Europe — EMA
Grofibrat 200
Learn about Grofibrat 200, a fenofibrate oral tablet for hypertriglyceridemia and mixed dyslipidemia, including uses, side effects, and precautions.
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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?+
Which lipid disorders are treated with Grofibrat 200?+
Can Grofibrat 200 be taken together with statin medications?+
What laboratory tests should be monitored while on Grofibrat 200?+
Is Grofibrat 200 safe for patients with chronic kidney disease?+
What are the most common side effects of Grofibrat 200?+
Which serious adverse reactions require immediate medical attention?+
How should Grofibrat 200 be stored?+
Can Grofibrat 200 be used during pregnancy or breastfeeding?+
What is the typical duration of therapy with Grofibrat 200?+
Are there any foods or supplements that should be avoided while taking Grofibrat 200?+
What should be done if a dose of Grofibrat 200 is missed?+
Product details
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