Cyclogest (200mg)

Cyclogest (200mg) Contents Progesterone. Description Each pessary contains 400 mg Progesterone PhEur. Excipients/Inactive Ingredients: Vegetable fat. Indications/Uses Cyclogest is indicated for the: 1) Treatment of premenstrual syndrome, including premenstrual tension and depression. 2) Treatment of puerperal depression. 3) Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women. Dosage/Direction for Use For the treatment of premenstrual syndrome and puerperal depression: 200 mg daily to 400 mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptoms are present at ovulation commence treatment on day 12. For luteal phase support as part of an ART treatment: 400 mg administered vaginally twice a day starting at oocyte retrieval. The administration of Cyclogest should be continued for 38 days, if pregnancy has been confirmed. Use in special populations: There is no experience with use of Cyclogest in patients with impaired liver or renal function. Paediatric population: There is no relevant use of Cyclogest in the paediatric population. Elderly: No clinical data have been collected in patients over age 65. Overdosage There is a wide margin of safety with Cyclogest pessaries, but overdosage may produce euphoria or dysmenorrhoea. Contraindications Hypersensitivity to the active substance or to any of the excipients listed in Description. Undiagnosed vaginal bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Severe hepatic dysfunction or disease. Known missed abortion or ectopic pregnancy. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.