Important Uses and Safety Information You Should Know About SIMCOR

Uses

• SIMCOR^® (simvastatin/niacin extended-release) is a prescription medication that is used when treatment with simvastatin alone or niacin extended-release alone is not enough, and when a diet low in saturated fat and cholesterol and other non-drug measures alone have not been successful.
  
  
• SIMCOR is used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol, and triglycerides and to increase HDL "good" cholesterol.
  
  
• No additional benefit of SIMCOR on heart disease over and above that shown for simvastatin alone and niacin alone has been demonstrated.
  
  

Important Safety Information

• SIMCOR should not be used if you have liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing; and if you are allergic to any product ingredient.
  
  
• Contact your health care provider if symptoms of unexplained muscle pain, tenderness, or weakness occur, as this may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred. This risk is increased when SIMCOR is taken with certain types of medications.
  
  
• Tell your health care provider about any other medications, including vitamins, or nutritional supplements you are taking.
  
  
• SIMCOR is associated with increases in liver enzymes as measured by blood tests. Your health care provider should do blood tests before and during treatment with SIMCOR to check for liver problems. SIMCOR should be used with caution if you consume large amounts of alcohol or have a history of liver disease.
  
  
• SIMCOR may cause an increase in blood sugar levels. If you have diabetes or higher than normal blood sugar levels, you should carefully check blood sugar levels during treatment especially during the first few months of SIMCOR use and report any changes to your health care provider.
  
  
• Tell your health care provider if you have a history of kidney problems or gout.
  
  
• Women of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR. If you are pregnant, stop SIMCOR and contact your health care provider.
  
  
• Flushing (warmth, redness, itching, and/or tingling of the skin) is a common side effect that may subside after several weeks of consistent use. Additional symptoms may include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling. Flushing may vary in severity and is more likely to occur when starting therapy or during dose increases. By taking SIMCOR at bedtime, flushing will most likely occur during sleep. If flushing wakes you up, take your time getting up, especially if feeling dizzy, faint, or taking blood pressure medications.
  
  
• Other common side effects include headache, itching, nausea, back pain, and diarrhea.

This is the most important information to know about SIMCOR. For more information, talk with your health care provider. Please click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

Reference:

SIMCOR [package insert]. North Chicago, IL: Abbott Laboratories.