Simcor

Included as part of the PRECAUTIONS section.

• AbbVie Inc.

Serious side effects have been reported with Simcor including the following:

• heart problems. Use of Simcor may cause an increase in the following: coronary heart disease death, nonfatal heart attack, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures.
• a disease of muscle tissue (myopathy) and/or a breakdown of muscle tissue that releases a damaging protein into the blood (rhabdomyolysis). This is a condition in which muscle tissue breaks down, releasing proteins into the blood that can damage other organs, especially the kidney. The risk increases with higher doses. Tell your healthcare provider right away about any unexplained muscle pain, tenderness, or weakness.
• liver damage.  Your doctor will probably order a blood test to measure liver function before you start taking Simcor. 
• changes in your blood test values. Increases in blood sugar, increases in HbA1c, reduction in platelets (cells which help with clotting), increase in the time it takes your blood to clot (increase in prothrombin time), increase in uric acid, and decrease in phosphorus.

Do not take Simcor if you:

• are allergic to Simcor or any of its ingredients
• have active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• have active peptic ulcer disease
• have arterial bleeding
• use strong CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone
• use gemfibrozil, cyclosporine, danazol, verapamil or diltiazem
• are pregnant or may become pregnant
• are breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simcor falls into category X. It has been shown that women taking Simcor during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

If you take too much Simcor, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of simvastatin and niacin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of simvastatin and niacin combination in the elderly. However, elderly patients are more likely to have muscle problems, which may require caution in patients receiving this medicine.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Cyclosporine
• Danazol
• Darunavir
• Erythromycin
• Fosamprenavir
• Gemfibrozil
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Paritaprevir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Amiodarone
• Amlodipine
• Atorvastatin
• Azithromycin
• Bezafibrate
• Carbamazepine
• Ceritinib
• Cerivastatin
• Ciprofibrate
• Ciprofloxacin
• Clofibrate
• Colchicine
• Conivaptan
• Dabigatran Etexilate
• Dalfopristin
• Daptomycin
• Delavirdine
• Diltiazem
• Eltrombopag
• Eslicarbazepine Acetate
• Fenofibrate
• Fenofibric Acid
• Fluconazole
• Fusidic Acid
• Lomitapide
• Lovastatin
• Lumacaftor
• Niacin
• Pazopanib
• Pitavastatin
• Quinupristin
• Ranolazine
• Risperidone
• Rosuvastatin
• Simeprevir
• Simvastatin
• Tadalafil
• Verapamil
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albiglutide
• Alitretinoin
• Bosentan
• Clopidogrel
• Dasatinib
• Digoxin
• Dronedarone
• Efavirenz
• Fosphenytoin
• Interferon Beta
• Levothyroxine
• Oat Bran
• Oxcarbazepine
• Pectin
• Phenytoin
• Rifampin
• St John's Wort
• Ticagrelor
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry Juice
• Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Chinese ancestry or
• Hypothyroidism (an underactive thyroid), not well-controlled or
• Kidney disease, severe or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Bleeding, arterial (coming from an artery) or
• Liver disease, active or
• Liver enzymes, elevated or
• Peptic ulcer disease, active—Should not be used in patients with these conditions.

• Dehydration or
• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Epilepsy (seizures), not well-controlled or
• Hypotension (low blood pressure) or
• Major surgery or trauma, recent or
• Metabolic disorders, severe or
• Sepsis (severe infection in the blood)—Patients with these conditions may be at risk for muscle or kidney problems.

• Diabetes—This medicine may increase blood sugar levels.

• Gout—Use with caution. May make this condition worse.

• Tell all of your health care providers that you take Simcor. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow the diet and workout plan that your doctor told you about.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take colesevelam, colestipol, or cholestyramine within 4 hours of this medicine.
• Avoid grapefruit and grapefruit juice.
• Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease. Alcohol may cause more flushing.
• If you are Chinese and taking niacin products, talk with your doctor. You could have a greater risk of muscle problems.
• If you are 65 or older, use Simcor with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking Simcor.

You should not take Simcor if you are allergic to niacin or simvastatin, or if you have liver disease, stomach ulcer, or severe bleeding.

Do not use Simcor if you are pregnant.

Do not breast-feed while using this medicine.

The following drugs should not be used while you are taking Simcor: cyclosporine, danazol, nefazodone, gemfibrozil; clarithromycin, erythromycin, telithromycin; fluconazole, itraconazole, ketoconazole, posaconazole; amiodarone, diltiazem, verapamil; boceprevir, telaprevir; atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, or tipranavir.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

More frequent side effects include: myopathy and nausea. See below for a comprehensive list of adverse effects.