NOLVADEX TABLET 10 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TAMOXIFEN CITRATE 15.2 mg EQV TAMOXIFEN

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

L02BA01

Dosage:

10 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

TAMOXIFEN CITRATE 15.2 mg EQV TAMOXIFEN 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ASTRAZENECA UK LTD

Authorization status:

ACTIVE

Authorization date:

1988-05-06

Patient Information leaflet

07/AC/SG/ONC.000-536-375.4.0 
Page 1/8 

NOLVADEX AND NOLVADEX_-_D  
_TAMOXIFEN CITRATE  _

TABLETS  

QUALITATIVE AND QUANTITATIVE COMPOSITION  
NOLVADEX contains Tamoxifen Citrate
Ph. Eur. 15.2 mg (equivalent to 10 mg of 
tamoxifen).  
NOLVADEX-D contains Tamoxifen Citrate Ph. Eur.
30.4 mg (equivalent to 20 mg of 
tamoxifen).  

PHARMACEUTICAL FORM  
Tablet.  

THERAPEUTIC INDICATION  
NOLVADEX is indicated for the treatment of breast cancer. 

POSOLOGY AND METHOD OF ADMINISTRATION  
Route of administration: Oral.  

ADULTS (INCLUDING ELDERLY): The dosage range is 20 to 40
mg daily, given either in 
divided doses twice daily or as a single dose once daily.  

USE IN CHILDREN  
The use of NOLVADEX is not recommended in children, as safety
and efficacy have 
not been established (see Pharmacodynamic and Pharmacokinetics
properties).  

CONTRAINDICATIONS  
_PREGNANCY: _NOLVADEX must not be given during pregnancy.
Premenopausal 
patients must be carefully examined before treatment to exclude
the possibility of 
pregnancy (see also Pregnancy and lactation).  

NOLVADEX should not be given to patients
who have experienced hypersensitivity 
to the product or any of its ingredients.  

SPECIAL WARNINGS AND PRECAUTIONS FOR USE  
Menstruation is suppressed in a proportion of premenopausal women
receiving 
NOLVADEX for the treatment of breast cancer.  

An increased incidence of endometrial changes including
hyperplasia, polyps, 
cancer and uterine sarcoma (mostly malignant mixed Mullerian
tumours), has been 
reported in association with NOLVADEX treatment.
The underlying mechanism is 
unknown, but may be related to the oestrogen-like effect
of NOLVADEX. Any 
patient receiving or having previously received NOLVADEX, who
report abnormal 
gynaecological symptoms, especially vaginal bleeding, or
who presents with  
07/AC/SG/ONC.000-536-375.4.0 
P

Summary of Product characteristics

1
NOLVADEX
® AND NOLVADEX
®
-D
(TAMOXIFEN CITRATE)
1.
NAME OF THE MEDICINAL PRODUCT
NOLVADEX, 10 mg, tablets
NOLVADEX, 20 mg (NOLVADEX - D), tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOLVADEX
contains
Tamoxifen
Citrate
Ph.
Eur.
15.2
mg
(equivalent
to
10
mg
of
tamoxifen).
NOLVADEX-D contains Tamoxifen Citrate Ph. Eur. 30.4 mg (equivalent to
20 mg of
tamoxifen).
3.
PHARMACEUTICAL FORM
Tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
NOLVADEX is indicated for the treatment of breast cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
ADULTS (INCLUDING ELDERLY)
The dosage range is 20 to 40 mg daily, given either in divided doses
twice daily or as a single
dose once daily.
USE IN CHILDREN
The use of NOLVADEX is not recommended in children, as safety and
efficacy have not
been established (see Pharmacodynamic and Pharmacokinetics
properties).
4.3
CONTRAINDICATIONS
_PREGNANCY: _
NOLVADEX must not be given during pregnancy. Premenopausal patients
must
be carefully examined before treatment to exclude the possibility of
pregnancy (see also
Pregnancy and lactation).
NOLVADEX should not be given to patients who have experienced
hypersensitivity to the
product or any of its ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Menstruation is suppressed in a proportion of premenopausal women
receiving NOLVADEX
for the treatment of breast cancer.
2
An increased incidence of endometrial changes including hyperplasia,
polyps, cancer and
uterine
sarcoma
(mostly
malignant
mixed
Mullerian
tumours),
has
been
reported
in
association with NOLVADEX treatment. The underlying mechanism is
unknown, but may be
related
to
the
oestrogen-like
effect
of
NOLVADEX.
Any
patient
receiving
or
having
previously
received
NOLVADEX,
who
report
abnormal
gynaecological
symptoms,
especially vaginal bleeding, or who presents with menstrual
irregularities, vaginal discharge
and symptoms such as pelvic pain or pressure should be promptly
investigated.
In patients with hereditary angioedema, NOLVADEX may