Essential information

Diane-35^® description: Active ingredients: Each tablet (21 coated tablets) contains 0.035 mg ethinylestradiol and 2.0 mg cyproterone acetate.¹

Indication: Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism in women of reproductive age. This includes patients with polycystic ovary syndrome requiring treatment of these symptoms. For the treatment of acne, Diane-35^® should be used when topical therapy or systemic antibiotic treatments are not considered appropriate. Since Diane-35^® is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives.¹

Contraindications: Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident; presence or a history of prodromi of a thrombosis (e.g. transient ischemic attack, angina pectoris); history of migraine with focal neurological symptoms; diabetes mellitus with vascular involvement; severe hepatic disease as long as liver function values have not returned to normal; use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir, and combinations of these; presence or history of liver tumors (benign or malignant); known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts); undiagnosed vaginal bleeding; concomitant use with another hormonal contraceptive; known or suspected pregnancy; lactation; hypersensitivity to the active substances or to any of the excipients. Diane-35^® is not for use in men.¹

Special warnings and precautions for use: For further information on the following conditions/risks refer to the package insert: VTE, ATE, diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory disease, sickle cell disease, migraine, cervical cancer, breast cancer, benign or malignant liver tumors, hypertriglyceridemia, increases in blood pressure, jaundice and/or pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, hereditary angioedema, acute or chronic disturbances of liver function, cholestatic jaundice, diabetes mellitus, endogenous depression, epilepsy, Crohn’s disease, ulcerative colitis, chloasma, cardiac or renal dysfunction, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, irregular bleeding.¹

Undesirable effects: The most commonly reported adverse reactions with Diane-35^® when used in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism in women of reproductive age are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain and breast tenderness. Serious adverse reaction is thromboembolism.¹