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|Vytorin

Vytorin

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.

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 other medicines that contain simvastatin or ezetimibe
• you are taking a fibrate (eg, clofibrate, fenofibrate), gemfibrozil, an HIV protease inhibitor (eg, ritonavir, lopinavir, nelfinavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, erythromycin, clarithromycin, troleandomycin), mibefradil, or nefazodone
• you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

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 planning to become pregnant or you are a woman of childbearing age
• 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 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:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vytorin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vytorin :

Use Vytorin as directed by your doctor. Check the label on the medicine for exact dosing instructions. 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.
• If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours 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.
• Do not eat grapefruit or drink grapefruit juice at the same time you take Vytorin . Grapefruit and grapefruit juice may increase the risk of side effects from Vytorin . Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking Vytorin .
• Most people with high cholesterol do not feel sick. Do not miss any doses. Taking Vytorin at the same time each day will help you to remember to take it.
• 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.

Ask your health care provider any questions you may have about how to use Vytorin .

Important safety information:

• Vytorin may cause 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 immediately if you experience muscle pain, tenderness, or weakness, especially with a fever.
• 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 11 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:

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

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; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Vytorin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vytorin out of the reach of children and away from pets.

General information:

• If you have any questions about Vytorin , please talk with your doctor, pharmacist, or other health care provider.
• Vytorin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vytorin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.