Product Information

Ezetimibe and Simvastatin tablet

What is this medicine?

EZETIMIBE; SIMVASTATIN blocks the body's ability to absorb and make cholesterol. This product can help lower blood cholesterol. It helps patients whose cholesterol level is not controlled by diet alone.

What should my health care professional know before I receive 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 reaction to Ezetimibe; Simvastatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take the tablets by mouth. Swallow the tablets with a drink of water. 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 the tablet 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.

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. Take only one dose per day. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following:

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

This medicine 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 should I watch for while taking this medicine?

This drug 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.

Visit your prescriber or health care professional for regular checks on your progress. You will need to have regular tests 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 (examples: clarithromycin, erythromycin, itraconazole, ketoconazole). Your prescriber may decide to temporarily stop taking ezetimibe; 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.

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

What side effects may I notice from receiving this medicine?

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

• 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

This list may not describe all possible side effects.

Where can I keep my medicine?

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

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