Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: BASF AS, P.O Box 420, 1327 Lysaker, Norway
Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1.
Omacor contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
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.
Oral anticoagulants: See section 4.4 Special Warnings and Precautions for Use.
Omacor has been given in conjunction with warfarin without haemorrhagic complications. However, the prothrombin time must be checked when Omacor is combined with warfarin or when treatment with Omacor is stopped.
There are no adequate data from the use of Omacor in pregnant women. Studies in animals have not shown reproductive toxicity. The potential risk for humans is unknown and therefore Omacor should not be used during pregnancy unless clearly necessary.
There are no data on the excretion of Omacor in animal and human milk. Omacor should not be used during lactation.
There are no adequate data on the effect of Omacor on fertility.
Effects and 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.
The frequencies of adverse reactions are ranked according to the following: very common (>1/10), common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10000 to <1/1000); very rare (<1/10000); not known.
Rare: hypersensitivity
Uncommon: hyperglycaemia, gout
Uncommon: dizziness, dysgeusia, headache
Uncommon: hypotension
Uncommon: epistaxis
Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting)
Uncommon: gastrointestinal haemorrhage
Rare: liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased)
Uncommon: rash
Rare: urticaria
Not known: pruritus
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: HPRA Pharmacovigilance, Website: www.hpra.ie.
Not applicable.
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