Femara (letrozole) 2.5 mg tablets are approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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Important Safety Information
Femara is only indicated in postmenopausal women. You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. You should not take Femara if you are pregnant as it may cause harm to an unborn child. You should also discuss with your doctor what to do if you are nursing a child.
The use of Femara may cause decreases in the density of your bones, increases in bone fractures and osteoporosis. Monitoring of the density of your bones may be required.
Some patients taking Femara had an increase in cholesterol. Your doctor may require the monitoring of cholesterol in your blood.
Some women reported fatigue, dizziness and drowsiness with Femara. Until you know how it affects you, use caution before driving or operating machinery.
Some women had moderate, temporary decreases in white blood cell counts. The medical significance of this is not known.
The most serious side effects seen with Femara are bone effects (fractures, decreased bone density and osteoporosis) and increases in cholesterol. Other common side effects seen with Femara include joint pain, nausea, weight decrease, vaginal irritation, and pain in the extremities. Other important less commonly reported side effects include blood clots, other cancers, stroke, heart attack and endometrial cancer.
Femara is a once-daily, convenient prescription tablet. Your doctor may tell you to take Femara every other day if you have severe liver disease. Always take your medicine exactly as prescribed by your doctor.
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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.