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

Marketing Authorization Holder

Takeda Pharmaceuticals, LLC (Russia)

Manufactured By

Brunel Healthcare Manufacturing Limited (United Kingdom)

Or

Takeda Pharma A/S (Denmark)

For

TAKEDA PHARMACEUTICALS INTERNATIONAL, AG (Switzerland)

Dosage Form

Vitrum® Omega-3 Plus

Capsules: 30, 60, 100 or 120 pcs.

Dosage Form, Packaging, and Product Composition

Capsules with a mass of 1382 mg.

¹ % of the Recommended Daily Intake Level (RULP) according to TR TS 022/2011, Appendix 2;
² % of the Adequate Intake Level (ALP) according to the “Unified Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary-Epidemiological Surveillance (Control)” (Chapter II, Section 1, Appendix 5);
* does not exceed the upper permissible intake level.

Composition fish oil, capsule shell (gelatin, thickener glycerol), vitamin E (D-alpha-tocopherol), sunflower oil, antioxidant (mixed tocopherols).

30 pcs. – polyethylene bottles (1) – cardboard boxes.
60 pcs. – polyethylene bottles (1) – cardboard boxes.
100 pcs. – polyethylene bottles (1) – cardboard boxes.
120 pcs. – polyethylene bottles (1) – cardboard boxes.

Therapeutic Category

Dietary supplement – source of polyunsaturated omega-3 fatty acids

Properties

A dietary supplement – an additional source of polyunsaturated omega-3 fatty acids, including eicosapentaenoic and docosahexaenoic acids, and vitamin E.

It helps reduce cholesterol levels in the body, normalizes lipid metabolism, thereby reducing the risk of developing atherosclerosis and cardiovascular diseases (due to the PUFAs in the fish oil composition, which are involved in normalizing lipid metabolism and help prevent the development of atherosclerotic vascular lesions).

It supports intelligence (due to the PUFAs in the fish oil composition, which are involved in building cell membranes, including those of the brain and neuroretina, and help maintain brain productivity and cognitive functions, including under high mental stress).

It reduces the risk of developing rheumatoid diseases and normalizes metabolic processes (due to the fact that PUFAs are precursors of biologically active substances (eicosanoids) involved in anti-inflammatory reactions and immune response reactions, as well as due to vitamin E, which performs an antioxidant function, protecting polyunsaturated fatty acids in cell membranes from oxidation, which helps protect the body’s cells from damage).

The components of Vitrum^® Omega-3 Plus support the structure and function of the skin and hair.

It helps normalize lipid metabolism and reduce the risk of developing atherosclerosis.

It has antioxidant activity.

Scope of Application

Of the Vitrum^® Omega-3 Plus product

As a dietary supplement – an additional source of polyunsaturated omega-3 fatty acids. It helps:

• Reduce cholesterol levels in the body;
• Normalize lipid metabolism;
• Maintain intelligence;
• Reduce the risk of developing rheumatoid diseases;
• Normalize metabolic processes;
• Maintain the structure and function of the skin and hair.

ICD codes

Dosage Regimen

Adults and children over 14 years – 1-2 caps./day, with meals.

The duration of administration is 1 month. If necessary, the course can be repeated after one month.

Side effects

Possible allergic reactions.

Contraindications

• Individual intolerance to the product components;
• Pregnancy;
• Breastfeeding.

Use during pregnancy and lactation

The use of the product is contraindicated during pregnancy and breastfeeding.

Special instructions

A dietary supplement, not a medicinal product.

It is recommended to consult a doctor before use.

Storage Conditions

The product should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F) and relative air humidity not exceeding 60%.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-Counter

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.