PROGESTERONE

For the treatment of premenstrual syndrome and puerperal depression: 200mg daily to 400mg 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 Progesterone should be continued for 38 days, if pregnancy has been confirmed.

Use in special populations:

There is no experience with use of Progesterone in patients with impaired liver or renal function. 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.

Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data) SYSTEM ORGAN CLASS Common Uncommon Not known Nervous system disorder Somnolence Gastrointestinal disorders Abdominal pain, Abdominal discomfort Diarrhoea and flatulence may occur with rectal administration.

Reproductive system and breast disorders Breast pain Menstruation may occur earlier than expected, or, more rarely, menstruation may be delayed. g. rash, pruritus) General disorders and administration site conditions Soreness, some leakage of the pessary base Adverse reactions in patients undergoing luteal support as a part of ART treatment is presented in the table below: SYSTEM ORGAN CLASS Common Uncommon Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm Psychiatric disorders Mood altered Nervous system disorder Somnolence Headache, dizziness, dysgeusia Vascular disorders Hot flush Haemorrhage Gastrointestinal disorders Abdominal distension, abdominal pain, constipation Diarrhoea, vomiting, flatulence, gastric dilatation Skin and subcutaneous tissue disorders 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 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. uk/yellowcard

Progesterone is not indicated in threatened miscarriage. Treatment should be discontinued in the event of a missed miscarriage. 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 progestins 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 thrombo-embolic 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-progestin combination drugs.

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

Progesterone contains the hormone progesterone which is present in significant concentrations in women during the second half of the menstrual cycle and during pregnancy. This should be borne in mind when treating patients with conditions that may be hormone-sensitive.

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. - 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.