leflunomide - oral, Arava (cont.)
PRECAUTIONS: Before taking leflunomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system disorder (e.g., HIV infection), current/recent infection (e.g., tuberculosis), cancer, bone marrow/blood disorder, kidney disease, liver disease (e.g., hepatitis B or C), alcohol abuse, heart disease (e.g., congestive heart failure), high blood pressure, lung disease.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can make you dizzy and also cause liver disease.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).This medication must not be used during pregnancy. It may harm an unborn baby. Before starting this medication, women of childbearing age must have a negative pregnancy test before starting this medication. Men and women must use effective forms of birth control (e.g., condoms and birth control pills) while taking this medication. Consult your doctor for more details and to discuss reliable forms of birth control. (See also Warning section.)It is not known whether this medication affects the sperm. To minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider stopping the medication and using another drug (cholestyramine) as directed to help this drug leave the body before attempting to father a child. (See How to Use section.) Consult your doctor for more details.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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