GENRX TAMOXIFEN tamoxifen 20mg (as citrate) tablet bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

tamoxifen citrate

제공처:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Tamoxifen citrate

승인 상태:

Registered

환자 정보 전단

GENRX TAMOXIFEN
1
GENRX TAMOXIFEN
_Contains the active ingredient, tamoxifen (as tamoxifen citrate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE
This leaflet answers some common
questions about tamoxifen. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is GenRx
Tamoxifen. It is used in the treatment
of breast cancer.
Although women have been helped
by tamoxifen it is not a cure for
breast cancer.
Tamoxifen can be used in two ways.
It can help treat a cancer which is in,
or has spread from, the breast. It can
also be used in women who have had
a cancer lump removed. Tamoxifen
may decrease or prevent the spread
of cancer cells to other parts of the
body.
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.
_HOW IT WORKS _
Tamoxifen acts mainly by blocking
the effects of oestrogen, a female sex
hormone found naturally in the body.
In some types of breast cancer,
oestrogen can help cancer cells grow.
There is no evidence that this
medicine is addictive.
_USE IN CHILDRE

제품 특성 요약

Product Information – Australia
GenRx Tamoxifen Tablets
Page 1
GENRX TAMOXIFEN (TAMOXIFEN CITRATE)
1.
NAME OF THE MEDICINE
Tamoxifen citrate.
2.&3.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
Each tablet contains tamoxifen citrate equivalent to 20 mg tamoxifen
and the following inactive
ingredients: lactose, magnesium stearate, povidone, sodium starch
glycollate, and maize starch.
For the full list of excipients, see Section 6.1 List of excipients
White, round, convex tablets, 9 mm in diameter with 20 embossed on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palliative treatment of breast cancer.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended daily dose of tamoxifen is 20 mg. A dose of 40 mg once
a day may be used in
patients with advanced breast cancer in which no response is seen with
the minimal dose.
Tamoxifen is not indicated for use in children.
Response is usually not achieved until after a treatment period of 2
to 3 months.
The current recommended treatment duration is five years; however the
optimum duration has not
been established.
Older people
Similar dosing regimens of tamoxifen have been used in older people
with breast cancer and
in some of these patients it has been used as sole therapy.
CHILDREN
Tamoxifen is not indicated for use in children.
Method of administration
For administration by the oral route.
4.3 CONTRAINDICATIONS
Tamoxifen must not be given during pregnancy. Premenopausal patients
must be carefully
examined before treatment for breast cancer to exclude the possibility
of pregnancy.
Tamoxifen should not be given to patients who have experienced
hypersensitivity to the product
or any of its ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Product Information – Australia
GenRx Tamoxifen Tablets
Page 2
AN INCREASED INCIDENCE OF ENDOMETRIAL CHANGES INCLUDING HYPERPLASIA,
ENDOMETRIAL POLYPS,
CANCER AND UTERINE SARCOMA (MOSTLY MALIGNANT MIXED MULLERIAN TUMOURS)
HAS BEEN REPORTED IN
ASSOCIATION WITH TAMOXIFEN TREATMENT. THE INCI