Generess® Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) 0.8 mg/25 mcg

Balanced
Cycle Control

Generess® Fe can provide her with the convenience and security she needs using a balance
of 25 mcg of estrogen and the trusted progestin norethindrone in a 24/4 regimen.

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*In women who experienced withdrawal bleeding, the mean median intensity of withdrawal bleeding decreased from Cycle 2 (1.83/3.0) to Cycle 13 (1.64/3.0).

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.

+ References

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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