Lipanthyl Penta 145 Special Precautions

Secondary cause of hypercholesterolemia such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease or alcoholism should be treated before LIPANTHYL PENTA 145 therapy is considered.
Secondary causes of hyperlipidaemia may occur during pharmacological treatment with diuretics, beta-blockers, oestrogens, gestagens, combined oral contraceptives, immunosuppressants and protease inhibitors. In these cases, tests should be carried out to establish whether primary or secondary hyperlipidaemia is involved (these medicinal products may trigger a rise in lipid values).
Liver: As with other lipid-lowering drugs, increases have been reported in transaminase levels in some patients whilst taking fenofibrate. In the majority of the observed cases, the elevations were temporary, minor and asymptomatic. It is recommended that transaminase levels are monitored every 3 months during the first 12 months of treatment and regularly thereafter.
Patients displaying elevated transaminase levels should be closely monitored. Treatment should be discontinued if ASAT (SGOT) and ALAT (SGPT) levels increase to more than 3 times the upper limit of normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), and diagnosis is confirmed by laboratory testing, fenofibrate therapy should be discontinued.
Pancreas: Pancreatitis has been reported in patients taking fenofibrate (see Contraindications and Adverse Reactions). In patients with severe hypertriglyceridemia, this may be due to insufficient efficacy of the medicinal product, a direct drug effect or a secondary phenomenon mediated through cholelithiasis with obstruction of the common bile duct.
Muscle: Muscle toxicity including rare cases of rhabdomyolysis, with or without renal failure, has been reported with the administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in case of hypoalbuminaemia and previous renal insufficiency.
Patients with predisposing factors for myopathy and/or rhabdomyolysis, including age above 70 years, personal or family history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at increased risk of developing rhabdomyolysis. For these patients, the benefits and risks of fenofibrate therapy should be carefully weighed up.
Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in creatine phosphokinase (CPK) (levels exceeding five times the upper normal range). In such cases, the medicinal product should be stopped.
The risk of muscle toxicity may be elevated if this medicinal product is combined with another fibrate or with an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscle disease. Consequently, the combination of fenofibrate with an HMG-CoA reductase inhibitor or another fibrate should be reserved to patients with severe combined hyperlipidemia and high cardiovascular risk without any history of muscle disease and with close monitoring of potential muscle toxicity.
Renal function: LIPANTHYL PENTA 145 is contraindicated in severe renal impairment (see Contraindications).
LIPANTHYL PENTA 145 should be used with caution in patients with mild to moderate renal insufficiency. Dose adjustment is required in patients with an eGFR between 30 and 59 ml/min/1.73 m² (see Dosage & Administration).
Reversible elevations in serum creatinine have been reported in patients receiving fenofibrate monotherapy or co-administered with statins. Elevations in serum creatinine were generally stable over time with no evidence of continued increase with long-term therapy. A return to baseline values was observed following discontinuation of treatment.
During clinical trials, 10% of patients had a creatinine increase from baseline greater than 30 μmol with co-administered fenofibrate and simvastatin versus 4.4% with statin monotherapy. 0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values >200 μmol/l.
Treatment should be interrupted when the creatinine levels is 50% above the upper limit of normal. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.
Excipients: This medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials (the ACCORD lipid trial and FIELD study) in patients with type 2 diabetes mellitus.
Effects on the ability to drive and use machines: LIPANTHYL PENTA 145 has no or negligible effect on the ability to drive and use machines.