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Vitrum® Vision Plus (Tablets) Instructions for Use

Marketing Authorization Holder

Takeda Pharmaceuticals, LLC (Russia)

Manufactured By

Eagle Nutritionals Inc. (USA)

For

TAKEDA PHARMACEUTICALS INTERNATIONAL, AG (Switzerland)

Labeled By

UNIPHARM, Inc. (USA)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Form

Bottle OTC Icon Vitrum® Vision Plus Film-coated tablets: 15, 30, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Product Composition

Film-coated tablets, with a mass of 854 mg.

1 tab. % of RSPL1 or AIL2
Ascorbic acid (vit. C) 60 (54-90) mg 100 (90-150)%1*
Riboflavin (vit. B2) 1.2 (1.08-1.8) mg 75 (68-113)%1*
Tocopherol acetate (vit. E, TE) 6.7 (6.0-10.05) mg 67 (60-100)%1*
Lutein 4 (3.6-5.6) mg 80 (72-112)%2*
Beta-carotene 1.5 (1.35-2.25) mg 30 (27-45)%2
Zeaxanthin 0.5 (0.45-0.75) mg 50 (45-75)%2
Anthocyanins 15 (13.5-22.5) mg 30 (27-45)%2
Flavonoids, calculated as rutin 17 (15.3-20.4) mg 57 (51-68)%2
Zinc 5 (4.5-6.3) mg 33 (30-42)%1
Selenium 25 (22.5-37.5) µg 36 (32-54)%1

1 % of the Recommended Daily Intake Level (RSPL) according to TR TS 022/2011, Appendix 2;
2 % of the Adequate Intake Level (AIL) 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 anti-caking agent dicalcium phosphate, Lutein, vitamin C (Ascorbic acid), bilberry extract, tablet coating Opadry yellow II (stabilizer hypromellose, colorant titanium dioxide, carrier polydextrose, anti-caking agent talc, maltodextrin, medium-chain triglycerides, colorant Riboflavin), stabilizer stearic acid, anti-caking agent microcrystalline cellulose, vitamin E (Tocopherol acetate), rutin, stabilizer silicon dioxide, stabilizer croscarmellose sodium, Zeaxanthin, stabilizer magnesium stearate, Beta-carotene , zinc oxide, selenomethionine, vitamin B2 (Riboflavin).

15 pcs. – blisters (1) – cardboard boxes.
15 pcs. – blisters (2) – cardboard boxes.
15 pcs. – blisters (4) – cardboard boxes.
15 pcs. – blisters (6) – cardboard boxes.
15 pcs. – blisters (8) – cardboard boxes.
30 pcs. – polyethylene bottles (1) – cardboard boxes.
60 pcs. – polyethylene bottles (1) – cardboard boxes.
100 pcs. – polyethylene bottles (1) – cardboard boxes.

Therapeutic Category

Dietary supplement for maintaining visual function

Properties

Dietary supplement – an additional source of vitamins B2, C, E, minerals: zinc, selenium; source of flavonoids, anthocyanins, carotenoids: beta-carotene, lutein, zeaxanthin.

It helps to relieve irritation, protect the eyes from fatigue, improve vision, enhance visual adaptation in twilight conditions and during prolonged work with monitors and electronic devices (displays), as well as strengthen the walls of the eye vessels, and maintain the level of nutrients necessary for the eyes.

Scope of Application

Of the Vitrum® Vision Plus product

As a dietary supplement – an additional source of vitamins, carotenoids, bioflavonoids, and minerals. It helps:

  • Protect the eyes from fatigue;
  • Improve vision;
  • Adapt vision in twilight conditions and during prolonged work with monitors and electronic devices (displays);
  • Strengthen the walls of the eye vessels;
  • Relieve irritation;
  • Maintain the necessary level of nutrients.

ICD codes

ICD-10 code Indication
H53.1 Subjective visual disturbances
ICD-11 code Indication
9D51 Transient vision loss
9D5Z Subjective visual disturbances, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Adults take 1 tablet per day with meals. The duration of intake is 1 month. If necessary, the intake 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

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 – 2 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.

Medical Disclaimer

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