DIANE-35 0.035mg / 2mg dragees medication leaflet

G03HB01 ethinyl estradiol + cyproterone • Genito urinary system and sex hormones | Antiandrogens | Antiandrogens and estrogens

Ethinylestradiol and cyproterone are used together to treat hormonal disorders in women, particularly those caused by an excess of androgens. This combination is indicated for the treatment of severe acne, seborrhea, hirsutism (excessive hair growth in typically male areas), and androgenic alopecia. It can also be used as a combined oral contraceptive, providing protection against pregnancy.

Cyproterone is a potent antiandrogen that blocks the effects of androgens, thereby reducing symptoms caused by their excess. Ethinylestradiol is a synthetic estrogen that stabilizes the menstrual cycle and helps reduce androgen production by the ovaries. Together, these substances regulate hormonal imbalances and alleviate associated symptoms.

While this combination is effective, its use may cause side effects. The most common include nausea, headaches, breast tenderness, mood changes, and weight gain. In rare cases, more serious reactions may occur, such as venous thromboembolism, high blood pressure, or liver disorders. Women who smoke, especially those over 35 years old, are at an increased risk of cardiovascular complications.

This combination should be used as directed by a doctor, and the patient should adhere to the prescribed schedule. Regular medical check-ups are important to monitor for potential side effects and assess overall health. If severe symptoms occur, such as chest pain, difficulty breathing, or severe leg pain, immediate medical attention is necessary.

General data about DIANE-35 0.035mg / 2mg

Substance: ethinyl estradiol + cyproterone

Date of last drug list: 01-06-2025

Commercial code: W64045001

Concentration: 0.035mg / 2mg

Pharmaceutical form: dragees

Quantity: 21

Product type: original

Price: 15.04 RON

Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

Manufacturer: BAYER AG - GERMANIA

Holder: BAYER AG - GERMANIA

Number: 12690/2019/01

Shelf life: 5 years