IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

AMLODIPINE/ATORVASTATIN - ORAL

(am-LOE-di-peen/a-TOR-va-STAT-in)

COMMON BRAND NAME(S): Caduet

USES: This product contains 2 medications: amlodipine and atorvastatin. Amlodipine is a calcium channel blocker and is used to treat high blood pressure or prevent chest pain (angina). It works by relaxing the blood vessels so that blood can flow more easily and the heart does not need to work so hard. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Preventing chest pain can help improve your ability to exercise. Atorvastatin is used along with a proper diet to help lower \"bad\" cholesterol and fats (such as LDL, triglycerides) and raise \"good\" cholesterol (HDL) in the blood. It belongs to a group of drugs known as \"statins.\" It works by reducing the amount of cholesterol made by the liver. Lowering \"bad\" cholesterol and triglycerides and raising \"good\" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication 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 dosage is based on your medical condition, response to treatment, age, 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). Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 1 hour before or at least 4 hours after taking these medications. These products can react with atorvastatin, preventing its full absorption. Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It may take up to 2 weeks before you get the full benefit of amlodipine, and up to 4 weeks before you get the full benefit of atorvastatin. It is important to continue taking this medication even if you feel well. Most people with high blood pressure or high cholesterol/triglycerides do not feel sick. If this product is used for chest pain, it must be taken regularly to be effective. It should not be used to treat chest pain when it occurs. Use other medications (such as nitroglycerin placed under the tongue) to relieve chest pain as directed by your doctor. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase, your chest pain occurs more often).

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet, tiredness, or flushing may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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. Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat. 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. Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). 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.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to amlodipine or atorvastatin; or to other calcium channel blockers (such as nifedipine); 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, certain structural heart problems (aortic/mitral stenosis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with atorvastatin. Ask your doctor or pharmacist for more information. To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Older adults may be more sensitive to the side effects of the drug, especially muscle problems and dizziness. This product must not be used during pregnancy. Atorvastatin may harm an unborn baby. Therefore, 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. Amlodipine passes into breast milk. It is unknown if atorvastatin 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: gemfibrozil, telaprevir, ritonavir. Other medications can affect the removal of atorvastatin from your body, which may affect how atorvastatin works. Examples include colchicine, saquinavir, telithromycin, certain azole antifungals (such as itraconazole, ketoconazole, posaconazole), among others. Do not take any red yeast rice products while you are taking amlodipine/atorvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking amlodipine/atorvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems. Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

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. Symptoms of overdose may include: severe dizziness, fainting, fast heartbeat.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose (within 12 hours), skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.