LETROZOLE AN letrozole 2.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letrozole

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Letrozole

Authorization status:

Registered

Patient Information leaflet

_Letrozole AN tablets – Consumer Medicine Information _
_ _
_Letrozole AN CMI v3.0 _
_ _
_ _
_Page 1 _
LETROZOLE AN TABLETS
_Letrozole tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Letrozole AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking Letrozole
AN
against
the
benefits
they
expect it will have for 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 LETROZOLE AN IS
USED FOR
Letrozole
AN
is
used
for
the
treatment
of
breast
cancer
in
post-menopausal
women
i.e.
women
who
no
longer
have
periods, either because of their
natural age or following surgery
or chemotherapy
Letrozole belongs to a family of
medicines
called
aromatase
inhibitors
(also
referred
to
as
antioestrogens).
They
function
by decreasing the amount of the
hormone
oestrogen
that
is
produced in your body.
The growth of certain types of
breast
cancer
is
promoted
by
oestrogen.
These
cancers
are
known
as
“oestrogen-dependent”.
Decreasing
the
production
of
oestrogen may aid to prevent the
cancer from growing.
This might be the first time you
are
taking
an
"antioestrogen"
such
as
Letrozole
AN
or
you
might
have
taken
another
"antioestrogen"
such
as
tamoxifen in the past.
If you have any questions about
why
Letrozole
AN
has
been
prescribed
for
you,
ask
your
doctor.
You may have been prescribed
Letrozole AN by your doctor for
another reason.
Letrozole AN is only obtainable
with a doctor’s prescription.
Letrozole AN is not addictive.
BEFORE YOU TAKE
LETROZOLE AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO
NOT
TAKE
LETROZOLE
AN
IF
YOU ARE ALLERGIC TO:
•
Letrozole,
the
active
ingredient in this medicine
•
Any of the other ingredients
of this medicine listed at the
end of this leaflet.
If you get an allergic reaction,
sym

Summary of Product characteristics

Australian Product Information
Letrozole AN PI v3.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
LETROZOLE AN _(LETROZOLE) _
_ _
1 NAME OF THE MEDICINE
Letrozole
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Letrozole AN tablet contains letrozole 2.5 mg.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Letrozole AN is presented as yellow, round, biconvex, film-coated
tablets, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of postmenopausal women with hormone receptor
positive breast cancer
(see section 5.1 Pharmacodynamics properties – Clinical Trials).
The safety and efficacy of neoadjuvant use of letrozole has not been
established. Letrozole is
not indicated in hormone receptor negative disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dose of Letrozole AN is one tablet daily.
In the adjuvant setting, treatment should continue for 5 years or
until tumour relapse occurs,
whichever comes first.
In the extended adjuvant setting, the optimal treatment duration with
Letrozole AN is not
known, the planned duration of treatment in the pivotal study was 5
years. However, at the
time of the analysis, the median duration of treatment was 24 months,
25% of patients were
treated for at least three years and less than 1% of patients were
treated for the planned 5
years. The median duration of follow up was 28 months. Treatment
should be discontinued
at tumour relapse.
In the adjuvant setting the median duration of treatment was 25
months, 73% of the patients
were treated for more than 2 years, 22% of the patients for more than
4 years. The median
duration
of
follow
up
was
30
months
(the
efficacy
data
mentioned
in
section
5.1
Pharmacodynamics properties – Clinical Trials are based on the
Primary Core Analysis with
a median duration of follow up of 26 months).
In patients with metastatic disease, treatment with Letrozole AN
should continue until tumour
progression is evident.
Australian Product Information
Letrozole AN