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Benign gynaecological conditions (including endometrial polyps, endometriosis, and ovarian cysts) and gynaecological procedures (including hysteroscopy, dilation and curettage, and hysterectomy) were also tamoxifen found to occur more frequently with tamoxifen use. Women will need a prescription gynecologic (GYN) examination before therapy, tamoxifen and during therapy, at regular intervals. . While this finding is in prescription line with the pharmacodynamic properties of prescription tamoxifen, a prescription causal relationship has not tamoxifen been established (see section.4). Do not breast tamoxifen feed while taking this medication. It allows continued monitoring of the benefit/risk balance of the medicinal product. Neutropeniaa (this can sometimes be severe) Agranulocytosisa Transient falls in platelet prescription counts usually between 80,000 - 90,000 per cu mm but occasionally lower have been reported in patients taking tamoxifen for tamoxifen tamoxifen breast cancer The tendency towards thrombophlebitis may increase and transient thrombocytopenia may occur. In nsabp P1, the majority of women were white (96 race was not reported in the other trials. Although the clinical prescription relevance tamoxifen of these changes is unknown, some of them, especially vaginal adenosis, are similar to those seen in young women who were exposed to DES in-utero and who have a 1 in 1000 prescription risk of developing. Therefore, Tamoxifen treatment may increase the incidence of endometrial cancer. The clinical relevance of these findings has not been established. Paediatric population In an uncontrolled trial in 28 girls aged 210 years with McCune Albright Syndrome (MAS who received 20 mg once a day for up to 12 months duration, mean uterine volume increased after 6 months. Less serious side effects such as hot flushes, vaginal discharge, menstrual irregularities and gynaecological conditions may also occur. The frequency has been calculated using the upper limit of the 95 confidence interval for the point estimate (based on 3/X, where X represents the total sample size.g. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Effects of age and menopausal status No age-related effects of tamoxifen on breast cancer incidence were reported in the primary risk reduction trials. Other relevant exclusion criteria included the current use of oral contraceptives (nsabp P1, Royal Marsden recent or current hormone replacement therapy (nsabp P1 and current anticoagulant use (ibis-1). Let your health care professional know if you have ever had a blood clot that required medical treatment. 5.3 Preclinical safety data Tamoxifen was not mutagenic in a range of in vitro and in vivo mutagenicity tests. For example, the hormone testosterone, made in the testicles and is responsible for male characteristics such as deepening voice and increased body hair. . III primary prevention of breast cancer: Tamoxifen treatment for the primary prevention of breast cancer should only be initiated by a medical practitioner experienced in prescribing for this indication, and as part of a shared care pathway arrangement, with appropriate patient. For the full list of excipients, see section.1. Interestingly, studies have indicated that tamoxifen is most useful for women who have ER breast cancer and are post -menopausal. Not all side effects are listed above. Your fertility, meaning your ability to conceive or father a child, may be affected by tamoxifen. . Notify your health care provider within 24 hours if you notice that one leg is swollen, red, painful and/or warm to touch and the other is not. Risk is increased when tamoxifen is used in combination with cytotoxic agents Interstitial pneumonitis Gastrointestinal prescription disorders Nausea Vomiting Diarrhoea Constipation Pancreatitis Hepatobiliary disorders Changes in liver enzyme Fatty liver Cirrhosis of the liver Cholestasisa Hepatitis Hepatic tamoxifen failurea Hepatocellular injurya Hepatic necrosisa. Primary reduction of breast cancer risk Tamoxifen reduces, but does not eliminate the risk of breast cancer. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.