Product image of Grofibrat 200 (Fenofibrate) supplied by GNH India

Grofibrat 200

Active Ingredient:
Fenofibrate
Origin:
EU

Grofibrat 200 (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.

Manufacturer / TM Owner

Gedeon Richter Polska Sp. Z. O.O.

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Indications & Clinical Uses

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

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

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.

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.

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.

Typical adverse events include gastrointestinal upset (nausea, abdominal pain), headache, elevated liver enzymes, muscle aches (myalgia), and occasional dry mouth or increased thirst.

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.

Store the tablets at room temperature, away from excess heat and moisture. Keep the container tightly closed and out of reach of children.

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.

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.

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.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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