Omega-3 Acid Ethyl Esters are indicated as an adjunct to diet for reducing very high triglyceride (TG) levels (>500 mg/dl) in adult patients. It is also used as an adjunct in secondary prevention in patients who have had a myocardial infarction within the previous 3 months. Additionally, it may help reduce joint inflammation associated with mild arthritis, support mood and impulse control, and may be used in age-related macular degeneration.

Each soft gelatin capsule contains Omega-3-Acid Ethyl Esters BP 1000 mg, comprising a combination of:

• Eicosapentaenoic Acid BP 80 mg
• Docosahexaenoic Acid BP 120 mg

Omega-3-acid ethyl esters reduce triglyceride production in the liver, although the exact mechanism is not fully understood. They inhibit the enzyme acyl-CoA: 1,2-diacylglycerol acyltransferase, which reduces triglyceride synthesis and increases peroxisomal beta-oxidation, thereby enhancing fatty acid metabolism. They also reduce triglyceride formation by competing for enzymes involved in triglyceride synthesis, increase triglyceride clearance by enhancing lipoprotein lipase activity, and decrease the production of very-low-density lipoprotein cholesterol (VLDL-C).

In hypertriglyceridaemia: it can be taken as a single dose of 4 capsules (4 gm) or 2 capsules (2 gm) twice daily.

In previously myocardial infarction patients: It can be taken 1 capsule (1 gm) daily with food. Patients should be placed on an appropriate lipid lowering diet before receiving Omega-3 Acid Ethyl Esters and should continue this diet during treatment.

In joint inflammation associated with mild arthritis: The dose is 2.7 gm daily.

In mood disorders & impulse control and age-related macular degeneration: The dose is 1 capsule (1 gm) per day. Or, as directed by the registered physician.

Omega-3-acid ethyl esters have been used together with warfarin without reported hemorrhagic complications. However, prothrombin time should be monitored when Omega-3-acid ethyl esters are used with warfarin or when treatment with Omega-3-acid ethyl esters is discontinued.

It is contraindicated in patients with known hypersensitivity to any component of this medication.

Immune system disorders: Rare—hypersensitivity reactions.

Metabolism and nutrition disorders: Uncommon—hyperglycemia, gout.

Nervous system disorders: Uncommon—dizziness, dysgeusia, headache.

Vascular disorders: Uncommon—low blood pressure (hypotension).

Respiratory, thoracic and mediastinal disorders: Uncommon—nosebleed (epistaxis).

Gastrointestinal disorders: Common—gastrointestinal disturbances including abdominal bloating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, belching, gastroesophageal reflux disease, nausea, or vomiting. Uncommon—gastrointestinal bleeding.

Hepatobiliary disorders: Rare—liver function abnormalities including increased transaminases, alanine aminotransferase (ALT), and aspartate aminotransferase (AST).

Skin and subcutaneous tissue disorders: Uncommon—rash. Rare—urticaria.

Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known whether it is excreted in human breast milk. Caution should be taken when administered to breastfeeding mothers.

Due to a moderate increase in bleeding time at high doses (e.g., 4 capsules), patients receiving anticoagulant therapy should be closely monitored and anticoagulant dosage adjusted if necessary. Routine monitoring should still be continued in such patients. Increased bleeding risk should be considered in patients with high risk of hemorrhage such as severe trauma or surgery. Use in children is not recommended due to lack of safety and efficacy data. Omega-3-acid ethyl esters may reduce thromboxane A2 production, but other coagulation factors are generally unaffected. Some studies show mild prolongation of bleeding time within normal limits without clinically significant bleeding. Small increases in AST and ALT (within normal range) have been observed; however, there is no evidence of increased risk in hepatic impairment. Liver enzymes (ALT, AST) should be monitored in patients showing signs of liver damage, especially at high doses. This medicine is not indicated for exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). Limited experience exists in secondary endogenous hypertriglyceridemia, particularly in uncontrolled diabetes. There is no clinical experience with combination use with fibrates.

Other lipid-regulating agents.

Store below 25°C in a cool, dry place.