TAMOXIFEN TABLET 20 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TAMOXIFEN CITRATE EQV TAMOXIFEN

Available from:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC code:

L02BA01

Dosage:

20 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

TAMOXIFEN CITRATE EQV TAMOXIFEN 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD

Authorization status:

ACTIVE

Authorization date:

1992-07-03

Summary of Product characteristics

73426_s1 - P: Tamoxifen (as citrate) (Tamoxifen), SG, Tablets, SMPC
06
23.02.2023
YG
05.07.2023
YG
160x560mm
Kfar Saba
9 pt
Profile
Black
Tamoxifen / Singapore / 160 x 560 mm Side A
322K08282-03
TAMOXIFEN TABLET 20 MG
1. NAME OF THE MEDICINAL PRODUCT
Tamoxifen Tablet 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30.4 mg of tamoxifen citrate equivalent to 20 mg
of tamoxifen.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablet
Round, white, biconvex tablets, engraved: `20’ above score line and
`T’ below on one side, and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Tamoxifen is used for the treatment of breast cancer.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
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 Tamoxifen is not recommended in children, as safety and
efficacy have not been established (see
Pharmacodynamic and Pharmacokinetics properties).
4.3. CONTRAINDICATIONS
Tamoxifen must not be given during pregnancy. Pre-menopausal patients
must be carefully examined before treatment for
breast cancer or infertility to exclude the possibility of pregnancy
(see section 4.6.).
Tamoxifen 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 pre-menopausal women
receiving tamoxifen 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
tamoxifen treatment. The underlying mechanism
is unknown but may be related to the oestrogen-like effect properties
of tamoxifen. Any patient receiving or having
previously received tamoxifen who reports abnormal gynaecological
symptoms, especially vaginal bleeding, or who
pre