Dydrogesterone tablet is indicated in 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.

Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an estrogen-primed uterus, thereby providing protection against the increased risk of endometrial hyperplasia and carcinogenesis induced by estrogens. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no estrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.

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. Presentation 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. Presentation should be given with oestrogen.
• Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation 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 oestrogen therapy, 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 Presentational 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 Presentation. 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.

No specific interaction studies have been conducted.

• Hypersensitivity to the active ingredient or any of the excipients.
• Known or suspected progestogen-dependent tumors.
• Unexplained vaginal bleeding.
• When used for prevention of endometrial hyperplasia (in women receiving estrogens).
• Thrombophlebitis or thromboembolic disorders.
• Presence or history of cerebrovascular or coronary artery disease.
• Liver disease or impaired liver function, history of cholestatic jaundice or pruritus during pregnancy, and conditions like Dubin-Johnson syndrome or Rotor syndrome.
• History of herpes during pregnancy.
• Sickle cell anemia.
• Benign or malignant liver tumors that develop during the use of oral contraceptives.

The most commonly reported adverse drug reactions in patients treated with Dydrogesterone (without estrogen therapy) include:

• Migraine or headache
• Nausea
• Menstrual irregularities
• Breast pain or tenderness

So far, no harmful effects have been identified with the use of Dydrogesterone during pregnancy. The drug passes into breast milk. A potential risk to the breastfed infant cannot be ruled out; therefore, it should not be used during breastfeeding. There is no evidence that it reduces fertility.

Before starting treatment for abnormal bleeding, the cause should be determined. Breakthrough bleeding or spotting may occur during the first few months. If such bleeding continues or appears later, further investigation, including an endometrial biopsy, may be needed to rule out malignancy.

Treatment should be discontinued if any of the following occur:

• Severe headache or migraine indicating possible cerebral ischemia
• Significant increase in blood pressure
• Development of venous thromboembolism (VTE)

In cases of recurrent or threatened miscarriage, fetal viability should be confirmed and monitored throughout treatment. Dydrogesterone may occasionally affect liver function, sometimes with symptoms. It should be used cautiously in patients with liver disease and discontinued in severe cases.

Patients with a history of depression should be closely monitored; treatment must be stopped if severe depression returns.

Dydrogesterone is generally well tolerated. No serious overdose effects have been reported. In case of recent overdose (within 2–3 hours), gastric lavage may be considered. No specific antidote is available; treatment should be symptomatic. These measures also apply to children.

Female sex hormones

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