DUPHASTON Film-coated tablet Ref.[50849] Active ingredients: Dehydroprogesterone

Dosages, treatment schedule and duration of treatment may be adapted to the severity of the dysfunction and the clinical response.

Dysmenorrhoea: 10 or 20 mg dydrogesterone per day from day 5 to day 25 of the menstrual cycle.

Endometriosis: 10 to 30 mg dydrogesterone per day from day 5 to day 25 of the cycle or continuously.

Dysfunctional uterine bleeding: When treatment is started to arrest a bleeding episode, 20 or 30 mg dydrogesterone per day is to be given for up to 10 days.

For continuous treatment, 10 or 20 mg dydrogesterone per day should be given during the second half of the menstrual cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Withdrawal bleeding occurs if the endometrium has been adequately primed with either endogenous or exogenous estrogen.

Secondary amenorrhoea: 10 or 20 mg dydrogesterone per day, to be given daily for 14 days during the second half of the theoretical menstrual cycle to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Pre-menstrual syndrome: 10 mg dydrogesterone twice daily starting with the second half of the menstrual cycle until the first day of the next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Irregular cycles: 10 or 20 mg dydrogesterone per day starting with the second half of the menstrual cycle until the first day of the next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Threatened abortion: An initial dose of up to 40 mg dydrogesterone may be given followed by 20 or 30 mg per day until symptoms remit.

Habitual abortion: 10 mg dydrogesterone twice daily until the twelfth week of pregnancy.

Infertility due to luteal insufficiency: 10 or 20 mg dydrogesterone daily starting with the second half of the menstrual cycle until the first day of the next cycle. Treatment should be maintained for at least three consecutive cycles.

Hormone replacement therapy:

• Continuous sequential therapy: An estrogen is dosed continuously and one tablet of 10 mg dydrogesterone is added for the last 14 days of every 28 day cycle, in a sequential manner.
• Cyclic therapy: When an estrogen is dosed cyclically with a treatment-free interval, usually 21 days on and 7 days off. One tablet of 10 mg dydrogesterone is added for the last 12 - 14 days of estrogen therapy.
• Depending on the clinical response, the dosage can subsequently be adjusted to 20 mg dydrogesterone per day.

There is no relevant use of dydrogesterone before menarche. The safety and efficacy of dydrogesterone in adolescents aged 12-18 years has not been established. Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made.

Method of administration

For oral use.

For administration of higher dosages the tablets should be taken evenly distributed over the day.

Limited data are available with regard to overdose in humans. Dydrogesterone was well tolerated after oral dosing (maximum daily dose taken to date in humans 360 mg). There are no specific antidotes and treatment should be symptomatic. This information is also applicable for overdosing in children.

5 years.

This medicinal product does not require any special storage conditions.

Keep out of the reach and sight of children.

Blister strips of aluminium foil and PVC film, uncoated or coated with PVDC, of 20 film-coated tablets.

This medicinal product may pose a risk to the aquatic environment. Medicines no longer required should not be disposed of via wastewater or household waste. Any unused product or waste material should be disposed of in accordance with local requirements or returned to the pharmacy.