NOLVADEX 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

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; Gelatin; hypromellose; macrogol 300; lactose monohydrate; maize starch; magnesium stearate; titanium dioxide

Administration route:

Oral

Units in package:

30 tablets (hospital pack), 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of breast cancer NOLVADEX is indicated for the treatment of breast cancer. Primary reduction of breast cancer risk NOLVADEX 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: white to off white, round, film coated tablet (marked NOLVADEX -10,; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-11

Patient Information leaflet

NOLVADEX
®
_Tamoxifen citrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
In this leaflet, NOLVADEX means
Nolvadex or Nolvadex-D tablets.
This leaflet answers some of the
common questions people ask about
NOLVADEX. It does not contain all
the information that is known about
NOLVADEX.
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
NOLVADEX 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 NOLVADEX IS
FOR
NOLVADEX is used to either 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
NOLVADEX for reducing the risk of
breast cancer occurring, your
knowledge of treatment risks
becomes more important because you
don't currently have breast cancer.
NOLVADEX 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.
NOLVADEX 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
NOLVADEX reduces, but does not
eliminate, the risk of breast cancer.
NOLVADEX blocks the actions of
oestrogen. Oestrogen is a natura

Summary of Product characteristics

1 of 15
AUSTRALIAN PRODUCT INFORMATION
NOLVADEX
®
(TAMOXIFEN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Tamoxifen citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOLVADEX tablets each contain tamoxifen citrate (15.2 mg) equivalent
to 10 mg of tamoxifen.
NOLVADEX-D tablets each contain tamoxifen citrate (30.4 mg) equivalent
to 20 mg of tamoxifen.
_Both NOLVADEX and NOLVADEX-D also contain an excipient with known
effect: lactose _
_monohydrate._
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NOLVADEX is presented as white to off-white, round, biconvex film
coated tablets, impressed
with "NOLVADEX 10" on one face, and plain on the reverse face.
NOLVADEX-D is presented as white to off-white, octagonal shaped,
biconvex film coated tablets,
impressed with "NOLVADEX-D" on one face, and plain on the reverse
face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF BREAST CANCER
NOLVADEX is indicated for the treatment of breast cancer.
PRIMARY REDUCTION OF BREAST CANCER RISK
NOLVADEX 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 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.
2 of 15
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.
NOLVADEX reduces, but does n