Lebreta 2.5mg (Letrozole Tablets)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
03-01-2022
Ciri produk Ciri produk (SPC)
03-01-2022

Bahan aktif:

LETROZOLE

Boleh didapati daripada:

DUOPHARMA HAPI SDN. BHD.

INN (Nama Antarabangsa):

LETROZOLE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

DUOPHARMA HAPI SDN. BHD.

Risalah maklumat

                                1
LEBRETA 2.5MG
(Letrozole Tablets)
_CONSUMER MEDICATION _
_INFORMATION _
_LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Lebreta Tablet _
is used
for
2.
How
_Lebreta Tablet _
works
3.
Before using
_Lebreta Tablet_
4.
How to use
_Lebreta Tablet_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_8._
_ _
_Lebreta Tablet _
9.
Product Description
10.
Manufacturer
and
Product
Registration
Holder
11.
Date of revision
WHAT _LEBRETA TABLET _IS USED FOR
Letrozole is used to treat breast
cancer in women who have gone
through menopause i.e. cessation
of periods.
It is used to prevent cancer from
happening again. 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.
If you have any questions about
how Letrozole works or why this
medicine has been prescribed for
you, ask your doctor.
HOW _ LEBRETA TABLET _WORKS
_Lebreta _
contains
an
active
substance
called
letrozole.
It
belongs to a group of medicines
called aromatase inhibitors. It is
a
hormonal
(or
“endocrine”)
breast cancer treatment. Growth
of
breast
cancer
is
frequently
stimulated
by
oestrogens
which
are
female
sex
hormones.
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 tumor cells slow or
stop growing and/or spreading to
other parts of the body.
BEFORE USE _LEBRETA TABLET_
-
_ When you must not use it_
Do not take
_Lebreta_
:
•
if you are allergic to
Letrozole or any of the
other
ingredients
of
this
medicine (listed in
PRODUCT
DESCRIPTION
)
•
if you still have periods, i.e.
if
you
have
not
yet
gone
through the menopause
• if you are pregnant, trying
to get pregnant or think yo
                                
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Ciri produk

                                Lebreta (Letrozole TabIets 2.5 mg)
DESCRIPTION AND COMPOSITION:
coloured, round
on one side and
on other side.
PHARMACODYNAMICS:
The growth of some cancers of the breast is stimulated or maintained
by
estrogens. The elimination of oestrogen-mediated stimulatory effects
is
a prerequisite for tumour response in cases where the growth of tumour
tissue
depends
on
the
presence
of
oestrogens.
In
postmenopausal
women, estrogens are mainly derived from the action of the aromatase
enzyme, which converts adrenal androgens (primarily androstenedione
and testosterone) to oestrone (E1) and oestradiol (E2). The
suppression of
estrogen biosynthesis in peripheral tissues and in the cancer tissue
itself can
therefore be achieved by
result, letrozole interferes with estrogen-induced stimulation or
maintenance
of growth of hormonally responsive (estrogen and/or progesterone
receptor
positive or receptor unknown) breast cancers.
Letrozole is
a non-steroidal aromatase inhibitor
and is highly
in
inhibiting
aromatase
activity.
It
inhibits
the
aromatase
enzyme
by
competitively binding to the haem group of aromatase, a cytochrome
P450
enzyme which catalyzes conversion of androgens to estrogens
androstenedione to estrone and testosterone to estradiol) resulting in
a
signi
cancer tissue. Aromatase inhibition by letrozole appears to be
c, with
sparing of other cytochrome P450 enzymes of the same class involved in
glucocorticoid and mineralocorticoid synthesis.
There is no changes in plasma concentrations of androgens
(androstenedione
and testosterone) or in plasma concentrations of androstenedione among
postmenopausal patients treated with daily doses of letrozole
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 are thyroid function as evaluated by TSH,
T4 and
T3 uptake.
PHARMCOKINETICS:
Absorption
Letrozole is rapidly and completely absorbed from the gastrointestinal
tract.
Food decreases the rate but not
                                
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