TAMOXIFEN LUPIN tamoxifen (as citrate) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tamoxifen citrate, Quantity: 30.34 mg (Equivalent: tamoxifen, Qty 20 mg)

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; brilliant scarlet 4R; povidone

Administration route:

Oral

Units in package:

60, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of breast cancer TAMOXIFEN LUPIN is indicated for the treatment of breast cancer.,Primary reduction of breast cancer risk TAMOXIFEN LUPIN 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: Pink, round biconvex tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-07-24

Patient Information leaflet

TAMOXIFEN LUPIN V 1.0
1
TAMOXIFEN LUPIN
TABLETS
_Tamoxifen (as citrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tamoxifen Lupin
tablets. 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 risks of you taking Tamoxifen
Lupin tablets 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 TAMOXIFEN LUPIN
IS USED FOR
Tamoxifen Lupin tablets are 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
Tamoxifen Lupin for reducing the
risk of breast cancer occurring, your
knowledge of treatment risks
becomes more important because you
don't currently have breast cancer.
Tamoxifen Lupin 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.
Tamoxifen Lupin 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
Tamoxifen Lupin reduces, but does
not eliminate, the risk of breast
cancer.
Tamoxifen Lupin contains the active
ingredient ta

Summary of Product characteristics

Tamoxifen Lupin v 1.0
AUSTRALIAN PRODUCT INFORMATION
TAMOXIFEN LUPIN (TAMOXIFEN (AS CITRATE)) TABLETS
1
NAME OF THE MEDICINE
Tamoxifen (as citrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAMOXIFEN LUPIN tablets contain 20 mg tamoxifen (as citrate)
Excipients with known effect:
Contains sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients
.
3
PHARMACEUTICAL FORM
Tamoxifen (as citrate) 20 mg tablets are pink, round and biconvex.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TREATMENT OF BREAST CANCER
TAMOXIFEN LUPIN is indicated for the treatment of breast cancer.
PRIMARY REDUCTION OF BREAST CANCER RISK
TAMOXIFEN LUPIN 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
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
TREATMENT OF BREAST CANCER
The initial dose is 20 mg once daily. In advanced breast cancer, if no
response is seen, dosage may
be increased to 40 mg 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.
TAMOXIFEN LUPIN reduces, but does not eliminate, the risk of breast
cancer. In clinical trials,
tamoxifen decreased the incidence of oestrogen receptor-positive
tumours, but did not alter the
incidence of oestrogen receptor-negative tumours. The use of tamoxifen
should be as part of a
program including regular breast surveillance tailored to the
individual woman, taking into account
the risk of breast cancer.
Tamoxifen