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active ingredient: ethyl ester of omega-3-unsaturated fatty acids 90;
1 capsule contains 1000 mg of ethyl ester of omega-3-unsaturated fatty acids 90, which includes 460 mg of ethyl ester of eicosapentaenoic acid (EPA) and 380 mg of ethyl ester of docosahexaenoic acid (DHA) (α-tocopherol is used as an antioxidant);
excipients: capsule shell: gelatin, glycerin, medium chain triglycerides, lecithin, purified water.
Hypertriglyceridemia. In endogenous hypertriglyceridemia, Omacor should be used as an adjunct to diet if dietary measures are insufficient to achieve an adequate response: type IV – in the form of monotherapy; types IIb / III – in combination with statins, if the control of triglyceride levels in the blood is insufficient.
Hypersensitivity to the active substance, to soybeans, peanuts or any of the other ingredients.
Use with caution in patients with known sensitivity or allergy to fish.
A moderate increase in bleeding time (at high doses, ie 4 capsules per day) requires monitoring of patients with coagulation disorders or patients receiving anticoagulant therapy or other drugs that may affect coagulation (eg, acetylsalicylic acid). ) and appropriate dose adjustment of the anticoagulant as needed (see section “Interactions with other medicinal products and other types of interactions”). The use of this drug does not exclude the need for supervision commonly needed in such patients.
Extended bleeding time in patients at high risk of bleeding (due to severe trauma, surgery, etc.) should be considered.
The formation of thromboxane A2 is reduced during drug treatment. No significant effect on other coagulation factors was observed. Clinical studies have not shown an increase in the incidence of bleeding episodes.
Some patients reported a slight but significant increase (within the normal range) of AST and ALT, but at the same time there were no data indicating an increased risk for patients with liver failure. Patients with any manifestation of liver dysfunction (especially when taking a high dose, ie 4 capsules per day) need control of ALT and AST.
Omakor is not indicated for the treatment of exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). Experience in the use of secondary endogenous hypertriglyceridemia (especially in decompensated diabetes) is limited. There are no data on the use of the drug in combination with fibrates in the treatment of hypertriglyceridemia.
Method of administration and dose.
After myocardial infarction
1 capsule a day.
Initial dose – 2 capsules per day (in 1 or 2 doses). In case of insufficient effect, the dose can be increased to 4 capsules per day. The duration of treatment is determined by the doctor depending on the individual characteristics of the body.
The capsules can be taken with food to prevent gastrointestinal disorders.
There is no information on the use of Omakor in children and adolescents aged 70 years and in patients with hepatic impairment (see section “Application Features”) and limited use in patients with renal impairment.
Due to the lack of data on the efficacy and safety of Omacor, it is not recommended for use in children in this category of patients.
In the absence of these specific recommendations, no. Treatment should be symptomatic.