Omesoft

Omesoft-acid ethyl esters has been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Omesoft-acid ethyl esters is combined with warfarin or when treatment with Omesoft-acid ethyl esters is stopped.

It is contraindicated in patients who exhibit hypersensitivity to any component of this medication.

Immune system disorders: Rare- hypersensitivity;

Metabolism and nutrition disorders: Uncommon-hyperglycaemia, gout;

Nervous system disorders: Uncommon- dizziness, dysgeusia, headache;

Vascular disorders: Uncommon- hypotension;

Respiratory thoracic and mediastinal disorders: Uncommon- epistaxis;

Gastrointestinal disorders: Common- gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting), Uncommon- gastrointestinal haemorrhage;

Hepatobiliary disorders: Rare- liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased);

Skin and subcutaneous tissue disorders: Uncommon- rash, Rare-urticarial.

Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether it is excreted in human milk. Caution should be exercised when Omega-3-acid ethyl esters are administered to a lactating mother.

Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules), patients receiving anti-coagulant therapy must be monitored and the dosage of anti-coagulant 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 haemorrhage (because of severe trauma, surgery, etc). In the absence of efficacy and safety data, use of this medication in children is not recommended. During treatment with Omesoft-acid ethyl esters, 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. 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). Omesoft-acid ethyl esters 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.

Store below 25°C in a dry & cool place.