Ezetimibe; Simvastatin Tablets

What is this medication?

EZETIMIBE; SIMVASTATIN (ez ET i mibe; SIM va stat in) treats high cholesterol. It works by decreasing bad cholesterol and fats (such as LDL, triglycerides) and increasing good cholesterol (HDL) in your blood. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Vytorin

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Frequently drink alcohol
• Kidney disease
• Liver disease
• Muscle cramps, pain
• Thyroid disease
• An unusual or allergic reaction to ezetimibe, simvastatin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Take this medication at least 2 hours before or at least 4 hours after taking a bile acid sequestrant.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Adagrasib
• Antiviral medications for HIV or AIDS
• Certain antibiotics, such as clarithromycin, erythromycin, telithromycin
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• Conivaptan
• Cyclosporine
• Danazol
• Gemfibrozil
• Idelalisib
• Mifepristone, RU-486
• Nefazodone
• Supplements, such as red yeast rice

This medication may also interact with the following:

• Alcohol
• Certain medications for blood pressure or heart disease, such as amlodipine, diltiazem, verapamil
• Certain medications for irregular heartbeat, such as amiodarone and dronedarone
• Certain medications that treat or prevent blood clots, such as warfarin
• Colchicine
• Digoxin
• Grapefruit juice
• Lomitapide
• Niacin
• Ranolazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Your care team may tell you to stop taking this medication if you develop muscle problems. If your muscle problems do not go away after stopping this medication, contact your care team.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. Estrogen and/or progestin hormones may not work as well while you are taking this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended. Talk to your care team about other forms of contraception.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

If you are going to need surgery or another procedure, tell your care team that you are using this medication.

Taking this medication is only part of a total heart healthy program. Ask your care team if there are other changes you can make to improve your overall health.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Headache
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container until you are ready to take it. Protect from light. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the trash or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.