Vitrum^® Junior (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Vitrum® Junior

Chewable tablets: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets from light brown to orange-light brown in color, with light and dark specks, round, flat, with a beveled edge, with a score on one side, with a light fruity odor.

Excipients : sorbitol – 100 mg, sucrose – 250 mg, stearic acid – 100 mg, colloidal silicon dioxide – 7 mg, magnesium stearate – 18 mg, microcrystalline cellulose – 118.8 mg, citric acid – 13 mg, orange flavor – 15 mg, pineapple flavor – 3 mg, aspartame – 10 mg, sunset yellow dye (E110) – 2 mg.

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

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A combined drug, the action of which is determined by the effects of the vitamins and minerals included in its composition.

The specially selected doses correspond to the daily requirement of a child for vitamins, macro- and microelements. It helps to increase the non-specific defenses of the body.

Indications

Prevention and treatment of hypovitaminosis and deficiency of macro- and microelements in children and adolescents, including:

• During the period of intensive growth;
• With increased physical and mental stress;
• During the recovery period after past illnesses;
• With unbalanced or inadequate nutrition.

ICD codes

Dosage Regimen

Administer the drug orally after a meal to minimize potential gastrointestinal discomfort.

Chew the tablet thoroughly before swallowing; do not swallow it whole.

For children from 4 to 7 years of age, the dosage is one-half (1/2) tablet once daily.

For children over 7 years of age and adolescents, the dosage is one (1) tablet once daily.

Ensure the daily dose is not exceeded.

The duration of use is determined by the physician based on the clinical indication and patient response.

For long-term prophylactic use, conduct regular medical assessments.

Do not administer to children under 4 years of age due to the risk of choking and inappropriate dosage form.

Avoid concomitant use with other multivitamin or mineral supplements to prevent cumulative overdose, particularly of vitamins A and D and iron.

In case of accidental ingestion of a significantly higher than recommended dose, seek immediate medical attention or contact a poison control center.

Adverse Reactions

Allergic reactions are possible.

Urine may turn intense yellow, and stool may turn dark in color, which is not dangerous.

Contraindications

• Hypervitaminosis A and D;
• Children under 4 years of age;
• Hypersensitivity to any component of the drug.

Pediatric Use

Contraindicated in children under 4 years of age

Geriatric Use

Prescribed for children and adolescents

Special Precautions

The recommended dose should not be exceeded.

Overdose

Symptoms: nausea, weakness, visual disturbances, gastrointestinal disorders.

In case of accidental overdose, consult a doctor.

Treatment: activated charcoal orally, gastric lavage, symptomatic therapy.

Drug Interactions

Concomitant use with other drugs containing vitamins and iron is not recommended to avoid overdose.

Storage Conditions

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

Shelf Life

Shelf life – 5 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.