Simvastatin

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective or appropriate for you. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

• Simvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL and triglycerides) and raise "good" cholesterol (HDL) in the blood.
• The medication belongs to a group of drugs known as "statins" and works by reducing the amount of cholesterol produced by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.
• In addition to committing to a healthy diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight and stopping smoking. Consult your medical provider for more details.

• Take this medication by mouth as directed by your medical provider, usually once daily in the evening.
• If you are using the tablet form of this medication, you may take it with or without food.
• If you are using the liquid form of this medication, take it on an empty stomach. Shake the bottle well for at least 20 seconds before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon, as you may not get the correct dose.
• The dosage is based on your medical condition, response to treatment, age and other medications you may be taking. Be sure to tell your medical provider and pharmacist about all the products you use, including prescription drugs, nonprescription drugs and herbal products.
• The usual maximum dose for this medication is 40 milligrams a day. If you have been instructed by your medical provider to take more than 40 milligrams, continue on that same dose. However, you should promptly talk with them about the risks and benefits of a higher dose.
• Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
• Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your medical provider instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your medical provider or pharmacist for more details.
• Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day and continue the medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.
• It is very important to continue to follow your medical provider's advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

• Remember that this medication has been prescribed because your medical provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not experience serious side effects.
• A potential side effect is atrial fibrillation. If you develop a rapid or irregular heart rate, chest pain, feeling lightheaded, or trouble breathing seek an evaluation at an ER immediately.
• This drug can potentially cause blood vessel disorders, including inflammation, or lung disease.
• This drug may precipitate or worsen myasthenia gravis.
• A very small number of people taking Simvastatin may experience mild memory problems or confusion. If these rare effects occur, talk to your medical provider.
• In rare cases, statins may cause or worsen diabetes. Talk to your medical provider about the benefits and risks.
• In rare cases, this drug may cause muscle problems that can lead to very serious conditions called rhabdomyolysis and autoimmune myopathy. Older adults and people of Chinese descent may be at higher risk. Tell your medical provider right away if you develop any of the following symptoms during treatment and if they last after your medical provider stops this drug: muscle pain, tenderness or weakness (especially with fever or unusual tiredness), or signs of kidney problems such as change in amount of urine or dark urine.

• In rare cases, this medication may cause liver problems. Tell your medical provider right away if you develop symptoms of liver problems, including:

  • Nausea or vomiting that doesn't stop
  • Yellowing eyes or skin
  • Dark urine
  • Stomach or abdominal pain

• A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • Rash
  • Itching or swelling, especially of the face/tongue/throat
  • Severe dizziness
  • Trouble breathing

• This is not a complete list of possible side effects. If you notice other effects not listed above, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

• Before taking Simvastatin, tell your medical provider or pharmacist if you are allergic to it or have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Go to your patient dashboard and request a callback for more details.
• Some dosage forms may contain propylene glycol, large amounts of which could potentially be toxic.
• Before using this medication, tell your medical provider or pharmacist your medical history—especially of liver disease, kidney disease or alcohol use.
• Before having surgery, tell your doctor or dentist about all the products you use—including prescription drugs, nonprescription drugs and herbal products.
• Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with Simvastatin. Ask your medical provider or pharmacist for more information.
• Older adults may be more sensitive to the side effects of this drug, especially muscle problems.
• During pregnancy, this medication should be used only when there is a clear need. It may harm an unborn baby. Discuss the risks and benefits with your medical provider.
• It is unknown whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your medical provider before breast-feeding.

• Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
• Keep a list of all the products you use—including prescription/nonprescription drugs and herbal products—and share it with your medical provider and pharmacist.
• Do not start, stop or change the dosage of any medicines without your medical provider's approval.
• Cyclosporine, Danazol, Daptomycin, Gemfibrozil and "blood thinners" such as Warfarin may interact with this drug.

• Certain medications can affect the removal of Simvastatin from your body, which may affect how the medication works. Some examples include:

  • Amiodarone
  • Amlodipine
  • Digoxin
  • Diltiazem
  • St. John's wort
  • Verapamil
  • Treosulfan
  • Certain azole antifungals such as Itraconazole, Ketoconazole, Posaconazole and Voriconazole
  • Cobicistat
  • Colchicine
  • Macrolide antibiotics such as Clarithromycin, Erythromycin, Azithromycin, Ciprofloxacin
  • Nefazodone
  • HIV protease inhibitors such as Nelfinavir
  • Ritonavir
  • Telithromycin
• People of Chinese descent should not take Niacin at doses used to lower cholesterol (1 gram or more) when taking this medication. Doing so may increase the risk of side effects—especially muscle problems. Talk with your medical provider for details.
• Do not take any red yeast rice products while you are taking Simvastatin, as some red yeast rice products may also contain a statin called Lovastatin. Taking Simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

If someone has overdosed and is experiencing serious symptoms—such as passing out or trouble breathing—call 911. If symptoms from taking this medication are less severe, call your local poison control center at 1-800-222-1222 right away.

Do not share this medication with others. Lab and/or medical tests (such as blood cholesterol/triglyceride levels and liver function) should be performed while you are taking this medication. Keep all medical and lab appointments. Consult your medical provider for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

• Store at room temperature away from light and moisture. Do not refrigerate or freeze. Do not store in the bathroom.
• Discard the suspension form of this medication one month after opening the bottle, even if there is medication left.
• Keep all medications away from children and pets.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more information.