LETROZOLE GENERICHEALTH letrozole 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letrozole

Available from:

Generic Health Pty Ltd

INN (International Name):

Letrozole

Authorization status:

Registered

Patient Information leaflet

Letrozole generichealth CMI v2 Sep2017
Page 1 of 4
CONSUMER MEDICINE INFORMATION
LETROZOLE GENERICHEALTH
letrozole
What is in this leaflet
This leaflet answers some
common questions about
Letrozole generichealth.
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
generichealth 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
generichealth is used for
Letrozole generichealth 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 generichealth
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 or you may
have taken another
"antioestrogen" such as
tamoxifen in the past.
Your doctor may have
prescribed Letrozole
generichealth for another
reason. Ask your doctor if you
have any questions about
why Letrozole generichealth
has been prescribed for you.
Letrozole generichealth is
available only with a doctor's
prescription.
There is no evidence that
Letrozole generichealth is
addictive.
Before you take
Letrozole generichealth
When not to take it
Do not take Letrozole
generichealth if you are
allergic to medicines
containing letrozole 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

Summary of Product characteristics

Letrozole generichealth
PRODUCT INFORMATION
NAME OF THE MEDICINE
Letrozole. The chemical name for letrozole is
4, 4'-[(1H-1, 2, 4-triazol-1-yl)- methylene]bis-
benzonitrile
. Its structural formula is:
C
17
H
11
N
5
Molecular weight: 285.3 CAS No.: 112809-51-5
DESCRIPTION
Letrozole is a white to off-white, crystalline powder. It is
practically insoluble in water, freely
soluble in methylene chloride and sparingly insoluble in methanol.
Letrozole generichealth tablets comes in one strength and contain 2.5
mg of letrozole. The
tablets also contain sodium starch glycollate, microcrystalline
cellulose, magnesium stearate,
maize starch, lactose, Opadry II 85F32410 Yellow (ARTG 107176). The
tablets are gluten free.
PHARMACOLOGY
PHARMACOTHERAPEUTIC GROUP
Non-steroidal aromatase inhibitor (inhibitor of oestrogen
biosynthesis); antineoplastic agent.
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. 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 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 postmenopausal 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.
LETROZOLE GENERICHEALTH – Product information
Page 22 of 17
In postmenopausal patients with advanced breast cancer, daily doses of
0.1 to 5 mg letrozole
sup