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Lipway: Special warnings: There have been report of muscle damage, including exceptional cases of rhabdomyolysis, with fibrates. This may occur more frequently in patients with hypoalbuminaemia.
Muscle damage should be suspected in any patient who has diffuse myalgia, painful muscular sensitivity and/or major elevation of muscular CPK (5 times the normal level), in this situation the treatment should be discontinued.
Moreover, the risk of muscle damage may be increased if the drug is administered in combination with another fibrate or with an HMG CoA reductase inhibitor (see Interactions).
Precautions for use: If a satisfactory reduction of serum lipid concentrations has not been obtained after a period of administration of several months (3 to 6 months), additional or different therapeutic measures should be considered.
Elevation, generally transient, of transaminase levels have been observed in some patients. On the basis of current knowledge, this would appear to justify the following measures: Liver function tests recommended every 3 months for the first year (discontinue treatment if significantly raised).
Discontinuation of the treatment if ASAT and ALAT concentrations increase to over 3 times the upper normal limit.
If the patient is receiving concomitant oral anticoagulant treatment, closer monitoring of prothrombin time, as expressed by the INR, is essential (see Interactions).
Effects On The Ability To Drive And Use Machines: Not applicable.
