LETERO (Letrozole Tablets 2.5 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LETROZOLE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

LETROZOLE

Unit dalam pakej:

10x10'stablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

LETERO (LETROZOLE TABLETS 2.5 MG)
Letrozole (2.5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_LETERO (Letrozole) _
is used
for
2.
How
_LETERO (Letrozole)_
works
3.
Before you use
_LETERO (Letrozole)_
4.
How to use
_LETERO (Letrozole)_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_LETERO _
_(Letrozole)_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _LETERO (LETROZOLE)_ IS USED FOR
Letrozole is used to treat breast cancer in
women
who
have
gone
through
menopause
i.e
cessation
of
periods.
It
can
be
used
as
first
treatment
before
breast cancer surgery in case immediate
surgery is not suitable or it can be used
as
first
treatment
after
breast
cancer
surgery or following five years treatment
with tamoxifen. Letrozole is also used to
prevent breast tumour spreading to other
parts
of
the
body
in
patients
with
advanced breast cancer.
HOW _LETERO (LETROZOLE)_ WORKS
Letrozole
reduces
the
amount
of
oestrogen
by
blocking
an
enzyme
(“aromatase”) involved in the production
of oestrogens and therefore may block
the growth of breast cancer that needs
oestrogens to grow. As a consequence
tumour cells slow or stop growing and/or
spreading to other parts of the body.
BEFORE YOU USE _LETERO (LETROZOLE)_
-
_When you must not use it _
_Pregnancy and lactation _
Do not take
_LETERO (LETROZOLE)_
if
you
are
pregnant,
trying
to
get
pregnant
or
think
you
may
be
pregnant.
Do not take
_LETERO (LETROZOLE)_
if
you
are
breast-feeding.
Ask
your
doctor or pharmacist for advice before
taking any medicine.
_ _
-
_Before you start to use it _
-
Do not take this if you are allergic
Letrozole
or
to
any
other
of
ingredients of this medicine.
-
If you still have periods, i.e. if you
have
not
yet
gone
through
the
menopause.
_Taking other medicines _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE _LETERO (LETROZOLE)_
-

Ciri produk

LETROZOLE TABLETS 2.5 MG
HETERO NAME OF THE PRODUCT
LETERO (Letrozole Tablets 2.5 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name
: Letrozole
Strength
: 2.5 mg
PRODUCT DESCRIPTION
Letrozole Tablets 2.5 mg
Dark yellow colored, round shaped, slightly biconvex bevel edged film
coated tablets
debossed with ‘5’ on one side and ‘H’ on the other side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Endocrine therapy. Hormone antagonist and
related agents:
aromatase inhibitor, ATC code: L02BG04.
_Pharmacodynamic effects _
The elimination of oestrogen-mediated growth stimulation is a
prerequisite for tumour
response in cases where the growth of tumour tissue depends on the
presence of oestrogens
and endocrine therapy is used. In postmenopausal women, oestrogens are
mainly derived
from the action of the aromatase enzyme, which converts adrenal
androgens - primarily
androstenedione
and
testosterone
-
to
oestrone
and
oestradiol.
The
suppression
of
oestrogen biosynthesis in peripheral tissues and the cancer tissue
itself can therefore be
achieved by specifically inhibiting the aromatase enzyme.
Letrozole is a non-steroidal aromatase inhibitor. It inhibits the
aromatase enzyme by
competitively binding to the haem of the aromatase cytochrome P450,
resulting in a
reduction of oestrogen biosynthesis in all tissues where present.
Letrozole
is
highly
specific
in
inhibiting
aromatase
activity.
Impairment
of
adrenal
steroidogenesis has not been observed. No clinically relevant changes
were found in the
plasma concentrations of cortisol, aldosterone, 11-deoxycortisol,
17-hydroxyprogesterone,
LETROZOLE TABLETS 2.5 MG
HETERO
and
ACTH
or
in
plasma
renin
activity.
Glucocorticoid
and
mineralocorticoid
supplementation is not necessary.
No changes were noted in plasma concentrations of androgens
(androstenedione and
testosterone) indicating that the blockade of oestrogen biosynthesis
does not lead to
accumulation of androgenic precursors. Plasma levels of LH and FSH are
not affected by
letrozole in patients, nor is thyroid function as ev