Niacin; Simvastatin Tablets

What is this medicine?

NIACIN; SIMVASTATIN (NYE a sin; SIM va stat in) is used in combination with a healthy diet to lower bad cholesterol and raise good cholesterol.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, break, or chew. Take this medicine in the evening with a low-fat snack. Do not take this medicine with grapefruit juice, hot beverages, or alcohol-containing beverages. If you also take cholestyramine or colestipol, take this medicine at least 4 to 6 hours after your cholestyramine or colestipol dose. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or palpitations

• confusion

• dark urine

• feeling faint or lightheaded, falls

• fever or chills

• joint pain

• loss of memory

• muscle cramps, pain

• nausea, vomiting

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.

• stomach pain and loss of appetite

• unusually weak

• yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• diarrhea

• headache

• heartburn

• stomach upset or bloating

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• boceprevir

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• certain antiviral medicines for HIV or AIDS

• cyclosporine

• danazol

• diltiazem

• gemfibrozil

• medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole

• mifepristone, RU-486

• nefazodone

• other niacin products

• red yeast rice

• telaprevir

• verapamil

This medicine may also interact with the following medications:

• alcohol

• amiodarone

• amlodipine

• dronedarone

• fluconazole

• grapefruit juice

• medicine for blood pressure or heart disease

• ranolazine

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems

• diabetes

• frequently drink alcoholic beverages

• kidney disease

• liver disease

• muscle aches or weakness

• ulcers of intestine or stomach

• an unusual or allergic reaction to niacin, simvastatin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or healthcare provider for regular checks on your progress. You may need regular tests to make sure your liver is working properly.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not drink hot drinks or alcohol at the same time you take this medicine. Hot drinks and alcohol can increase the flushing caused by this medicine, which can be uncomfortable.

This drug is only part of a total heart-health program. Your doctor or a dietician can suggest a low-cholesterol and low-fat diet to help. Avoid alcohol and smoking, and keep a proper exercise schedule.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Tell your doctor or healthcare provider right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness. Your doctor or healthcare provider may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your healthcare provider.

Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or an infant are possible. Talk to your doctor or pharmacist for more information.

If you are going to have surgery tell your doctor or healthcare provider that you are taking this drug.

Some drugs may increase the risk of side effects from this medicine. If you are given certain antibiotics or antifungals, your doctor or health care professional may stop this medicine for a short time. Check with your doctor or pharmacist for advice.

This medicine may cause a decrease in Co-Enzyme Q-10. You should make sure that you get enough Co-Enzyme Q-10 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare provider.