LETROZOLE ACTAVIS 2.5mg
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
letrozole, Quantity: 2.5 mg
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Letrozole
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; maize starch; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Administration route:
Oral
Units in package:
30 tablets, 100 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of postmenopausal women with hormone receptor positive breast cancer (see Clinical Trials). The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.
Product summary:
Visual Identification: Round, yellow, lenticular film-coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2011-09-22
Patient Information leaflet
LETROZOLEACTAVIS/102011/CMI-1
1
Letrozole Actavis
_contains the active ingredient letrozole _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about LETROZOLE
ACTAVIS.
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
ACTAVIS 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 ACTAVIS
is used for
LETROZOLE ACTAVIS 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 ACTAVIS 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 ACTAVIS for another
reason. Ask your doctor if you have
any questions about why
LETROZOLE ACTAVIS has been
prescribed for you.
LETROZOLE ACTAVIS is available
only with a doctor's prescription.
There is no evidence that
LETROZOLE ACTAVIS is addictive.
Before you take
LETROZOLE ACTAVIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LETROZOLE ACTAVIS
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 hives, swelling of
the face, lips or tongue whic
Read the complete document
Summary of Product characteristics
Letrozole Actavis
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 Actavis tablets come 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 ACTAVIS – Product information
Page 2 of 17
In postmenopausal patients with advanced breast cancer, daily doses of
0.1 to 5 mg letrozole
suppressed plasma conce
Read the complete document
