ABACAVIR/LAMIVUDINE 600/300 APOTEX abacavir 600mg (as sulfate) and lamivudine 300mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

abacavir sulfate,lamivudine

Available from:

Apotex Pty Ltd

INN (International Name):

Abacavir sulfate,Lamivudine

Authorization status:

Registered

Patient Information leaflet

ABACAVIR/LAMIVUDINE
600/300 APOTEX TABLET
_Contains the active ingredients abacavir (as sulfate) and lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, WHICH
CONTAINS
ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC
REACTION) WHICH
CAN BE LIFE-THREATENING IF TREATMENT WITH THIS MEDICINE IS CONTINUED.
CONTACT YOUR
DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING
ABACAVIR AND
LAMIVUDINE COMBINATION TABLETS IF:
1.
YOU GET A SKIN RASH OR
2.
YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING
GROUPS:
•
FEVER
•
SHORTNESS OF BREATH, SORE THROAT OR COUGH
•
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
•
SEVERE TIREDNESS OR ACHINESS OR GENERAL ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR AND
LAMIVUDINE
COMBINATION TABLETS, NEVER TAKE ABACAVIR AND LAMIVUDINE, OR ANY OTHER
MEDICINAL
PRODUCT CONTAINING ABACAVIR, AS YOU MAY DEVELOP A LIFE-THREATENING
REACTION WHICH
CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR AND LAMIVUDINE PACK,
TO REMIND YOU
AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE
REMOVED
FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER
BEFORE YOU TAKE
ABACAVIR AND LAMIVUDINE.
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
This medicine contains the active
ingredients abacavir (as sulfate) and
lamivudine which belong to a group
of medicines called antiretrovirals.
Abacavi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ABACAVIR/LAMIVUDINE 600/300 APOTEX
(ABACAVIR SULFATE AND LAMIVUDINE) TABLET
WARNING:
ABACAVIR,
A
COMPONENT
OF
ABACAVIR
AND
LAMIVUDINE
COMBINATION
TABLETS,
IS
ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE
LIFE-THREATENING, AND IN RARE CASES FATAL.
ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, OR ANY OTHER MEDICINAL
PRODUCT CONTAINING
ABACAVIR, MUST NEVER BE RESTARTED FOLLOWING A HYPERSENSITIVITY
REACTION (SEE SECTIONS 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS
(UNDESIRABLE EFFECTS)).
1
NAME OF THE MEDICINE
Abacavir (as sulfate) and lamivudine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg abacavir (as sulfate) and 300 mg
lamivudine as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Orange coloured, modified capsule-shaped, biconvex film-coated tablet
with engraved “APO”
on one side and “600/300” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir and lamivudine combination tablets are a combination of two
nucleoside analogues
(abacavir and lamivudine).
Abacavir and lamivudine combination tablets are 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
Abacavir/Lamivudine 600/300 APOTEX tablets are intended for oral
administration.
DOSAGE
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Abacavir
and
lamivudine combination tablets should not
be
administered to
adults
or
adolescents who weigh less than 40 kg because it is a fixed-dose
tablet that cannot be dose
reduced.
Abacavir and lamivudine combination tablets can be taken with or
without food.
2
Abacavir and lamivudine combination tablets should not be prescribed
for patients requiring
dosage
adjustments,
such
as
those
with
creatinine
clearance
< 50
mL/min.
Separate
preparations of abaca