Caryon 10

Indications for Use

Progesterone Deficiencies:

• Management of threatened miscarriage
• Treatment of habitual miscarriage
• Alleviation of dysmenorrhea (painful periods)
• Support in the management of endometriosis
• Addressing secondary amenorrhea (absence of periods)
• Regulation of irregular menstrual cycles
• Treatment for dysfunctional uterine bleeding
• Infertility treatment due to luteal insufficiency
• Luteal phase support in Assisted Reproductive Technology (ART)

Hormone Replacement Therapy (HRT):

Used to mitigate the effects of unopposed estrogen on the endometrial lining during hormone replacement therapy for women with an intact uterus, whether due to natural or surgically induced menopause.

Note: Always follow your registered healthcare provider’s guidance when taking this medication.

Pharmacology

Dydrogesterone is an oral progestogen that helps establish a fully secretory endometrium in an estrogen-primed uterus, providing protection against the potential risks of endometrial hyperplasia and cancer induced by estrogen. It is recommended for all forms of progesterone deficiency. Dydrogesterone has no estrogenic, androgenic, thermogenic, anabolic, or corticosteroid activity.

Dosage and Administration

Follow your doctor’s prescribed dosage instructions precisely.

For Progesterone Deficiencies:

• Threatened Miscarriage: 40 mg (4 tablets) initially, followed by 10 mg (1 tablet) every 8 hours until symptoms subside.
• Habitual Miscarriage: 10 mg (1 tablet) twice daily up to the 20th week of pregnancy.
• Dysmenorrhea: 10 mg (1 tablet) twice daily from day 5 to day 25 of the menstrual cycle.
• Endometriosis: 10 mg (1 tablet) 2-3 times daily from day 5 to day 25 of the cycle, or continuously.
• Dysfunctional Bleeding (To stop bleeding): 10 mg (1 tablet) twice daily for 5-7 days, often used alongside estrogen.
• Dysfunctional Bleeding (To prevent bleeding): 10 mg (1 tablet) twice daily from day 11 to day 25 of the cycle, with estrogen.
• Amenorrhea: Take estrogen daily from day 1 to day 25, alongside 10 mg Dydrogesterone twice daily from day 11 to day 25.
• Irregular Cycles: 10 mg (1 tablet) twice daily from day 11 to day 25 of the cycle.
• Infertility Due to Luteal Insufficiency: 10 mg (1 tablet) daily from day 14 to day 25 for at least 6 consecutive cycles. Continue during the first month of pregnancy with habitual miscarriage dosage.
• Luteal Support in ART: 10 mg (3 tablets) daily, starting on oocyte retrieval day and continuing for 10 weeks if pregnancy is confirmed.

Hormone Replacement Therapy:

• For Continuous Estrogen Therapy, take 1 tablet daily for 14 consecutive days of a 28-day cycle.
• For Cyclical Estrogen Therapy, take 1 tablet daily for the last 12-14 days of the estrogen cycle.

Note for Doctors:

If endometrial response is insufficient, 20 mg Dydrogesterone is recommended. Patients: Consult your doctor if unsure about your estrogen therapy.

Contraindications:

Do not use if allergic to the active substance or any ingredients. Avoid in cases of suspected or known progestogen-dependent tumors (e.g., meningioma).

Side Effects

Common side effects observed during clinical trials include:

• Migraines or headaches
• Nausea
• Menstrual irregularities
• Breast pain or tenderness

Pregnancy and Lactation

Dydrogesterone has been used in over 10 million pregnancies with no harmful effects reported. However, it is not recommended during lactation as the effects on breast milk excretion are unknown.

Precautions and Warnings

• Breakthrough Bleeding: If this occurs, an investigation is required to rule out endometrial malignancy.
• Conditions to Monitor: If you experience severe headache, increased blood pressure, or venous thromboembolism, discontinue use.
• Monitoring During Pregnancy: In cases of threatened or habitual miscarriage, pregnancy progress should be monitored.

Depression Warning:

Those with a history of depression should be monitored carefully. If severe depression reoccurs, treatment should be stopped.

Overdose Effects

Dydrogesterone has been well tolerated even at high doses (up to 360 mg daily). If an overdose is suspected, gastric lavage may be performed within 2-3 hours. No specific antidote is available, and treatment should be symptomatic.

Therapeutic Class:

Female Sex Hormones

Storage Conditions:

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