Caution in patients w/ known sensitivity or allergy to fish. Dose-dependent increased risk of atrial fibrillation in patients w/ established CV disease or CV risk factors treated w/ omega-3-acid ethyl esters. Permanently discontinue treatment if atrial fibrillation develops. Thromboxane A2 production may fall during treatment. Periodically monitor patients receiving concomitant anticoagulant or other drugs affecting coagulation (eg, ASA, warfarin & coumarin). Routine monitoring of the entire lipid profile is recommended. Regularly monitor LDL-C especially in patients w/ type IV & V dyslipidaemia. Not recommended as monotherapy in type IIb dyslipidaemia. Regularly monitor hepatic function (especially ALT) in patients w/ hepatic impairment. Should not be used during pregnancy unless clearly necessary. Exercise caution when administered to woman who is breastfeeding. Limited information regarding use in patients w/ renal impairment. No information regarding use in childn & adolescents, in elderly >70 yr or in patients w/ hepatic impairment. Not recommended in childn.