Microgest

• Premenstrual syndrome

Micronized Progesterone is indicated in- Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women. Treatment of premenstrual syndrome, including premenstrual tension and depression. Treatment of puerperal depression.

N/A

Hypersensitivity to the active substance or to any of the excipients Undiagnosed vaginal bleeding Known or suspected progesterone sensitive malignant tumors 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

Micronized Progesterone Vaginal Pessary is structurally and biologically identical to natural endogenous progesterone. Absorption: Vaginal administration of Progesterone 400 mg every 12 h in healthy women has been shown effective in rapidly achieving and maintaining serum progesterone concentrations at physiological levels appropriate to the mid-luteal phase of the ovarian cycle and early pregnancy. Distribution: Progesterone is approximately 96 % to 99 % bound to serum proteins, primarily to serum albumin and corticosteroid binding globulin. Biotransformation: Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation and epimerization. Elimination: Progesterone undergoes renal and biliary elimination.

Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine or phenytoin) may increase the elimination rate and thereby decrease the bioavailability of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Micronized Progesterone has not been assessed and is therefore not recommended.

Micronized Progesterone is devoid of estrogenic, androgenic and mineralocorticoid effects. Mild somnolence and other CNS side effects like depression, breast tenderness and bloating are reported. Side effects are less when vaginal route is used.

Micronized Progesterone is not indicated in threatened miscarriage. Treatment should be discontinued in the event of a missed miscarriage. Micronized Progesterone should be discontinued if any of the following conditions are suspected: Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis or retinal thrombosis.

Renal impaired patient: There is no experience with the use of Progesterone in patients with impaired liver or renal function.Pediatric population: There is no relevant use of Progesterone in the pediatric population.Elderly: No clinical data have been collected in patients over age 65.