LETROZOLE FBM letrozole 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letrozole

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Letrozole

Authorization status:

Registered

Patient Information leaflet

LETROZOLE FBM/NOVEMBER2013/CMI-2
1
LETROZOLE FBM
_contains the active ingredient letrozole _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about LETROZOLE FBM.
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 FBM
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 FBM is
used for
LETROZOLE FBM 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 FBM belongs to a group
of medicines called aromatase
inhibitors also called
‘antioestrogens’. These medicines
work by reducing the production of
oestrogen in your body.
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 "antioestrogen" such as
LETROZOLE FBM or you may have
taken another "antioestrogen" such
as femara or tamoxifen in the past.
Your doctor may have prescribed
LETROZOLE FBM for another
reason. Ask your doctor if you have
any questions about why
LETROZOLE FBM has been
prescribed for you.
LETROZOLE FBM is available only
with a doctor's prescription.
There is no evidence that
LETROZOLE FBM is addictive.
Before you take
LETROZOLE FBM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LETROZOLE FBM IF YOU
ARE ALLERGIC TO MEDICINES
CONTAINING LETROZOLE OR AROMATASE
INHIBITORS (CLASS) MEDICINE
OR ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or t

Summary of Product characteristics

Letrozole FBM_PI_11032016
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LETROZOLE FBM
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 FBM
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 FBM_PI_11032016
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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 sulphat