TAMOXIFEN 10MG 30 TAB STRIP; tamoxifen, hormonal agents .
ACTIVE-INGREDIENT OF TAMOXIFEN 10MG 30 TAB STRIP
Tamoxifen citrate 15.2 mg . (equivalent to 10 mg of tamoxifen )
INDICATION OF TAMOXIFEN 10MG 30 TAB STRIP
tamoxifen is indicated for : the treatment of anovulatory infertility . The treatment of neoplastic breast disease .
DOSAGE OF TAMOXIFEN 10MG 30 TAB STRIP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
anovulatory infertility : pregnancy , must be excluded before starting a course of therapy , whether initial or subsequent . For women who are menstruating regularly but with anovular cycles , the initial course of treatment consists of daily doses of 20 mg of tamoxifen administrated on the second , third , fourth and fifth days of the menstrual cycle . if unsatifactory basal temperature or poor pre-ovulatory cervical mucus indicated that this initial course of treatment has been unsuccessful , further courses may be given during subsequent menstrual cycles , increasing the dosage to 40 mg and then to 80 mg daily . for women who are not menstruating regularly , the initial course may begin on any day . if no signs of ovulation are demonstrable , a subsequent course of treatment should start 45 days later with the dosage increased as described above . if a patient responds by menstruating , further courses of treatment should commence on the second day of each cycle . neoplastic breast disease : 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 .
OVER-DOSAGE OF TAMOXIFEN 10MG 30 TAB STRIP
on theoretical grounds , overdosage would be expected to cause enhancement of the anti-oestrogenic side effects mentioned above . Observations in animals show that extreme overdosage (100 – 200 times recommended daily dose ) may produce oestrogenic effects . there is nop specific antinode to overdosage and treatment must be symptomatic . further information : effect on ability to drive or operate machinery : there is no evidence that temoxifen results in impairment of these activities .
CONTRA-INDICATION OF TAMOXIFEN 10MG 30 TAB STRIP
tamoxifen must not be given during pregnancy . There have been a small number of reports of spontaneous abortions , birth defects and defects and foetal death after women have taken tamoxifen , although no causal relationship gas been established . reproductive toxicology studies in rats , rabbits and monkeys have shown no teratogenic potential . in rodent models of foetal reproductive tract development , tamoxifen was associated with changes similar to those caused by oestradiol , ethynyloestradiol , clomiphene and diethylstillboestrol (DES) . although the clinical relevance of these changes in unknown , some of them , espicially vaginal adenosis , are similar to those seen in young women who were exposed to DES in utero and who have a 1 in 100 risk of developing clear-cell carcinoma of the vagina or cervix . omnly a small number of pregnant women have been exposed to tamoxifen . such exposure has not been reported to cause subsequent vaginal adenosis or clear – cell carcinoma of the vagina or cervix in young women exposed in utero to tamoxifen . women should be advised not to advised not to become pregnant whilst taking tamoxifen and should use barrier to other non-hormonal contraceptive methods if sexually active . premenopausal patients must be carefully examined before treatment to exclude pregnancy . women should be appraised of the potential risks to the foetus , should they become pregnant whilst taking tamoxifen or within two months of cessation of therapy .
STORAGE OF TAMOXIFEN 10MG 30 TAB STRIP
store at room temperature not exceeding 30 C , in dry place .
PACK OF TAMOXIFEN 10MG 30 TAB STRIP
a carton box containing 30 tablets , in 3 ( milky pvc/AL) strips + pamphlet .
TAMOXIFEN 10MG 30 TAB STRIP MANUFACTURED BY
AMRIYA FOR PHARMACEUTICAL INDUSTRIES .