Ezetimibe - Simvastatin 10-40mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

EZETIMIBE/SIMVASTATIN - ORAL

(e-ZET-i-mibe/SIM-va-STAT-in)

COMMON BRAND NAME(S): Vytorin

USES: This combination medication is used along with a proper diet to help lower \"bad\" cholesterol and fats (such as LDL, triglycerides) and raise \"good\" cholesterol (HDL) in the blood. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as \"statins.\" It works by reducing the amount of cholesterol made by the liver. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details. Lowering \"bad\" cholesterol and triglycerides and raising \"good\" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the evening. Dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Chinese patients taking niacin may require lower doses of simvastatin. Ask your doctor for more details. The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking these medications. These medications can react with this product, preventing its full absorption. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. It is very important to continue to follow your doctor\'s advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very small number of people taking simvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor. Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks. This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information. Older adults may be more sensitive to the side effects of this medication, especially muscle problems. This medication must not be used during pregnancy. Simvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How To Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: \"blood thinners\" (such as warfarin), cyclosporine, danazol, gemfibrozil. Other medications can affect the removal of simvastatin from your body, which may affect how simvastatin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat, colchicine, delavirdine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as nelfinavir, ritonavir), telaprevir, telithromycin, among others. Do not take any red yeast rice products while you are taking ezetimibe/simvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.