Liptruzet

Liptruzet may cause serious side effects. See "Drug Precautions" section.

The most common side effects of Liptruzet include:

• muscle and body pain
• changes in your liver function tests

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Liptruzet. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Grapefruit and grapefruit juice may interact with this medication and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range of Liptruzet (ezetimibe/atorvastatin) is 10/10 mg/day to 10/40 mg/day.

The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40 mg/day in the evening.

If you take too much Liptruzet, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

Ezetimibe and atorvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, heart attack, stroke) caused by clogged blood vessels. It is also used to treat a condition called homozygous familial hypercholesterolemia (HoFH).

Ezetimibe is a cholesterol absorption inhibitor and atorvastatin is an HMG-CoA reductase inhibitor, or statin. These medicines will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.

This medicine was available only with your doctor's prescription.

The atorvastatin/ezetimibe combination (Liptruzet(R)) was withdrawn from the United States market on June 2, 2015.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, a major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Not able to pass urine or change in how much urine is passed.
• Trouble swallowing.
• Feeling very tired or weak.
• Very upset stomach or throwing up.
• Feeling confused.
• Memory problems or loss.
• Low mood (depression).
• This medicine may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call your doctor right away if you have muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call your doctor right away if you have muscle signs that last after your doctor has told you to stop taking this medicine.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Liptruzet, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Liptruzet. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Liptruzet.

Review Date: October 4, 2017

Take Liptruzet exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or dissolve a Liptruzet tablet. Swallow it whole.

While using this medicine, you may need frequent blood tests.

If you have major surgery or a severe injury or infection, make sure any doctor caring for you knows you are taking Liptruzet.

Store at room temperature away from moisture and heat. Keep Liptruzet tablets in the foil pouch or plastic case when not in use.

After opening a foil pouch, store it in a dry place protected from light. Discard any tablets not used within 30 days after opening the pouch.

Each time you take a tablet out of a blister card, place the card back into the plastic case.

Applies to atorvastatin / ezetimibe: oral tablet

Along with its needed effects, atorvastatin / ezetimibe may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atorvastatin / ezetimibe:

• Abdominal or stomach pain
• confusion
• difficult breathing
• difficulty with moving
• irregular heartbeat
• muscle, joint, or bone pain
• muscle stiffness
• muscle weakness
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• weakness or heaviness of the legs

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chills
• dark-colored urine
• diarrhea
• fever
• gaseous abdominal or stomach pain
• general tiredness and weakness
• hives, welts, or skin rash
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• severe nausea or vomiting
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the eyes, face, or inside of the nose
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes and skin

Some side effects of atorvastatin / ezetimibe may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• dizziness
• feeling of warmth
• pain or tenderness around the eyes and cheekbones
• redness of the face, neck, arms, and occasionally, upper chest
• stuffy or runny nose
• sudden sweating
• tightness in the chest

• Being forgetful
• bloating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• constipation
• discouragement
• fast heartbeat
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of memory
• pains in the stomach, side, or abdomen, possibly radiating to the back
• tiredness
• trouble concentrating
• trouble sleeping