Qlaira

2 dark yellow FC tab each containing Estradiol valerate 3 mg, 5 medium red FC tab each containing Estradiol valerate 2 mg, dienogest 2 mg, 17 light yellow FC tab each containing Estradiol valerate 2 mg, dienogest 3 mg, 2 dark red FC tab each containing Estradiol valerate 1 mg, 2 hormone-free white FC tab

OC. Heavy &/or prolonged menstrual bleeding in women w/o organic pathology who elect to use OC.

1 tab daily for 28 consecutive days starting on day 1 of menstrual cycle (1st day of bleeding). Start each subsequent pack the day after last tab of previous calendar pack.

May be taken with or without food.

Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or CVA; prodromi of thrombosis (eg, transient ischaemic attack, angina pectoris); benign or malignant liver tumors. High risk of venous or arterial thrombosis. History of migraine w/ focal neurological symptoms. DM w/ vascular involvement. Known or suspected sex-steroid influenced malignancies eg, of genital organs or breasts. Undiagnosed vag bleeding. Severe hepatic disease (liver function values have not returned to normal). Known or suspected pregnancy.

Discontinue use in case of increase in frequency or severity of migraine. W/draw treatment if sustained clinically significant HTN develops. Consider discontinuation in acute or chronic liver function disturbances; recurrence of cholestatic jaundice which occurred 1st during pregnancy or previous use of sex steroids. Not to be used as protection against HIV infections (AIDS) & other STD. Increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, DVT, pulmonary embolism & CVA. Chloasma especially in women w/ history of chloasma gravidarum. Irregular bleeding (spotting or breakthrough bleeding) especially during 1st mth of use. Obesity (BMI >30 kg/m²), family history of venous or arterial thromboembolic events, prolonged immobilization, major surgery, any leg surgery or major trauma, heavy smoking especially in women >35 yr, dyslipoproteinemia, HTN, migraine, valvular heart disease, atrial fibrillation; DM, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) & sickle cell disease. Activated protein C resistance, hyperhomocysteinemia, antithrombin-III & protein C & S deficiency, antiphospholipid Abs (anticardiolipin Abs, lupus anticoagulant). Tumors; malignancies. Increased risk of pancreatitis in women w/ existing or family history of hypertriglyceridemia. Jaundice &/or pruritus related to cholestasis, gallstone formation, porphyria, SLE, hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss. Reduced efficacy w/ missed doses, GI disturbances or concomitant medications. Women w/ hereditary angioedema exogenous estrogens. Avoid sun or UV radiation exposure in women w/ tendency to chloasma. Renal impairment. Stop treatment during pregnancy. Not recommended during lactation. Not indicated after menopause.

Depression/depressed mood, emotional lability, decrease & loss of libido; migraine; nausea; breast pain, unscheduled uterine bleeding.

Increased sex hormone clearance & breakthrough bleeding &/or contraceptive failure w/ drugs that induce microsomal enzymes. Increased clearance w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Increased or decreased plasma conc of estrogen or progestin w/ HIV/HCV PIs & NNRTIs. Increased plasma conc of estrogen or progestin or both w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice. May increase or decrease plasma & tissue conc of lamotrigine.

Oral Contraceptives

G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.

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