Diane 35 (Cyproterone acetate, Ethinyl estradiol) – 21 tablets

Diane 35 is used for the treatment of androgen-dependent diseases in women, such as pronounced form of acne, especialy those which are accompanied by seborrhea or by inflamation or formation of nodes, androgenetic alopecia and mild forms of hirsutism and it is also combined oral contraceptive to prevent pregnancy. Each of 21 tablets contains two different female hormones, which are cyproterone acetate (2 mg) and enthinyl estradiol (0.035 mg).

Indications: oral contraceptive, acne treatment preparations

Side effects: dizzines, headache, mental depression, nausea, abdominal pain, breast pain, breast tenderness, increase in body weight. Less common side effects are migraine, rash, melasma. Rare side affects are arterial thromboembolism, cerebral haemorrage, cerebral thrombosis, coronary thrombosis, gall bladder disease, hepatic adenomas, hypertension, contact lens intolerance, thrombosis, breast secretion, vaginal secretion, decrease in body weight. If you notice any side effects not mentioned in this leaflet, please inform your doctor.

Contraindications: you should not use Diane 35 if you have any of the following conditions:

• thromboplebitis, thromboembolic disorders, history of deep-vein thrombophlebitis, cerebral vascualr disease, MI, coronary artery disease
• known or suspected breast carcinoma or estrogen-dependent neoplasia, carcinoma of endometrium
• hepatic adenomas / carcinomas
• undiagnosed abnormal genital bleeding
• known or suspected pregnancy
• cholestatic jaundice of pregnancy / jaundice with prior pill use
• hypersensitivity to any component of the product
• acute liver disease
• uncontrolled hypertension
• diabetes mellitus with vascular complications
• If anything on the above list applies to you, tell your doctor before starting to use Diane 35.

Important information: you may need to be kept under close observation if:

• you smoke
• you have diabetes
• you are overweight
• you have a high blood pressure
• you have a heart valve disorder or a certain heart rythm disorder
• you or someone in your close family has had a thrombosis, a heart attack or a stroke
• you suffer from migraine
• you suffer from epilepsy
• you or someone in your close family have or have had high cholesterol or triglycerides
• you or someone in your close family have or have had a breast cancer
• you have a liver or gallbladder disease
• you have an operation, or if your ability to move around is limited for a long period of time
• If any of above conditions appear for the first time, come back or get worse while using the Diane 35, you should contact your doctor.