Zocor (Simvastatin)

Along with its intended action, any medication may cause unwanted effects.

The following side effects that may occur, generally do not require medical attention, and may come and go during treatment. If any of the following persist or become troublesome, do check with your doctor, nurse or pharmacist:

• Constipation, diarrhea, gas, stomach upset, nausea

• Pain in the abdomen

• Headache

• Skin rash

• Poor memory

• Memory loss

• Confusion

• Trouble sleeping

• Depression

• Erectile dysfunction

• Breathing problems including persistent cough and/or shortness of breath or fever.

Possible side effects reported with other statins:

• Sleep disturbances, including nightmares.

Side effects such as myalgia (muscle pain), myopathy (muscle disease with aching or weakness) [that in very rare cases may not go away after stopping ZOCOR], rhabdomyolysis (a muscle wasting disease or muscle breakdown), associated tenderness, and rare cases of muscle breakdown resulting in kidney damage that can lead to death have been reported with other drugs of this class, known as HMG-CoA reductase inhibitors (“statins”), including ZOCOR. This risk of muscle breakdown is greater for patients taking higher doses of ZOCOR, particularly the 80 mg dose. This risk of muscle breakdown is also greater for older patients (65 years of age and older), female patients, patients with abnormal kidney function, and patients with thyroid problems.

See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor should do blood tests to check your liver before you start taking ZOCOR and if you have any symptoms of liver problems while you take ZOCOR.

ZOCOR can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking ZOCOR, contact your doctor, nurse or pharmacist.

Before taking ZOCOR, tell your doctor, nurse or pharmacist if you:

• are pregnant, intend to become pregnant, are breast-feeding or intend to breast-feed

• have thyroid problems

• regularly drink three or more alcoholic drinks daily

• are taking any other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe

• are taking any other medications, including prescription, nonprescription and natural health products as drug interactions are possible

• have a family history of muscular disorders

• had any past problems with the muscles (pain, tenderness), after using an HMG-CoA reductase inhibitor (“statin”) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin, pravastatin (Pravachol) or rosuvastatin (Crestor), or have developed an allergy or intolerance to them

• have kidney or liver problems

• have diabetes. Slightly increased blood sugar can occur when you take ZOCOR. Discuss with your doctor, nurse or pharmacist your risk of developing diabetes

• have undergone surgery or other tissue injury

• do excessive physical exercise

• are of childbearing age. Cholesterol compounds are essential elements for the development of a fetus. Cholesterol-lowering drugs can harm the fetus. If you are of childbearing age, discuss with your doctor, nurse or pharmacist the potential hazards to the fetus and the importance of birth control methods.

• become pregnant. ZOCOR should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor, nurse or pharmacist.

• are Asian.

When starting or increasing the dose of ZOCOR, or at any time, if you experience any unexplained muscle pain, tenderness or weakness, you must report promptly to your doctor, nurse or pharmacist.

Be sure to tell your doctor, nurse or pharmacist you are taking ZOCOR before undergoing any major elective surgery or if you have any other new major medical issues.

You should tell your doctor, nurse or pharmacist about all drugs that you are using or plan to use, including those obtained without a prescription, while taking ZOCOR. You should also tell any doctor who is prescribing a new medication for you that you are taking ZOCOR.

Because taking ZOCOR with any of the following drugs or substances can increase the risk of muscle problems, it is particularly important to tell your doctor, nurse or pharmacist if you are taking:

• antifungal agents (such as itraconazole, ketoconazole, posaconazole, or voriconazole)

• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)

• boceprevir or telaprevir (drugs used to treat hepatitis C virus infection)

• the antibiotics erythromycin, clarithromycin, telithromycin^‡, and fusidic acid (intravenous^‡ or oral^‡)

• the antidepressant nefazodone^‡

• medicines containing cobicistat

• cyclosporine (immunosuppressant)

• danazol

• fibrates/fibric acid derivatives (bezafibrate and gemfibrozil) (drug to treat lipids problems)

• amiodarone (a drug used to treat an irregular heartbeat)

• verapamil, or diltiazem, or amlodipine (drugs used to treat high blood pressure, angina, or other heart conditions)

• lomitapide (a drug used to treat a serious and rare genetic cholesterol condition)

• grapefruit juice (which should be avoided while taking ZOCOR).

It is also important to tell your doctor, nurse or pharmacist if you are taking corticosteroids, anticoagulants (drug that prevents blood clots, such as warfarin), colchicine (a medicine used for gout), digoxin (a drug used to treat heart problems), niacin, or fenofibrate, another fibric acid derivative.