OMACOR 1000MG 28 SOFTGELS

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Post-myocardial infarction:: Adjuvant treatment for secondary prevention of myocardial infarction, in combination with standard therapies (including statins, antiplatelet agents, beta-blockers, and angiotensin converting enzyme inhibitors).

Hypertriglyceridemia:

Endogenous hypertriglyceridemia, as an adjunct to a diet for which prescription alone has proven insufficient to provide an adequate response:

Type IV as monotherapy.
Type IIb/III in combination with statins, when triglyceride control is inadequate.

Dosage forms and presentations

Softgel capsule (oblong; made of transparent gelatin containing a pale yellow oil): 28 units per bottle.

DOSAGE AND ADMINISTRATION

Post-myocardial infarction :

1 softgel per day.

Hypertriglyceridemia:: The recommended initial daily dose is 2 softgels. In the absence of an adequate response, the dose may be increased to 4 softgels per day.

It is recommended that the softgels be ingested with meals to avoid gastrointestinal upset.
Clinical data on the use of Omacor in children, in patients over 70 years of age and in patients with renal impairment are limited (see Warnings and Precautions).
No information on the use of Omacor in children and adolescents or in patients with hepatic impairment is available (see Warnings and Precautions for Use).

Excipients : Softgel content: Alpha-tocopherol (antioxidant that can be mixed with soybean oil). Soft capsule shell: gelatin, glycerol, purified water, medium chain triglycerides, lecithin (soybean).

Notable excipient: soybean oil.

Ethyl esters 90 of omega-3 acids	1000 mg
(including 840 mg of elcosapentaenoic acid (EPA, as ethyl ester: 460 mg) and docosahexaenoic acid (DHA, as ethyl ester: 380 mg))