GENOX 10 tamoxifen 10mg (as citrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tamoxifen citrate, Quantity: 15.2 mg (Equivalent: tamoxifen, Qty 10 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; magnesium stearate; croscarmellose sodium; mannitol

Administration route:

Oral

Units in package:

60 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of breast cancer. GENOX is indicated for the treatment of breast cancer. Primary reduction of breast cancer risk. GENOX is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

Product summary:

Visual Identification: A white, 7.0 mm, round, biconvex, tablet, debossed with 'TN' over '10' on one side of the tablet and 'G' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1992-06-03

Patient Information leaflet

GENOX
_tamoxifen (as citrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GENOX.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking GENOX against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT GENOX IS USED
FOR
GENOX is used to treat breast cancer
or reduce the risk of breast cancer
occurring if you are at increased risk
of breast cancer.
If you and your healthcare
professional are considering using
GENOX for reducing the risk of
breast cancer occurring, your
knowledge of treatment risks
becomes more important because you
don't currently have breast cancer.
GENOX therapy may be
uncommonly associated with serious
side effects such as deep vein
thrombosis (DVT - blood clots in
veins of your leg), pulmonary
embolus (blood clots in your lungs)
and uterine cancer. In some women,
these events were fatal. Less serious
side effects such as hot flushes,
vaginal discharge, menstrual
irregularities and gynaecological
conditions may also occur. Whether
the benefits of treatment outweigh
the risks depends on your age, health
history, your level of breast cancer
risk and on your personal judgement.
GENOX therapy to reduce the risk of
breast cancer may not be appropriate
for all women at increased risk for
breast cancer. An assessment with
your healthcare professional of the
potential benefits and risks prior to
starting therapy for reduction in
breast cancer risk is essential. You
should understand that GENOX
reduces, but does not eliminate, the
risk of breast cancer.
GENOX contains the active
ingredient tamoxifen, which works
by blocking the actions of estrogen.
Estrogen is a natural female sex
hormone. In some types of breast
cancer, estrogen can help cancer cells
to

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
GENOX
_Tamoxifen citrate tablet _
1
NAME OF THE MEDICINE
Tamoxifen (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GENOX tablet contains the active ingredient tamoxifen citrate
equivalent to 10 mg or 20 mg of
tamoxifen.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
GENOX 10: a white, 7.0 mm, round, biconvex, tablet, debossed with
‘TN’ over ‘10’ on one side of the tablet
and G on the other side.
GENOX 20: a white, 9.5 mm, round, biconvex, tablet debossed with
‘TN’ above the score and ‘20’ below the
score on one side of the tablet and G on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF BREAST CANCER
GENOX is indicated for the treatment of breast cancer.
PRIMARY REDUCTION OF BREAST CANCER RISK
GENOX is indicated for the primary reduction of breast cancer risk in
women either at moderately increased
risk (lifetime breast cancer risk 1.5 to 3 times the population
average) or high risk (lifetime breast cancer risk
greater than 3 times the population average).
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_TREATMENT OF BREAST CANCER _
The initial dose is 20 mg (two GENOX 10 tablets or one GENOX 20
tablet) once daily. In advanced breast
cancer, if no response is seen, dosage should be increased to 40 mg
(four GENOX 10 tablets or two GENOX
20 tablets) once daily.
_PRIMARY REDUCTION OF BREAST CANCER RISK _
The recommended maximum dose is 20 mg daily for 5 years. There are
insufficient data to support a higher
dose or longer period of use.
An assessment of the potential benefits and risks prior to starting
therapy for reduction in breast cancer risk is
essential. Validated algorithms are available that calculate breast
cancer risk based on features such as age,
family history, genetic factors, reproductive factors, and history of
breast disease.
GENOX reduces, but does not eliminate, the risk of breast cancer. In
clinical trials, tamoxifen decreased the
incidence of estrogen receptor-posit