Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
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 section 4.8). If atrial fibrillation develops, treatment should be permanently discontinued.
Omacor should be used with caution in patients with known sensitivity or allergy to fish.
In the absence of efficacy and safety data, use of this medication in children is not recommended.
Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited.
Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary (see section 4.5 Interaction with other Medicinal Products and other forms of Interaction). Use of this medication does not eliminate the need for the surveillance usually required for patients of this type.
Make allowance for the increased bleeding time in patients at high risk of haemorrhage (because of severe trauma, surgery, etc).
During treatment with Omacor, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.
Only limited information regarding the use in patients with renal impairment is available.
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 hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).
There is no experience regarding hypertriglyceridaemia in combination with fibrates.

Effects on Driving

4.7 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.