TAMOXIFEN CITRATE 40 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TAMOXIFEN CITRATE

Available from:

Generics (UK) Limited

INN (International Name):

TAMOXIFEN CITRATE

Dosage:

40 Milligram

Pharmaceutical form:

Tablets

Authorization status:

Withdrawn

Authorization date:

2006-07-01

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamoxifen Tablets B.P. 40mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Tamoxifen Citrate equivalent to 40 mg
of Tamoxifen.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, round biconvex tablets embossed with “TN40” on
one side and a “G” on the reverse.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the treatment of breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The usual daily dosage is 20 to 40 mg once daily or in two
divided doses.
4.3 CONTRAINDICATIONS
Tamoxifen must not be taken during pregnancy. Tamoxifen should
not be used in women at risk of pregnancy. Women 
of childbearing potential must be examined carefully
before starting therapy to exclude any possibility of pregnancy.
Tamoxifen should not be given to patients who have experienced
hypersensitivity to the product or any of its 
ingredients.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Investigations in different _in vivo_ and _in
vitro_ systems have shown that tamoxifen
has a genotoxic potential following 
hepatic activation. Gonadal tumours in mice and
liver tumours in rats receiving tamoxifen have been reported in
long 
term studies. The clinical relevance of these findings has not been
established.
A small number of cases of endometrial hyperplasia,
endometrial polyps and endometrial carcinomas have been 
reported in association with tamoxifen treatment. Although the risk
of developing endometrial cancer in patients is 
low, symptoms of endometrial pathology (abnormal vaginal bleeding
including menstrual irregularities, post 
menopausal bleeding, vaginal discharge) in patients treated with
tamoxifen should be promptly investigated.
Hypercalcaemia has appeared on initiation of therapy in
a few patients with bony metastases.
Additional symptoms such as �