2.Generess® Fe prescribing information. Morristown, NJ: Watson Pharma, Inc. March 2012.
Important Safety Information
GENERESS FE is an estrogen/progestin COC indicated for use by women to prevent pregnancy.
You should not use GENERESS FE if you are over 35 and smoke as it increases the risk of having serious heart-related events. You should not use GENERESS FE if you are at high risk of blood clots, if you have abnormal uterine bleeding, breast or liver cancer, liver disease, high blood pressure, or uncontrolled high blood cholesterol. 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 and should not take GENERESS FE if you are breastfeeding. If you experience yellowing of the skin 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. The most common adverse events associated with the use of GENERESS FE included nausea/vomiting, headaches/migraine, depression/mood complaints, pain with menstrual bleeding, acne, increased weight, breast pain/tenderness and anxiety. GENERESS FE will not protect against HIV infection (AIDS) or other sexually transmitted diseases.
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.