SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very small number of people taking atorvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor. Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks. This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine). This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting. 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/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, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. The manufacturer directs not to crush, dissolve, or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed, dissolved, or chewed. Follow your doctor's directions on how to take this medication. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or use this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. If you are taking a bile acid sequestrant (such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking the bile acid sequestrant. These medications may bind to ezetimibe/atorvastatin, preventing your body from fully absorbing the drug. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this 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 doctor's advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this product.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or atorvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, 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 this product. Ask your doctor or pharmacist for more information. Older adults may be more sensitive to the side effects of this drug, especially muscle problems. This medication must not be used during pregnancy. Atorvastatin may harm an unborn baby. It is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How To Use section. 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 doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: daptomycin, gemfibrozil. Other medications can affect the removal of atorvastatin from your body, which may affect how atorvastatin works. Examples include cyclosporine, glecaprevir plus pibrentasvir, telaprevir, telithromycin, ritonavir, among others. Do not take any red yeast rice products while you are taking ezetimibe/atorvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/atorvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.