LAMIVUDINE/ZIDOVUDINE VIATRIS 150/300 lamivudine 150 mg / zidovudine 300 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamivudine, Quantity: 150 mg; zidovudine, Quantity: 300 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Lamivudine,Zidovudine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; propylene glycol; magnesium stearate; sodium starch glycollate type A; titanium dioxide; hypromellose

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lamivudine and zidovudine combination tablet is indicated for use alone or in combination with other antiretroviral therapies in the treatment of HIV infection.

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex film coated tablet, debossed with "M" on left of the scoreline and "103" on right, on one side and scored on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2012-10-03

Patient Information leaflet

LAMIVUDINE 150 MG +
ZIDOVUDINE 300 MG
ALPHAPHARM
_lamivudine and zidovudine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start LAMIVUDINE
150mg + ZIDOVUDINE 300mg
ALPHAPHARM. This leaflet
answers some common questions
about LAMIVUDINE 150mg +
ZIDOVUDINE 300mg
ALPHAPHARM.
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
LAMIVUDINE 150mg +
ZIDOVUDINE 300mg
ALPHAPHARM against the benefits
they expect it will have on you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LAMIVUDINE
150MG + ZIDOVUDINE
300MG ALPHAPHARM
IS USED FOR
LAMIVUDINE 150mg +
ZIDOVUDINE 300mg
ALPHAPHARM contains
lamivudine and zidovudine which
belongs to a group of medicines
called antiretrovirals.
Please note that lamivudine is
available as a stand alone tablet (as
LAMIVUDINE ALPHAPHARM
lamivudine 150mg & 300mg tablets).
Lamivudine with zidovudine is used
alone or with other antiretrovirals, to
slow down the progressing of human
immunodeficiency virus (HIV)
infection, which can lead to Acquired
Immune Deficiency Syndrome
(AIDS) and other related illnesses
(e.g. AIDS-related Complex or
ARC).
Lamivudine with zidovudine does
not cure AIDS or HIV infection, but
slows production of human
immunodeficiency virus. In this way
it stops ongoing damage to the body's
immune system, which fights
infection.
Lamivudine with zidovudine does
not reduce the risk of passing HIV
infection to others. You can still pass
on the HIV virus when taking this
medicine, although the risk is
lowered by effective antiretroviral
therapy. Discuss with your doctor the
precautions needed to avoid infecting
other people.
While taking LAMIVUDINE 150mg
+ ZIDOVUDINE 300mg
ALPHAPHARM and/or any other
therapy for HIV disease, you may
continue to develop other infect

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LAMIVUDINE 150MG +
ZIDOVUDINE 300MG ALPHAPHARM
_Lamivudine and zidovudine tablets _
_ _
1
NAME OF THE MEDICINE
Lamivudine and Zidovudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamivudine with Zidovudine tablets are a fixed combination product
containing lamivudine 150 mg and
zidovudine 300 mg.
The product information for Lamivudine tablets contains additional
information specific for lamivudine.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
LAMIVUDINE 150mg + ZIDOVUDINE 300mg ALPHAPHARM Lamivudine 150 mg and
Zidovudine
300 mg tablets: White to off-white capsule shaped, bi-convex film
coated tablet, debossed with “M” on left
of the scoreline and “103” on right, on one side and scored on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine and zidovudine combination tablet is indicated for use
alone or in combination with other
antiretroviral therapies in the treatment of HIV infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lamivudine with zidovudine combination tablets may be administered
with or without food. Food reduces
the
C
max
and extends the T
max
of lamivudine but the amount of drug absorbed is not reduced. The
clinical
significance of this is not known (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
).
To ensure administration of the entire recommended dose, the tablet(s)
should be swallowed whole and not
divided or crushed. If the patient is unable to swallow whole tablets,
the tablets may be crushed and 100% of
the crushed tablets could be added to a small amount of semi-solid
food or liquid, all of which should be
consumed immediately (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
).
For situations where discontinuation of therapy with one of the active
constituents of lamivudine and
zidovudine combination tablets, or dose reduction is necessary,
separate preparations of lamivudine tablets
and zidovudine tablets are available.
The dosing regimens for paediatric patients weighing 14-30 kg is based
p