INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NEOPHEDAN-10 TABLETS
NEOPHEDAN-20 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NEOPHEDAN-10 TABLETS
NEOPHEDAN-20 TABLETS

COMPOSITION:
Each tablet contains:
Tamoxifen citrate equivalent to Tamoxifen 10 mg, or
Tamoxifen citrate equivalent to Tamoxifen 20 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 26 Cytostatic agents.

PHARMACOLOGICAL ACTION:
Neophedan is an anti-oestrogenic agent that blocks the peripheral functions of oestrogens on target tissues. Neophedan binds to oestrogen receptors in a fashion similar to that of oestradiol. The complex of the receptor and the anti-oestrogen may bind to nuclear chromatin in a typical manner and for a longer time than the normal hormone-receptor complex. Furthermore, anti-oestrogens may deplete the cytoplasm of free receptors. Either or both of these effects could severely impair the growth of an oestrogen dependant tumour.
Neophedan also prevents the normal “feedback inhibition” of control of oestrogen synthesis in the hypothalamus and pituitary gland and this causes an increased secretion of luteinising hormone release factor follicle stimulating hormone release factor and gonadotropins. The formation of large and cystic ovaries is the result of increased concentrations of gonadotropins, leading to ovarian stimulation, ovulation, and sustained function of corpora lutea.

INDICATIONS:
Palliative treatment of advanced carcinoma of the breast in postmenopausal women.

CONTRA-INDICATIONS:
Neophedan should not be given during pregnancy, and should be used with caution in women with functioning ovaries.

WARNINGS:
Endometrial changes:
An increased incidence of endometrial changes, including hyperplasia, polyps and cancer has been reported in association with tamoxifen treatment. Any patients receiving or having previously received tamoxifen, who report vaginal bleeding, should be promptly investigated.

DOSAGE AND DIRECTIONS FOR USE:
In the management of breast cancer
Initial dose:
10 mg twice daily. If no response is seen within one month, the dosage should be increased to 20 mg twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse effects with Neophedan include hot flushes, oedema, vaginal bleeding, pruritus vulvae, gastro-intestinal disturbances, dizziness, rashes, hypercalcaemia, and tumour pain. Transient thrombocytopenia and leucopenia have been reported. There have also been reports of headache, depression, fatigue, confusion, leg cramps, alopecia and dry skin.
There may be an increased tendency to develop deep vein thromboses; pulmonary embolism has occurred. Hypercalcaemia may develop in patients with bony metastases. Blurred vision and loss of visual acuity, corneal opacities, and retinopathies have occurred, mostly following administration of very high doses.
In pre-menopausal women, Neophedan completely suppresses menstruation and cystic ovarian swelling may develop.
Tamoxifen was genotoxic in some in-vitro and in-vivo genotoxicity tests in rodents. 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”. Treat symptomatically.

IDENTIFICATION:
Neophedan-10 White biconvex tablets with a diameter of 8,00 mm.
Neophedan-20 Flat, white, bisected tablet, with bevelled edges, with a diameter of 9,50 mm.

PRESENTATION:
Neophedan-10 Securitainers containing 30 and 250 tablets.
Neophedan-20 Securitainers containing 30 and 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C Protect from light. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Neophedan-10         S/26/379.
Neophedan-20         S/26/380.

NAME AND BUSINESS ADDRESS OF APPLICANT:
BODENE (PTY) LTD trading as Intramed
6 Gibaud Road
Port Elizabeth 6001
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21/7/1986

        D518-12-00
        A&S PRINTERS

Current: October 2003
Source: Community Pharmacy

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