Tamoxifen Ebewe

Tamoxifen Ebewe Special Precautions

tamoxifen

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Special Precautions
Special caution and monitoring is to be taken to patients with: liver and kidney disease, diabetes mellitus, thromboembolic disease in the medical history, visual disturbances.
An increased incidence of endometrial changes, including hyperplasia, polyps and cancer, has been reported in association with tamoxifen treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the oestrogenic properties of tamoxifen.
Before starting the treatment any patients receiving or having previously received tamoxifen should be given at least 6-monthly intervals gynaecological as well as internal examinations, and any unusual symptoms, abnormal vaginal bleeding, or who present with menstrual irregularities, vaginal discharge and symptoms such as pelvic pain or pressure should be investigated promptly.
Women taking tamoxifen for prophylaxis of breast cancer should be monitored carefully for endometrial hyperplasia. If atypical hyperplasia develop, tamoxifen should be discontinued while the condition is treated and a hysterectomy should be considered before tamoxifen is re-started.
Visual disturbance including decreased visual acuity, corneal opacities, cataracts and retinopathy have been described. Therefore ophthalmological examinations are recommended prior and periodical during the treatment and if visual abnormalities occur (decrease of the eyesight). The examination, may detect early corneal or retinal lesions which may be reversible on stopping treatment.
Before starting the treatment an allround gynaecologic examination (exclusion of pregnancy) as well as internal examination of the patient has to be done. During treatment gynaecologic examinations have to be done at least in 6-monthly intervals because of possible endometrium lesions and changes.
In case of pre-existing liver diseases the liver status has to be monitored carefully. Blood count (especially thrombocytes), liver- and kidney-functions, serum calcium and blood sugar are to be controlled periodically. Further periodical controls (lung- and bone x-ray, ultrasound liver) are recommended to see possible early metastasizing.
Effect on ability to drive and use machines: Tamoxifen therapy is unlikely to impair driving performance or the ability to operate machines.
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