ANASTROZOLE-GH 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:

Generic Health Pty Ltd

INN (International Name):

Anastrozole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; sodium starch glycollate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

10,14,20,28,30,50,56,60,84,90,98,100,300,500

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, film-coated, round, biconvex tablet, debossed with "ANA" and "1" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-06-28

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ANASTROZOLE-GH
(ANASTROZOLE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about anastrozole. It does not
contain all the information that is
known about anastrozole.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
anastrozole 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 need to read it again.
WHAT ANASTROZOLE-GH 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.
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.
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
ANASTROZOLE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed anastrozole for
another reason.
Anastrozole is only available
with a doctor's prescription.
Anastrozole is not addictive.
BEFORE YOU TAKE
ANASTROZOLE-GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ANASTROZOLE IF YOU
ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
Anastrozole may affect your
developing baby if you take it
during pregnancy.
DO NOT BREASTFEED WHILE TAKING
ANASTROZOLE.
Your baby can take in
anastrozole from breast milk if
you are breastfeeding.
DO NOT TAKE ANASTROZOLE-GH IF
YOU HAVE AN ALLERGY TO:
•
anastrozole, the active
ingredient of Anastrozole-
GH;
•
any of the other ingredients
of Anastrozole-GH listed at
the end of this leaflet;
•
other anti-oestrogen
medicine

Summary of Product characteristics

Anastrozole-GH v5.0
Page 1 of 16
(anastrozole) film-coated tablet
AUSTRALIAN PRODUCT INFORMATION – ANASTROZOLE-GH
(ANASTROZOLE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Anastrozole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg anastrozole.
Excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Anastrozole-GH is a white, film-coated, round, biconvex tablet,
debossed with “ANA” and “1” on one
side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Adjuvant treatment of early breast cancer in postmenopausal women with
estrogen/progesterone-
receptor-positive disease.
ADVANCED BREAST CANCER
First line treatment of advanced breast cancer in postmenopausal women
with estrogen/progesterone-
receptor-positive disease.
Treatment of advanced breast cancer in postmenopausal women with
disease progression following
tamoxifen therapy. Patients with estrogen-receptor-negative disease
and patients who have not
responded to previous tamoxifen therapy rarely respond to anastrozole.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS INCLUDING THE ELDERLY
One tablet (1 mg) to be taken orally once a day.
Anastrozole-GH v5.0
Page 2 of 16
(anastrozole) film-coated tablet
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.
USE IN ADULTS WITH RENAL IMPAIRMENT
No dose change is recommended.
USE IN ADULTS WITH 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
USE IN RENAL IMPAIRMENT AND HEPATIC