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Acne and hirsutism in women; oral contraceptive in women with androgen-associated symptoms


Pregnancy; lactation; severe disturbances of liver function; recurrent cholestatic jaundice; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes in arteries or veins and states which predispose to such diseases (eg disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases); severe migraine or cerebrovascular insufficiency; sickle-cell anaemia; existing or treated cancer of the breast or the endometrium; undiagnosed vaginal bleeding; severe diabetes with vascular changes; disturbances of lipometabolism; a history of herpes of pregnancy; otosclerosis with deterioration in previous pregnancies. Strict medical supervision is required in patients with diabetes or a tendency to diabetes, high blood pressure, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor, asthma, depression, or states in which fluid retention occurs. Reasons for immediate discontinuation of Diane-35 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 (for example, unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and tightness in the chest, pending operations (six weeks beforehand), immobilisation (for instance following accidents). In all these cases there may be an increased risk of thrombosis. Further reasons for discontinuation are: onset of jaundice, onset of hepatitis, itching of the whole body, significant rise in blood pressure, pregnancy.

Adverse reactions:

More common: * abdominal, cramping, or bloating * breast pain, tenderness, or swelling * dizziness * nausea * swelling of ankles and feet * unusual tiredness or weakness * vomiting Less common: * brown, blotchy spots on exposed skin * gain or loss of body or facial hair * increased or decreased interest in sexual intercourse * increased sensitivity of skin to sunlight * weight gain or loss. Check with your doctor as soon as possible if any of the following side effects occur: More common (usually less common after the first 3 months of use): * changes in the uterine bleeding pattern during or between menstrual periods (such as decreased bleeding, breakthrough bleeding or spotting between periods, prolonged bleeding, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes) Less common: * headaches or migraines (although headaches may lessen for many users, for others, they may increase in number or become worse) * increased blood pressure * vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge * for women with diabetes: mild increase of blood sugar-faintness, nausea, pale skin, or sweating Rare: * depression * swelling, pain, or tenderness in upper abdominal area * for women who smoke tobacco: pains in stomach, side, or abdomen; yellow eyes or skin * for women with a history of breast disease: lumps in breast Get emergency medical help immediately if any of the following side effects occur: Rare: * abdominal or stomach pain (sudden, severe, or continuing) * coughing-up of blood * headache (severe or sudden) * loss of coordination (sudden) * loss of vision or change in vision (sudden) * pains in chest, groin, or leg (especially in calf of leg) * shortness of breath (sudden or unexplained) * slurring of speech (sudden) * weakness, numbness, or pain in arm or leg (unexplained)


The efficacy of the contraceptive pill may be decreased in the case of irregular tablet-taking or when it is administered concomitantly with other medicines such as the anti-epileptic agents, antibiotics, barbiturates and rifampicin, and in patients with very rare individual metabolic disturbances (possible first symptom: intermenstrual bleeding). Mild laxatives do not impair the action of the tablets. Oral contraceptive failure may occur with concomitant antibiotic therapy. For maximal protection, additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for seven days afterwards. Those on long-term antibiotic therapy need only take extra precautions for the first two weeks of antibiotic therapy. Spotting and breakthrough bleeding are possible signs of diminished contraceptive effectiveness. With vomiting or diarrhoea, the absorption of oral contraceptives may be diminished and women should be advised to use additional methods of contraception at the time of such disorders in order to prevent a possible pregnancy, which would be a compelling reason for the discontinuation of this medicine treatment. Insulin and other hypoglycaemic requirements may change. Effects on laboratory tests Oral contraceptives may interfere with some laboratory estimations, in particular hormones, glucose tolerance, thyroid function, blood coagulation, serum triglycerides and liver function tests.


The clinical and epidemiological experience with estrogen/progestogen combinations like this medicine is predominantly based on combined oral contraceptives (COC). Therefore, the following warnings related to the use of COC apply also for this medicine. If any of the conditions/risk factors mentioned below is present, the benefits of the use of this medicine should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether its use should be discontinued.



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