FloLipid

What is FloLipid used for?

• FloLipid is used to slow the progress of heart disease.
• It is used to lower bad cholesterol and raise good cholesterol (HDL).
• FloLipid is also used to lower triglycerides.
• It is used to lower the chance of heart attack, stroke, and death in some people.
• FloLipid may be given to you for other reasons. Talk to your doctor.

Before taking FloLipid, tell your doctor:

• If you are allergic to FloLipid; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with FloLipid, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with FloLipid. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with FloLipid.
• If you have any of these health problems: Active liver disease or a rise in liver enzymes.
• If you are pregnant or may be pregnant. Do not take FloLipid if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take FloLipid.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take FloLipid with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take FloLipid?

• Tell all of your health care providers that you take FloLipid. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Follow the diet and workout plan that your doctor told you about.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease.
• Avoid grapefruit and grapefruit juice.
• If you are Chinese, talk with your doctor. You could have a greater risk of muscle problems.
• If you are 65 or older, use FloLipid with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking FloLipid.
• If you are pregnant or you get pregnant while taking FloLipid, call your doctor right away.

How is FloLipid best taken?

Use FloLipid as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take in the evening.
• Take on an empty stomach.
• Shake well for at least 20 seconds before each use.
• Measure liquid doses carefully. Use the measuring device that comes with FloLipid. If there is none, ask the pharmacist for a device to measure FloLipid.
• Do not use a household teaspoon or tablespoon to measure FloLipid. Doing so could lead to the dose being too high.
• Keep taking FloLipid as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of FloLipid that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A heartbeat that does not feel normal.
• Not able to pass urine or change in how much urine is passed.
• 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 FloLipid.
• 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.

What are some other side effects of FloLipid?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stomach pain.
• Upset stomach.
• Constipation.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out FloLipid?

• Store at room temperature. Do not refrigerate or freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat.
• After opening, throw away any part not used after 30 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about FloLipid, 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 FloLipid 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to FloLipid. 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 this medicine.