What are the main uses of Fenofibrate 48 mg tablets. How does Fenofibrate work to lower cholesterol levels. What are the potential side effects and interactions of Fenofibrate. How should Fenofibrate be taken for optimal results.

Understanding Fenofibrate: A Powerful Cholesterol-Lowering Medication

Fenofibrate is a prescription medication that belongs to a class of drugs known as fibric acid derivatives. It is primarily used to treat various types of cholesterol problems, including mixed dyslipidemia, severe hypertriglyceridemia, and primary hypercholesterolemia. Available in both oral tablet and capsule forms, Fenofibrate works by increasing the breakdown and removal of harmful cholesterol from the body, thereby reducing the risk of serious health complications such as heart attacks and strokes.

How does Fenofibrate work to lower cholesterol levels?

Fenofibrate operates by activating a specific protein called peroxisome proliferator-activated receptor alpha (PPAR-alpha). This activation leads to increased production of enzymes that break down triglycerides and LDL cholesterol. Additionally, Fenofibrate enhances the production of HDL cholesterol, often referred to as “good” cholesterol. By targeting multiple aspects of lipid metabolism, Fenofibrate effectively improves overall cholesterol profiles in patients with various lipid disorders.

Fenofibrate 48 mg: Dosage and Administration

The 48 mg dosage of Fenofibrate is commonly prescribed for patients with high cholesterol levels. It’s essential to take this medication exactly as directed by your healthcare provider. Typically, Fenofibrate is taken once daily with or without food. To maximize its effectiveness, it’s recommended to take Fenofibrate at the same time each day.

Can the dosage of Fenofibrate be adjusted?

Yes, the dosage of Fenofibrate can be adjusted based on individual patient response and tolerability. Your doctor may start with a lower dose and gradually increase it to achieve optimal cholesterol-lowering effects. Regular blood tests will be conducted to monitor your lipid levels and determine if any dose adjustments are necessary.

Primary Uses of Fenofibrate 48 mg Tablets

Fenofibrate 48 mg tablets are primarily prescribed for three main types of cholesterol problems:

• Mixed dyslipidemia: A condition characterized by high levels of LDL cholesterol and triglycerides, coupled with low levels of HDL cholesterol.
• Severe hypertriglyceridemia: This refers to very high levels of triglycerides in the blood, which can increase the risk of pancreatitis and cardiovascular disease.
• Primary hypercholesterolemia: A condition marked by very high levels of LDL cholesterol, often due to genetic factors.

By addressing these lipid disorders, Fenofibrate helps reduce the risk of atherosclerosis, heart disease, and other cardiovascular complications associated with abnormal cholesterol levels.

Potential Side Effects of Fenofibrate

While Fenofibrate is generally well-tolerated, it can cause both mild and serious side effects. It’s crucial to be aware of these potential reactions and report any concerning symptoms to your healthcare provider promptly.

What are the most common side effects of Fenofibrate?

The more common side effects of Fenofibrate include:

• Headache
• Back pain
• Nausea
• Indigestion
• Stuffy or runny nose
• Stomach pain

These side effects are usually mild and may resolve on their own within a few days or weeks. However, if they persist or worsen, it’s important to consult your doctor.

Are there any serious side effects associated with Fenofibrate?

Yes, Fenofibrate can potentially cause serious side effects, including:

1. Liver problems: Symptoms may include yellowing of the skin or eyes, dark urine, abdominal pain, and unexplained weakness.
2. Severe allergic reactions: Signs include swelling of the face, lips, tongue, or throat, difficulty breathing, and skin rashes.
3. Muscle problems: Fenofibrate can cause myopathy, leading to muscle pain, tenderness, or weakness.
4. Rhabdomyolysis: A severe condition where muscle breakdown can lead to kidney damage.

If you experience any of these serious side effects, seek medical attention immediately.

Interactions and Precautions with Fenofibrate

Fenofibrate can interact with various medications and medical conditions, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications, supplements, and medical conditions before starting Fenofibrate therapy.

Which medications may interact with Fenofibrate?

Fenofibrate may interact with several medications, including:

• Blood thinners (e.g., warfarin)
• Other cholesterol-lowering medications (e.g., statins)
• Immunosuppressants (e.g., cyclosporine)
• Certain diabetes medications
• Bile acid sequestrants

These interactions can potentially increase the risk of side effects or reduce the effectiveness of either medication. Your doctor may need to adjust dosages or monitor you more closely if you’re taking any of these drugs concurrently with Fenofibrate.

Maximizing the Benefits of Fenofibrate Treatment

To get the most out of your Fenofibrate treatment, it’s important to combine medication use with lifestyle modifications. These changes can enhance the cholesterol-lowering effects of Fenofibrate and improve overall cardiovascular health.

How can lifestyle changes complement Fenofibrate therapy?

Consider incorporating the following lifestyle modifications to maximize the benefits of Fenofibrate:

• Adopt a heart-healthy diet low in saturated fats and rich in fruits, vegetables, and whole grains
• Engage in regular physical activity, aiming for at least 150 minutes of moderate-intensity exercise per week
• Maintain a healthy weight or work towards weight loss if overweight or obese
• Quit smoking and limit alcohol consumption
• Manage stress through relaxation techniques or mindfulness practices

By combining these lifestyle changes with Fenofibrate therapy, you can significantly improve your lipid profile and reduce your risk of cardiovascular disease.

Monitoring and Follow-up During Fenofibrate Treatment

Regular monitoring is essential when taking Fenofibrate to ensure its effectiveness and detect any potential side effects early. Your healthcare provider will likely schedule periodic check-ups and blood tests to assess your progress and make any necessary adjustments to your treatment plan.

How often should lipid levels be checked while taking Fenofibrate?

Typically, your doctor will recommend checking your lipid levels 4 to 8 weeks after starting Fenofibrate therapy. Subsequently, lipid panels may be performed every 3 to 6 months, depending on your individual response to treatment and overall health status. These regular check-ups allow for timely dose adjustments and ensure that you’re achieving optimal cholesterol control.

In addition to lipid levels, your healthcare provider may also monitor liver function tests and creatinine kinase levels to detect any potential liver or muscle-related side effects. It’s crucial to attend all scheduled appointments and follow your doctor’s recommendations for monitoring and follow-up care.

Long-term Considerations for Fenofibrate Users

Fenofibrate is often prescribed as a long-term medication to manage chronic lipid disorders. As such, it’s important to consider the long-term implications of Fenofibrate use and discuss any concerns with your healthcare provider.

Is it safe to take Fenofibrate indefinitely?

For many patients, long-term use of Fenofibrate is safe and effective when taken as prescribed and monitored regularly. However, the need for continued therapy should be reassessed periodically based on your lipid levels, overall health, and risk factors for cardiovascular disease. Your doctor may consider adjusting or discontinuing Fenofibrate if your cholesterol levels remain well-controlled over an extended period or if you experience persistent side effects.

It’s important to maintain open communication with your healthcare provider throughout your Fenofibrate treatment journey. Discuss any concerns, side effects, or changes in your health status promptly to ensure that your treatment plan remains optimal for your individual needs.

Alternative Treatments and Combination Therapy

While Fenofibrate is an effective medication for managing lipid disorders, it may not be suitable for everyone. In some cases, alternative treatments or combination therapy may be recommended to achieve optimal cholesterol control.

What are some alternatives to Fenofibrate for cholesterol management?

Alternative treatments for managing cholesterol levels include:

• Statins: Another class of cholesterol-lowering medications that work by inhibiting cholesterol production in the liver
• Bile acid sequestrants: Medications that bind to bile acids in the intestines, indirectly lowering cholesterol levels
• Niacin: A B vitamin that can help raise HDL cholesterol and lower triglycerides
• PCSK9 inhibitors: Injectable medications that can significantly lower LDL cholesterol levels
• Omega-3 fatty acid supplements: May help lower triglyceride levels in some patients

Your healthcare provider will consider factors such as your specific lipid profile, medical history, and risk factors when determining the most appropriate treatment approach for you.

Can Fenofibrate be used in combination with other cholesterol-lowering medications?

Yes, Fenofibrate can be used in combination with other cholesterol-lowering medications, particularly statins, to achieve more comprehensive lipid control. This combination therapy may be especially beneficial for patients with mixed dyslipidemia or those who have not achieved adequate cholesterol reduction with a single medication.

However, combining Fenofibrate with certain other medications, such as high-dose statins, may increase the risk of muscle-related side effects. Your doctor will carefully consider the potential benefits and risks of combination therapy and monitor you closely for any adverse reactions.

Patient Education and Self-Management

Empowering patients with knowledge about their condition and treatment is crucial for successful cholesterol management. Understanding the importance of medication adherence, recognizing potential side effects, and adopting healthy lifestyle habits are all key components of effective self-management.

How can patients actively participate in their cholesterol management?

Patients can take an active role in their cholesterol management by:

• Educating themselves about their specific lipid disorder and treatment options
• Adhering to their prescribed medication regimen and reporting any missed doses to their healthcare provider
• Keeping a record of their cholesterol levels and tracking progress over time
• Monitoring for potential side effects and promptly reporting any concerns to their doctor
• Implementing and maintaining lifestyle modifications to support cholesterol control
• Attending regular check-ups and follow-up appointments as scheduled
• Asking questions and seeking clarification about their treatment plan when needed

By actively engaging in their care, patients can significantly improve their chances of achieving and maintaining optimal cholesterol levels, reducing their risk of cardiovascular complications in the long term.

In conclusion, Fenofibrate 48 mg tablets offer an effective treatment option for patients with various lipid disorders. When used as prescribed and in combination with appropriate lifestyle modifications, Fenofibrate can significantly improve cholesterol profiles and reduce the risk of cardiovascular disease. However, it’s essential to be aware of potential side effects, drug interactions, and the importance of regular monitoring. By working closely with their healthcare providers and taking an active role in their treatment, patients can maximize the benefits of Fenofibrate therapy and achieve better overall health outcomes.

Side Effects, Dosage, Uses, and More

Highlights for fenofibrate

1. Fenofibrate oral tablet is available as brand-name drugs and as a generic drug. Brand names: Fenoglide, Tricor, and Triglide.
2. Fenofibrate comes in two forms: oral tablet and oral capsule.
3. Fenofibrate oral tablet is used to treat high cholesterol levels. It’s mainly used to treat severe high triglycerides (a type of bad cholesterol).

Serious liver damage warning: Fenofibrate can cause serious liver damage. This can occur within the first few weeks of treatment or after several months of treatment. It can require a liver transplant and may be life threatening. Symptoms of liver damage include dark urine, an upset stomach or stomach pain, muscle pain, feeling tired, or yellowing of your skin or eyes. Contact your doctor immediately if you experience any of these symptoms.

Severe allergic reaction warning: Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life threatening. Some reactions can occur days or weeks after starting this drug. Among the possible reactions are Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms, an issue that is called DRESS. Call 911 or go to the emergency room right away if you have a rash, swelling of your face, tongue, or throat, or trouble breathing.

Severe muscle problems warning: This medication can cause severe muscle problems, including myopathy, which can cause muscle pain, tenderness, or weakness. Myopathy can also lead to rhabdomyolysis. This condition causes muscle to break down, and it can cause kidney damage and even death. If you notice unusual pain or weakness in your muscles, call your doctor right away, especially if you feel more tired than usual or have a fever. Your doctor may decide to stop your treatment with this medication. Call your doctor right away if muscle problems last after you have stopped taking this drug.

Fenofibrate is a prescription drug. It comes in two forms: oral tablet and oral capsule.

The oral tablet is available as the brand-name drugs Fenoglide, Tricor, and Triglide. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Fenofibrate may be used as part of a combination therapy. This means you may need to take it with other cholesterol drugs, such as statins.

Why it’s used

Fenofibrate is used to improve cholesterol levels in three types of cholesterol problems:

• Mixed dyslipidemia: high levels of LDL (bad) cholesterol and triglycerides, and low levels of HDL (good) cholesterol
• Severe hypertriglyceridemia: very high levels of triglycerides
• Primary hypercholesterolemia: very high levels of LDL cholesterol

Fenofibrate helps lower high levels of harmful cholesterol, mainly triglycerides. It also helps increase levels of HDL (good) cholesterol.

How it works

Fenofibrate belongs to a class of drugs called fibric acid derivatives. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Fenofibrate works by increasing the breakdown and removal of bad cholesterol from your body. This helps reduce the risk of cholesterol building up in your blood vessels and causing serious health problems, such as heart attack or stroke.

Fenofibrate oral tablet can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking fenofibrate. This list does not include all possible side effects.

For more information on the possible side effects of fenofibrate, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects that can occur with use of fenofibrate include:

• headache
• back pain
• nausea
• indigestion
• stuffy or runny nose
• stomach pain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver problems. Symptoms can include:
  • yellowing of your skin or the whites of your eyes
  • dark-colored urine
  • pain in the abdomen (stomach area)
  • decreased appetite
  • unexplained or unusual weakness
• Severe allergic reactions. Symptoms can include:
  • swelling of the face, eyes, lips, tongue, hands, arms, feet, ankles, or lower legs
  • trouble breathing or swallowing
  • rash
  • peeling or blistering skin

Fenofibrate oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with fenofibrate. This list does not contain all drugs that may interact with fenofibrate.

Before taking fenofibrate, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Blood-thinning drug

Warfarin is a drug that’s used to thin the blood. Taking it with fenofibrate raises your risk of bleeding. If you take these drugs together, your doctor may do blood tests more often or change your dosage of warfarin.

Cholesterol drugs

Taking fenofibrate with certain cholesterol drugs called bile acid sequestrants may make it harder for your body to absorb fenofibrate. To prevent this, you should take fenofibrate 1 hour before taking the bile acid sequestrant, or 4–6 hours after taking it. Examples of bile acid sequestrants include:

• cholestyramine
• colesevelam
• colestipol

Also, taking fenofibrate with cholesterol drugs called statins raises your risk of rhabdomyolysis. This is a serious condition that breaks down muscle. Examples of statin drugs include:

• atorvastatin
• fluvastatin
• lovastatin
• pitavastatin
• pravastatin
• rosuvastatin
• simvastatin

Diabetes drugs

Taking fenofibrate with certain diabetes drugs called sulfonylureas raises your risk of low blood sugar. Examples of these drugs include:

• glimepiride
• glipizide
• glyburide

Gout drug

Colchicine is a drug used to treat gout. Taking it with fenofibrate raises your risk of muscle pain.

Immunosuppressants

Taking fenofibrate with certain drugs that suppress your body’s immune response can increase the level of fenofibrate in your body. This raises your risk of side effects from fenofibrate. Examples of these drugs include:

• cyclosporine
• tacrolimus

The fenofibrate dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using fenofibrate to treat
• your age
• the form of fenofibrate you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Generic: Fenofibrate

• Form: oral tablet
• Strengths: 40 mg, 48 mg, 54 mg, 107 mg, 120 mg, 145 mg, 160 mg

Brand: Fenoglide

• Form: oral tablet
• Strengths: 40 mg, 120 mg

Brand: Tricor

• Form: oral tablet
• Strengths: 48 mg, 145 mg

Brand: Triglide

• Form: oral tablet
• Strength: 160 mg

Dosage for primary hypercholesterolemia and mixed dyslipidemia

Adult dosage (ages 18 years and older)

Brand-name drugs

• Fenoglide: 120 mg per day.
• Tricor: 145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 120–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for severe hypertriglyceridemia

Adult dosage (ages 18 years and older)

Brand-name drugs:

• Fenoglide: 40–120 mg per day.
• Tricor: 48–145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 40–120 mg per day or 48–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special dosage considerations

For people with kidney disease: If you have mild kidney disease, you may need a lower dose of fenofibrate.

This drug comes with several warnings.

Muscle pain warning

This drug raises your risk of muscle pain and a serious muscle problem called rhabdomyolysis. The risk is higher if you take the drug along with statins.

Liver damage warning

Fenofibrate can cause abnormal results in tests of liver function. These abnormal results can indicate liver damage. This drug can also cause other liver damage and inflammation after years of use.

Gallstones warning

Fenofibrate raises your risk of gallstones.

Pancreatitis warning

Fenofibrate raises your risk of pancreatitis (inflammation of the pancreas).

Severe allergic reaction warning

Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life-threatening. Some reactions can occur days or weeks after starting this drug. These include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. This last type of reaction is often called DRESS.

Symptoms of a severe reaction can include:

• rash, especially if it appears suddenly
• peeling or blistering skin
• nausea and vomiting
• trouble breathing
• itching
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with liver disease: Fenofibrate can cause liver problems, which could lead to liver failure. Let your doctor know if you have a history of liver disease. Your doctor can tell you if fenofibrate is safe for you. If you have active liver disease, you should not take fenofibrate.

For people with kidney disease: Fenofibrate may cause abnormal results from tests of kidney function. These changes are typically temporary and not harmful. To be safe, your doctor may monitor your kidney function more often. If you have severe kidney disease, you should not take fenofibrate.

Warnings for other groups

For pregnant women: There haven’t been enough studies done in humans to show if fenofibrate poses a risk to a human fetus. Research in animals has shown a risk to the fetus when the mother takes the drug. However, animal studies don’t always predict the way humans would respond.

Talk with your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: Fenofibrate may pass into breast milk and cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

Fenofibrate oral tablet is used for long-term treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your cholesterol levels may not be controlled. This raises your risk of serious health problems such as heart disease, heart attack, or stroke.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• headache
• back pain
• nausea
• muscle pain
• diarrhea
• common cold
• upper respiratory tract infection

If you think you’ve taken too much of the drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Your cholesterol levels should improve. You won’t feel fenofibrate working, but your doctor will check your cholesterol levels using blood tests. Your doctor may adjust your dosage based on the results of these tests.

Keep these considerations in mind if your doctor prescribes fenofibrate for you.

General

• Fenofibrate tablets should be taken with food. This can help increase the amount of drug your body absorbs.
• Take this drug at the time(s) recommended by your doctor.
• Don’t cut or crush the tablets.

Storage

• Store Fenoglide and Tricor tablets at room temperature between 59°F and 86°F (15°C and 30°C).
• Store generic fenofibrate tablets and Triglide tablets between 68°F and 77°F (20°C and 25°C).
• Don’t store these medications in moist or damp areas, such as bathrooms.
• Keep Triglide in its moisture-protective container until you’re ready to take it.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will monitor your health during your treatment with this drug. They’ll do blood tests to help make sure your cholesterol levels are within the range your doctor feels is best for you. The tests will also tell if your medication is working.

Also, your doctor will likely monitor certain health issues. This can help make sure you stay safe while taking this drug. These issues include:

• Kidney function. Blood tests can check how well your kidneys are working. If your kidneys aren’t working well, your doctor may lower your dosage of this drug.
• Liver function. Blood tests can check how well your liver is working. If your tests are abnormal, it may mean that fenofibrate is causing damage to your liver. Your doctor may switch you to a different medication.
• Lipid levels. Blood tests can check how well this drug is lowering your cholesterol and triglycerides. Your doctor may change your therapy based upon these results.

Your diet

In addition to taking this drug, you should follow a heart-healthy diet to help control your cholesterol levels. Talk with your doctor about a diet plan that’s right for you.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Fenofibrate Viatris Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.

”>Why am I using FENOFIBRATE VIATRIS?

FENOFIBRATE VIATRIS contains the active ingredient fenofibrate. FENOFIBRATE VIATRIS
is used to help regulate cholesterol and triglycerides which are fat-like substances
in the blood.
For more information, see Section 1. Why am I using FENOFIBRATE VIATRIS? in the full CMI.

What should I know before I use FENOFIBRATE VIATRIS?

Do not use if you have ever had an allergic reaction to fenofibrate or any of the
ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use FENOFIBRATE VIATRIS? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with FENOFIBRATE VIATRIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I use FENOFIBRATE VIATRIS?

The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor
may prescribe a lower dose if you have kidney problems.

More instructions can be found in Section 4. How do I use FENOFIBRATE VIATRIS? in the full CMI.

What should I know while using FENOFIBRATE VIATRIS?

For more information, see Section 5. What should I know while using FENOFIBRATE VIATRIS? in the full CMI.

Are there any side effects?

For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.

Active ingredient(s):
fenofibrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using FENOFIBRATE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using FENOFIBRATE VIATRIS.

Where to find information in this leaflet:

1. Why am I using FENOFIBRATE VIATRIS?

2. What should I know before I use FENOFIBRATE VIATRIS?

3. What if I am taking other medicines?

4. How do I use FENOFIBRATE VIATRIS?

5. What should I know while using FENOFIBRATE VIATRIS?

6. Are there any side effects?

7. Product details

Why am I using FENOFIBRATE VIATRIS?

FENOFIBRATE VIATRIS contains the active ingredient fenofibrate. FENOFIBRATE VIATRIS belongs to a group of medicines known as fibric acid derivatives.

FENOFIBRATE VIATRIS works through the activation of a cell nuclear receptor called
PPARα, which reduces the amount of triglycerides and bad cholesterol made in the body
and increases the good cholesterol.

Cholesterol is present in many foods and is also made in your body by the liver. If
your body does not balance the amount of cholesterol it needs with the amount of cholesterol
eaten, then your cholesterol becomes too high.

High cholesterol is more likely to occur with certain diseases or if you have a family
history of high cholesterol.

When you have high levels of cholesterol it may ‘stick’ to the inside of your blood
vessels instead of being carried to the parts of the body where it is needed.

Over time, this can form hard areas (called plaque) on the walls of your blood vessels,
making it more difficult for the blood to flow. This blocking of your blood vessels
can lead to heart disease (such as heart attack and angina), and stroke.

Cholesterol is carried through the body by different proteins, LDL and HDL. LDL cholesterol
is the ‘bad’ cholesterol that can block your blood vessels. HDL cholesterol is the
‘good’ cholesterol that is thought to remove the ‘bad’ cholesterol from the blood
vessels.

In most patients, FENOFIBRATE VIATRIS reduces the bad cholesterol and can actually
raise the good cholesterol.

Patients with type 2 diabetes may have some level of diabetic retinopathy, a complication
of diabetes that may lead to vision loss or impairment. FENOFIBRATE VIATRIS has been
shown to slow the progression of diabetic retinopathy in patients diagnosed with this
condition.

FENOFIBRATE VIATRIS does not reduce the cholesterol that comes from fat in food.

Therefore, when you are taking FENOFIBRATE VIATRIS, you also need to follow a low
fat diet and other measures, such as exercise and weight control.

FENOFIBRATE VIATRIS is used to help regulate cholesterol and triglycerides which are
fat-like substances in the blood.

What should I know before I use FENOFIBRATE VIATRIS?

Warnings

Do not use FENOFIBRATE VIATRIS if:

you are allergic to fenofibrate, any fibrates (such as gemfibrozil) or any of the
ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.

Always check the ingredients to make sure you can use this medicine.

you are taking another fibrate.

you are allergic to peanuts, peanut oil, soy lecithin or related products.

it after the expiry date printed on the pack or if the packaging is damaged or shows
signs of tampering.

Check with your doctor if you:

have any other medical conditions:

liver disease

severe kidney disease

disease of the gallbladder or pancreas

experienced muscle pain, tenderness or weakness from other medicines used to treat
high cholesterol or triglycerides.

take any medicines for any other condition.

have any allergies to any other medicines, foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

It may affect your developing baby if you take it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

The active ingredient in FENOFIBRATE VIATRIS passes into breast milk and there is
a possibility your baby may be affected.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines may interfere with FENOFIBRATE VIATRIS and affect how it works.

oral anti-coagulants (medicines used to prevent blood clots)

other cholesterol regulating medicines including fibrates

ciclosporin (a medicine which suppresses the immune system)

glitazones (medicines to reduce sugar levels)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FENOFIBRATE VIATRIS.

How do I use FENOFIBRATE VIATRIS?

How much to take

The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor
may prescribe a lower dose if you have kidney problems.

Swallow the tablet(s) whole with a full glass of water.

Follow the instructions provided and use FENOFIBRATE VIATRIS until your doctor tells
you to stop.

When to take FENOFIBRATE VIATRIS

FENOFIBRATE VIATRIS can be taken at any time of the day, with or without food. Any
dietary measures started before treatment with FENOFIBRATE VIATRIS should be continued.

If you forget to use FENOFIBRATE VIATRIS

FENOFIBRATE VIATRIS should be used regularly at the same time each day. If you miss
your dose at the usual time, take it as soon as you remember, and then go back to
taking your medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of getting an unwanted side effect.

If you use too much FENOFIBRATE VIATRIS

If you think that you have used too much FENOFIBRATE VIATRIS, you may need urgent
medical attention.

You should immediately:

phone the Poisons Information Centre
(Australia telephone 13 11 26) or advice, or

contact your doctor, or

go to the Emergency Department at your nearest hospital.

Symptoms of an overdose may include:

diarrhoea

nausea

You should do this even if there are no signs of discomfort or poisoning.

What should I know while using FENOFIBRATE VIATRIS?

Things you should do

Have your blood fats checked when requested by your doctor to make sure FENOFIBRATE
VIATRIS is working.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking FENOFIBRATE VIATRIS.

Call your doctor straight away if you:

become pregnant while you are taking this medicine.

Remind any doctor, surgery, dentist or pharmacist you visit that you are using FENOFIBRATE
VIATRIS.

Things you should not do

Do not stop using this medicine suddenly.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.

Do not give this medicine to anyone else, even if they have the same condition as
you.

Do not give FENOFIBRATE VIATRIS to anyone under the age of 18 years.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FENOFIBRATE
VIATRIS affects you.

FENOFIBRATE VIATRIS may cause dizziness in some people

Drinking alcohol

Tell your doctor if you drink alcohol.

Drinking large quantities of alcohol may increase your chance of FENOFIBRATE VIATRIS
causing liver problems.

Things that may help you reduce the chance of coronary heart disease

Lowering high cholesterol can help reduce your chances of having Coronary Heart Disease
(CHD). However, your chances of having CHD may be increased by several other factors
including high blood pressure, cigarette smoking, diabetes, excess weight, family
history of CHD, being a male and being a woman who has reached menopause.

Some self-help measures suggested below may help your condition and help reduce your
chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures
and for more information.

Diet – continue the healthy diet recommended by your doctor, dietician or pharmacist.

Weight – your doctor may advise you to lose weight if you are overweight.

Exercise – make exercise a part of your routine – walking is good. Ask your doctor
for advice before starting exercise.

Smoking – your doctor will advise you to stop smoking.

Looking after your medicine

Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the box or the blister pack they may not keep well.

Keep the medicine in a cool, dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:

in the bathroom or near a sink, or

in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.

Do not use this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.

Product details

This medicine is only available with a doctor’s prescription.

What FENOFIBRATE VIATRIS contains