Simvastatin

Simvastatin is used to

• reduce the risk of heart attack and stroke in patients at high risk of these developing
• decrease the amount of cholesterol (a fat-like substance)

Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing how much cholesterol your body makes. This lowers the amount of cholesterol that can build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Simvastatin comes as a tablet and as a suspension to take by mouth. Take tablets once a day in the evening. Take the suspension once a day in the evening on an empty stomach. Take simvastatin at around the same time every day.

Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake suspension well for at least 20 seconds before each use.

If you will be taking the simvastatin suspension, do not use a household teaspoon to measure your dose. To make sure you receive the correct dose, use a properly marked measuring device such as a medicine spoon or oral syringe. Ask your pharmacist if you need help getting or using a measuring device.

Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks.

Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking simvastatin,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with simvastatin. Other medications may cause dosing changes or extra monitoring when taken with simvastatin. Make sure you have discussed any medications you are currently taking or plan to take before starting simvastatin with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking simvastatin, please get the advice of your doctor or pharmacist.
• the following nonprescription product may interact with simvastatin: niacin. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking simvastatin. Do not start this medication while taking simvastatin without discussing with your healthcare provider.
• tell your doctor if you have liver disease. Your doctor will order blood tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take simvastatin if you have liver disease or if the tests show that you may be developing liver disease.
• tell your doctor if you drink more than two alcoholic beverages per day, if you are 65 years of age or older, or if you are Asian, especially if you are Chinese. Also tell your doctor if you have or have ever had an underactive thyroid gland, diabetes, seizures, muscle aches or weakness, low blood pressure, or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking simvastatin, call your doctor immediately. Simvastatin can harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking simvastatin.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking simvastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking simvastatin.
• ask your doctor about the safe use of alcoholic beverages while you are taking simvastatin. Alcohol can increase the risk of serious side effects.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at https://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for a missed one.

Simvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• stomach pain
• nausea
• headache
• memory loss or forgetfulness
• confusion
• itchy or red skin

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help.

• muscle pain, tenderness, or weakness with or without fever or lack of energy; tiredness, or weakness; fever or chills
• dark-colored urine that may look red; yellowing of the skin or eyes; pain in the upper right part of the stomach; loss of appetite
• decreased urination
• flushing
• blisters
• rash, hives, itching; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; hoarseness
• joint pain
• sensitivity to light

This medication may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature. Do not freeze or refrigerate the suspension. Be sure to use the suspension within 30 days of opening the bottle and discard any remaining medication after 30 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests during your treatment, especially if you develop symptoms of liver damage.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking simvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Flolipid^®
• Zocor^®

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• Simcor^® (containing Niacin, Simvastatin)^¶
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