 600/300 tablets. It does not
contain all of the available
information.
It does not take the place of talking
to your doctor or pharmacist (also
known as a chemist).
All medicines have benefits and
risks. Your doctor has weighed the
expected benefits of you taking
ABACAVIR/LAMIVUDINE SUN
600/300 tablets against the risks this
medicine could 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 ABACAVIR/
LAMIVUDINE SUN
600/300 TABLETS ARE
USED FOR
ABACAVIR/LAMIVUDINE SUN
600/300 tablets contain abacavir
and lamivudine which belong to a
group of medicines called
antiretrovirals. These are also
available as separate medicinal
products: Ziagen (abacavir) and
3TC (lamivudine).
ABACAVIR/LAMIVUDINE
SUN 600/300 tablets are used
together with other antiretrovirals
to slow down the progression of
human immunodeficiency virus
(HIV) infection, which can lead to
Acquired Immune Deficiency
Syndrome (AIDS) and other
related illnesses (eg AIDS-related
Complex or ARC).
ABACAVIR/LAMIVUDINE
SUN 600/300 tablets do not cure
AIDS or kill the HIV virus, but
delays further damage to the
immune system by stopping
production of new viruses.
ABACAVIR/LAMIVUDINE
SUN 600/300 tablets do not
reduce the risk of passing the
infection to others.
You will still be able to pass on
the HIV virus by sexual activity or
PATIENTS TAKING ABACAVIR/LAMIVUDINE SUN 600/300, WHICH CONTAINS
ABACAVIR, MAY
DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH
CAN BE
LIFE-THREATENING IF TREATMENT WITH ABACAVIR/LAMIVUDINE SUN 600/300 IS
CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE O

Summary of Product characteristics

ABACAVIR/LAMIVUDINE 600/300 SUN pi-v1.3
Page | 1
AUSTRALIAN PRODUCT INFORMATION
ABACAVIR/LAMIVUDINE SUN 600/300
(ABACAVIR AND LAMIVUDINE) FILM-COATED TABLETS
1 NAME OF THE MEDICINE
Abacavir (present as sulfate) and lamivudine .
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ABACAVIR/LAMIVUDINE SUN 600/300 film-coated tablet contains 600
mg of abacavir
as abacavir sulfate and 300 mg lamivudine.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange, film-coated, capsule shaped tablets, debossed with RF 90 on
one side and plain on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ABACAVIR/LAMIVUDINE SUN 600/300 tablets are a combination of two
nucleoside
analogues
(abacavir
and
lamivudine).
ABACAVIR/LAMIVUDINE
SUN
600/300
is
indicated in antiretroviral combination therapy for the treatment of
Human
Immunodeficiency
Virus (HIV) infection in adults and adolescents from 12 years of age.
4.2 DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
ABACAVIR/LAMIVUDINE SUN 6 0 0 / 3 0 0 tablets should not be
administered to adults or
ABACAVIR,
A
COMPONENT
OF
ABACAVIR/LAMIVUDINE
SUN
600/300
TABLETS,
IS
ASSOCIATED WITH HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES
FATAL. ABACAVIR/LAMIVUDINE SUN 600/300 TABLETS, OR ANY
OTHER MEDICINAL PRODUCT
CONTAINING ABACAVIR (KIVEXA, TRIUMEQ, TRIZIVIR
AND ZIAGEN),
MUST NEVER
BE
RESTARTED
FOLLOWING
A
HYPERSENSITIVITY
REACTION
(see
Section
4.4
SPECIAL
WARNINGS AND PRECAUTIONS FOR USE AND
S e c t i o n
4 . 8
ADVERSE
EFFECTS (UNDESIRABLE EFFECTS).
ABACAVIR/LAMIVUDINE 600/300 SUN pi-v1.3
Page | 2
adolescents who weigh less than
40 kg because it is a fixed-dose tablet that cannot be dose
reduced.
ABACAVIR/LAMIVUDINE SUN 600/300 tablets can be taken with or without
food.
ABACAVIR/LAMIVUDINE SUN 600/300
tablets
should
not
be
prescribed
for
patients
requiring dosage adjustments, such as
those with creatinine clearance