May be taken with or without food.
Administration
May be taken with or without food.
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Contraindications
Abnormal uterine bleeding of unknown origin, uncontrolled thyroid or adrenal impairment, presence of an organic intracranial lesion (e.g. pituitary tumour), hormone-dependent tumours, ovarian cysts or enlargement not due to PCOS. Active liver disease or history of hepatic impairment. Pregnancy.
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Special Precautions
Patient with uterine fibroids, PCOS, pre-existing or family history of hyperlipidaemia. Lactation. Patient Counselling This drug may cause dizziness, lightheadedness or visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Prior to therapy, obtain serum estrogen and triglycerides level; rule out primary pituitary or ovarian failure, endometriosis or endometrial carcinoma, adrenal and thyroid disorders, hyperprolactinaemia, and male factor infertility. Monitor ovulation by obtaining urinary LH, serum estradiol, and progesterone, and/or performing ultrasound. Perform pelvic exam and pregnancy test prior to each cycle of therapy. Assess for signs and symptoms of OHSS (e.g. severe abdominal pain or bloating, vomiting, diarrhoea, excessive weight gain, dyspnoea, or changes in urination).
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Adverse Reactions
Significant: Ovarian hyperstimulation syndrome (OHSS), ovarian enlargement and cyst formation (high doses or prolonged treatment), visual disturbances (e.g. blurred vision, scintillating scotomata, phosphenes), multiple or ectopic pregnancy, new-onset or exacerbation of endometriosis; hypertriglyceridaemia, hypersensitivity reactions (including anaphylaxis and angioedema). Rarely, ovarian cancer.
Cardiac disorders: Tachycardia, palpitations.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, abdominal symptoms or pelvic discomfort (e.g. distention, bloating, pain), pancreatitis.
General disorders and administration site conditions: Fatigue.
Investigations: Increased transaminases.
Nervous system disorders: Headache, dizziness, lightheadedness, paraesthesia, convulsions.
Psychiatric disorders: Nervousness, insomnia, depression, anxiety, mood disturbances.
Renal and urinary disorders: Increased urinary frequency or volume.
Reproductive system and breast disorders: Menorrhagia, breast discomfort, abnormal uterine haemorrhage.
Skin and subcutaneous tissue disorders: Rash, urticaria, dermatitis. Very rarely, alopecia.
Vascular disorders: Vasomotor flushes.
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CIMS Class
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ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
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