Description

Progesterone deficiencies: Treatment of threatened miscarriage Treatment of habitual miscarriage Treatment of dysmenorrhoea Treatment of endometriosis Treatment of secondary amenorrhoea Treatment of irregular cycles Treatment of dysfunctional uterine bleeding Treatment of infertility due to luteal insufficiency Luteal support as part of an Assisted Reproductive Technology (ART) Hormone Replacement Therapy: To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus.

The most commonly reported adverse drug reactions of patients treated with Dydrogesterone in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.

It is estimated that more than 10 million pregnancies have been exposed to Dydrogesterone. So far there were no indications of a harmful effect of Dydrogesterone use during pregnancy. No data exist on excretion of Dydrogesterone in mother's milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother's milk in small quantities. Whether there is a risk to the child is not known. Therefore Dydrogesterone should not be used during the lactation period.

Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered. Severe headache, migraine or symptoms that may indicate cerebral ischemia. Marked increase in blood pressure. Occurrence of venous thromboembolism (VTE) In cases of habitual or threatened abortion, the viability of the foetus should be ascertained. It is also necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive. Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with dydrogesterone must be stopped

Dydrogesterone was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.

Female Sex hormones

Store at below 30°C in a dry place protected from light. Keep out of reach of children.