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:

•: Have liver problems (acute liver failure or decompensated cirrhosis).
•: Are allergic to anything in amlodipine and atorvastatin tablets. The active ingredients are atorvastatin calcium and amlodipine besylate. Stop using amlodipine and atorvastatin tablets and get medical help right away if you have symptoms of a serious allergic reaction including:
o: swelling of your face, lips, tongue or throat
o: problems breathing or swallowing
o: fainting or feeling dizzy
o: very rapid heartbeat
o: severe skin rash or itching
o: flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain

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 unexplained muscle aches or weakness
•: drink more than 2 glasses of alcohol daily
•: have heart disease
•: have diabetes
•: have thyroid problems
•: have kidney problems
•: had a stroke
•: are pregnant or plan to become pregnant. Amlodipine and atorvastatin tablets may harm your unborn baby. If you become pregnant, stop taking amlodipine and atorvastatin tablets and call your doctor right away.
•: are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take amlodipine and atorvastatin tablets or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take amlodipine and atorvastatin tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Amlodipine and atorvastatin tablets and certain other medicines can increase the risk of muscle problems or other side effects. Especially tell your doctor if you take medicines for:

your immune system

• cholesterol (gemfibrozil)

• infections (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and

voriconazole)

• birth control pills

• heart failure (digoxin)

• gout (colchicine)

• niacin

• fibrates

• viruses that treat HIV, AIDS, or hepatitis C (anti-virals)

o tipranavir plus ritonavir	o glecaprevir plus pibrentasvir
o ledipasvir plus sofosbuvir	o simeprevir
o saquinavir plus ritonavir	o darunavir plus ritonavir
o fosamprenavir	o fosamprenavir plus ritonavir
o elbasvir plus grazoprevir	o letermovir

o: nelfinavir

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.

Ask your doctor or pharmacist for a list of medicines if you are not sure. Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist when you get a new medicine.

How should I take amlodipine and atorvastatin tablets?

•: Take amlodipine and atorvastatin tablets exactly as your doctor tells you to take it.
•: Do not change your dose or stop amlodipine and atorvastatin tablets without talking to your doctor.
•: Your doctor may do blood tests to check your cholesterol levels during your treatment with amlodipine and atorvastatin tablets. Your dose of amlodipine and atorvastatin tablets may be changed based on these blood test results.
•: Take amlodipine and atorvastatin tablets each day at any time of 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 may start you on a cholesterol-lowering 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 you missed your last dose. Wait and take the next dose at your regular time. Do not take 2 doses of amlodipine and atorvastatin tablets at the same time. If you take too much amlodipine and atorvastatin tablets or overdose, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking amlodipine and atorvastatin tablets?

: Avoid drinking more than 1.2 liters of grapefruit juice each day.

What are possible side effects of amlodipine and atorvastatin tablets?

Amlodipine and atorvastatin tablets can cause serious side effects including:

•: Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and, rarely, cause kidney damage that can lead to death.

Tell your doctor right away if you have:

o: unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take amlodipine and atorvastatin tablets.
o: muscle problems that do not go away after your doctor has told you to stop taking amlodipine and atorvastatin tablets. Your doctor may do further tests to diagnose the cause of your muscle problems.

Your chances of getting muscle problems are higher if you:

o: are taking certain other medicines while you take amlodipine and atorvastatin tablets
o: drink large amounts of grapefruit juice
o: are 65 years of age or older
o: have thyroid problems (hypothyroidism) that are not controlled
o: have kidney problems
o: are taking higher doses of 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:
o: feel tired or weak
o: nausea or vomiting
o: loss of appetite
o: upper belly pain
o: dark amber colored urine
o: yellowing of your skin or the whites of your eyes
•: Low blood pressure or dizziness
•: Muscle rigidity, tremor and/or abnormal muscle movement
•: Increase in blood sugar level. Your blood sugar level may increase while you are taking amlodipine and atorvastatin tablets.

Exercise regularly and make healthy food choices to maintain healthy body weight.

Call your doctor right away if:

•: 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 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:

• nasal congestion, sore throat, runny nose	• muscle and joint pain
• diarrhea	• pain in extremity
• urinary tract infection	• upset stomach
• nausea	• musculoskeletal pain
• muscle spasms	• trouble sleeping
• throat pain	• swelling of your legs or ankles

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°F to 77°F (20°C 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.

General information about the safe and effective use of amlodipine and atorvastatin tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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 symptoms that you have. It may harm them.

tablets. If you want more information about amlodipine and atorvastatin tablets, talk with your doctor. You can ask your pharmacist or doctor for information about amlodipine and atorvastatin tablets that is 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-1465-2.0
Revised: May 2024