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Patient Info
INFORMATION FOR THE PATIENT
See Patient Labeling printed below. ADVERSE REACTIONS Text Continues Below
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS Section). ° Thrombophlebitis and venous thrombosis with or without embolism
° Arterial thromboembolism
° Pulmonary embolism
° Myocardial infarction
° Cerebral hemorrhage
° Cerebral thrombosis
° Hypertension
° Gallbladder disease
° Hepatic adenomas or benign liver tumors The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: ° Nausea
° Vomiting
° Gastrointestinal symptoms (such as abdominal cramps and bloating)
° Breakthrough bleeding
° Spotting
° Change in menstrual flow
° Amenorrhea
° Temporary infertility after discontinuation of treatment
° Edema
° Melasma which may persist
° Breast changes: tenderness, enlargement, secretion
° Change in weight (increase or decrease)
° Change in cervical erosion and secretion
° Diminution in lactation when given immediately postpartum
° Cholestatic jaundice
° Migraine
° Rash (allergic)
° Mental depression
° Reduced tolerance to carbohydrates
° Vaginal candidiasis
° Change in corneal curvature (steepening)
° Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: ° Pre-menstrual syndrome
° Cataracts
° Changes in appetite
° Cystitis-like syndrome
° Headache
° Nervousness
° Dizziness
° Hirsutism
° Loss of scalp hair
° Erythema multiforme
° Erythema nodosum
° Hemorrhagic eruption
° Vaginitis ° Porphyria
° Impaired renal function
° Hemolytic uremic syndrome
° Acne
° Changes in libido
° Colitis
° Budd-Chiari Syndrome DETAILED PATIENT LABELING PLEASE NOTE This labeling is revised from time to time as important new medical information becomes available. Therefore, please review this labeling carefully. ORTHO TRI-CYCLEN 28 Day Regimen Each white tablet contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol. Each light blue tablet con-tains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol. Each blue tablet contains 0.250 mg norgesti-mate and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients. ORTHO-CYCLEN 28 Day Regimen Each blue tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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