EZETIMIBE/SIMVASTATIN-ORAL (cont.)
SIDE EFFECTS: Headache may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly. This drug can sometimes cause muscle damage. Although uncommon, this may lead to very serious muscle damage called rhabdomyolysis, which in rare cases can be fatal. Seek immediate medical attention if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/abdominal pain, persistent nausea, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking ezetimibe/simvastatin, tell your doctor or pharmacist if you think you are allergic to it; or to other drugs called "statins"; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), poorly controlled diabetes, alcohol use. Developing severe muscle damage, which is rare, can sometimes lead to serious kidney problems (see the Side Effects section in this handout). This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before you stop taking your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis or severe metabolic, endocrine, or electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control to prevent pregnancy while taking this drug. One of these drugs (simvastatin) may cause harm to your unborn child. It is not known if either drug passes into breast milk. A drug similar to simvastatin passes into breast milk, and because of this drug's potential risk of undesirable effects on a nursing infant, breast-feeding is not recommended while using ezetimibe/simvastatin. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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