Vitrum^® Cardio Omega-3 (Capsules) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

C10AX06 (Omega-3 triglycerides, including other esters and acids)

Active Substances

Omega-3 acid ethyl esters (Ph.Eur. European Pharmacopoeia)

Tocopherol (Ph.Eur. European Pharmacopoeia)

Dosage Form

Vitrum® Cardio Omega-3

Capsules 1000 mg+2 mg: 30, 60, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, transparent, from light yellow to dark yellow, oval; the capsule contents are a transparent oily liquid from light yellow to dark yellow in color with a specific odor.

Excipients: gelatin -261.7 mg, glycerol – 117.8 mg, purified water – 235.5 mg.

30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating lipid metabolism

Pharmacotherapeutic Group

Hypolipidemic agent

Pharmacological Action

A combined preparation containing polyunsaturated fatty acids of the omega-3 family: eicosapentaenoic acid, docosahexaenoic acid, and vitamin E.

It has a therapeutic effect in lipid metabolism disorders caused by severe hypertriglyceridemia and has an anti-inflammatory effect.

It helps normalize the content of LDL and VLDL, change the fluid properties of cell membranes, and increase the functional activity of membrane receptors, which improves the lipid-cellular interaction of lipoproteins with enzymes and lipoprotein metabolism.

The antiplatelet effect of the drug is associated with its influence on the lipid composition of cell membranes, including erythrocyte membranes, characterized by a decrease in arachidonic acid content and an increase in eicosapentaenoic acid levels.

As a result, the synthesis of thromboxane A₂ and other dienoic eicosanoids (derivatives of arachidonic acid) that enhance platelet aggregation is reduced, and the synthesis of thromboxane A₃ and other trienoic eicosanoids from eicosapentaenoic acid, which do not have a proaggregant effect, is increased.

This complex of essential polyunsaturated fatty acids is used to normalize lipid metabolism and reduce the risk of atherosclerosis.

Vitamin E has antioxidant activity, participates in tissue respiration and other important processes of tissue metabolism; it protects cells and tissues from the damaging effects of excessive amounts of free radicals and lipid peroxidation products.

Pharmacokinetics

The action of Vitrum Cardio Omega-3 is the combined action of its components, therefore conducting kinetic observations is not possible; all components together cannot be tracked using markers or bioassays.

Indications

• Prevention of conditions caused by dyslipidemia (lipid metabolism disorder);
• As part of complex therapy for lipid metabolism disorders, including diet, statins, antiplatelet agents;
• Vitamin E deficiency.

ICD codes

Dosage Regimen

Administer the drug orally.

Take with water.

Ingest 30 minutes after a meal.

For adults for preventive purposes, prescribe 1 capsule per day.

For therapeutic purposes, prescribe 2 to 3 capsules per day.

The minimum course of treatment is 3 months.

Determine the need for repeated courses individually.

Do not exceed the recommended daily dosage.

Swallow the capsule whole; do not chew.

Adverse Reactions

From the digestive system a sensation of fishy taste, burping with a fishy taste in the first days of administration, a laxative effect are possible.

Other allergic reactions.

Contraindications

• Exacerbation of chronic cholecystitis;
• Exacerbation of chronic pancreatitis;
• Exacerbation of hepatobiliary system diseases;
• Cholelithiasis;
• Pathological conditions including hemorrhagic syndrome;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

During pregnancy and lactation, the drug should be used only as prescribed by a doctor.

Use in Hepatic Impairment

Contraindicated in exacerbation of chronic cholecystitis; in exacerbation of chronic pancreatitis; in exacerbation of hepatobiliary system diseases; in cholelithiasis.

Pediatric Use

The drug is prescribed for adults.

Special Precautions

During the administration of Vitrum Cardio Omega-3, it is not recommended to take other medicines containing vitamin E.

Overdose

Symptoms manifestations of hypervitaminosis – pain in the epigastric region, dyspeptic phenomena (nausea, vomiting, diarrhea); with long-term use in high doses, exacerbation of chronic pancreatitis is possible.

Treatment drug withdrawal, symptomatic therapy.

Drug Interactions

Data on the drug interactions of the drug are not provided.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.