ANASTROZOLE SANDOZ anastrozole 1 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

anastrozole, Quantity: 1 mg

Dostopno od:

Sandoz Pty Ltd

INN (mednarodno ime):

Anastrozole

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: colloidal anhydrous silica; hyprolose; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type A; lactose monohydrate; titanium dioxide; hypromellose; macrogol 4000

Pot uporabe:

Oral

Enote v paketu:

30 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Early breast cancer: Adjuvant treatment of early breast cancer in post-menopausal women with estrogen/progesterone receptor positive disease. Advanced breast cancer: First line treatment of advanced breast cancer in post-menopausal women with estrogen/progesterone receptor positive disease. Treatment of advanced breast cancer in post-menopausal 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.

Povzetek izdelek:

Visual Identification: white round biconvex film-coated tablet without breaking notch, embossment "A1" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status dovoljenje:

Licence status A

Datum dovoljenje:

2008-07-31

Navodilo za uporabo

ANASTROZOLE SANDOZ
1
ANASTROZOLE
SANDOZ
_Anastrozole Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Anastrozole Sandoz.
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 risk of you taking Anastrozole
Sandoz against the benefits it is
expected to 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
ANASTROZOLE
SANDOZ IS USED
FOR
Anastrozole Sandoz 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 Sandoz 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 Sandoz may slow or
stop the growth of cancer.
FOLLOW ALL DIRECTIONS GIVEN BY YOUR
DOCTOR.
They may differ from the
information contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ANASTROZOLE
SANDOZ WAS PRESCRIBED FOR YOU.
Your doctor may have prescribed
Anastrozole Sandoz for another
reason.
Anastrozole Sandoz is only available
with a doctor’s prescription.
Anastrozole Sandoz is not addictive.
BEFORE YOU TAKE
ANASTROZOLE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ANASTROZOLE SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
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
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT OR INTEND

Lastnosti izdelka

220223-Anastrozole Sandoz-pi
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
ANASTROZOLE SANDOZ
®
(ANASTROZOLE) TABLETS
1
NAME OF THE MEDICINE
Anastrozole
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients of known effect: lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Anastrozole Sandoz 1 mg: white, round, biconvex film coated tablet
without breaking notch
and embossment ‘A1’ on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS (INCLUDING THE ELDERLY) _
One tablet (1 mg) to be taken orally once daily.
_ _
For early breast cancer, the recommended duration of treatment should
be five years. For
patients
being
switched
to
anastrozole
from
tamoxifen,
the
switch
should
occur
after
completion of two to three years of tamoxifen therapy. There are no
data to support switching
at earlier or later time points.
_INFANTS AND CHILDREN _
Not recommended for use in children.
DOSAGE ADJUSTMENT IN:

renal impairment
No dose change is recommended for patients with renal impairment.
220223-Anastrozole Sandoz-pi
Page 2 of 15

hepatic impairment
No dose change is recommended for patients with hepatic impairment
.
4.3
C
ONTRAINDICATIONS
Anastrozole must not be administered during pregnancy (see Section 4.6
Fertility, pregnancy
and lactation – Use in pregnancy) or lactation.
Known hypersensitivity to the active substance or to any of the
excipients of this product