Ezetimibe/Simvastatin, Oral

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KEY POINTS

• This medicine is taken by mouth to lower cholesterol. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: cholesterol lowering medicine

Generic and brand names: ezetimibe/simvastatin, oral; Vytorin

What is this medicine used for?

This is a combination of 2 medicines taken by mouth to lower levels of total cholesterol, LDL (bad) cholesterol, and triglycerides in the blood. It also helps to increase the amount of HDL (good) cholesterol in your blood. It is used when you cannot control your cholesterol levels by diet and exercise alone.

High doses of this medicine should only be used by people who have been taking it for 12 months or longer without ill effect.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Liver or kidney problems
• Low blood pressure
• Problems with alcohol abuse
• Thyroid problems
• Unexplained muscle pain or weakness
• Seizures
• Also, tell your healthcare provider if you drink alcohol regularly or if you have more than 2 alcoholic drinks per day.

Tell your healthcare provider about all the medicines you are taking. Taking certain medicines or foods with this medicine may increase your risk of serious muscle problems. These medicines include certain antifungals and antibiotics, HIV protease inhibitors, certain hepatitis C virus protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol. Do not start any new medicines, supplements, or natural remedies while you are taking this medicine unless your healthcare provider approves.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Talk with your healthcare provider about effective forms of birth control. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes for the length of time prescribed. Do not stop taking this medicine without your healthcare provider's approval. This medicine will lower your cholesterol level only when you take it regularly. Continue to follow the diet or exercise program your healthcare provider prescribes.

Check with your healthcare provider before using this medicine in children under age 10 or in children who have not reached puberty.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

If your healthcare provider has also prescribed a another cholesterol lowering medicine such as cholestyramine, colesevelam, or colestipol, take ezetimibe/simvastatin at least 2 hours before or at least 4 hours after taking the other medicine.

What if I miss a dose?

If you miss a dose of this medicine, take the missed dose as soon as you remember that same day. If you do not remember until the next day, skip the missed dose. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

While you are taking this medicine or after you stop taking this medicine, report any unusual muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever, feel ill, or feel more tired than usual.

Tell your healthcare provider about ALL the prescription and nonprescription medicines and natural remedies that you take.

You will need blood tests regularly to see if the medicine is working. You will also have liver function tests to see how the medicine may be affecting your liver. Keep all your appointments.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Avoid drinking alcohol or have less than 3 drinks a day. Drinking too much alcohol while taking this medicine may increase your risk for liver problems. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

A low-fat diet and regular exercise are important to reduce cholesterol. Follow your healthcare provider's advice. Because alcohol may increase triglyceride levels, do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; irregular heartbeat; unusual muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual; yellowing of your skin or eyes, dark or reddish urine, light-colored bowel movements; severe nausea or vomiting; severe stomach pain; unexplained loss of appetite; unusual tiredness or weakness; trouble or decreased urinating; unexplained swelling, breathing problems, constant cough.

Other: Mild nausea or vomiting, diarrhea, mild stomach pain or gas, constipation, mild rash or itching, headache, mild dizziness, memory loss, confusion, tingling, stuffy or runny nose, sore throat, mild tiredness, trouble sleeping, erectile dysfunction, depression, back pain, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), daptomycin (Cubicin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), dasatinib (Sprycel), enzalutamide (Xtandi), erlotinib (Tarceva), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), nilotinib (Tasigna), and temsirolimus (Torisel)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Danazol
• Dexamethasone
• Eltrombopag (Promacta)
• Erectile dysfunction medicines such as avanafil (Stendra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec) and pantoprazole (Protonix)
• Medicines to treat or prevent blood clots such as ticagrelor (Brilinta) and warfarin (Coumadin)
• Natural remedies such as green tea, red yeast rice, and St. John’s wort
• Nefazodone
• Other cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), gemfibrozil (Lopid), and lomitapide (Juxtapid) (Take this medicine 2 hours before or 4 hours after you take cholestyramine, colesevelam, or colestipol.)
• Quinine
• Sildenafil (Revatio, Viagra)
• Simeprevir (Olysio)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.