Amlodipine Besylate, Atorvastatin Calcium Oral tablet

What is this medicine?

AMLODIPINE; ATORVASTATIN (am LOE di peen; a TORE va sta tin) is a combination of 2 drugs. Amlodipine is a calcium-channel blocker used to lower high blood pressure. It also relieves chest pain caused by angina. Atorvastatin blocks the body's ability to make cholesterol. It can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol problem
• heart problems, including heart failure or aortic stenosis
• hormone disorder like diabetes or under-active thyroid
• infection
• kidney or liver disease
• low blood pressure
• recent surgery
• seizures (convulsions)
• severe injury
• an unusual or allergic reaction to Amlodipine; Atorvastatin, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take the tablets with or without food. Do not change the amount of grapefruit juice you drink from day to day while taking this drug, or avoid grapefruit juice altogether. Take your doses at regular intervals. Do not take your medicine more often then directed. Do not suddenly stop taking this medicine. Ask your doctor or health care professional how you can gradually reduce the dose.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• clofibrate
• fenofibrate
• gemfibrozil
• itraconazole
• other cholesterol medicines known as statins like fluvastatin, pravastatin and simvastatin
• telithromycin
• voriconazole
• red yeast rice

This medicine may also interact with the following medications:

• cyclosporine
• digoxin
• female hormones, like estrogens or progestins and birth control pills
• grapefruit juice
• medicines for fungal infections like fluconazole, itraconazole, ketoconazole, voriconazole
• medicines for high blood pressure
• niacin
• some antibiotics like clarithromycin, erythromycin, and troleandomycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need to have regular tests to make sure your liver is working properly.

Tell your doctor or health care professional as soon as you can if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

This medicine contains a cholesterol lowering agent, but is only part of a total cholesterol-lowering program. Your physician or dietitian can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule.

Check your blood pressure and pulse rate regularly. Ask your doctor or health care professional what your blood pressure and pulse rate should be and when you should contact him or her.

You may feel dizzy or lightheaded. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks. They can make you more dizzy, increase flushing and rapid heartbeats.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• chest pain
• dark urine
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• fever
• muscle pain, weakness
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• swelling of ankles, legs
• trouble passing urine or change in the amount of urine
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• facial flushing
• gas
• headache
• nausea, vomiting
• stomach upset or pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.