Tomexia Special Precautions

TOMEXIA 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 TOMEXIA 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. 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 hemorrhage (because of severe trauma, surgery, etc).
During treatment with TOMEXIA, 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).
TOMEXIA is not indicated in exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). There is only limited experience in secondary endogenous hypertriglyceridemia (especially uncontrolled diabetes).
There is no experience regarding hypertriglyceridemia in combination with fibrates.