GNH USA

Europe — EMA

Grofibrat M

Grofibrat M is an oral fenofibrate medication for hypercholesterolemia, hypertriglyceridemia, and mixed dyslipidemia, detailing uses, side effects, precautions, and drug interactions.

Fenofibrate

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What is Fenofibrate?

Grofibrat M is an oral prescription medication that contains the active ingredient fenofibrate. It is marketed in the European Union as a generic fibrate, supplied in tablet form (strength not specified). Fenofibrate belongs to the fibrate class and works as a lipid‑lowering agent by activating PPARα, helping to reduce elevated cholesterol and triglyceride levels. It is prescribed for patients with abnormal lipid profiles and is taken under medical supervision.

What is Fenofibrate used for?

Grofibrat M is indicated for the management of several lipid disorders in adults, particularly when dietary measures alone have not achieved target levels.

- Treatment of primary hypercholesterolemia to lower LDL‑cholesterol levels. - Reduction of elevated triglyceride concentrations in hypertriglyceridemia. - Management of mixed dyslipidemia with combined high cholesterol and triglycerides. - Adjunctive therapy for patients at risk of cardiovascular events when lifestyle measures are inadequate. - Use in combination with statins for enhanced lipid control under physician guidance. - Treatment of secondary dyslipidemia associated with diabetes mellitus. - Management of lipid abnormalities in metabolic syndrome.

What are the side effects of Fenofibrate?

Like other fibrates, Grofibrat M may cause a range of adverse effects. Most are mild, dose‑related, and reversible, but patients should be aware of the typical symptoms that can arise during therapy. Patients should report any persistent or worsening symptoms to their healthcare provider, especially if they involve muscle pain, weakness, or signs of liver dysfunction.

Common: - Mild gastrointestinal discomfort such as nausea or abdominal pain - Headache - Elevated liver enzymes (transient) - Muscle cramps - Dizziness - Fatigue - Sleep disturbances - Dry mouth

Serious: - Severe muscle injury (rhabdomyolysis) - Significant liver injury - Allergic reactions including rash or angioedema - Acute kidney injury (rare) - Blood clotting abnormalities (rare) - Severe pancreatitis (very rare)

What precautions apply to Fenofibrate?

Precautions for Grofibrat M focus on patient selection, monitoring, and conditions that may increase the risk of adverse events. Before starting therapy, clinicians should evaluate liver and kidney function, review concomitant medications, and consider the patient’s overall cardiovascular risk profile.

- Check liver enzymes and kidney function; avoid in severe hepatic impairment. - Monitor lipid profile, liver tests, and creatinine regularly while on therapy. - Use caution if patient has gallstones or biliary disease. - Avoid if known hypersensitivity to fenofibrate or other fibrates. - Pregnancy and breastfeeding safety are unknown; prescribe only when benefits outweigh risks.

What does Fenofibrate interact with?

Grofibrat M can interact with several medicines, affecting its efficacy or increasing toxicity. Recognizing these interactions helps clinicians manage therapy safely. Interactions may alter drug concentrations, increase the risk of muscle damage, affect coagulation, or modify lipid outcomes, so dose adjustments or additional monitoring may be required.

Avoid: - Concurrent use with gemfibrozil, as it markedly raises fenofibrate plasma levels and risk of myopathy. - Co‑administration with strong CYP3A4 inhibitors (e.g., ketoconazole) that can increase exposure.

Use with caution: - Statins (especially simvastatin) – monitor for muscle toxicity. - Warfarin – may enhance anticoagulant effect; monitor INR. - Oral contraceptives – may slightly increase triglyceride levels; observe lipid response.

Frequently asked questions

What condition does Grofibrat M treat?+
Grofibrat M is used to lower elevated cholesterol and triglyceride levels in adults with hypercholesterolemia, hypertriglyceridemia, or mixed dyslipidemia.
How does fenofibrate work to lower lipids?+
Fenofibrate activates the peroxisome proliferator‑activated receptor alpha (PPARα), which increases the breakdown of triglyceride‑rich lipoproteins and enhances clearance of cholesterol from the bloodstream.
Is Grofibrat M available without a prescription?+
No. Grofibrat M is classified as a prescription‑only medication (Rx) in the European Union.
Can Grofibrat M be taken with a statin?+
It can be co‑prescribed with a statin, but clinicians should monitor for signs of muscle toxicity such as pain or weakness.
What laboratory tests are recommended while using Grofibrat M?+
Baseline and periodic monitoring of liver enzymes, renal function (creatinine), and lipid profile are recommended to assess efficacy and safety.
Should patients avoid alcohol while on Grofibrat M?+
Alcohol can increase the risk of liver irritation; patients are advised to limit alcohol intake and discuss consumption with their healthcare provider.
What are common side effects of Grofibrat M?+
Common side effects include mild gastrointestinal upset, headache, transient elevation of liver enzymes, muscle cramps, dizziness, fatigue, sleep disturbances, and dry mouth.
What serious adverse reactions require immediate medical attention?+
Severe muscle injury (rhabdomyolysis), significant liver injury, allergic reactions such as rash or angioedema, acute kidney injury, blood clotting abnormalities, and pancreatitis are considered serious and should be reported promptly.
Is Grofibrat M safe during pregnancy or breastfeeding?+
Safety in pregnancy and lactation has not been established; it should only be used if the potential benefits outweigh the risks and under medical supervision.
How should Grofibrat M be stored?+
Store the tablets at room temperature, away from moisture and heat, and keep them out of reach of children.
Can Grofibrat M interact with oral contraceptives?+
Yes, it may slightly increase triglyceride levels; lipid response should be monitored when used together.
What should I do if I miss a dose of Grofibrat M?+
If a dose is missed, take it as soon as remembered unless it is close to the time of the next scheduled dose; do not double‑dose. Consult a healthcare professional for personalized guidance.
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

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