Indication
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.
Dosage & Administration
Always take Progest 10 mg tablet exactly as your doctor has prescribed. Progesterone deficiencies: • Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit. • Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy. • Dysmenorrhoea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle. • Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously. • Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Progest should be given with oestrogen. • Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Progest should be given with oestrogen. • Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Progest twice daily from day 11 to day 25 of the cycle. • Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. • Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage. • Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed. Hormone Replacement Therapy: In combination with continuous oestrogentherapy, take one tablet daily for 14 consecutive days of a 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy. For doctors: If endometrial biopsies or ultrasound reveal inadequate progestational response, 20 mg Dydrogesterone should be prescribed. For patients: If you are not sure what type of oestrogen therapy you are on, talk to your Doctor before taking Progest. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.
Method of Administration
For oral use only.
Precautions
Before initiating Dydrogesterone treatment for dysfunctional uterine bleeding, an organic cause must be ruled out. 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, if necessary by endometrial biopsy to exclude endometrial malignancy.
Use in Pregnancy & Lactation
Pregnancy: 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.
Breastfeeding: 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.
