Simvastatin/
Niacin

Simvastatin/Niacin is used for:

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Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with an appropriate diet. It may also be used for other conditions as determined by your doctor.

Simvastatin/Niacin is an HMG-CoA reductase inhibitor and niacin combination. The HMG-CoA reductase inhibitor works by reducing the production of certain fatty substances in the body, including cholesterol. The niacin reduces low-density lipoprotein (LDL, "bad") cholesterol and triglycerides and increases HDL cholesterol.

Do NOT use Simvastatin/Niacin if:

• you are allergic to any ingredient in Simvastatin/Niacin
• you are pregnant or breast-feeding
• you have abnormal liver function tests, active liver disease, active peptic ulcer disease, or certain types of active bleeding (arterial bleeding)
• you are taking cyclosporine, danazol, fibrates (eg, clofibrate), gemfibrozil, an HIV protease inhibitor (eg, ritonavir), an azole antifungal (eg, itraconazole), a macrolide antibiotic (eg, clarithromycin), a ketolide (eg, telithromycin), mibefradil, or nefazodone

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

Before using Simvastatin/Niacin :

Some medical conditions may interact with Simvastatin/Niacin . 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 have a history of liver problems; abnormal liver function tests; yellowing of the skin or eyes; kidney problems; diabetes; underactive thyroid; electrolyte, endocrine, or metabolism problems; blood or bleeding problems (eg, low blood platelet levels); low blood pressure; gout; muscle pain or weakness; seizures; or ulcers
• if you are dehydrated, have a severe infection or a recent serious injury, or are very ill
• if you drink large amounts of alcohol or if you have a history of alcohol abuse
• if you are scheduled to have surgery or if you have received an organ transplant
• if you have taken or are taking immediate-release (short-acting) niacin or another product that contains niacin
• if you have not previously taken simvastatin or a long-acting niacin. Simvastatin/Niacin should only be used in patients who already take simvastatin or long-acting niacin

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

• Amiodarone, azole antifungals (eg, itraconazole), colchicine, conivaptan, fibrates(eg, clofibrate, gemfibrozil), cyclosporine, danazol, delavirdine, diltiazem, HIV protease inhibitors (eg, ritonavir), imatinib, ketolides (eg, telithromycin), macrolide antibiotics (eg, clarithromycin ), mibefradil, nefazodone, streptogramins (eg, quinupristin), verapamil, or voriconazole because the risk of myopathy (eg, muscle pain, tenderness, or weakness) may be increased
• Bosentan, carbamazepine, efavirenz, rifampin, or St. John's wort because they may decrease Simvastatin/Niacin 's effectiveness
• Anticoagulants (eg, warfarin), digoxin, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Simvastatin/Niacin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Simvastatin/Niacin 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 Simvastatin/Niacin :

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

• Take Simvastatin/Niacin by mouth at bedtime with a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of low-fat milk), unless your doctor tells you otherwise. Taking Simvastatin/Niacin with a low-fat snack may reduce flushing and stomach upset from Simvastatin/Niacin .
• Do not drink alcohol or hot drinks, or eat spicy foods around the time you take Simvastatin/Niacin . This may also help to reduce the risk of flushing.
• Taking an aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen) 30 minutes before you take Simvastatin/Niacin may also help to reduce the risk of flushing. Check with your doctor for more information.
• Swallow Simvastatin/Niacin whole. Do not break, crush, or chew before swallowing.
• Eating grapefruit or drinking grapefruit juice may increase the amount of Simvastatin/Niacin 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) while you are using Simvastatin/Niacin . Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Simvastatin/Niacin .
• If you take cholestyramine or colestipol, take Simvastatin/Niacin at least 4 to 6 hours after you take cholestyramine or colestipol.
• Take Simvastatin/Niacin on a regular schedule to get the most benefit from it. Taking Simvastatin/Niacin at the same time each day will help you remember to take it.
• Continue to take Simvastatin/Niacin even if you feel well. Do not miss any doses.
• If you miss a dose of Simvastatin/Niacin , 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. If you miss taking Simvastatin/Niacin for several days in a row, contact your doctor before you start to take it again. Your dose may need to be adjusted.

Ask your health care provider any questions you may have about how to use Simvastatin/Niacin .

Important safety information:

• Simvastatin/Niacin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Simvastatin/Niacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• For best results, Simvastatin/Niacin 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 take more than the recommended dose without checking with your doctor.
• Tell your doctor or dentist that you take Simvastatin/Niacin before you receive any medical or dental care, emergency care, or surgery. Simvastatin/Niacin may need to be stopped for a few days before surgery.
• Flushing may occur with Simvastatin/Niacin and can last for several hours. This effect may go away after several weeks of consistent use. If flushing wakes you at night and you feel faint or dizzy, sit up or stand slowly. This is especially important if you also take certain other medicines (eg, blood thinners, blood pressure medicines). Talk with your doctor if flushing becomes bothersome.
• Simvastatin/Niacin may cause serious muscle problems. Contact your doctor right away if you develop any unexplained muscle pain, tenderness, or weakness.
• Certain conditions may increase your risk for serious muscle problems. These may include dehydration; low blood pressure; major surgery or injury; severe infection; uncontrolled seizures; or serious metabolism, endocrine, or electrolyte problems. Contact your doctor right away if you develop one of these conditions.
• Diabetes patients - Simvastatin/Niacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.
• Simvastatin/Niacin has niacin in it. Before you start any new medicine, check the label to see if it has niacin or nicontinamide in it too. This includes vitamins and other supplements. If it does or you are not sure, check with your doctor or pharmacist.
• Women who may become pregnant should use effective birth control while taking Simvastatin/Niacin . Check with your doctor if you have questions about using birth control.
• Lab tests, including liver function tests, blood sugar, blood cholesterol tests, and creatine phosphokinase (CPK) blood levels, may be performed while you use Simvastatin/Niacin . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Simvastatin/Niacin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
• Simvastatin/Niacin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not take Simvastatin/Niacin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Simvastatin/Niacin is found in breast milk. Do not breast-feed while taking Simvastatin/Niacin .

Possible side effects of Simvastatin/Niacin :

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:

Back pain; constipation; diarrhea; flushing (eg, dizziness, itching, redness, tingling, warmth); headache; nausea; runny or stuffy nose; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in amount of urine produced; dark urine; fast or irregular heartbeat; fainting; fever; joint pain; memory problems; muscle pain, tenderness, or weakness; numbness or persistent tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea or stomach pain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual tiredness, discomfort, or weakness; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

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

General information:

• If you have any questions about Simvastatin/Niacin , please talk with your doctor, pharmacist, or other health care provider.
• Simvastatin/Niacin 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 Simvastatin/Niacin . 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.

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