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What are simvastatin tablets?

SIMVASTATIN (Zocor®) blocks the body’s ability to make cholesterol. Simvastatin can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet. Generic simvastatin tablets are available.

What should I tell my health care provider before I take this medicine?

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

• an alcohol problem
• any hormone disorder (such as diabetes, under-active thyroid)
• blood salt imbalance
• infection
• kidney disease
• liver disease
• low blood pressure
• muscle disorder or condition
• recent surgery
• seizures (convulsions)
• severe injury
• an unusual or allergic reaction to simvastatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take simvastatin tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If you take the tablets once a day, it is best to take your dose in the evening hours (like with the evening meal) or at bedtime. You may take this medicine with or without food. Do not take simvastatin with grapefruit juice; orange juice may be used instead. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

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 drug(s) may interact with simvastatin?

Do not take Simvastatin with any of the following:

• amprenavir
• atazanavir
• clarithromycin
• delavirdine
• erythromycin
• grapefruit juice
• indinavir
• itraconazole
• ketoconazole
• lopinavir; ritonavir
• mibefradil
• nefazodone
• nelfinavir
• red yeast rice
• ritonavir
• saquinavir

Simvastatin may also interact with the following medications:

• alcohol
• amiodarone
• barbiturates (examples: phenobarbital, butalbital, primidone)
• bosentan
• carbamazepine
• cyclosporine
• danazol
• digoxin
• diltiazem
• efavirenz
• fluconazole
• medicines to lower cholesterol or triglycerides (examples: fenofibrate, gemfibrozil, niacin)
• medicine used to stop early pregnancy (mifepristone, RU-486)
• nicardipine
• oxcarbazepine
• phenytoin
• rifampin, rifabutin, or rifapentine
• St. John’s Wort
• telithromycin
• troleandomycin
• verapamil
• voriconazole
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking simvastatin?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

• dark yellow or brown urine
• decreased urination, difficulty passing urine
• fever
• muscle pain, tenderness, cramps, or weakness
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• skin rash, itching
• unusual tiredness or weakness
• yellowing of the skin or eyes

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

• constipation
• headache
• upset stomach, indigestion, gas, heartburn

What should I watch for while taking simvastatin?

Visit your prescriber or health care professional for regular checks on your progress. You may need to have blood tests drawn to make sure your liver is working properly.

Tell your prescriber or health care professional as soon as you can if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

Some medicines increase the risk of muscle side effects while taking simvastatin. Discuss your drug regimen with your health care provider if you are prescribed certain antibiotics or antifungals which are not recommended to be taken with simvastatin (examples: clarithromycin, erythromycin, itraconazole, ketoconazole). Your prescriber may decide to temporarily stop taking simvastatin while you are taking a short course of the antibiotic or antifungal therapy. Alternatively, your health care provider may prescribe another antibiotic or antifungal medicine for your condition.

Simvastatin is only part of a total cholesterol-lowering program. Your physician or dietician can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

If you are going to have surgery tell your prescriber or health care professional that you are taking simvastatin.

This medicine should not be used by women who are pregnant or breast-feeding. There is a potential for serious side effects to an unborn child or to an infant. Talk to your health care professional or pharmacist for more information.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

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What is/are Zocor?

SIMVASTATIN is known as a HMG-CoA reductase inhibitor or ’statin’. It lowers the level of cholesterol and triglycerides in the blood. This drug may also reduce the risk of heart attack, stroke, or other health problems in patients with risk factors for heart or blood vessel disease. Diet and lifestyle changes are often used with this drug. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care providers before I take this medicine?

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

frequently drink alcoholic beverages
kidney disease
liver disease
muscle aches or weakness
other medical condition
an unusual or allergic reaction to simvastatin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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 medicine?

Do not take this medicine with any of the following:

medicines for fungal infections like itraconazole, ketoconazole
nefazodone
other medicines for high cholesterol
red yeast rice
some antibiotics like clarithromycin, erythromycin, telithromycin
some medicines for HIV infection like amprenavir, indinavir, ritonavir

This medicine may also interact with the following:

alcohol
amiodarone
cyclosporine
danazol
diltiazem
grapefruit juice
fluconazole
verapamil
voriconazole
warfarin

This list may not describe all possible interactions. Give your health care providers 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 side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
dark urine
fever
joint pain
muscle cramps, pain
redness, blistering, peeling or loosening of the skin, including inside the mouth
trouble passing urine or change in the amount of urine
unusually weak or tired
yellowing of the eyes or skin

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

constipation
heartburn
stomach gas, pain, upset

This list may not describe all possible side effects.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check-ups. You may need regular tests to make sure your liver is working properly.

Tell you doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

This drug is only part of a total heart-health program. Your doctor or a dietician can suggest a low-cholesterol and low-fat diet to help. Avoid alcohol and smoking, and keep a proper exercise schedule.

Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

If you are going to have surgery tell your health care professional that you are taking this drug.

Some drugs may increase the risk of side effects from simvastatin. If you are given certain antibiotics or antifungals, your doctor or health care professional may stop simvastatin for a short time. Check with your doctor or pharmacist for advice.

Where should I keep this medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.