AZASTROLE anastrozole 1 mg film-coated tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Anastrozole

Beszerezhető a:

Eris Pharmaceuticals (Australia) Pty Ltd

INN (nemzetközi neve):

Anastrozole

Betegtájékoztató

AZASTROLE™
CONSUMER MEDICINE INFORMATION
Anastrozole 1 mg film-coated tablets
What is in this leaflet_ _
This leaflet answers some of the common questions about AZASTROLE.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed
the
risks
of
taking
AZASTROLE against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again.
What AZASTROLE is used for
AZASTROLE is used to treat breast cancer in women who no longer have
their menstrual
periods either naturally, due to their age or after surgery,
radiotherapy or chemotherapy.
AZASTROLE is a non-steroidal aromatase inhibitor, which reduces the
amount of oestrogen
(female sex hormone) made by the body. In some types of breast cancer,
oestrogen can help
the cancer cells grow. By blocking oestrogen, AZASTROLE may slow or
stop the growth of
cancer.
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR.
They may differ from the information contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AZASTROLE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed AZASTROLE for another reason.
AZASTROLE is only available with a doctor's prescription.
AZASTROLE is not addictive
Before you take AZASTROLE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AZASTROLE IF YOU ARE PREGNANT OR INTEND TO BECOME
PREGNANT.
AZASTROLE may affect your developing baby if you take it during
pregnancy.
DO NOT BREASTFEED WHILE TAKING AZASTROLE.
Your baby can take in AZASTROLE from breast milk if you are
breastfeeding.
DO NOT TAKE AZASTROLE IF YOU HAVE AN ALLERGY TO:

Anastrozole, the active ingredient of AZASTROLE;.

Any of the other ingredients of AZASTROLE listed at the end of this
leaflet; or

Other anti-oestrogen medicines.
Symptoms of an allergic reaction may include shortness of breath,
wheezing or diffi

Termékjellemzők

Page 1 of 17
PRODUCT INFORMATION
AZASTROLE
FILM-COATED TABLETS
_ _
NAME OF THE MEDICINE
The active ingredient in AZASTROLE Tablets is anastrozole.
The structural formula is:
CAS: 120511-73-1
Chemical name:

,

,

’,

’-tetramethyl-5-(1_H_-1,2,4-triazol-1-ylmethyl)-_m-_
benzenediacetonitrile.
_ _
DESCRIPTION
Anastrozole is a fine white to off white powder. It is freely soluble
in most organic
solvents slightly soluble in water (0.707 mg/mL at 25ºC) and
insoluble in n-hexane.
Inactive ingredients: hypromellose, lactose, macrogol 400, magnesium
stearate,
povidone, sodium starch glycollate, titanium dioxide, Opadry White
Y1-7000
PHARMACOLOGY
Anastrozole is a potent and highly selective nonsteroidal aromatase
inhibitor. It
significantly lowers serum oestradiol concentrations and has no
detectable effect
on formation of adrenal corticosteroids or aldosterone.
Many breast cancers have oestrogen receptors and growth of these
tumours can
be stimulated by oestrogen. In post-menopausal women, oestradiol is
produced
primarily
from
the
conversion
of
androstenedione
to
oestrone
through
the
aromatase enzyme complex in peripheral tissues. Oestrone is
subsequently
converted
to
oestradiol.
Many
breast
cancers
also
contain
aromatase;
the
importance of tumour generated oestrogens is uncertain.
Page 2 of 17
Reducing circulating estradiol levels has been shown to produce a
beneficial effect
in women with breast cancer. In postmenopausal women, anastrozole at a
daily
dose of 1 mg produced estradiol suppression of greater than 80% using
a highly
sensitive assay.
Anastrozole
does not possess any progestogenic, androgenic or
oestrogenic
activity.
Daily doses of anastrozole up to 10 mg do not have any effect on
cortisol or
aldosterone secretion, measured before or after standard ACTH
challenge testing.
Corticoid supplements are therefore, not needed.
In a phase III/IV study, there was a neutral effect on plasma lipids
in those patients
treated with anastrozole.
PHARMACOKINETICS:
_ABSORPTION_
Absorption of anastrozole is ra