- 1. Generess® Fe prescribing information. Parsippany, NJ: Watson Pharma, Inc. March 2012.
- 2. Data on file. Actavis Pharma, Inc.
- 3. Birth control patient education booklet. The American Congress of Obstetricians and Gynecologists. http://www.acog.org/publications/patient_ education/ab020.cfm. Accessed January 28, 2011.
- 4. Menstruation patient education booklet. The American Congress of Obstetricians and Gynecologists. http://www.acog.org/publications/patient_ education/bp049.cfm. Accessed April 6, 2011.
- 5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 18th ed. New York, NY: Ardent Media; 2004.
- 6. Birth control pills. Planned Parenthood Web site. http://www.plannedparenthood.org/health-topics/birth-control/birth-control-pill-4228.htm. Accessed January 18, 2013.
INDICATION AND USAGE for Generess® Fe
Generess Fe is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT SAFETY INFORMATION about Generess Fe, including Boxed Warning
WARNING TO WOMEN WHO SMOKE
Do not use Generess Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Do not use Generess Fe if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, or if you are or may be pregnant.
Treatment with Generess Fe should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Generess Fe any earlier than 4 weeks after having a baby or if you are breastfeeding. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Generess Fe. If you are pre-diabetic or diabetic, your doctor should monitor you while using Generess Fe and should evaluate you if you have any significant change in headaches or irregular menstrual bleeding.
Generess Fe increases the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability.
The most common side effects reported by women taking Generess Fe were nausea/vomiting, headaches/migraine, depression/mood complaints, pain with menstrual bleeding, acne, increased weight, breast pain/tenderness, and anxiety.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
Please see the FDA-Approved Patient Information Leaflet for Generess Fe, including Boxed Warning.
To report a side effect from one of our products, please call the Actavis Drug Safety Department at 1-800-272-5525.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.