Vytorin is used for:

Treating high cholesterol along with a cholesterol-lowering diet. It may also be used for other conditions as determined by your doctor.

Vytorin is a combination of 2 medicines. Ezetimibe works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or “statin.” It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone.

Do NOT use Vytorin if:

• you are allergic to any ingredient in Vytorin
• you have liver problems or ongoing abnormal liver function test results
• you are taking another medicine that contains simvastatin or ezetimibe
• you are taking an HIV protease inhibitor (eg, nelfinavir, lopinavir, ritonavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, clarithromycin, erythromycin, troleandomycin), mibefradil, or nefazodone
• you are pregnant or breast-feeding

Before using Vytorin :

Some medical conditions may interact with Vytorin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are a woman of childbearing age
• if you have kidney problems, muscle problems, or a family history of muscle problems; low blood pressure; uncontrolled seizures; or serious metabolic, endocrine, or electrolyte problems
• if you are scheduled for major surgery, have recently had a major trauma, or have a severe infection or history of alcohol abuse
• if you have had an organ transplant and are taking medicine to suppress a rejection reaction

Some MEDICINES MAY INTERACT with Vytorin . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, itraconazole, ketoconazole), cyclosporine, danazol, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate), fluconazole, gemfibrozil, HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressives (eg, tacrolimus), mibefradil, nefazodone, niacin, nicotinic acid, streptogramins, telithromycin, verapamil, or voriconazole because side effects, such as muscle pain, may occur
• Bosentan, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John’s wort because they may decrease Vytorin ‘s effectiveness
• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Vytorin

How to use Vytorin :

Use Vytorin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Vytorin . Talk to your pharmacist if you have questions about this information.
• Take Vytorin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
• Taking Vytorin at the same time each day will help you remember to take it.
• If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours after taking Vytorin . Check with your doctor if you have questions.
• For best results, Vytorin should be used along with exercise, a low-cholesterol/low-fat diet, and a weight-loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.
• Eating grapefruit or drinking grapefruit juice may increase the amount of Vytorin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Vytorin .
• Most people with high cholesterol do not feel sick. Continue to take Vytorin even if you feel well. Do not miss any doses.
• If you miss a dose of Vytorin , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Important safety information:

• Vytorin may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Vytorin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• It may take several weeks for Vytorin to work.
• Proper dental care is important while you are taking Vytorin . Brush and floss your teeth and visit the dentist regularly.
• Vytorin may harm your liver. Your risk may be greater if you drink alcohol while you are using Vytorin . Talk to your doctor before you take Vytorin or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Vytorin may cause injury to your muscles, especially when taken at higher doses or when taken with certain other medicines. Contact your doctor right away if you experience muscle pain, tenderness, or weakness, especially with a fever.
• Some patients taking Vytorin have reported poor memory or trouble sleeping. If you experience these effects, check with your doctor.
• Lab tests, including blood cholesterol levels, liver function tests, or muscle tests, may be performed while you use Vytorin . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Vytorin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Vytorin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Vytorin is found in breast milk. Do not breast-feed while taking Vytorin .

Possible side effects of Vytorin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flu-like symptoms; headache; pain in the arms or legs; tiredness; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; change in the amount of urine; chest pain; dark urine; depression; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; numbness, tingling, burning, or weakness in the arms, hands, feet, or legs; pale stools; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.