PATIENT INFORMATION®
VYTORIN [VI-tor-in](ezetimibe and simvastatin)
tablets, for oral use
Read this Information carefully before you start taking VYTORIN® and each time you get a VYTORIN.
There may be new information. This information does not take the place of talking with your healthcare
provider about your medical condition or your treatment. If you have any questions about VYTORIN,
ask your healthcare provider. Only your healthcare provider can determine if VYTORIN is right for you.
What is VYTORIN?
VYTORIN is a prescription medicine that contains the cholesterol lowering medicines, simvastatin andezetimibe:• VYTORIN is used along with diet to lower elevated low-density lipoprotein cholesterol (LDL-C) or
bad cholesterol in:o adults with primary hyperlipidemia (high level of fats in your blood).
o adults and children 10 years of age and older with heterozygous familial
hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels ofbad cholesterol.
• VYTORIN is also used with other cholesterol lowering treatments to lower elevated LDL-C levels inadults with homozygous familial hypercholesterolemia (HoFH). HoFH is an inherited condition thatcauses high levels of bad cholesterol.
•Simvastatin when used as a component of VYTORIN is used to lower:
o the risk of death by lowering the risk of heart disease death.
o the risk of heart attacks and strokes.
o 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 thataffect blood flow and the blood vessels in the brain), peripheral vascular disease (a bloodcirculation disorder that causes the blood vessels outside of your heart and brain to narrow,block, or spasm), and diabetes, who are at high risk for heart disease problems.

The safety and effectiveness of VYTORIN has not been established in children younger than 10 yearsof age with inherited heterozygous familial hypercholesterolemia (HeFH) or other types ofhyperlipidemia.
Do not take VYTORIN 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, telithromycin).
o HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, oratazanavir and cobicistat-containing 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, ezetimibe, or any of the ingredients in VYTORIN. See the end of thisPatient Information leaflet for a complete list of ingredients in VYTORIN.

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.
Before you take VYTORIN, 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 insome cases muscles used for breathing), ocular myasthenia (a disease causing eye muscleweakness).

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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 VYTORIN, call yourhealthcare provider right away to discuss stopping VYTORIN.
are breastfeeding or plan to breastfeed. It is not known if VYTORIN passes into your breast milk.
Do not breastfeed while taking VYTORIN.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you starttaking any new medicines.
Tell your healthcare provider who prescribes VYTORIN if another healthcare provider increases thedose of another medicine you are taking.
VYTORIN may affect the way other medicines work, and other medicines may affect how VYTORIN
works. Especially tell your healthcare provider if you take:••digoxin (a drug used to treat irregular heartbeat).
coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).

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fibric acid derivatives (such as fenofibrate).

Taking VYTORIN with certain substances can also increase the risk of muscle problems. Especially tell
your healthcare provider if you take:
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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.
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 newmedicine.
How should I take VYTORIN?
••••••Take VYTORIN exactly as your healthcare provider tells you to take it.
Do not change your dose or stop taking VYORIN without talking to your healthcare provider.
Take VYTORIN 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 yournext dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses ofVYTORIN at the same time. Talk with your healthcare provider if you have questions about amissed dose.
While taking VYTORIN, continue to follow your cholesterol-lowering diet and to exercise as yourhealthcare provider told you to.
Your healthcare provider may do blood tests to check your cholesterol while you take VYTORIN.
Your healthcare provider may change your dose of VYTORIN if needed.

If you take too much VYTORIN, call your healthcare provider or Poison Help Line at 1-800-222-1222 orgo to the nearest hospital emergency room right away.
What are the possible side effects of VYTORIN?
VYTORIN may cause serious side effects including:•Muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle
breakdown, can be serious 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 afever or feel more tired than usual, while you take VYTORIN.
o you have muscle problems that do not go away even after your healthcare provider has
advised you to stop taking VYTORIN. Your healthcare provider may do further tests todiagnose the cause of your muscle problems.
Your chances of getting muscle problems are higher if you:ooooooo••

are taking certain other medicines while you take VYTORIN.
are 65 years of age or older.
are female.
have thyroid problems (hypothyroidism) that are not controlled.
have kidney problems.
are taking higher doses of VYTORIN.
are Chinese.

Liver problems. Your healthcare provider should do blood tests to check your liver before you starttaking VYTORIN and if you have any symptoms of liver problems while you take VYTORIN. Callyour 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). VYTORIN may cause an increase in your blood sugar
levels.

The most common side effects of VYTORIN include:
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headacheincreased liver enzyme levels
muscle pain
upper respiratory infection
diarrhea

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 VYTORIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
How should I store VYTORIN?
• Store VYTORIN at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Keep VYTORIN in its original container until you use it.
• Keep VYTORIN in a tightly closed container.
Keep VYTORIN and all medicines out of the reach of children.

General information about safe and effective use of VYTORIN.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information
leaflet. Do not use VYTORIN for a condition for which it was not prescribed. Do not give VYTORIN toother people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about VYTORIN that is written for
health professionals.
What are the ingredients in VYTORIN?
Active Ingredients: ezetimibe and simvastatin.
Inactive Ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium,
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.
Distributed by: Organon LLC, a subsidiary ofJersey City, NJ 07302, USA
For patent information: www.organon.com/our-solutions/patent/© 2024 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-og0653a-t-2402r001
This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 2/2024