Revised SPC: Dianette (Cyproterone acetate/ Ethinylestradiol)
The SPC has been updated in line with the outcome of the Article-31 referral, relating to the risk of meningioma with cyproterone. Although available data do not indicate a risk for low-dose medicines, they should not be used in people who have or have had a meningioma.
Source:
electronic Medicines compendium
SPS commentary:
Following a review of the risk of meningioma with cyproterone, the European Medicine Agency recommended that restrictions be put in place for the use of cyproterone medicines with daily doses of 10mg or above. Although available data do not indicate a risk for low-dose cyproterone medicines containing 1-2mg cyproterone in combination with ethinylestradiol or estradiol valerate and used for acne, hirsutism, contraception, or hormone replacement therapy, they should not be used in people who have or have had a meningiomas, as a precaution.