Omacor Special Precautions

Systematic reviews and meta-analyses of randomized controlled clinical trials highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl esters compared to placebo. The observed risk is highest with a dose of 4 g/daily (see Adverse Reactions). If atrial fibrillation develops, treatment should be permanently discontinued.
Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules), patients with bleeding disorders or receiving anticoagulant therapy or other drugs affecting coagulation (e.g acetylsalicylic acid or NSAIDs) must be monitored and the dosage of anticoagulant adjusted if necessary (see Interactions). Make allowance for the increased bleeding time in patients at high risk of hemorrhage (because of severe trauma, surgery, etc.).
Make allowance for the increased bleeding time in patients at high risk of hemorrhage (because of severe trauma, surgery, etc.).
During treatment with Trademark, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Clinical studies did not show increased frequency of bleeding episodes. In some patients a small but significant increase (within normal values) in ASAT and ALAT was reported, but there are no data indicating an increased risk for patients with hepatic impairment. ALAT and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage, i.e. 4 capsules).
Omacor is not indicated in exogenous hypertiglyceridaemia (type 1 hyperchylomicronaemia).
Effects on ability to drive and use machines: Effects on ability to drive and use machines have not been studied. Nevertheless, Omacor is expected to have no or negligible influence on the ability to drive and use machines.