Description
DUPHASTON 10MG
Excipients/Inactive Ingredients:Â Core:Â Lactose monohydrate, Hypromellose, Maize starch, Colloidal anhydrous silica, Magnesium stearate.
Film-Coating:Â Hypromellose, Macrogol 400, Titanium dioxide (E171).
Film-Coating:Â Hypromellose, Macrogol 400, Titanium dioxide (E171).
Dosage/Direction for Use
Always take Duphaston exactly as the doctor has prescribed. If there are any questions, contact the doctor or pharmacist.
If the patient forgets to take the tablet(s), do not take a double dose to compensate for it. If the patient requires further information, please ask the doctor or pharmacist for advice.
For hormone replacement therapy: In combination with continuous estrogen therapy, take one tablet daily for 14 consecutive days of a 28-day cycle.
In combination with cyclical estrogen therapy, take one tablet daily during the last 12 to 14 days of estrogen therapy.
For doctors: If endometrial biopsies or ultrasounds reveal inadequate progestational response, 20 mg of dydrogesterone should be prescribed.
If the patient is not sure what type of estrogen therapy, talk to the doctor before taking Duphaston.
Posology for specific indications:Â Dysmenorrhoea (painful menstruation):Â Take one tablet twice daily from day 5 to day 25 of the cycle.
Endometriosis (abnormal growth of uterine tissues outside the uterus):Â Take one tablet two or three times daily from day 5 to day 25 of the cycle or continuously (as prescribed by the doctor).
Dysfunctional bleeding (to stop bleeding):Â Take one tablet twice daily for five to seven days.
Dysfunctional bleeding (to prevent bleeding):Â Take one tablet twice daily from day 11 to day 25 of the cycle.
Amenorrhoea (cessation of menstruation): The doctor should prescribe estrogen along with Duphaston. Then take the estrogen once daily from day 1 to day 25 of the cycle, together with one tablet of dydrogesterone twice daily from day 11 to day 25 of the cycle.
If the patient forgets to take the tablet(s), do not take a double dose to compensate for it. If the patient requires further information, please ask the doctor or pharmacist for advice.
For hormone replacement therapy: In combination with continuous estrogen therapy, take one tablet daily for 14 consecutive days of a 28-day cycle.
In combination with cyclical estrogen therapy, take one tablet daily during the last 12 to 14 days of estrogen therapy.
For doctors: If endometrial biopsies or ultrasounds reveal inadequate progestational response, 20 mg of dydrogesterone should be prescribed.
If the patient is not sure what type of estrogen therapy, talk to the doctor before taking Duphaston.
Posology for specific indications:Â Dysmenorrhoea (painful menstruation):Â Take one tablet twice daily from day 5 to day 25 of the cycle.
Endometriosis (abnormal growth of uterine tissues outside the uterus):Â Take one tablet two or three times daily from day 5 to day 25 of the cycle or continuously (as prescribed by the doctor).
Dysfunctional bleeding (to stop bleeding):Â Take one tablet twice daily for five to seven days.
Dysfunctional bleeding (to prevent bleeding):Â Take one tablet twice daily from day 11 to day 25 of the cycle.
Amenorrhoea (cessation of menstruation): The doctor should prescribe estrogen along with Duphaston. Then take the estrogen once daily from day 1 to day 25 of the cycle, together with one tablet of dydrogesterone twice daily from day 11 to day 25 of the cycle.
Premenstrual syndrome:Â Take one tablet twice daily from day 11 to day 25 of the cycle.
Irregular cycles:Â Take one tablet twice daily from day 11 to day 25 of the cycle.
Threatened abortion:Â Take four tablets at once, then one tablet every eight hours until symptoms abate.
Habitual abortion:Â Take one tablet twice daily until the twentieth week of pregnancy.
Infertility due to luteal (yellow body) insufficiency:Â Take one tablet daily from day 14 to 25 of the cycle. Continue the treatment for at least six consecutive cycles. In addition, it is advisable to continue treatment for the first few months of pregnancy as described under “Habitual abortion”. If the patient is uncertain about how long to continue the treatment, talk to the doctor.
Luteal support as part of an Assisted Reproductive Technology (ART) treatment: Take one tablet three times daily (30mg daily) starting on the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.
Duphaston is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Irregular cycles:Â Take one tablet twice daily from day 11 to day 25 of the cycle.
Threatened abortion:Â Take four tablets at once, then one tablet every eight hours until symptoms abate.
Habitual abortion:Â Take one tablet twice daily until the twentieth week of pregnancy.
Infertility due to luteal (yellow body) insufficiency:Â Take one tablet daily from day 14 to 25 of the cycle. Continue the treatment for at least six consecutive cycles. In addition, it is advisable to continue treatment for the first few months of pregnancy as described under “Habitual abortion”. If the patient is uncertain about how long to continue the treatment, talk to the doctor.
Luteal support as part of an Assisted Reproductive Technology (ART) treatment: Take one tablet three times daily (30mg daily) starting on the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.
Duphaston is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Overdosage
Limited data are available with regard to overdose in humans. Dydrogesterone was well tolerated after oral dosing (the maximum daily dose taken to date in humans was 360mg). There are no specific antidotes and treatment should be symptomatic. This information is also applicable for overdose in children.
Contraindications
Known hypersensitivity to the active substance or to any of the excipients.
Known or suspected progestogen-dependent neoplasms (e.g. meningioma).
Undiagnosed vaginal bleeding.
Contraindications are related to the use of estrogen when Duphaston is used in combination with estrogen (see also the contraindication in the product information of the estrogen preparation).
Treatment for luteal support as part of an Assisted Reproductive Technology (ART) treatment should be discontinued upon diagnosis of abortion or miscarriage.
Known or suspected progestogen-dependent neoplasms (e.g. meningioma).
Undiagnosed vaginal bleeding.
Contraindications are related to the use of estrogen when Duphaston is used in combination with estrogen (see also the contraindication in the product information of the estrogen preparation).
Treatment for luteal support as part of an Assisted Reproductive Technology (ART) treatment should be discontinued upon diagnosis of abortion or miscarriage.
Special Precautions
Before initiating dydrogesterone treatment for abnormal bleeding the etiology of 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.
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