Tamoxifen Sandoz

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Tamoxifen citrate 15.2mg equivalent to tamoxifen 10 mg;  

Διαθέσιμο από:

Sandoz New Zealand Limited

INN (Διεθνής Όνομα):

Tamoxifen citrate 15.2 mg (=tamoxifen 10 mg)

Δοσολογία:

10 mg

Φαρμακοτεχνική μορφή:

Film coated tablet

Σύνθεση:

Active: Tamoxifen citrate 15.2mg equivalent to tamoxifen 10 mg   Excipient: Hypromellose Lactose monohydrate   Macrogol 4000 Magnesium stearate Microcrystalline cellulose Povidone Sodium starch glycolate Titanium dioxide

Μονάδες σε πακέτο:

Blister pack, PVC/PVDC/Al x 30's (not marketed), 30 tablets

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Chemische Fabrik Berg GmbH

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al x 30's - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al x 60's - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Ημερομηνία της άδειας:

1998-11-16

Φύλλο οδηγιών χρήσης

TAMOXIFEN SANDOZ
®
1
TAMOXIFEN SANDOZ
®
_tamoxifen citrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions 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 has 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 treat
breast cancer.
It contains the active ingredient
tamoxifen citrate. Tamoxifen citrate
is an anti-oestrogen which blocks the
effect of oestrogen. Oestrogen is a
natural female sex hormone.
In some types of breast cancer,
oestrogen can help cancer cells to
grow. By blocking its effect
Tamoxifen Sandoz stops or slows the
growth of cancer cells.
Your doctor will have explained why
you are being treated with Tamoxifen
Sandoz and told you what dose to
take.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR.
They may differ from the
information contained in this leaflet.
Your doctor may have prescribed
Tamoxifen Sandoz for another
reason. Ask your doctor if you have
any questions about why this
medicine was prescribed for you.
There is no evidence that Tamoxifen
Sandoz is addictive.
BEFORE YOU TAKE
TAMOXIFEN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE TAMOXIFEN SANDOZ IF
YOU ARE PREGNANT, TRYING TO BECOME
PREGNANT OR ARE BREASTFEEDING.
We do not know if it is safe for your
to take it while you are pregnant. It
may affect your baby if you take it at
any time during pregnancy.
DISCUSS CONTRACEPTION WITH YOUR
DOCTOR.
Although Tamoxifen Sandoz blocks
female hormones, it is not a
contraceptive.
Tamoxifen Sandoz should not be
used during pregnancy as birth
defects can result. A nine month
interval is recommended between

Αρχείο Π.Χ.Π.

230320-Tamoxifen Sandoz-ds
Page 1 of 9
NEW ZEALAND DATA SHEET
TAMOXIFEN SANDOZ (TAMOXIFEN CITRATE) FILM-COATED TABLETS
1.
PRODUCT NAME
Tamoxifen Sandoz
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tamoxifen Sandoz 10 mg: Each tablet contains tamoxifen citrate
equivalent to tamoxifen 10
mg.
Tamoxifen Sandoz 20 mg: Each tablet contains tamoxifen citrate
equivalent to tamoxifen 20
mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
10 MG:
Tablet, film coated, 7 mm round, white, biconvex, plain both sides.
20 MG:
Tablet, film coated, 9 mm round, white, biconvex, plain one side and
scored on the
other.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Tamoxifen Sandoz is indicated for the treatment of breast cancer; the
response is similar to that
seen with either estrogens or androgens but tamoxifen appears to
produce less marked side-
effects and to be more acceptable to the patient.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS (INCLUDING THE ELDERLY) _
_Breast cancer _
The dosage range is 20 to 40 mg daily given either in divided doses
twice daily or as a single
dose once daily. In early disease, it is currently recommended that
treatment is given for not
less than 5 years. The optimal duration of tamoxifen therapy remains
to be determined.
_CHILDREN _
Tamoxifen is not indicated for use in children.
METHOD OF ADMINISTRATION
For oral administration.
4.3.
C
ONTRAINDICATIONS
Tamoxifen must not be administered during pregnancy. Premenopausal
patients must be
carefully examined before treatment for breast cancer to exclude the
possibility of pregnancy.
There have been a small number of reports of spontaneous abortions,
birth defects and foetal
230320-Tamoxifen Sandoz-ds
Page 2 of 9
deaths after women have taken tamoxifen, although no causal
relationship has been established
(refer to Section 4.4 Special warnings and precautions for use).
Tamoxifen should not be given to patients who have experienced
hypersensitivity to the
product or any of its ingredients.
4.