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USES OF ZOCOR

ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high cholesterol. For patients at high risk of coronary heart disease (CHD) because of existing heart disease, diabetes, vascular disease, or history of stroke, ZOCOR is indicated along with diet to reduce the risk of death by reducing coronary death; reduce the risk of heart attack and stroke; and reduce the need for revascularization procedures.

WHEN ZOCOR SHOULD NOT BE USED

ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a preservative.

Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.)

Women who are or may become pregnant: Pregnant women should not take ZOCOR because it may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once.

Women who are breast-feeding should not take ZOCOR.

SIDE EFFECTS

Most patients tolerate treatment with ZOCOR well; however, like all prescription drugs, ZOCOR can cause side effects, and some of them can be serious. Side effects that do occur are usually mild and short-lived. Only your doctor can weigh the risks versus the benefits of any prescription drug. In clinical studies with ZOCOR, less than 1.5% of patients dropped out of the studies because of side effects. In 2 large, 5-year studies, patients taking ZOCOR experienced similar side effects to those patients taking placebo (sugar pills). Some of the side effects that have been reported with ZOCOR or related drugs are listed below. This list is not complete. Be sure to ask your doctor about side effects before taking ZOCOR and to discuss any side effects that occur.

Digestive System: Constipation, diarrhea, upset stomach, gas, heartburn, stomach pain/cramps, anorexia, loss of appetite, nausea, inflammation of the pancreas, hepatitis, jaundice, fatty changes in the liver, and, rarely, severe liver damage and failure, cirrhosis, and liver cancer.

Muscle, Skeletal: Muscle cramps, aches, pain, and weakness; joint pain; muscle breakdown.

Nervous System: Dizziness, headache, insomnia, tingling, memory loss, damage to nerves causing weakness and/or loss of sensation and/or abnormal sensations, anxiety, depression, tremor, loss of balance, psychic disturbances.

Skin: Rash, itching, hair loss, dryness, nodules, discoloration.

Eye/Senses: Blurred vision, altered taste sensation, progression of cataracts, eye muscle weakness.

Hypersensitivity (Allergic) Reactions: On rare occasions, a wide variety of symptoms have been reported to occur either alone or together in groups (referred to as a syndrome) that appeared to be based on allergic-type reactions, which may rarely be fatal. These have included 1 or more of the following: a severe generalized reaction that may include shortness of breath, wheezing, digestive symptoms, and low blood pressure and even shock; an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing; symptoms mimicking lupus (a disorder in which a person’s immune system may attack parts of his or her own body); severe muscle and blood vessel inflammation, sometimes including rash; bruises; various disorders of blood cells (that could result in anemia, infection, or blood clotting problems) or abnormal blood tests; inflamed or painful joints; hives; fatigue and weakness; sensitivity to sunlight; fever, chills; flushing; difficulty breathing; and severe skin disorders that vary from rash to a serious burn-like shedding of skin all over the body, including mucous membranes such as the lining of the mouth.

Other: Loss of sexual desire, breast enlargement, impotence.

Laboratory Tests: Liver function test abnormalities including elevated alkaline phosphatase and bilirubin; thyroid function abnormalities.