Vitrum^® (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Vitrum^®

Film-coated tablets: 30, 60, 100, 120, or 130 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from peach to whitish-peach in color, capsule-shaped, with a score on one side and an engraving “VITRUM” on the other; a specific odor is allowed.

	1 tab.
Retinol acetate (vit. A) and beta-carotene¹	5000 IU²
Alpha-tocopherol acetate (vit. E)	30 IU³
Colecalciferol (vit. D₃)	400 IU⁴
Phytomenadione (vit. K₁)	25 mcg
Ascorbic acid (vit. C)	60 mg
Thiamine mononitrate (vit. B₁)	1.5 mg
Riboflavin (vit. B₂)	1.7 mg
Calcium pantothenate in terms of pantothenic acid (vit. B₅)	10 mg
Pyridoxine hydrochloride (vit. B₆)	2 mg
Folic acid (vit. B₉)	400 mcg
Cyanocobalamin (vit. B₁₂)	6 mcg
Nicotinamide (vit. PP)	20 mg
Biotin (vit. H)	30 mcg
Potassium chloride in terms of potassium	40 mg
Calcium hydrogen phosphate in terms of calcium	162 mg
Magnesium oxide in terms of magnesium	100 mg
Calcium hydrogen phosphate in terms of phosphorus	125 mg
Ferrous fumarate in terms of iron	18 mg
Copper oxide in terms of copper	2 mg
Zinc oxide in terms of zinc	15 mg
Manganese sulfate in terms of manganese	2.5 mg
Potassium iodide in terms of iodine	150 mcg
Sodium molybdate in terms of molybdenum	25 mcg
Sodium selenate in terms of selenium	25 mcg
Chromium chloride in terms of chromium	25 mcg
Nickel sulfate in terms of nickel	5 mcg
Sodium metavanadate in terms of vanadium	10 mcg
Tin chloride in terms of tin	10 mcg
Silicon dioxide in terms of silicon	10 mcg
Potassium chloride in terms of chloride	36.3 mg

¹ synonym beta-carotene;
² equivalent to 1515 mcg of retinol equivalent;
³ equivalent to 30 mg of alpha-tocopherol acetate;
⁴ equivalent to 10 mcg of colecalciferol.

Excipients: microcrystalline cellulose – 68.79 mg, stearic acid – 42 mg, croscarmellose sodium – 28 mg, magnesium stearate – 14 mg.

Shell composition: hypromellose – 27.2 mg, titanium dioxide – 12.47 mg, triacetin – 3 mg, sunset yellow dye (E110) – 0.32 mg, allura red dye (E129) – 0.01 mg.

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

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + minerals

Pharmacological Action

A multivitamin preparation with minerals. The action of the preparation is determined by the properties of the active substances included in its composition.

It is a modern balanced complex containing 13 vitamins and 17 minerals.

One tablet per day provides an adult’s body with all the vitamins and minerals necessary to strengthen health and maintain well-being.

Indications

Prevention of hypovitaminosis, deficiency of minerals and trace elements, including:

During periods of intense mental and physical stress;
During the recovery period after illnesses;
With insufficient and unbalanced nutrition.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E50-E64	Other types of nutritional deficiencies (E50-E64)
Z54	Convalescence
Z73.0	Burn-out
Z73.3	Stress, not elsewhere classified (physical and mental strain)

ICD-11 code	Indication
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 orally once daily.

Administer the tablet after a meal to improve tolerability and absorption.

Swallow the tablet whole with a sufficient amount of water; do not crush or chew.

The duration of administration is determined individually based on clinical need.

This regimen is indicated only for adults.

Do not exceed the recommended daily dose of one tablet.

Avoid concomitant use with other vitamin A or D-containing preparations due to the risk of hypervitaminosis.

Adverse Reactions

Possible allergic reactions to the components of the preparation.

Contraindications

Hypervitaminosis of vitamin A;
Hypervitaminosis of vitamin D;
Childhood and adolescence under 18 years of age;
Hypersensitivity to the components of the preparation.

Use in Pregnancy and Lactation

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

Pediatric Use

The use of the preparation is contraindicated in childhood and adolescence under 18 years of age.

Special Precautions

The recommended dose of the preparation should not be exceeded.

Effect on the ability to drive vehicles and machinery

The preparation does not affect the ability to drive a car and operate other machinery.

Overdose

Symptoms: nausea, weakness, gastrointestinal disorders. In case of overdose, the patient should consult a doctor.

Treatment: oral administration of activated charcoal, gastric lavage, symptomatic therapy.

Drug Interactions

The preparation contains iron and calcium, therefore, when used concomitantly with antibiotics of the tetracycline group, as well as antimicrobial agents – fluoroquinolone derivatives, the absorption of the latter from the gastrointestinal tract is slowed down.

Ascorbic acid enhances the action and side effects of antimicrobial agents from the sulfonamide group.

Antacid preparations containing aluminum, magnesium, calcium, as well as cholestyramine, reduce the absorption of iron.

With the simultaneous use of thiazide diuretics, the likelihood of hypercalcemia increases.

It is not recommended to use Vitrum^® concomitantly with preparations containing vitamins A and D, as this increases the risk of overdose of these vitamins.

Storage Conditions

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

Shelf Life

Shelf life – 5 years.

Dispensing Status

The preparation is available without a prescription.

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