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.
COMMON BRAND NAME(S): Simcor
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. Niacin is also known as vitamin B3 (nicotinic acid), one of the B vitamins. It works by reducing the amount of cholesterol made by the liver and by helping the body remove fats from the blood. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver.
Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Lowering triglycerides may also help decrease the risk of pancreas problems (pancreatitis) in people at risk.
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. Talk with your doctor for more details.
HOW TO USE: Take this medication by mouth with a low-fat snack as directed by your doctor, usually once daily at bedtime. Taking this drug with food will help reduce side effects (such as flushing, upset stomach).
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
To reduce the risk of flushing, avoid alcohol, hot beverages, and spicy foods near the time you take niacin. You may be able to reduce or prevent flushing by taking a plain aspirin (non-enteric coated, 325 milligrams) or a nonsteroidal anti-inflammatory drug (such as 200 milligrams of ibuprofen) 30 minutes before taking niacin. Ask your doctor if this treatment is right for you, especially if you are also taking a "blood thinner" such as warfarin.
The niacin in this product is an extended-release form. Your doctor may instruct you to first take the individual extended-release niacin until you reach the right dose and then switch you over to this combination product. Niacin is also available in other forms (for example, immediate- and sustained-release). If you have not taken niacin before, or if you have been using one of the other forms, your doctor should direct you to start at the lowest dose of this medication. Consult your doctor or pharmacist for more details.
Dosage is based on your medical condition, response to treatment, 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 this product 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 4 to 6 hours before or after taking these medications.
Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day. It may take up to 4 weeks before you get the full benefit of this drug.
It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.
Do not stop taking this medicine unless directed by your doctor. If you stop taking this product, you may need to start back at a lower dose and slowly increase the dose again. If you have not taken this medication for an extended period (more than 7 days), consult your doctor or pharmacist for instructions on starting it again.
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.
Tell your doctor right away if any of these unlikely but serious side effects occur: severe dizziness, fainting, fast/pounding heartbeat, swelling ankles/feet/hands, shortness of breath, toe/joint pain, easy bruising/bleeding, black/tarry stools, vomit that looks like coffee grounds.
This drug may infrequently 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), 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.
This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Simcor (simvastatin niacin extended release) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to niacin 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 having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
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.
To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Older adults may be more sensitive to the side effects of this drug, 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 immediately.
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 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, vitamin or dietary products that contain niacin or nicotinamide.
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 niacin/simvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking niacin/simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.
This product may interfere with certain laboratory tests (including urine catecholamine tests, copper-based urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. 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, liver function tests) 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 away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Information last revised November 2014. Copyright(c) 2014 First Databank, Inc.