PATIENT INFORMATION

Amlodipine and Atorvastatin Tablets

Read the patient information that comes with amlodipine and atorvastatin tablets before you start taking them, and each time you get a refill. There may be new information. This information does not replace talking with your doctor about your condition or treatment. If you have any questions about amlodipine and atorvastatin tablets, ask your doctor or pharmacist.

What are amlodipine and atorvastatin tablets?

Amlodipine and atorvastatin tablets are a prescription drug that combines Norvasc® (amlodipine besylate) and Lipitor® (atorvastatin calcium) in one pill.

Amlodipine and atorvastatin tablets are used in adults who need both Norvasc and Lipitor.

Norvasc is used to treat:

• High blood pressure (hypertension) and
• Chest pain (angina) and
• Blocked arteries of the heart (coronary artery disease)

Lipitor is used to lower the levels of "bad" cholesterol and triglycerides in your blood. It can also raise the levels of "good" cholesterol.

Lipitor is also used to lower the risk for 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 levels of "good" cholesterol, heart disease in the family.

Lipitor can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:

• diabetic eye or kidney problems, smoking, or high blood pressure.

Amlodipine and atorvastatin tablets have not been studied in children.

Who should not use amlodipine and atorvastatin tablets?

Do not use amlodipine and atorvastatin tablets if you:

• Are pregnant or think you may be pregnant, or are planning to become pregnant. Amlodipine and atorvastatin tablets may harm your unborn baby. If you get pregnant, stop taking amlodipine and atorvastatin tablets and call your doctor right away.
• Are breastfeeding. Amlodipine and atorvastatin tablets can pass into your breast milk and may harm your baby. Do not breastfeed if you take amlodipine and atorvastatin tablets.
• Have liver problems.
• Are allergic to anything in amlodipine and atorvastatin tablets. The active ingredients are atorvastatin calcium and amlodipine besylate. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before taking amlodipine and atorvastatin tablets?

Tell your doctor about all of your health conditions, including, if you have:

• heart disease
• muscle aches or weakness
• diabetes
• thyroid problems
• kidney problems
• or drink more than 2 glasses of alcohol daily

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Amlodipine and atorvastatin tablets and some other medicines can interact, causing serious side effects. Especially tell your doctor if you take medicines for:

You can use nitroglycerin and amlodipine and atorvastatin tablets together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking amlodipine and atorvastatin tablets.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How should I take amlodipine and atorvastatin tablets?

• Take amlodipine and atorvastatin tablets once a day, exactly as your doctor tells you. Do not change your dose or stop amlodipine and atorvastatin tablets without talking to your doctor.
• Take amlodipine and atorvastatin tablets each day at any time of day, at about the same time each day. Amlodipine and atorvastatin tablets can be taken with or without food.
• Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
• Your doctor should start you on a low-fat diet before giving you amlodipine and atorvastatin tablets. Stay on this low-fat diet when you take amlodipine and atorvastatin tablets.
• If you miss a dose, take it as soon as you remember. Do not take amlodipine and atorvastatin tablets if it has been more than 12 hours since your missed dose. Just take the next dose at your regular time. Do not take 2 doses of amlodipine and atorvastatin tablets at the same time.
• If too much amlodipine and atorvastatin tablets are taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What should I avoid while taking amlodipine and atorvastatin tablets?

• Avoid getting pregnant. If you get pregnant, stop taking amlodipine and atorvastatin tablets right away and call your doctor.
• Do not breastfeed. Amlodipine and atorvastatin tablets can pass into your breast milk and may harm your baby.

What are possible side effects of amlodipine and atorvastatin tablets?

Amlodipine and atorvastatin tablets can cause serious side effects. These side effects happen only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or amlodipine and atorvastatin tablets are stopped. These serious side effects include:

• Muscle problems. Amlodipine and atorvastatin tablets can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with amlodipine and atorvastatin tablets.
• Liver problems. Your doctor should do blood tests to check your liver before you start taking amlodipine and atorvastatin tablets and if you have symptoms of liver problems while you take amlodipine and atorvastatin tablets. Call your doctor right away if you have the following symptoms of liver problems:
  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark amber colored urine
  • yellowing of your skin or the whites of your eyes
• Low blood pressure or dizziness
• Muscle rigidity, tremor and/or abnormal muscle movement

Call your doctor right away if:

• you have muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a rare muscle problem.
• muscle problems that do not go away even after your doctor has advised you to stop taking amlodipine and atorvastatin tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.
• allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away
• you have nausea and vomiting, stomach pain
• you are passing brown or dark-colored urine
• you feel more tired than usual
• your skin and white of your eyes get yellow
• you have allergic skin reactions
• Chest pain that does not go away or gets worse. Sometimes when you start amlodipine and atorvastatin tablets or increase your dose, chest pain can get worse or a heart attack can happen. If this happens, call your doctor or go to the emergency room right away.

Common side effects of amlodipine and atorvastatin tablets include:

• Diarrhea
• Swelling of your legs or ankles
• Nausea
• Upset stomach
• Muscle and joint pain
• Alterations in some laboratory blood tests

Additional side effects have been reported: tiredness, tendon problems, memory loss, and confusion.

Talk to your doctor or pharmacist about side effects that bother you or do not go away.

There are other side effects of amlodipine and atorvastatin tablets. Ask your doctor or pharmacist for a complete list.

How do I store amlodipine and atorvastatin tablets?

• Store amlodipine and atorvastatin tablets at room temperature, 68 to 77°F (20 to 25°C).
• Do not keep medicine that is out-of-date or that you no longer need.
• Keep amlodipine and atorvastatin tablets and all medicines out of the reach of children. Keep medicines in places where children cannot get it.

General information about amlodipine and atorvastatin tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use amlodipine and atorvastatin tablets for a condition for which it was not prescribed. Do not give amlodipine and atorvastatin tablets to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about amlodipine and atorvastatin tablets. If you want more information, talk with your doctor. Ask your doctor or pharmacist for information about amlodipine and atorvastatin tablets written for health professionals.

What is high blood pressure (hypertension)?

You have high blood pressure when the force of blood against the walls of your arteries stays high. This can damage your heart and other parts of your body. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

What is angina (chest pain)?

Angina is a pain that keeps coming back when part of your heart does not get enough blood. It feels like something is pressing or squeezing your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaw, or back.

What is cholesterol?

Cholesterol is a fat-like substance made in your body. It is also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol can clog your blood vessels.

What is a heart attack?

A heart attack occurs when heart muscle does not get enough blood. Symptoms include chest pain, trouble breathing, nausea, and weakness. Heart muscle cells may be damaged or die. The heart cannot pump well or may stop beating.

What is a stroke?

A stroke occurs when nerve cells in the brain do not get enough blood. The cells may be damaged or die. The damaged cells may cause weakness or problems speaking or thinking.

WHAT ARE THE INGREDIENTS IN AMLODIPINE AND ATORVASTATIN TABLETS?

Active ingredients: amlodipine besylate, atorvastatin calcium

Inactive ingredients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium stearate

Film coating: Opadry® II White 85F28751 (polyvinyl alcohol, titanium dioxide, PEG 3000, and talc) or Opadry® II Blue 85F10919 (polyvinyl alcohol, titanium dioxide, PEG 3000, talc, and FD&C blue # 2)

Distributed by:
Prasco Laboratories
Mason, OH 45040 USA

LAB-1465-1.0
Revised: January 2021