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Duphaston 10mgDuphaston

film-coated tablets

10 mg dydrogesterone

 

 

 

Read all of this leaflet carefully before you start taking this medicine. It Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. may harm them, even if their symptoms are the same as yours.

 

Duphaston is a round, biconvex, scored, white coloured film-coated tablet for oral administration, one side with inscription S, the other side with inscription '155' on either side of the break mark containing 10 mg dydrogesterone. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

 

Excipients: Lactose monohydrate, bypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 white (hypromellose, macrogol 400, titanium dioxide (E171))

 

Indications

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.

 

Progesterone deficiencies

Treatment of progesterone deficiencies such as:

Treatment of dysmenorrhoea

Treatment of endometriosis

Treatment of secondary amenorrhoea

Treatment of irregular cycles

Treatment of dysfunctional uterine bleeding

Treatment of pre-menstrual syndrome

Treatment of threatened and habitual abortion, associated with proven progesterone deficiency

Treatment of infertility due to luteal insufficiency

 

Dosage and administration

Hormone replacement therapy:

In combination with continuous oestrogen therapy, one tablet of 10 mg dydrogesterone daily during 14 consecutive days per cycle of 28 days.

In combination with cyclical oestrogen therapy, one tablet of 10 mg dydrogesterone daily during the last 12 - 14 days of oestrogen therapy.

If endometrial biopsies or ultrasound would reveal inadequate progestational response, 20 mg dydrogesterone should be prescribed.

 

Dysmenorrhoea :

10 mg twice daily from day 5 to day 25 of the cycle.

 

Endometriosis :

10 mg two or three times daily from day 5 to day 25 of the cycle or continuously.

 

Dysfunctional bleeding:

10 mg twice daily for five to seven days (to arrest bleeding).

 

Dysfunctional bleeding:

10 mg twice daily from day 11 to day 25 of the cycle (to prevent bleeding)

 

Amenorrhoea :

an oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg dydrogesterone twice daily from day 11 to day 25 of the cycle.

 

Pre-menstrual syndrome:

10 mg twice daily from day 11 to day 25 of the cycle.

 

Irregular cycles:

10 mg twice daily from day 11 to day 25 of the cycle.

 

Threatened abortion:

40 mg at once, then 10 mg every eight hours until symptoms remit.

 

Habitual abortion:

10 mg twice daily until the twentieth week of pregnancy.

 

Infertility due to luteal insufficiency:

10 mg daily from day 14 to 25 of the cycle. Treatment should be maintained for at least six consecutive cycles. It is advisable to continue treatment for the first few months of pregnancy as described under 'Habitual abortion'.

 

Duphaston is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.

 

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Known or suspected progestogen dependent neoplasms

Undiagnosed vaginal bleeding

If used to prevent endometrial hyperplasia (in women using estrogens): Contraindications for use of oestrogens in combination with progestagens, such as Dydrogesterone.

 

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