*For women who had periods, the average intensity of their periods was lighter over time.
- 1. Data on file. Actavis Pharma, Inc.
- 2. Generess® Fe prescribing information. Parsippany, NJ: Watson Pharma, Inc. March 2012.
What is Generess® Fe?
Generess Fe is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT RISK INFORMATION
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.
Who should not take Generess Fe?
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.
What else should I know about taking Generess Fe?
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.
What are the most serious risks of taking Generess Fe?
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.
What are the possible side effects of Generess Fe?
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.