Important Safety Information

CADUET® (amlodipine besylate/atorvastatin calcium) tablets are not for everyone, including anyone who has previously had an allergic reaction to CADUET or to any of the inactive ingredients. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant.

If you take CADUET, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects that can lead to kidney problems, including kidney failure. Tell your doctor about all your medical conditions and all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before starting CADUET and during your treatment if you have symptoms of liver problems.

If you have had any heart problems, be sure to tell your doctor. It is rare, but when you first start taking the amlodipine component of CADUET or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.

Tell your doctor if you have diabetes. Elevated blood sugar levels have been reported with statins, including the atorvastatin component of CADUET.

Serious side effects of CADUET include muscle problems, kidney problems and low blood pressure or dizziness.

Common side effects include swelling of your legs or ankles, dizziness, tiredness, extreme sleepiness, nausea, flushing (hot or warm feeling in your face), arrhythmia (irregular heartbeat), heart palpitations (very fast heartbeat), diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests.

Indication

CADUET® (amlodipine besylate/atorvastatin calcium) tablets are a prescription drug that combines two medicines, NORVASC® (amlodipine besylate) and LIPITOR® (atorvastatin calcium) tablets. CADUET is used in adults who need both NORVASC and LIPITOR.

NORVASC® (amlodipine besylate) is prescribed to treat high blood pressure (hypertension), chest pain (angina) and blocked arteries of the heart (coronary artery disease). NORVASC can be used by itself or with other medicines that treat high blood pressure.

LIPITOR® (atorvastatin calcium) is used along with a low-fat diet to lower the LDL (“bad” cholesterol) and triglycerides in the blood. It can raise the HDL (“good” cholesterol) as well. LIPITOR is used to lower the risk of heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL, or family history of early heart disease.

LIPITOR can also lower the risk of heart attack or stroke in patients with diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure.

CADUET is one of many options for treating high blood pressure and high cholesterol, in addition to diet and exercise that you and your doctor can consider.

Please see Full Prescribing Information and Patient Information.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use.Visit MedWatch or call 1-800-FDA-1088.

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