Generess® Fe is an estrogen/progestin combined oral contraceptive (OC) indicated for use by women to prevent pregnancy.
IMPORTANT SAFETY INFORMATION
Women who are over 35 years old and smoke should not use Generess® Fe. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. Generess® Fe is contraindicated in pregnant patients, and those with a high risk of arterial or venous thrombotic disease, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, or liver disease. Use of Generess® Fe should be stopped if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Generess® Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, Generess® Fe treatment should be discontinued. Generess® Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic, should be monitored while using Generess® Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Generess® Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. The most commonly reported adverse events associated with the use of Generess® Fe included nausea/vomiting, headaches/migraine, depression/mood complaints, dysmenorrhea, acne, increased weight, breast pain/tenderness and anxiety. Generess® Fe will not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Please see full Prescribing Information.
Models are for illustrative purposes only.
1. Hampton RM, Short M, Bieber E, et al. Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. Contraception. 2001;63(6):289-295. 2. Kaunitz AM, Burkman RT, Fisher AC, LaGuardia KD. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol. 2009;114(6):1205-1212. 3. Data on file, Watson Laboratories, Inc. 4. Generess® Fe full Prescribing Information, Watson Pharma, Inc. March 2012. 5. Djerassi C. 2010. History of Oral Contraceptives. eLS.
Generess® is a registered trademark of Actavis, Inc.
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