LAMIVUDINE VIATRIS lamivudine 300 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamivudine, Quantity: 300 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Lamivudine

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lamivudine tablets in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and children.

Product summary:

Visual Identification: A white to off-white, film coated, oval shaped, biconvex tablet debossed with "M300" on one side of the tablet and blank on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2012-02-16

Patient Information leaflet

LAMIVUDINE
ALPHAPHARM
_contains the active ingredient lamivudine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start LAMIVUDINE
ALPHAPHARM tablets.
This leaflet answers some common
questions about LAMIVUDINE
ALPHAPHARM tablets. It does not
contain all 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. Some new risks are found even
when a medicine has been used for
many years. Your doctor has
weighed the risks of you taking
LAMIVUDINE ALPHAPHARM
tablets against the expected benefits
expected 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 LAMIVUDINE
ALPHAPHARM TABLETS
ARE USED FOR
LAMIVUDINE ALPHAPHARM
tablets contain lamivudine which
belongs to a group of medicines
called antivirals.
Lamivudine is used together with
other antivirals to slow down the
progression 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 does not cure AIDS or
kill the HIV virus, but prevents
further damage to the immune
system by stopping production of
new viruses.
You can still pass on HIV 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.
You will still be able to pass on the
HIV virus by sexual activity or by
contamination with infected blood.
You should still use proper
precautions.
While taking LAMIVUDINE
ALPHAPHARM tablets and/or any
other therapy for HIV disease, you
may continue to develop other
infections and other complications of
HIV infection. You should keep in
regular contact with the doctor who
is looking after you.
LAMIVUDINE ALPHAPHARM
tablets are not addictive.
Ask your doctor if you have any
q

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LAMIVUDINE ALPHAPHARM
_Lamivudine film-coated tablets _
1
NAME OF THE MEDICINE
Lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LAMIVUDINE ALPHAPHARM film-coated tablets contain 150 mg or 300 mg
lamivudine as the active
ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
LAMIVUDINE ALPHAPHARM 150 mg
film-coated tablets:
White to off-white film-coated, capsule shaped, biconvex
tablet debossed with “M105” on one side of the tablet and
a score line on the other side.
LAMIVUDINE ALPHAPHARM 300 mg
film-coated tablets:
White to off-white, film-coated, oval shaped, biconvex
tablet debossed with “M300” on one side of the tablet and
blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine tablets in combination with other antiretroviral agents is
indicated for the treatment of HIV
infected adults and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
Food reduces the C
max
and extends the T
max
but the amount of drug absorbed is not reduced. The clinical
significance of this is not known (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
).
Clinical studies indicate that lamivudine should be used in
combination with other antiretroviral therapies. In
controlled trials in adults, lamivudine was used in combination with
zidovudine 200 mg tds (see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS
).
Since accurate dosing cannot be achieved with this formulation, dosing
according to weight bands is
recommended for scored tablets. This dosing regimen for paediatric
patients weighing 14 - 30 kg is based
primarily on pharmacokinetic modelling. Therefore monitoring of
efficacy and safety is necessary in these
patients.
More
accurate
dosing
can
be
achieved
with
oral
solution
of
lamivudine
(see
Section
5.2
PHARMACOKINETIC PROPERTIES - PHARMACOKINETICS IN CHILDREN
).
To ensure administration of the entire recommended dose, the tablet(s)
should be swallowed whole and not
divided or crushed. If the patient is unabl