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.

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 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 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.

Keep 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 get better or if it gets worse (for example, your blood pressure readings remain high or increase, your chest pain occurs more often).

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 last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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.

Tell your doctor right away if you have any serious side effects, including:

• 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 last 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. Tell your doctor right away if you develop symptoms of liver problems, including:

• nausea/vomiting that doesn't stop
• yellowing eyes/skin
• dark urine
• stomach/abdominal pain

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.

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 (cannabis) 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 (cannabis).

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.

Older adults may be more sensitive to the side effects of the drug, especially muscle problems and dizziness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

Amlodipine passes into breast milk. It is unknown if atorvastatin passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 glecaprevir plus pibrentasvir, telithromycin, 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).

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, fast heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as blood cholesterol/triglyceride levels, liver function) should be done while you are taking this product. Keep all medical and lab appointments. 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.

If you miss a dose, take it as soon as you remember. If it is within 12 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

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.

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).