GNH USA

Europe — EMA

Grofibrat 200

Learn about Grofibrat 200, a fenofibrate oral tablet for hypertriglyceridemia and mixed dyslipidemia, including uses, side effects, and precautions.

Fenofibrate

Request sourcing

1
Pack/s

What is Fenofibrate?

Grofibrat 200 is an oral tablet that contains the active ingredient fenofibrate, a fibrate class lipid‑lowering agent. Marketed in the European Union, this prescription product is formulated to help manage elevated blood lipid levels. Fenofibrate works by activating peroxisome proliferator‑activated receptor alpha (PPARα), which increases the breakdown of triglyceride‑rich lipoproteins and improves cholesterol profiles. It is prescribed as part of a treatment plan that includes diet, exercise, and lipid‑modifying therapies.

What is Fenofibrate used for?

Grofibrat 200 is indicated for several lipid disorders that increase cardiovascular risk and may be used when lifestyle changes and other medications have not achieved target lipid levels.

- Hypertriglyceridemia (elevated triglyceride levels) - Mixed dyslipidemia (elevated triglycerides with low HDL cholesterol) - Primary hypercholesterolemia when statin therapy alone is insufficient - Secondary dyslipidemia associated with diabetes or metabolic syndrome - Familial hyperlipoproteinemia type III (dysbetalipoproteinemia) as an adjunct therapy - Prevention of pancreatitis in patients with severe hypertriglyceridemia - Adjunct therapy in patients with combined hyperlipidemia who are intolerant to higher statin doses - Management of dyslipidemia in patients with coronary artery disease as part of secondary prevention

What are the side effects of Fenofibrate?

The safety profile of Grofibrat 200 reflects the typical adverse events reported for fenofibrate therapy; most are mild and reversible, while a few may require medical attention.

Common: - Gastrointestinal discomfort such as nausea, abdominal pain, or dyspepsia - Headache or dizziness - Elevated liver enzymes (transaminases) - Muscle pain or weakness (myalgia) - Dry mouth or increased thirst

Serious: - Severe muscle injury (rhabdomyysis) especially when combined with statins - Acute liver failure or severe hepatitis - Allergic reactions such as rash, pruritus, or angioedema - Kidney dysfunction or worsening renal impairment

What precautions apply to Fenofibrate?

When prescribing Grofibrat 200, clinicians consider several precautionary measures to minimize risk and ensure appropriate use.

- Assess liver function before initiating therapy and monitor periodically. - Evaluate renal function, especially in patients with chronic kidney disease. - Use caution in patients with a history of gallstones or biliary disease. - Avoid in individuals with known hypersensitivity to fenofibrate or other fibrates. - Consider dose adjustment or alternative therapy in patients taking statins to reduce risk of myopathy. - Pregnant or breastfeeding women should only use under specialist supervision due to limited safety data.

What does Fenofibrate interact with?

Grofibrat 200 can interact with other medicines; understanding these interactions helps prevent adverse effects.

Avoid: - Concurrent use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may increase fenofibrate levels. - Combination with gemfibrozil significantly raises risk of myopathy and should be avoided. - Use with warfarin may enhance anticoagulant effect and increase bleeding risk.

Use with caution: - Co‑administration with statins (especially high‑intensity) requires monitoring of muscle enzymes. - Concomitant use with bile‑acid sequestrants may reduce fenofibrate absorption; separate dosing times. - NSAIDs may increase risk of renal impairment when given together.

Frequently asked questions

What is the mechanism of action of Grofibrat 200?+
Grofibrat 200 contains fenofibrate, which activates peroxisome proliferator‑activated receptor alpha (PPARα). Activation of PPARα increases the breakdown of triglyceride‑rich lipoproteins and enhances clearance of very‑low‑density lipoprotein particles, thereby lowering blood triglyceride and cholesterol levels.
Which lipid disorders are treated with Grofibrat 200?+
It is prescribed for hypertriglyceridemia, mixed dyslipidemia, primary hypercholesterolemia when statins alone are insufficient, secondary dyslipidemia linked to diabetes or metabolic syndrome, and certain familial lipid disorders such as type III dysbetalipoproteinemia.
Can Grofibrat 200 be taken together with statin medications?+
Co‑administration is possible but requires careful monitoring for muscle toxicity. When used with high‑intensity statins, clinicians should check creatine kinase levels regularly and consider dose adjustments to reduce the risk of myopathy.
What laboratory tests should be monitored while on Grofibrat 200?+
Baseline and periodic assessments of liver enzymes (ALT, AST), renal function (serum creatinine, eGFR), and lipid profile (triglycerides, LDL‑C, HDL‑C) are recommended. Creatine kinase may be measured if the patient experiences muscle symptoms.
Is Grofibrat 200 safe for patients with chronic kidney disease?+
Renal function should be evaluated before starting therapy. Dose adjustment or alternative treatment may be needed for patients with moderate to severe renal impairment, as reduced clearance can increase drug exposure.
What are the most common side effects of Grofibrat 200?+
Typical adverse events include gastrointestinal upset (nausea, abdominal pain), headache, elevated liver enzymes, muscle aches (myalgia), and occasional dry mouth or increased thirst.
Which serious adverse reactions require immediate medical attention?+
Patients should seek urgent care if they develop severe muscle pain with weakness, dark urine (possible rhabdomyolysis), signs of liver failure such as jaundice, or allergic reactions like rash, swelling, or difficulty breathing.
How should Grofibrat 200 be stored?+
Store the tablets at room temperature, away from excess heat and moisture. Keep the container tightly closed and out of reach of children.
Can Grofibrat 200 be used during pregnancy or breastfeeding?+
Safety data are limited; the medication should only be used during pregnancy or lactation if the potential benefit justifies the potential risk and under specialist supervision.
What is the typical duration of therapy with Grofibrat 200?+
Treatment duration depends on the individual’s lipid goals and response. Many patients use the medication long‑term, with periodic reassessment of lipid levels and safety parameters.
Are there any foods or supplements that should be avoided while taking Grofibrat 200?+
Patients should avoid excessive alcohol, which can raise triglyceride levels, and discuss the use of over‑the‑counter supplements such as omega‑3 fatty acids or niacin, as they may affect lipid measurements or increase the risk of side effects.
What should be done if a dose of Grofibrat 200 is missed?+
If a dose is missed, the patient should take it as soon as they remember unless it is close to the time of the next scheduled dose. In that case, skip the missed dose and continue with the regular dosing schedule; do not double‑dose.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Fenofibrate
Route
Oral Use
Manufacturer
Gedeon Richter Polska Sp. Z. O.O.
Origin
EU

Related products