Sandoz Fenofibrate E

Brand Name

Sandoz Fenofibrate E

Common Name

fenofibrate (crystals)

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Fenofibrate (crystals) belongs to the class of medications known as fibrates. It is used in addition to diet and exercise to treat certain types of high cholesterol levels.

Fenofibrate (crystals) reduces bad cholesterol (LDL [low-density lipoproteins] and VLDL [very low-density lipoproteins]) and triglycerides in your blood. It also increases good cholesterol (HDL [high-density lipoprotein]) levels. Bringing cholesterol levels in the blood into the desired range has been shown to reduce the risks associated with heart disease, such as heart attack.

Fenofibrate (crystals) may also be prescribed by your doctor in combination with a medication called ezetimibe that also lowers your cholesterol.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual adult dose of fenofibrate (crystals) is 145 mg once daily taken with or without food. The maximum recommended dose is 145 mg daily.

For seniors or people with reduced kidney function, the starting dose is 48 mg once daily with or without food.

Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

48 mg
Each white-to-off-white, biconvex, oblong tablet embossed with "F" on one side and "48" on the other contains 48 mg of fenofibrate. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, simethicone emulsion, and sodium lauryl sulphate.

145 mg
Each white-to-off-white, biconvex, oblong tablet embossed with "F" on one side and "145" on the other contains 145 mg of fenofibrate. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, simethicone emulsion, and sodium lauryl sulphate.

Who should NOT take this medication?

Do not take fenofibrate (crystals) if you:

• are allergic to fenofibrate or any ingredients of the medication
• are allergic to any other medication in the fibrate class (e.g., gemfibrozil, bezafibrate, clofibrate)
• are allergic to peanut or arachis oil, soya lecithin, or any related products
• are pregnant or breast-feeding
• are taking a "statin" cholesterol-lowering medication and have muscle problems
• have gallbladder disease
• have had a severe skin reaction to other fibrates (e.g., gemfibrozil, bezafibrate, clofibrate) or ketoprofen
• have pancreatitis
• have reduced liver function
• have severe reduced kidney function

Do not give this medication to children or adolescents less than 18 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• decreased interest in sexual activity
• diarrhea
• dizziness
• fatigue
• gas
• hair loss
• headache
• increased sensitivity of skin to sunlight
• joint pain
• nausea
• red, itchy skin
• skin rash
• stomach pain
• trouble sleeping
• vomiting
• weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of liver problems such as dark urine, general feeling of being unwell, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin
• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood cells: This medication can cause small, temporary decreases in red and white blood cell counts. Your doctor will check for this with blood tests during the first year of treatment.

Combination therapy: The use of fenofibrate and "statin" medications (e.g., atorvastatin, lovastatin, simvastatin) at the same time may increase the risk of side effects. Talk to your doctor about the risks and benefits of taking the two types of medications together.

Gallbladder disease: For some people, fenofibrate (crystals) aggravates gallbladder disease and can cause gallstones. If you have gallbladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience abdominal or stomach pain, gas, nausea, or bloating (especially after eating high-fat foods), contact your doctor.

Kidney function: People with reduced kidney function may be more at risk of certain side effects when taking fenofibrate (crystals). Depending on the degree of kidney function impairment, lower doses of fenofibrate (crystals) may be needed. People with severely reduced kidney function and those undergoing dialysis treatment should not take this medication.

Liver function: If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Fenofibrate (crystals) may cause decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Muscle problems: Treatment with this type of medication has been associated on rare occasions with muscle pain, usually in people with reduced kidney function. Contact your doctor as soon as possible if you notice unexplained muscle pain, tenderness, or weakness, particularly if you have malaise (a general feeling of illness) or fever.

Pancreatitis: Fenofibrate can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience severe upper abdominal pain, fever, chills, nausea, or vomiting while taking this medication, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it and contact your doctor immediately.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking fenofibrate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are more likely to have reduced kidney function and may need lower doses of this medication.

What other drugs could interact with this medication?

There may be an interaction between fenofibrate (crystals) and any of the following:

• cholestyramine resin
• colchicine
• colestipol
• cyclosporine
• erlotinib
• everolimus
• ezetimibe
• lomitapide
• phenytoin
• raltegravir
• "statin" medications (e.g., atorvastatin, lovastatin, simvastatin)
• sulfonylurea diabetes medications (e.g., gliclazide, glyburide)
• tacrolimus
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Fenofibrate-E