Ezetimibe (e-ZET-i-mibe), Simvastatin (sim-va-STAT-in)

Lowers high cholesterol and triglyceride levels in patients with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). May reduce the risk of heart attack, stroke, and blood vessel problems. This is a combination of a cholesterol absorption inhibitor and a statin.

Brand Name(s):

Vytorin

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the medicine in the evening.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with boceprevir, clarithromycin, cobicistat-containing medicines, cyclosporine, danazol, erythromycin, gemfibrozil, itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, voriconazole, or certain medicines to treat HIV/AIDS (including darunavir/ritonavir, nelfinavir, ritonavir).
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Amiodarone, cholestyramine, colchicine, daptomycin, digoxin, dronedarone, fenofibrate, fenofibric acid, lomitapide, niacin (vitamin B3), ranolazine
  • Blood pressure medicine (including amlodipine, diltiazem, verapamil)
  • Blood thinner (including warfarin)
  • Fibrate medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, diabetes, thyroid disease, or a history of stroke or heart disease. Tell your doctor if you drink alcohol regularly or have a history of liver disease. Tell your doctor if you are Chinese or have Chinese ancestry.
• This medicine may cause the following problems:
  • Severe muscle problems (including myopathy, immune-mediated necrotizing myopathy), especially when used with other medicines
  • Rhabdomyolysis (severe muscle weakness) that could lead to kidney damage
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Muscle pain, tenderness, or weakness
• Unusual tiredness

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088