SANDOZ FENOFIBRATE E

). Consequently, the co-administration of fenofibrate with a HMG-CoA reductase inhibitor or another fibrate should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease or other pre-disposing factors for myopathy (see WARNINGS AND PRECAUTIONS) and with a close monitoring of potential muscle toxicity.

Concomitant administration with ezetimibe:

Post marketing reports of adverse events have included rare cases of myopathy/rhabdomyolysis occurring in patients taking ezetimibe. Myopathy/ rhabdomyolysis should be considered in patients presenting with muscle pain during treatment with ezetimibe and fenofibrate, and consideration given to discontinuation of the drugs.

Most cases of myopathy/rhabdomyolsis resolved when drugs were discontinued. ADVERSE REACTIONS Adverse Drug Reaction Overview The most frequently reported adverse events include: gastrointestinal (epigastric distress, flatulence, abdominal pain, nausea, diarrhea, constipation), dermatologic (erythema, pruritus, urticaria), musculoskeletal (muscle pain and weakness, arthralgia), central nervous system (headache, dizziness, insomnia), miscellaneous (decreased libido, hair loss, weight loss).

Clinical Trials Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. S. and Europe, a total of 477 patients on fenofibrate and 386 patients on placebo were evaluated for adverse effects during 2 to 6 months of treatment.

5% of patients (26/477) treated with fenofibrate, the most common symptoms being abnormal elevation in transaminases, skin reactions and digestive disorders. 6% (10/386) were discontinued due to adverse effects. Adverse events, regardless of their causality, reported in more than 1% of patients are shown in Table 1.

3%) Safety was monitored for 3 years during the placebo-controlled DAIS study (see CLINICAL TRIALS) for both adverse events and laboratory anomalies. Fenofibrate was used safely in type 2 diabetic patients, as the overall incidence and severity of adverse events were comparable in fenofibrate and placebo groups.