PROGESTERONE

Posology Adults One 400 mg pessary administered vaginally twice a day starting at oocyte retrieval. If pregnancy has been confirmed, the administration of Progesterone should be continued for 38 days from the start of therapy. Paediatric population There is no relevant use of Progesterone in the paediatric population.

Elderly No clinical data have been collected in patients over age 65. Use in special populations There is no experience with use of Progesterone in patients with impaired liver or renal function. Method of administration For vaginal insertion.

g. rash, pruritus), night sweats Musculoskeletal and connective tissue disorders Arthralgia Renal and urinary disorders Pollakiuria, incontinence Reproductive system and breast disorders Breast pain Vaginal haemorrhage, pelvic pain, metrorrhagia, ovarian enlargement, vulvovaginal pruritus General disorders and administration site conditions Fatigue Feeling cold, feeling of body temperature change, application site pruritus, discomfort Investigations Weight increased As with other vaginal preparations, some leakage of the pessary base may occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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.

Although risk of thromboembolism has been associated with estrogens, a link with progestogens remains questionable. Therefore, in women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with Progesterone may further increase the risk.

In these women, the benefits of Progesterone administration need to be weighed against the risks. It should be noted however, that pregnancy itself carries an increased risk of thromboembolic events. Patients with a history of depression need to be closely observed.

Consider discontinuation if symptoms worsen. g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in glucose tolerance has been observed in a small number of patients on estrogen/progestogen combination drugs.

The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy. Progesterone is metabolised in the liver and should be used with caution in patients with hepatic dysfunction.

Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.

1. Undiagnosed vaginal bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Known missed abortion or ectopic pregnancy. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.

Severe hepatic dysfunction or disease.