When This Medicine Should Not Be Used:
Do not use this medicine if you had an allergic reaction to simvastatin or niacin. Do not use this medicine if you are pregnant or breastfeeding or if you have active liver disease, bleeding problems, or a stomach ulcer. Do not use this medicine if you also use the following medicines: boceprevir (Victrelis®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Nizoral®), certain blood pressure medicines (such as diltiazem, verapamil, Calan®, Cardizem®, Verelan®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®).

How to Use This Medicine:
Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• It is best to take this medicine at bedtime, with a low-fat snack.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is part of a complete plan for lowering cholesterol and triglycerides in your blood.

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

• Make sure your doctor knows if you also use amiodarone (Cordarone®), amlodipine (Norvasc®), colchicine (Colcrys®), digoxin (Lanoxin®), ranolazine (Ranexa®), voriconazole (Vfend®), other medicine to lower cholesterol (such as cholestyramine, colestipol, fenofibrate, Colestid®, Questran®, Tricor®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
• If you also use cholestyramine (Questran®) or colestipol (Colestid®), take it at least 4 to 6 hours before you take this medicine.
• Tell your doctor if you drink more than 2 glasses of alcohol per day or if you drink grapefruit juice.
• Talk to your doctor if you take vitamins that contain niacin or nicotinamide.
• Do not drink alcohol or hot beverages or eat spicy foods at the same time that you take this medicine. These items together with the medicine may cause you to feel warm or flushed.

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.
• Make sure your doctor knows if you have kidney disease, diabetes, gout, thyroid problems, or muscle pain or weakness. Tell your doctor if you have a history of liver disease or if you drink alcohol regularly.
• Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These may be symptoms of a serious muscle problem called myopathy.
• Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). Chinese patients who take large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury.
• Make sure any doctor or dentist who treats you knows that you use this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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, red skin rash
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Muscle pain, tenderness, or weakness
• Fever
• Unusual tiredness

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

• Confusion or problems with memory
• Headache
• Warmth or redness in your face, neck, arms, or upper chest

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