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

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tamoxifen citrate, Quantity: 30.4 mg (Equivalent: tamoxifen, Qty 20 mg)

Tilgjengelig fra:

Sandoz Pty Ltd

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: lactose monohydrate; titanium dioxide; microcrystalline cellulose; povidone; hypromellose; macrogol 4000; magnesium stearate; sodium starch glycollate

Administreringsrute:

Oral

Indikasjoner:

Treatment of breast cancer. ? TAMOXIFEN SANDOZ is indicated for the treatment of breast cancer.,Primary reduction of breast cancer risk ? TAMOXIFEN SANDOZ 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).

Produkt oppsummering:

Visual Identification: White, round, biconvex tablets with a score notch on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2001-09-26

Informasjon til brukeren

TAMOXIFEN SANDOZ
®
1
TAMOXIFEN SANDOZ
®
_tamoxifen citrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions people ask about
TAMOXIFEN SANDOZ. It does not
contain all the information that is
known about TAMOXIFEN
SANDOZ.
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
TAMOXIFEN SANDOZ 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
SANDOZ IS USED
FOR
TAMOXIFEN SANDOZ 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
TAMOXIFEN SANDOZ 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 SANDOZ 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 SANDOZ 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 SANDOZ reduces,
but does not eliminate, the risk of
breast cancer.
TAMOXIFEN S

Preparatomtale

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Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
TAMOXIFEN SANDOZ
® (TAMOXIFEN CITRATE) TABLETS
1.
NAME OF THE MEDICINE
Tamoxifen citrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tamoxifen Sandoz 10 mg tablet contains 10 mg tamoxifen citrate.
Each Tamoxifen Sandoz 20 mg tablet contains 20 mg tamoxifen citrate.
_List of excipients with known effect:_
Lactose monohydrate.
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tamoxifen Sandoz 10 mg tablets: white, round, biconvex, film coated
tablets in
blisters.
Tamoxifen Sandoz 20 mg tablets: white, round, biconvex, with a score
notch, film coated
tablets in
blisters.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_TREATMENT OF BREAST CANCER _
Tamoxifen Sandoz is indicated for the treatment of breast cancer.
_PRIMARY REDUCTION OF BREAST CANCER RISK _
Tamoxifen Sandoz 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
DOSAGE
_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.
211116-tamoxifen sandoz-pi
Page 2 of 15
Tamoxifen Sandoz reduces, but does not eliminate, the risk of breast
cancer. In clinical trials,
Tamoxifen Sandoz decreased th