DIANE-35

This medicine contains two active ingredients, 2 mg of cyproterone and 0,035 mg of ethinylestradiol.  Cyproterone belongs to a group of medicines called anti-androgens. These are medicines which have effect on the hormone androgen by lowering the amount of this hormone in the body and by stopping its actions. Ethinylestradiol is estrogen, a female sex hormone. This medicine is used for the prevention of pregnancy, for the treatment of painful and prolonged menstrual bleedings, pronounced forms of acne, androgenetic alopecia, and mild forms of hirsutism.

Is Diane-35 suitable for me?

Diane-35 is not suitable for everyone. Do not use it

• if you are allergic to cyproterone, ethinylestradiol or other ingredients of this medicine
• if you have or have ever had blood circulation disorder: deep vein thrombosis, pulmonary embolism, heart attack
• if you have or have had a stroke (caused by a blood clot or ruptured blood vessel in the brain)
• if you have or have ever had a condition that may be the first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischemic attack or small reversible stroke)
• if you have a migraine accompanied by, for example, visual impairment, inability of speech and weakness or stiffness of any part of the body
• if you have diabetes with damaged blood vessels
• if you have or have had pancreatitis (inflammation of the pancreas) associated with high levels of fat in the blood
• if you have jaundice or severe liver disease
• if you have or have ever had a cancer that may grow under the influence of sex hormones (eg, cancer of the breast or genital)
• if you have or have had a benign or malignant liver tumor
• If you have unexplained vaginal bleeding
• if you are pregnant or may be pregnant
• if you are breast-feeding

In particular, you must tell the doctor if you have:

• diabetes
• excessive body weight
• high blood pressure
• damage to the heart valve or heart rhythm disorder
• inflammation of the veins (superficial phlebitis)
• varicose veins
• migraine
• epilepsy
• had high levels of cholesterol or triglycerides (fatty components) in the blood
• liver disease or gall bladder
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• polycystic ovaries (ovarian disorder which can cause infertility, sometimes combined with androgenetic symptoms and increased risk of thrombosis)
• systemic lupus erythematosus (a disease that damages the skin of the whole body)
• hemolytic uremic syndrome (blood clotting disorder that causes kidney damage)
• sickle cell anemia
• conditions which appeared for the first time or worsened during pregnancy or previous use of sex hormones
• chloasma (yellowish-brown pigmentation on parts of the skin, especially on the face)
• hereditary angioedema
• are smoker

Diane-35 interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Diane-35?

This medicine is available in form of a film-coated tablet.

You should take Diane-35 exactly as instructed by your doctor or pharmacist.

• The dose is one tablet daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval.

Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor instructed. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day. Do not take two doses together if you miss a dose.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Diane-35 side effects?

Like all medicines Diane-35 can cause side effects, including:

Common:

• feeling sick
• stomach ache
• putting on weight
• headaches
• depressive moods or mood swings
• sore or painful breasts

Uncommon:

• being sick and stomach upsets
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash

Rare:

• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge
• venous blood clot

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.