SIDE EFFECTS: See also Warning section. Nausea, vomiting, diarrhea, abdominal pain, flushing, or skin/nail color changes may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly. This medication may cause your urine to turn a reddish color. This is a normal, harmless effect of the drug that usually stops within 2 days after each dose and should not be mistaken for blood in your urine. Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds). Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. Severe nausea, vomiting, and diarrhea may rarely cause a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin. Get medical help right away if you have any very serious side effects, including: chest pain, coughing up blood, sudden pain/swelling/redness usually in the leg. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using epirubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or to anthracenediones (e.g., mitoxantrone); 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: blood/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, recent heart attack, fast/slow/irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area). 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. Wash your hands well to prevent the spread of infections. To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist that you are using this medication. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially effects on the heart. This medication may affect the production of sperm in males, increasing the risk of fathering a child with birth defects. Therefore, men receiving treatment with this drug should use reliable forms of birth control (e.g., condoms). Consult your doctor for details and to discuss effective forms of birth control. This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details. This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. Women of child-bearing age and men using this medication should use reliable forms of birth control (such as birth control pills, condoms) to prevent pregnancy. Consult your doctor for details and to discuss effective forms of birth control. It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: cimetidine, other drugs that may affect the heart (including trastuzumab, anthracyclines such as doxorubicin).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.