PHARMACOLOGICAL ACTION Estradiol valerate and cyproterone acetate are completely absorbed after oral administration. During the absorption process and the first liver passage, estradiol valerate but not cyproterone acetate is extensively metabolised. Despite complete absorption and ester hydrolysis of estradiol valerate only 3% of the dose is bioavailable as estradiol after oral administration. Cyproterone acetate is completely bioavailable after oral administration. During the absorption process and the first liver passage estradiol valerate is rapidly hydrolysed to 17beta-estradiol and valeric acid. Cyproterone acetate is mainly metabolised to 15beta-OH cyproterone acetate, a pharmacologically active metabolite with similar high antiandrogenic but much lower progestogenic activity as compared to the parent drug. INDICATIONS Climen is indicated in patients (with intact uteri) suffering from climacteric symptomatology. Climen therapy may be used as an adjunct in preventing osteoporosis in postmenopausal women. CONTRA-INDICATIONS Pregnancy, lactation, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, previous or existing tumours of the liver, uterus, ovaries or breast or a suspicion of such tumours, endometriosis, existing or previous thromboembolic processes, severe diabetes mellitus with vascular changes, sickle-cell anaemia, disturbances of lipometabolism, a history of herpes of pregnancy, otosclerosis with deterioration during pregnancy. WARNINGS Climen is not a hormonal oral contraceptive preparation. Strict medical supervision is necessary in patients with diabetes, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor. Reasons for immediate discontinuation of Climen Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (eg disturbances of vision or hearing), first signs of thrombophlebitis or thromboembolic symptoms, a feeling of pain and tightness in the chest, pending operations (six weeks beforehand), immobilisation, onset of jaundice, onset of hepatitis, itching of the whole body, increase in epileptic seizures, significant rise in blood pressure, pregnancy.