ARIMIDEX anastrozole 1mg tablets blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

anastrozole, Quantity: 1 mg

थमां उपलब्ध:

AstraZeneca Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: macrogol 300; titanium dioxide; hypromellose; povidone; sodium starch glycollate; magnesium stearate; lactose monohydrate

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30 tablets

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Visual Identification: Round, white biconvex, film coated tablets. Debossed 'A' with an arrow head on one side and with 'Adx1' on the reverse side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

1996-12-17

सूचना पत्रक

ARIMIDEX
®
_Anastrozole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
ARIMIDEX. It does not contain all
the information that is known about
ARIMIDEX.
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
ARIMIDEX 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 ARIMIDEX IS
USED FOR
ARIMIDEX 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.
ARIMIDEX 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, ARIMIDEX 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 ARIMIDEX
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ARIMIDEX for another reason.
ARIMIDEX is only available with a
doctor's prescription.
ARIMIDEX is not addictive
BEFORE YOU TAKE
ARIMIDEX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ARIMIDEX IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
ARIMIDEX may affect your
developing baby if you take it during
pregnancy.
DO NOT BREASTFEED WHILE TAKING
ARIMIDEX.
Your baby can take in ARIMIDEX
from breast milk if you are
breastfeeding.
DO NOT TAKE ARIMIDEX IF YOU
HAVE AN ALLERGY TO:
•
Anastrozole, the active ingredient
of ARIMIDEX
•
Any of the other ingredients of
ARIMIDEX listed at the end of
this leaflet
•
Other anti-oestrogen medicines.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in brea

उत्पाद विशेषताएं

1 of 15
AUSTRALIAN PRODUCT INFORMATION
ARIMIDEX
®
(ANASTROZOLE)
1
NAME OF THE MEDICINE
Anastrozole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARIMIDEX 1 mg is a round, white, biconvex film-coated tablet
containing 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
ARIMIDEX is presented as a round, white, biconvex film-coated tablet
containing 1 mg of
anastrozole with the following markings impressed on tablet:
_Front: _
_ _
_Back: _
_ _
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 ARIMIDEX.
4.2
DOSE AND METHOD OF ADMINISTRATION
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 ARIMIDEX 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.
2 of 15
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
ARIMIDEX 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 AND HEPATIC IMPAIRMENT
The apparent oral clearance of anastro