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Secondary causes of hyperlipidemia: Secondary cause of hypercholesterolemia/hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated.
For hyperlipidaemic patients taking estrogens or contraceptives containing oestrogens it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen).
Liver function: As with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases these elevations were transient, minor and asymptomatic. It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment and thereafter periodically. Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if ASAT (SGOT) and ALAT (SGPT) levels increase to more than 3 times the upper limit of the normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), laboratory tests are to be conducted for verification and diagnosis is confirmed by laboratory testing, discontinuation of fenofibrate therapy should be considered.
Pancreatitis: Pancreatitis has been reported in patients receiving fenofibrate (see Contraindications and Adverse Reactions). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Muscle: Muscle toxicity, including very rare (Lipanthyl Penta) or rare (Lipanthyl Supra) cases of rhabdomyolysis, with or without renal failure (Lipanthyl Supra), has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency.
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years old, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative 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 CPK (Lipanthyl Penta: levels exceeding 5 times the upper normal range) (Lipanthyl Supra: levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped.
The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor (statins), especially in cases of pre-existing muscular disease.
Consequently, the co-prescription of fenofibrate with a statin (Lipanthyl Penta)/an HMG-CoA reductase inhibitor (Lipanthyl Supra) or another fibrate should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease and with a close monitoring of potential muscle toxicity (Lipanthyl Supra).
Lipanthyl Penta: This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.
Renal Function: Treatment should be interrupted in case of an increase in creatinine levels >50% and ULN (upper limit of normal). It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically (for dose recommendations, see Dosage & Administration).
Excipients: This medicinal product contains lactose, therefore patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Lipanthyl Penta: This medicinal product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
LIPANTHYL PENTA 145, film-coated tablet should not be taken in patients allergic to soybean lecithin or related products due to the risk of hypersensitivity reactions.
Effects on the ability to drive and use machines: LIPANTHYL PENTA 145/LIPANTHYL SUPRA 160 has no or negligible influence on the ability to drive and use machines.
