Zocor
(Simvastatin) Tablets

ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high
cholesterol when diet and exercise are inadequate. For patients with coronary heart disease (CHD)
and high cholesterol, ZOCOR is indicated as an addition to diet to reduce the risk of death by
reducing coronary death; to reduce the risk of heart attack; to reduce the risk for undergoing cardiac
procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty);
and to reduce the risk of stroke or transient ischemic attack (TIA).

Some people should not take ZOCOR. Discuss this with your doctor.

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.

Patients who are also taking the prescription drug Posicor
(mibefradil) should not take ZOCOR.

Liver: About 1% of patients who took ZOCOR in clinical trials
developed elevated levels of some liver enzymes. Patients who had these increases
usually had no symptoms. Elevated liver enzymes usually returned to normal levels when
therapy with ZOCOR was stopped.

In the ZOCOR Survival Study, the number of patients with more than one
liver enzyme level elevation to greater than 3 times the normal upper limit was no
different between the ZOCOR and placebo groups. Only 8 patients on ZOCOR and 5 on placebo
discontinued therapy due to elevated liver enzyme levels. Patients were started on 20 mg
of ZOCOR, and one third had their dose raised to 40 mg.

Your doctor should perform routine blood tests to check these
enzymes before you start treatment with ZOCOR and periodically thereafter (for example,
semiannually) for your first year of treatment or until one year after your last elevation
in dose. If your enzyme levels increase, your doctor should order more frequent
tests. If your liver enzyme levels remain unusually high, your doctor should discontinue
your medication.

Tell your doctor about any liver disease you may have had in the past
and about how much alcohol you consume. ZOCOR should be used with caution in patients who
consume large amounts of alcohol.

Muscle: Tell your doctor right away if you experience any muscle
pain, tenderness, or weakness at any time during treatment with ZOCOR, particularly if you
have a fever or if you are generally not feeling well, so your doctor can decide if ZOCOR
should be stopped. Some patients may have muscle pain or weakness while taking ZOCOR.
Rarely, this can include muscle breakdown resulting in kidney damage. The risk of muscle
breakdown is greater in patients taking certain other drugs along with ZOCOR, such as the
lipid-lowering drug Lopid (gemfibrozil), a fibrate; lipid-lowering doses of nicotinic acid
(niacin); the antibiotics erythromycin and clarithromycin; nefazodone; antifungal drugs
that are azole derivatives, such as itraconazole and ketoconazole; the calcium channel
blocker Posicor; or drugs that suppress the immune system (called immunosuppressive drugs,
such as Sandimmune [cyclosporine]). Therapy with ZOCOR should be temporarily interrupted
if you are going to take an azole derivative antifungal medication, such as itraconazole.
Patients using ZOCOR along with any of these other drugs should be carefully monitored by
their physician. The risk of muscle breakdown is greater in patients with kidney problems
or diabetes.

If you have conditions that can increase your risk of muscle
breakdown, which in turn can cause kidney damage, your doctor should temporarily withhold
or stop ZOCOR. Such conditions include severe infection, low blood pressure, major
surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled
seizures. Also, since there are no known adverse consequences of briefly stopping therapy
with ZOCOR, treatment should be stopped a few days before elective major surgery. Discuss
this with your doctor, who can explain these conditions to you.

Because there are risks in combining therapy with ZOCOR with
lipid-lowering doses of nicotinic acid (niacin) or with drugs that suppress the immune
system, your doctor should carefully weigh the potential benefits and risks. He or she
should also carefully monitor patients for any muscle pain, tenderness, or weakness,
particularly during the initial months of therapy and if the dose of either drug is
increased. Your doctor may also monitor the level of certain muscle enzymes in your body,
but there is no assurance that such monitoring will prevent the occurrence of severe
muscle disease.

Before starting treatment with ZOCOR, try to lower your
cholesterol by other methods such as diet, exercise, and weight loss. Ask your doctor
about how best to do this. Any other medical problems that can cause high cholesterol
should also be treated.

ZOCOR is less effective in patients with the
rare disorder known as homozygous familial hypercholesterolemia.

Drug Interactions: Because of possible
serious drug interactions, it is important to tell your doctor what other drugs you are
taking, including those obtained without a prescription.

ZOCOR can interact with Posicor, Lopid, niacin,
erythromycin, clarithromycin, nefazodone, certain antifungal drugs, and drugs that
suppress the immune system (called immunosuppressive drugs, such as Sandimmune). (See
WARNINGS, Muscle.)

Some patients taking lipid-lowering agents similar to ZOCOR
and coumarin anticoagulants (a type of blood thinner) have experienced bleeding and/or
increased blood clotting time. Patients taking these medicines should have their blood
tested before starting therapy with ZOCOR and should continue to be monitored.

Endocrine (Hormone) Function: ZOCOR and
other drugs in this class may affect the production of certain hormones. Caution should be
exercised if a drug used to lower cholesterol levels is administered to patients also
receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease
the levels or activity of hormones. If you are taking any such drugs, tell your doctor.

Central Nervous System Toxicity; Cancer, Mutations,
Impairment of Fertility: Like most prescription drugs, ZOCOR was required to be
tested on animals before it was marketed for human use. Often these tests were designed to
achieve higher drug concentrations than humans achieve at recommended dosing. In some
tests, the animals had damage to the nerves in the central nervous system. In studies of
mice with high doses of ZOCOR, the likelihood of certain types of cancerous tumors
increased. No evidence of mutations of or damage to genetic material has been seen. In one
study with ZOCOR, there was decreased fertility in male rats.

Pregnancy: Pregnant women should not take
ZOCOR because it may harm the fetus.

Safety in pregnancy has not been established. In
studies with lipid-lowering agents similar to ZOCOR, there have been rare reports of birth
defects of the skeleton and digestive system. Therefore, women of childbearing age should
not take ZOCOR unless it is highly unlikely they will become pregnant. If a woman does
become pregnant while taking ZOCOR, she should stop taking the drug and talk to her doctor
at once. The active ingredient of ZOCOR did not cause birth defects in rats at 6 times the
human dose or in rabbits at 4 times the human dose.

Nursing Mothers: Drugs taken by nursing
mothers may be present in their breast milk. Because of the potential for serious adverse
reactions in nursing infants, a woman taking ZOCOR should not breast-feed. (See WHEN
ZOCOR SHOULD NOT BE USED.)

Pediatric Use: ZOCOR is not recommended
for children or patients under 20 years of age.

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 a large,
long-term study, 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 one 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; 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.

NOTE: This summary provides important information about ZOCOR.
If you would like more information, ask your doctor or pharmacist to let you read the
professional labeling and then discuss it with them.