- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Legal status
One capsule contains
Omega-3-acid ethyl esters 90 1000mgcomprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460mg) and docosahexaenoic acid (DHA) ethyl ester (380mg).For a full list of excipients see section 6.1.
Post Myocardial InfarctionAdjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).
HypertriglyceridaemiaEndogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response:- type IV in monotherapy,- type IIb/III in combination with statins, when control of triglycerides is insufficient.
Post Myocardial InfarctionOne capsule daily.
HypertriglyceridaemiaInitial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily.The capsules may be taken with food to avoid gastrointestinal disturbances.There is limited clinical data regarding the use of Omacor in elderly patients over 70 years of age and patients with renal impairment (see section 4.4). There is no information regarding the use of Omacor in children and adolescents or in patients with hepatic impairment (see section 4.4).
WarningsBecause 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).In the absence of efficacy and safety data, use of this medication in children is not recommended.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.Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited. 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.
PregnancyThere 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.
LactationThere are no data on the excretion of Omacor in animal and human milk. Omacor should not be used during lactation.
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: rashRare: urticaria
Reporting of suspected adverse reactionsReporting 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
ATC code : C10AX06The omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential fatty acids.Omacor is active on the plasma lipids by lowering triglyceride levels as a result of a fall in VLDL (very low density lipoprotein), and the substance is also active on haemostasis and blood pressure.Omacor reduces the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis and they inhibit esterification of other fatty acids.The increase in peroxisomes of β-oxidation of fatty acids in the liver also contributes to the fall in triglycerides, by reducing the quantity of free fatty acids available for their synthesis. The inhibition of this synthesis lowers VLDL.Omacor increases LDL-cholesterol in some patients with hypertriglyceridaemia. A rise in HDL-cholesterol is only small, significantly smaller than seen after administration of fibrates, and not consistent.The long-term lipid-lowering effect (after more than one year) is not known. Otherwise there is no strong evidence that lowering triglycerides reduces the risk of ischaemic heart disease.During treatment with Omacor, there is a fall in thromboxane A2 production and a slight increase in bleeding time. No significant effect has been observed on the other coagulation factors.11324 patients, with recent MI (<3 months) and receiving a recommended preventative treatment associated with a Mediterranean diet, were randomised in the GISSI-Prevenzione study in order to receive Omacor (n=2836), vitamin E (n=2830), Omacor + vitamin E (n=2830) or no treatment (n=2828). GISSI-P was a multicentre, randomised, open-label study performed in Italy.The results observed over 3.5 years, with Omacor 1g/day, have shown a significant reduction of a combined endpoint including all-cause death, non fatal MI and non fatal stroke (decrease in relative risk of 15% [2-26] p=0.0226 in patients taking Omacor alone compared to control, and of 10% [1-18] p=0.0482 in patients taking Omacor with or without vitamin E). A reduction of the second pre-specified endpoint criteria including cardiovascular deaths, non fatal MI and non-fatal stroke has been shown (decrease in relative risk of 20% [5-32] p=0.0082 in patients taking Omacor alone compared to control, decrease in relative risk of 11% [1-20] p= 0.0526 in patients taking Omacor with or without vitamin E). The secondary analysis for each component of the primary endpoints has shown a significant reduction of all cause deaths and cardiovascular deaths, but no reduction of non fatal cardiovascular events or fatal and non fatal strokes.
BGP Products Ltd.
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