Clomed

Clomiphenum

One tablet contains clomifene citrate 50 mg. Excipient with known effect: lactose monohydrate 100 mg.

Indication: Clomed is indicated for induction of ovulation in anovulatory women wishing to conceive, in anovulation due to hypothalamic dysfunction, secondary amenorrhoea of various aetiologies (excluding that caused by pituitary, thyroid or adrenal disorders), post-oral-contraceptive amenorrhoea, Stein-Leventhal syndrome, oligoamenorrhoea and Chiari-Frommel syndrome.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Hepatic disease or impaired liver function − Pregnancy − Ovarian cyst (except polycystic ovary syndrome). − Loss of pituitary function − Thyroid or adrenal dysfunction − Undiagnosed abnormal uterine bleeding − Recent or previous visual disturbances − Hormone-dependent tumours − In patients with ovarian dysgenesis, menopause, or any other condition in which a response is not expected.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Liver function tests are recommended before initiating treatment. A detailed gynaecological examination must be carried out before initiating treatment. Treatment should be started when total urinary gonadotropin excretion is normal or at the lower limit of normal, the ovaries are normal on palpation, and thyroid and adrenal function are normal. In cases of ovulatory disorders, any other possible cause of infertility must be excluded or treated before starting treatment with clomifene. If ovarian enlargement or cystic ovarian changes occur, treatment should be discontinued until the ovaries return to normal size. Thereafter, the dose and duration of treatment should be reduced. The ovaries must be examined regularly […]