Niacin (Vitamin B3), Simvastatin Oral tablet

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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
• 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

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

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

• certain antibiotics like clarithromycin, erythromycin, telithromycin
• certain medicines for HIV, AIDS
• medicines for fungal infections like fluconazole, itraconazole, ketoconazole
• nefazodone
• other cholesterol medicines like gemfibrozil
• other niacin products
• red yeast rice

This medicine may also interact with the following medications:

• alcohol
• amiodarone
• cyclosporine
• danazol
• diltiazem
• grapefruit juice
• medicine for blood pressure or heart disease
• verapamil
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional 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.

If you are diabetic, close monitoring of your blood sugars can help your blood fat levels. This medicine may change the way your diabetic medicine works, and sometimes will require that your dosages be adjusted. Check with your doctor or health care professional.

Tell you doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

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

If you are going to have surgery tell your doctor or health care professional that you are taking this drug.

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
• dark urine
• feeling faint or lightheaded, falls
• fever or chills
• high blood sugar, ask your doctor for symptoms
• joint pain
• muscle cramps, pain
• nausea, vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• stomach pain and loss of appetite
• unusually weak or tired
• 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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.