Diane 35 Tab (21’s)

Cyproterone/Ethinylestradiol

Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age.
For the treatment of acne, Cyproterone acetate + Ethinylestradiol (Diane-35) should be used when topical therapy or systemic antibiotic treatments has failed.
Since Cyproterone acetate + Ethinylestradiol (Diane-35) is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see Contraindications).

Cyproterone acetate + Ethinylestradiol (Diane-35) is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Cyproterone acetate + Ethinylestradiol (Diane-35) is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Cyproterone acetate + Ethinylestradiol (Diane-35) can lead to intermenstrual bleedings and could deteriorate the therapeutic and contraceptive reliability.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last coated tablet and may not have finished before the next pack is started.