Do not use Nolvadex if:

• you are allergic to any ingredient in Nolvadex;
• you are using Nolvadex to reduce your risk of breast cancer and you have a history of blood clots in the lung or leg;
• you are using Nolvadex to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin);
• you are taking anastrozole.

• Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Nolvadex may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Nolvadex may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• New tumors have occurred in body sites other than the uterus in patients taking Nolvadex . It is unknown if Nolvadex may be the cause. Discuss any questions or concerns with your doctor.
• Women who take Nolvadex to reduce the risk of breast cancer should have a breast exam, mammogram, and gynecological exam before starting and during treatment with Nolvadex.
• Women who may become pregnant should begin taking Nolvadex during a menstrual period. Women who have irregular menstrual periods should have a pregnancy test immediately before starting Nolvadex. Talk to your doctor if you have any questions about how to begin taking Nolvadex.
• Women who may become pregnant must use effective nonhormonal birth control (eg, condoms, diaphragm) during sexual intercourse while they are taking Nolvadex and for 2 months after they stop taking it. Do not use hormonal birth control (eg, birth control pills); it may not work as well while you are taking Nolvadex. Discuss any questions about effective nonhormonal birth control with your doctor.
• Nolvadex will not prevent you from becoming pregnant.
• Lab tests, including breast exams, mammograms, gynecologic exams, complete blood counts, and liver function tests, may be performed while you use Nolvadex . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Nolvadex should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
• Pregnancy and breast-feeding: Nolvadex may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nolvadex while you are pregnant. It is not known if Nolvadex is found in breast milk. Do not breast-feed while taking Nolvadex.

Safety information

Check with your doctor if any of these most common side effects persist or become bothersome:

• bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.

• severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.

Nolvadex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.