Ovulet Special Precautions



Renata Limited


Full Prescribing Info
Special Precautions
Clomifene should not be used in patients with pre-existing mental depression or thrombophlebitis because of the risk of exacerbation.
Ovarian hyperstimulation syndrome and abnormal ovarian enlargement may occur, lowest dose is suggested to minimize this complication.
Ovarian cyst: Pelvic examination is necessary prior to start of and before each subsequent course of Clomifene citrate treatment. Clomifene citrate should not be given in the presence of an ovarian cyst (including endometriosis involving the ovary) except polycystic ovary since further enlargement of the cyst may occur. The lowest doses possible should be used to minimise ovarian enlargement or cyst formation; some patients with polycystic ovary syndrome may have an exaggerated response to usual doses of Clomifene. Patients should be instructed to report any abdominal or pelvic pain, distension, or weight gain, as this may indicate the presence or enlargement of ovarian cysts. They should also be evaluated for the presence of ovarian cysts before each cycle of treatment. If abnormal enlargement occurs, Clomifene should not be given until the ovaries have returned to pre-treatment size, and subsequent doses should be reduced.
Clomifene should be used with caution in patients with uterine fibroids, due to the potential for enlargement of the fibroids.
Multiple pregnancies: There is an increased chance of multiple pregnancies when conception occurs in relationship to Clomifene citrate therapy. The potential complications and hazards of multiple pregnancies should be discussed with the patient.
Pregnancy wastage and birth anomalies: The patient should be informed of the greater pregnancy risks associated with certain characteristics or conditions of any pregnant woman: e.g., age of female and male partner, history of spontaneous abortions, Rh genotype, abnormal menstrual history, infertility history (regardless of cause), organic heart disease, diabetes, exposure to infectious agents such as rubella, familial history of birth anomaly, and other risk factors that may be pertinent to the patient for whom Clomifene citrate is being considered. Based upon the evaluation of the patient, genetic counselling may be indicated.
Visual symptoms: Patients should be advised that blurring or other visual symptoms may occasionally occur during or shortly after therapy with Clomifene citrate. The significance of these visual symptoms is not understood. If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation performed.
Long-term cyclic therapy is not recommended, because of the uncertainty regarding increased risk of ovarian cancer: a maximum of 6 cycles of treatment has generally been advised.
Effects on the ability to drive and use machines: Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting.
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