What is this medication?

SIMVASTATIN (SIM va sta tin) treats high cholesterol and reduces the risk of heart attack and stroke. It works by decreasing the bad cholesterol and fats (such as LDL, triglycerides), and increasing good cholesterol (HDL) in your blood. It belongs to a group of medications called statins. Changes to diet and exercise are often combined with this medication.

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

COMMON BRAND NAME(S): FloLipid

What should I tell my care team before I take this medication?

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

• Diabetes (high blood sugar)
• If you often drink alcohol
• Kidney disease
• Liver disease
• Muscle cramps, pain
• Stroke
• Thyroid disease
• An unusual or allergic reaction to simvastatin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 10 for selected conditions, precautions do apply.

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 medication?

Do not take this medication with any of the following:

• Antiviral medications for HIV or AIDS
• Certain antibiotics like clarithromycin, erythromycin, telithromycin
• Certain medications for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole
• Conivaptan
• Cyclosporine
• Danazol
• Gemfibrozil
• Idelalisib
• Mifepristone, RU-486
• Nefazodone
• Supplements like red yeast rice

This medication may also interact with the following:

• Alcohol
• Certain medications for blood pressure or heart disease like amlodipine, diltiazem, verapamil
• Certain medications for irregular heart beat like amiodarone and dronedarone
• Certain medications that treat or prevent blood clots like warfarin
• Colchicine
• Digoxin
• Grapefruit juice
• Lomitapide
• Niacin
• Ranolazine

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 medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Your health care provider may tell you to stop taking this medication if you develop muscle problems. If your muscle problems do not go away after stopping this medication, contact your health care provider.

Do not become pregnant while taking this medication. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medication.

This medication may increase blood sugar. Ask your health care provider if changes in diet or medications are needed if you have diabetes.

If you are going to need surgery or other procedure, tell your health care provider that you are using this medication.

Taking this medication is only part of a total heart healthy program. Your health care provider may give you a special diet to follow. Avoid alcohol. Avoid smoking. Ask your health care provider how much you should exercise.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness, fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness, fatigue
• Muscle injury—unusual weakness, fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Redness, blistering, peeling or loosening of the skin, including inside the mouth

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

• Constipation
• Headache
• Nausea
• Stomach pain

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Do not refrigerate. Avoid exposure to extreme heat. Get rid of any unused medication 30 days after opening.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.