Adjustments to medicinal product information and risk minimization measures for medicinal products containing the active substances cyproterone acetate and ethinyl estradiol

13.06.2013

Summaries of the product characteristics and package leaflets of medicinal products containing cyproterone acetate and ethinyl estradiol will be aligned with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) endorsed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). The recommendations are based on an assessment of the risks and benefits of the said medicinal products, published on the Agency for Medicinal Products and Medical Devices web site on 23 May 2013.

In the Republic of Croatia, marketing authorization has been granted for the following cyproterone- and ethinylestradiol-containing medicines:

Diane-35 coated tablets, marketing authorization holder Bayer d.o.o.
Bellune 35 coated tablets, marketing authorization holder Pliva Hrvatska d.o.o.
Axira 35 film coating tablets, marketing authorization holder Farmal d.d.

The marketing authorization holders must take additional risk minimization measures to raise awareness of risks, signs and symptoms of thromboembolism in order to promptly diagnose and start treatment. Risk minimisation measures include providing educational materials to doctors and patients.

Information for patients:

Medicinal products containing cyproterone acetate and ethinyl estradiol should only be used to treat moderate to severe acne related to sensitivity to androgens and/or hirsutism (excessive growth of facial hair) in women of reproductive age
These medicinal products can only be used for treating acne when alternative treatments, such as topical and oral antibiotic treatment, have failed
You should not stop taking these medicines prior to consulting your doctor. The said medicinal products also act as hormonal contraceptives, so patients who wish to stop using them should start using another form of contraception to prevent unwanted pregnancy.
Always read the package leaflet and be aware of the risk of blood clots with these medicines. The risk of the formation of blood clots in vessels with these medicines is 1.5 to 2 times higher than with combined oral contraceptives containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Patients should be aware of the factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility. In the event of any relevant symptoms, such as pain and swelling in the legs, loss of breath or sharp chest pain, consult your doctor immediately.
For any additional questions, consult your doctor or pharmacist.

Information for healthcare professionals:

Healthcare professionals should follow the following recommendations:

Medicinal products containing cyproterone acetate and ethinyl estradiol should only be used to treat moderate to severe acne related to a sensitivity to androgens (with or without seborrhoea) and/or hirsutism (excessive growth of facial hair) in women of reproductive age
These medicinal products can only be used for treating acne when alternative treatments, such as topical and oral antibiotic treatment, have failed
These medicinal products act also as hormonal contraceptives, so they should not be used in combination with other hormonal contraceptives
Doctors should review patients taking these medicines in line with these recommendations at their next scheduled appointment
Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.