PATIENT INFORMATIONZOCOR® (zOH-kor)(simvastatin)
tablets, for oral use
Read this Patient Information before you start taking ZOCOR and each time you get a refill. There may be newinformation. This information does not take the place of talking with your healthcare provider about your medical
condition or your treatment.
What is ZOCOR?
ZOCOR is a prescription medicine that contains the cholesterol lowering medicine, simvastatin.
ZOCOR is used to lower:•••

the risk of death by lowering the risk of heart disease death.
the risk of heart attacks and strokes.
the need for certain types of heart and blood vessel procedures to improve blood flow called arterial
revascularization in people with known heart, cerebrovascular disease (conditions that affect blood flow and theblood vessels in the brain), peripheral vascular disease (a blood circulation disorder that causes the bloodvessels outside of your heart and brain to narrow, block, or spasm), and diabetes, who are at high risk for heartdisease problems.
ZOCOR is used along with diet to:• lower the level of low-density lipoprotein (LDL) cholesterol or “bad” cholesterol in adults with hyperlipidemia(high levels of fat in the blood), and in adults and children 10 years of age and older with heterozygous familial
hypercholesterolemia (an inherited condition that causes high levels of LDL).
• treat adults with a type of high cholesterol called primary dysbetalipoproteinemia.
• lower the level of triglycerides (type of fat in the blood) in adults.
ZOCOR is used along with other cholesterol lowering treatments to lower the level of low-density lipoprotein (LDL)in adults with a type of high cholesterol called homozygous familial hypercholesterolemia (an inherited condition
that causes high levels of LDL).
The safety and effectiveness of ZOCOR has not been established in children younger than 10 years of age withheterozygous familial hypercholesterolemia (HeFH) or other types of hyperlipidemia (high levels of fat in the blood).
Do not take ZOCOR if you:•take certain medicines called CYP3A4 inhibitors such as:o certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole, voriconazole).
o certain antibiotics (including erythromycin, clarithromycin).
o HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and darunavir/ritonavir) and cobicistatcontaining products such as (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate).
o certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir).
o the antidepressant nefazodone.
• take medicines called cyclosporine, danazol, or gemfibrozil.
• have liver problems.
• are allergic to simvastatin or any of the ingredients in ZOCOR. See the end of this Patient Information leaflet for
a complete list of ingredients in ZOCOR.
Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.
Before you take ZOCOR, tell your healthcare provider about all of your medical conditions, including if you:• have unexplained muscle aches or weakness.
• have or have had myasthenia gravis (a disease causing general muscle weakness including in some cases
muscles used for breathing), ocular myasthenia (a disease causing eye muscle weakness).
• have kidney problems.
• have liver problems or drink more than 2 glasses of alcohol daily.
• have thyroid problems.
• are 65 years of age or older.
• are of Chinese descent.
• are pregnant or plan to become pregnant. If you become pregnant while taking ZOCOR, call your healthcare
provider right away to discuss stopping ZOCOR.
• are breastfeeding or plan to breastfeed. It is not known if ZOCOR passes into your breast milk. Do notbreastfeed while taking ZOCOR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any newmedicines.
Tell your healthcare provider who prescribes ZOCOR if another healthcare provider increases the dose of anothermedicine you are taking.
ZOCOR may affect the way other medicines work, and other medicines may affect how ZOCOR works. Especiallytell your healthcare provider if you take:• digoxin (a drug used to treat irregular heartbeat).
• coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).
Taking ZOCOR with certain substances can also increase the risk of muscle problems. Especially tell your healthcare
provider if you take:• amiodarone or dronedarone (medicines used to treat an irregular heartbeat).
• verapamil, diltiazem, amlodipine, or ranolazine (medicines used to treat high blood pressure, chest pain
associated with heart disease, or other heart conditions).
• lomitapide (a medicine used to treat a serious and rare genetic cholesterol condition).
• daptomycin (a drug used to treat complicated skin and bloodstream infections).
• large doses of niacin or nicotinic acid, especially if you are of Chinese descent.
• fibric acid derivatives (such as fenofibrate).
• colchicine (a medicine used to treat gout).
• grapefruit juice.
Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ZOCOR?
• Take ZOCOR exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking ZOCOR without talking to your healthcare provider.
• Take ZOCOR 1 time each day in the evening.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose,skip the missed dose and go back to your regular schedule. Do not take 2 doses of ZOCOR at the same time.
Talk with your healthcare provider if you have questions about a missed dose.
• While taking ZOCOR, continue to follow your cholesterol-lowering diet and to exercise as your healthcare
provider told you to.
• Your healthcare provider may do blood tests to check your cholesterol while you take ZOCOR. Your healthcare
provider may change your dose of ZOCOR if needed.
• In case of overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222.
Advice is also available online at poisonhelp.org
What are the possible side effects of ZOCOR?
ZOCOR may cause serious side effects including:•Muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown, can beserious in some people and rarely cause kidney damage that can lead to death.
Tell your healthcare provider right away if:o you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel
more tired than usual, while you take ZOCOR.
o you have muscle problems that do not go away even after your healthcare provider has advised you tostop taking ZOCOR. Your healthcare provider may do further tests to diagnose the cause of your muscle
problems.
Your chances of getting muscle problems are higher if you:o are taking certain other medicines while you take ZOCOR.
o are 65 years of age or older.
o are female.
o have thyroid problems (hypothyroidism) that are not controlled.
o have kidney problems.
o are taking higher doses of ZOCOR.
o are Chinese.

•Liver problems. Your healthcare provider 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. Call your healthcare provider
right away if you have the following symptoms of liver problems:o feeling tired or weako loss of appetiteo right-sided upper belly paino dark urine
o yellowing of your skin or the whites of your eyes

• Increase in blood sugar (glucose) levels). ZOCOR may cause an increase in your blood sugar levels.
The most common side effects of ZOCOR include:• upper respiratory infection• headache• stomach (abdominal) pain
• constipation• nausea
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of ZOCOR.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZOCOR?
• Store ZOCOR between 41°F to 86°F (5°C to 30°C).
Keep ZOCOR and all medicines out of the reach of children.
General information about safe and effective use of ZOCOR.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not
use ZOCOR for a condition for which it was not prescribed. Do not give ZOCOR to other people, even if they havethe same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ZOCOR that is written for healthprofessionals.
What are the ingredients in ZOCOR?
Active ingredient: simvastatin.
Inactive ingredients: ascorbic acid, citric acid, hydroxypropyl cellulose, hypromellose, iron oxides, lactose,
magnesium stearate, microcrystalline cellulose, starch, talc, and titanium dioxide. Butylated hydroxyanisole isadded as a preservative.
Manufactured for: Organon LLC, a subsidiary ofJersey City, NJ 07302, USA
For patent information: www.organon.com/our-solutions/patent/© 2023 Organon group of companies. All rights reserved.
For more information, go to www.organon.com/our-focus/products-list/ or call 1-844-674-3200.
usppi-og0733-t-2308r001
This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 8/2023