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Vitrum® Superstress (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA01 (Multivitamins and Iron)

Dosage Form

Bottle OTC Icon Vitrum® Superstress Coated tablets: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets dark red in color, capsule-shaped; a specific odor is allowed.

1 tab.
DL-alpha-tocopheryl acetate (vit. E) 30 mg (30 IU)
Ascorbic acid (vit. C) 500 mg
Thiamine hydrochloride (vit. B1) 15 mg
Riboflavin (vit. B2) 10 mg
Pantothenic acid (as calcium pantothenate) (vit. B5) 20 mg
Pyridoxine hydrochloride (vit. B6) 5 mg
Folic acid (vit. Bc) 400 mcg
Cyanocobalamin (vit. B12) 12 mcg
Nicotinamide (vit. PP) 100 mg
Biotin (vit. H) 45 mcg
Iron (as ferrous fumarate) 27 mg

Excipients: calcium sulfate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, stearic acid, magnesium stearate.

Shell composition: hypromellose, titanium dioxide, triacetin, dye Allura Red AC (E129), dye Sunset Yellow FCF (E110).

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

Clinical-Pharmacological Group

Dietary supplement – an additional source of vitamins and trace elements

Pharmacological Action

Multivitamins with trace elements.

The pharmacological properties are determined by the complex of vitamins included in the preparation.

Indications

  • Use for the prevention and treatment of hypovitaminosis and iron deficiency during the recovery period following various illnesses, injuries, or surgical procedures.
  • Use during periods of increased mental and physical exertion to support nutritional status.

ICD codes

ICD-10 code Indication
E50-E64 Other types of nutritional deficiencies (E50-E64)
E61.1 Iron deficiency
Z54 Convalescence
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
5B5K.0 Iron deficiency
5B7Z Malnutrition, unspecified
QB7Z Convalescence, unspecified
QD85 Burn-out
QE01 Stress, not elsewhere classified

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.

Take one tablet once daily with a full glass of water. Administer the tablet after a meal to enhance tolerance and minimize potential gastrointestinal discomfort.

The standard course of therapy is one month. Do not exceed the recommended daily dosage. The decision to initiate repeated courses of treatment should be made only upon the recommendation of a physician.

Adverse Reactions

Monitor for allergic reactions, including skin rash, itching, and urticaria, which may occur in individuals with hypersensitivity to any component of the formulation.

Be aware that ingestion of iron-containing products commonly causes a harmless darkening of the stool, which is not a clinically significant finding. Discontinue use and consult a physician if any severe or persistent adverse effects develop.

Contraindications

  • Do not use in patients with a known hypersensitivity to any of the active substances or excipients listed in the composition.
  • Contraindicated in conditions of iron overload (e.g., hemochromatosis, hemosiderosis).
  • Do not administer to patients with vitamin B12 deficiency (pernicious anemia) that is not adequately treated, as high doses of other B vitamins may mask associated neurological symptoms.

Special Precautions

Do not exceed the recommended dose.

It is not recommended to use simultaneously with preparations containing the above substances.

Storage Conditions

Store at a temperature from 10°C (50°F) to 30°C (86°F), in a dry place out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the packaging.

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.

Medical Disclaimer

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