Essential information

Qlaira^® product description: Active ingredients: Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets each containing 3 mg estradiol valerate, 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest, 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest, 2 dark red tablets each containing 1 mg estradiol valerate, 2 white tablets that do not contain active substances.

Indication: Oral contraception. Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.

Contraindications: Presence or risk of venous thromboembolism (VTE), i.e. venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]), known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency, major surgery with prolonged immobilization, a high risk of venous thromboembolism due to the presence of multiple risk factors; Presence or risk of arterial thromboembolism (ATE), i.e. arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris), cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischemic attack, TIA), known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant), history of migraine with focal neurological symptoms, a high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as diabetes mellitus with vascular symptoms, severe hypertension, severe dyslipoproteinemia; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumors (benign or malignant); known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts); undiagnosed vaginal bleeding; hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions for use: For further information on the following conditions/risks refer to the package insert: VTE, ATE, cervical cancer, breast cancer, benign or malignant liver tumors, hypertriglyceridemia, increases in blood pressure, jaundice and/or pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, hereditary angioedema, acute or chronic disturbances of liver function, cholestatic jaundice, diabetes mellitus, endogenous depression, epilepsy, Crohn’s disease, ulcerative colitis, chloasma, cardiac or renal dysfunction, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, irregular bleeding.

Undesirable effects: The most commonly reported adverse reactions with Qlaira^® when used as an oral contraceptive or in the treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception are acne, breast discomfort, headache, intracyclic bleeding, nausea and weight increased. Serious adverse reactions are arterial and venous thromboembolism.