APO-ANASTROZOLE anastrozole 1 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

anastrozole, Quantity: 1 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Anastrozole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; magnesium stearate; lactose monohydrate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Early Breast Cancer. Adjuvant treatment of early breast cancer in postmenopausal women with oestrogen/progesterone-receptor-positive disease. Advanced Breast Cancer. First line treatment of advanced breast cancer in postmenopausal women with oestrogen/progesterone-receptor-positive disease. . Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with oestrogen-receptor-negative disease and patients who have not responded to previous tamoxifen therapy rarely respond to anastrozole.

Product summary:

Visual Identification: white, round, biconvex film-coated tablets, debossed '1' on one side, plain on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-02-25

Patient Information leaflet

APO- ANASTROZOLE TABLETS
1
APO-Anastrozole
Tablets
Anastrozole
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
What is in this leaflet
This leaflet answers some common
questions about anastrozole. 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 you using this medicine
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 the medicine.
You may want to read it again.
What this medicine is
used for
Anastrozole 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.
How it works
Anastrozole 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, anastrozole may
slow or stop the growth of cancer.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
Anastrozole is not recommended for
use in children.
Before you take this
medicine
When you must not take it
Do not take this medicine if you
have an allergy to:

anastrozole

any of the ingredients listed at the
end of this leaflet.

Other anti-oestrogen medicines.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue,
throat or other parts of the body

rash, itching or hives on the skin.
Do not take anastrozole if you are
still having menstrual periods.
Anastrozole should only be taken
by women who are no longer

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-ANASTROZOLE (ANASTROZOLE) TABLETS
1
NAME OF THE MEDICINE
Anastrozole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of anastrozole as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-ANASTROZOLE 1 MG:
A round, white, biconvex film-coated tablet with “1” on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Adjuvant
treatment
of
early
breast
cancer
in
postmenopausal
women
with
oestrogen/progesterone-receptor-positive disease.
ADVANCED BREAST CANCER
First
line
treatment
of
advanced
breast
cancer
in
postmenopausal
women
with
oestrogen/progesterone-receptor-positive disease.
Treatment of advanced breast cancer in postmenopausal women with
disease progression
following tamoxifen therapy. Patients with oestrogen-receptor-negative
disease and patients
who have not responded to previous tamoxifen therapy rarely respond to
anastrozole.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Anastrozole tablets are intended for oral administration.
DOSAGE
Adults including the elderly
One tablet (1 mg) to be taken orally once a day.
For early breast cancer, the recommended total duration of hormonal
therapy is 5 years. For
patients
being
switched
to
anastrozole
from
tamoxifen,
the
switch
should
occur
after
completion of 2 to 3 years of tamoxifen therapy. There are no data to
support switching at
earlier or later time points.
Children
Not recommended for use in children.
RENAL IMPAIRMENT
No dose change is recommended.
HEPATIC IMPAIRMENT
No dose change is recommended.
4.3
CONTRAINDICATIONS
Anastrozole must not be administered during pregnancy or lactation.
Known hypersensitivity to the active substance or to any of the
excipients of this product
(refer section 6.1 LIST OF EXCIPIENTS).
3
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
USE IN PRE-MENOPAUSAL WOMEN
Anastrozole is not recommended for use in pre-menopausal women as
safety an