Ezetimibe; Simvastatin tablets

What is this medication?

EZETIMIBE; SIMVASTATIN (ez ET i mibe; SIM va stat in) blocks the body's ability to absorb and make cholesterol. It is used to lower cholesterol. It is only for patients whose cholesterol level is not controlled by diet.

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

COMMON BRAND NAME(S): Vytorin

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

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

• Diabetes.
• Frequently drink alcoholic beverages.
• Kidney or liver disease.
• Muscle aches or weakness.
• An unusual or allergic reaction to ezetimibe, simvastatin, other medicines, foods, dyes, or preservatives.
• Pregnant or trying to get pregnant.
• Breast-feeding.

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine in the evening 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. While this drug may be prescribed for children as young as 10 years, 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 medicine with any of the following:

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

This medicine may also interact with the following medications:

• Alcohol.
• Certain medicines for blood pressure or heart disease like amlodipine, diltiazem, verapamil.
• Certain medicines for irregular heartbeat like amiodarone and dronedarone.
• Certain medicines 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 healthcare 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 doctor or healthcare provider for regular check-ups. You may need regular tests to make sure your liver is working properly.

Tell your doctor or healthcare provider right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness. Your doctor or healthcare provider may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care professional.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

This drug is only part of a total heart-health program. Your doctor or a dietitian 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 healthcare provider that you are taking this drug.

Some drugs may increase the risk of side effects from this medicine. If you are given certain antibiotics or antifungals, your doctor or healthcare provider may stop this medicine for a short time. Check with your doctor or pharmacist for advice.

This medicine may cause a decrease in Co-Enzyme Q-10. You should make sure that you get enough Co-Enzyme Q-10 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare provider.

What side effects may I notice from receiving this medication?

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.
• Confusion.
• Dark yellow or brown urine.
• Depression.
• Fever.
• Loss of memory.
• Muscle pain, tenderness, cramps, or weakness.
• Redness, blistering, peeling or loosening of the skin, including inside the mouth.
• Signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• Trouble passing urine or change in the amount of urine.
• Unusually weak.
• Yellowing of the skin or eyes.

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

• Constipation.
• Gas.
• Headache.
• Heartburn.
• Indigestion.
• 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.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

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.