1000 mg Omega-3-acid ethyl esters 90

Indications

Omacor is not indicated for exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes) so your doctor should check you carefully before prescribing Omacor if you suffer from this condition.

 

Always take Omacor exactly as your doctor has prescribed. If you have any questions, you should check with your doctor or pharmacist.

If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice.

Post Myocardial Infarction (following a heart attack)
Take one capsule daily.

Hypertriglyceridaemia (high blood lipids)
The starting dose is two capsules daily. If your response is not adequate your doctor may increase the dose to four capsules daily.

The capsules should be taken with food to avoid gastrointestinal disturbances.

There is no information regarding the use of Omacor in children, in elderly patients over 70 years of age, or in patients with hepatic impairment (liver disease), and only limited information regarding the use in patients with renal impairment (kidney disease).

 

Do not take Omacor if you are hypersensitive (allergic) to the active substance, to soya or to any of the excipients.

 

If you have a bleeding disorder or are receiving anticoagulant therapy or other drugs affecting coagulation (e.g., acetylsalicylic acid or NSAIDs), Omacor may cause a moderate increase in bleeding time (especially with the highest recommended dose, i.e. 4 capsules daily). Therefore your doctor will monitor you carefully and adjust the dosage of the anticoagulant or other medicines as necessary while you are taking Omacor (see section “Interactions with other medications”).

If you suffer from liver disease your doctor will monitor your liver function values (ASAT and ALAT) regularly; particularly if you are taking the highest recommended dosage, i.e. 4 capsules daily.

 

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

If you are taking an oral anticoagulant or any other drug that affects coagulation (e.g. acetylsalicylic acid or NSAIDs), please read above section “Warnings and special precautions for use” carefully.

Omacor has been given together with warfarin without haemorrhagic (bleeding) complications. However, if you are taking Omacor together with any drug affecting coagulation (PT/INR), your doctor will monitor your blood clotting times (specifically, the prothrombin time/international normalized ratio (PT/INR)) regularly. Monitoring is also necessary when treatment with Omacor is stopped.

 

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.

Pregnancy
There are no adequate data from the use of Omacor in pregnant women.

The potential risk for humans is unknown. Therefore Omacor should not be used during pregnancy unless clearly necessary. Lactation
There are no data on the excretion of Omacor in human milk. Omacor should not be used during lactation.

 

No studies on the effects on the ability to drive and use machines have been performed.

 

Like all medicines, Omacor may cause side effects, although not everybody experiences them. If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, please inform your doctor or pharmacist.

Immune system disorders:
Uncommon: hypersensitivity (allergic reaction)

 

Metabolism and nutrition disorders:
Rare: hyperglycaemia (high blood sugar)

 

Nervous system disorders:
Uncommon: dizziness, dysgeusia (abnormal taste sensation)
Rare: headache

 

Vascular disorders:
Very rare: hypotension (low blood pressure)

 

Respiratory, thoracic and mediastinal disorders:
Very rare: nasal dryness

 

Gastrointestinal disorders:
Common: dyspepsia (indigestion), nausea
Uncommon: abdominal pain, gastrointestinal disorders (gastro-oesophageal reflux disease, eructation, vomiting, or constipation), gastroenteritis
Very rare: lower gastrointestinal haemorrhage (symptoms include blood in the faeces and abdominal pain)

 

Hepatobiliary disorders:
Rare: liver disorders

 

Skin and subcutaneous tissue disorders:
Rare: acne, pruritic (itchy) rash
Very rare: urticaria (red, itchy rash)

 

Investigations:
Very rare: increased white blood cell count, increased blood lactate dehydrogenase, increased transaminases

 

The following adverse event has been reported spontaneously during postmarketing use of Omacor (frequency unknown).

 

Blood and lymphatic system disorder:
Haemorrhagic diathesis (increased susceptibility to bleeding)

 

There are no special recommendations. Treatment should be symptomatic.

 

Pharmacotherapeutic group: Omega-3-triglycerides including other esters and acids.

 

The following is a detailed description of how the active ingredients of Omacor work. For further explanations please consult your doctor.

 

The omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential fatty acids.

 

Omacor acts on plasma lipids by lowering triglyceride levels, which results in a fall in VLDL (very low density lipoprotein). 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. Rises in HDL-Cholesterol are only small, significantly smaller than seen after administration of fibrates, and occurs inconsistently.

 

The long-term lipid-lowering effect (after more than one year) is not known. Furthermore, 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 (less than 3 months) MI (myocardial infarction) and receiving 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 group, 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.

 

The following is a detailed description of how the active ingredients of Omacor are metabolized by the body. For further explanations please consult your doctor.

During and after absorption, there are three main pathways for the metabolism of the omega-3 fatty acids: the fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channelled to the peripheral lipid stores; the cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids; the majority is oxidised to meet energy requirements.

The concentration of omega-3 fatty acids, EPA and DHA, in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.

Animal pharmacokinetic studies have shown that there is a complete hydrolysis of the ethyl ester accompanied by satisfactory absorption and incorporation of EPA and DHA into the plasma phospholipids and cholesterol esters.

 

Not applicable

 

3 years
Do not store above 25ºC. Do not freeze.
Do not use the medicine after the expiry date stated on the carton.
Store in the original package.
Keep this medicine out of the reach and sight of children.