Indications

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.

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Pharmacology

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

Dosage & Administration

Always take Presentation 10 mg tablet exactly as your doctor has prescribed.

Presentationerone 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 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 Presentationational 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.

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Contraindications

Known hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms (e.g. meningioma).

Side Effects

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

Pregnancy & Lactation

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.

Precautions & Warnings

Before initiating Safyron 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 Safyron must be stopped

Overdose Effects

Safyron 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.

Therapeutic Class

Female Sex hormones

Storage Conditions

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