Discontinue use in suspected or confirmed VTE or ATE; in case of elective surgery at least 4 wk in advance; acute or chronic liver function disturbances; recurrence of cholestatic jaundice which occurred 1st during pregnancy or previous use of sex steroids. Not indicated after menopause. Not for protection against HIV infection &/or AIDS & other STD. Suspend intake if sustained clinically significant HTN develops during use. Increased risk of VTE if restarted after break in use of ≥4 wk; ATE (MI) or CVA eg, TIA, stroke; cervical cancer in long-term users (>5 yr); breast cancer; pancreatitis in women w/ or family history of hypertriglyceridaemia. Obesity (BMI >30 kg/m
2), prolonged or temporary immobilisation including air travel >4 hr, major surgery, any surgery to legs or pelvis, neurosurgery, or major trauma, +ve family history of VTE or ATE at relatively early age eg, before 50 yr, other medical conditions associated w/ VTE or adverse vascular events, increasing age (>35 yr), smoking, HTN, migraine. Benign & malignant liver tumours; severe upper abdominal pain, liver enlargement, signs of intra-abdominal haemorrhage. Jaundice &/or pruritus related to cholestasis; gallstone formation; porphyria; SLE; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss. Worsening of endogenous depression, epilepsy, Crohn's disease & ulcerative colitis. Mood changes & depressive symptoms shortly after treatment initiation. Reduced efficacy in the event of missed tab, GI disturbances during pink active tab taking or concomitant medicinal products. May influence results of certain lab tests, including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins eg, corticosteroid binding globulin & lipid/lipoprotein fractions, parameters of carbohydrate metabolism, coagulation & fibrinolysis. Unscheduled bleeding (spotting or bleeding) especially during 1st mth of use. Women w/ hereditary angioedema; history of chloasma gravidarum. Avoid sun or UV radiation exposure in women w/ tendency to chloasma. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Exclude malignancy or pregnancy if bleeding irregularities persist or occur after previously regular cycles. Check serum K during 1st cycle in patients w/ renal insufficiency & pre-treatment serum K in upper reference range & during concomitant use of K-sparing medicinal products. Carefully observe diabetic women particularly in early stage of use. Take complete medical history (including family history) & rule out pregnancy prior to initiation or reinstitution. Measure BP & perform physical exam. Co-administration w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Renal & hepatic impairment. Not indicated during pregnancy. Stop further intake if pregnancy occurs while on treatment. Not recommended until lactating mother has completely weaned her child. Lactating women should use alternative contraception method during treatment. Adolescents <16 yr.
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