LETROZOLE RBX letrozole 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Letrozole

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Letrozole

Patient Information leaflet

LETROZOLE RBX CMI V4 Sep 2013
1
LETROZOLE RBX TABLETS
LETROZOLE
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
LETROZOLE RBX
tablets.
It does not contain all the available information. It does not take
the
place of talking to your doctor or pharmacist.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN
THE MOST UP TO DATE INFORMATION ON THE MEDICINE.
This leaflet was last updated on the date at the end of this leaflet.
More recent information may be available. The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may
contain important information about the medicine and its use of which
you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of your taking
LETROZOLE RBX
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LETROZOLE RBX IS USED FOR
LETROZOLE RBX
is used to treat breast cancer in women who are post-
menopausal – that is, women who no longer have periods, either
naturally due to their age or after surgery or chemotherapy.
LETROZOLE RBX
contains the active ingredient letrozole. Letrozole
tablets are used to treat breast cancer in postmenopausal women, that
is, women who no longer have periods, either naturally due to their
age
or after surgery or chemotherapy.
LETROZOLE RBX CMI V4 Sep 2013
2
Letrozole
belongs
to
a
class
of
medicines
known
as
aromatase
inhibitors. They are also called “anti-oestrogens” because they
block
production of the hormone, oestrogen.
Oestrogen stimulates the growth of certain types of breast cancer.
These cancers are called “oestrogen-dependent.” Reducing the
production
of oestrogen may help to keep the cancer from growing.
This may be the first time you are taking an “anti-oestrogen” such
as
letrozole or you may have taken another “anti-estrogen” such

Summary of Product characteristics

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LETROZOLE RBX
LETROZOLE 2.5 MG TABLETS
NAME OF THE MEDICINE
Letrozole
Chemical Structure:
Molecular formula: C
17
H
11
N
5
Chemical name: 4, 4'-[(1
_H_
-1, 2, 4-triazol-1-yl)-methylene]bis-benzonitrile
Molecular weight: 285.303
CAS number: 112809-51-5
DESCRIPTION
Letrozole is a white or yellowish crystalline powder. It is
practically insoluble in water,
freely soluble in methylene chloride and sparingly soluble in
methanol.
Each film-coated tablet of
LETROZOLE RBX
contains letrozole 2.5 mg and the
inactive ingredients:
lactose, maize starch, hypromellose, microcrystalline cellulose,
sodium starch glycollate, colloidal anhydrous silica, magnesium
stearate, macrogol 6000,
titanium dioxide, purified talc and iron oxide yellow CI77492.
PHARMACOLOGY
PHARMACODYNAMICS
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.
LETROZOLE RBX PI V5 Jun 2013
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In
postmenopausal
women,
oestrogens
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
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. Data suggest that it
inhibits the
aromatase enzyme by competitively binding to the haem of the
cytochrome P450 subunit
of the enzyme, resulting in a reduction of oestrogen biosynthesis in
all tissues.
In healthy post-menopausal women, single doses of 0.1, 0.5 and 2.5 mg
letrozole
suppressed
serum
oestrone
and
oestradiol
by
75-78%
and
78%
from
baseline,
respectively. Maximum suppression was achieved in 48-78 h.
In post-menopausal patients with advanced breast cancer, daily doses
of 0.1 to 5 mg
letrozole suppressed plasma concentrations of oestradiol, oestrone,
and oestrone s