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Biovital® (Dragee, Gel) Instructions for Use

ATC Code

A11AB (Multivitamins in combination with other drugs)

Clinical-Pharmacological Group

Multivitamins with trace elements and components of natural origin

Pharmacotherapeutic Group

Multivitamin agent + other drugs

Pharmacological Action

Determined by the complex of vitamins and minerals included in the composition.

Indications

Used for the prevention and treatment of hypo- and avitaminosis, iron deficiency (including iron deficiency anemia).

  • During increased physical and mental stress;
  • During the recovery period after prolonged and/or severe illnesses (including infectious ones), as well as in the postoperative period;
  • As part of combination therapy in the treatment of diseases of the nervous and cardiovascular systems (nervous strain, sleep disturbance as a result of stress).

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.

Dragee

The drug is taken without chewing, before or during meals.

Adults and adolescents – 1-2 dragees 3 times/day; school-age children – 1 dragee 2 times/day.

The duration of treatment is determined on the recommendation of a doctor.

Gel

The drug is taken: adolescents and school-age children 1 teaspoon 2 times/day; younger and infant children 1/2 teaspoon 2-3 times/day.

The duration of treatment is determined by the doctor.

For the treatment of lesions of the oral mucosa in stomatitis, it is recommended to apply the gel to the mucous membranes and leave it for some time.

Adverse Reactions

Allergic reactions to the components of the drug.

Contraindications

  • Hypersensitivity to the components of the drug;
  • Increased iron content in the body.

Use with caution in preschool children.

Use in Pregnancy and Lactation

The drug can be taken during pregnancy and the period of breastfeeding, provided the recommended daily dose is observed.

Pediatric Use

Adolescents 1-2 dragees 3 times/day; school-age children 1 dragee 2 times/day.

Use with caution in preschool children.

Special Precautions

Urine may turn yellow, which is completely harmless and is explained by the presence of riboflavin.

All iron-containing drugs lead to a completely harmless black coloration of the stool.

Do not take other multivitamin preparations at the same time.

Instructions for patients with diabetes: 1 dragee corresponds to 0.02 XE.

Drug Interactions

The iron included in the preparation reduces the absorption of tetracyclines.

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

Storage Conditions

At a temperature not exceeding 25°C (77°F), in a place inaccessible to children. Do not store in a damp place.

Shelf Life

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

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

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Bayer Consumer Care, AG (Switzerland)

Manufactured By

A. Nattermann and Cie., GmbH (Germany)

Dosage Form

Bottle OTC Icon Biovital® Dragees: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Dragee round, biconvex (lentil-shaped), shiny, from dark red to pale crimson in color.

1 dragee
Retinol acetate 500 IU
Ascorbic acid 20 mg
Thiamine hydrochloride 250 mcg
Riboflavin 250 mcg
Pyridoxine hydrochloride 250 mcg
Folic acid 250 mcg
Cyanocobalamin 0.5 mcg
Nicotinamide 2.5 mg
Iron sulfate 50 mg,
   Including iron (II) 16 mg
Sodium-iron citrate complex (III) 50 mg,
   Including iron (III) 16.5 mg
Crataegus monogyna fruit dry extract (2.5-5:1) 4 mg
Dry extract of Crataegus leaves and flowers (4-7:1) 2.5 mg
Dry extract of motherwort herb (5.5-10:1) 1 mg

Excipients : stearyl alcohol, sucrose, gelatin, magnesium stearate, stearic acid, povidone, corn starch, butylated hydroxytoluene, dextrose syrup, dextrin, silicon, purified water.

15 pcs. – blisters (2) – cardboard boxes.
15 pcs. – blisters (4) – cardboard boxes.
15 pcs. – blisters (6) – cardboard boxes.

Marketing Authorization Holder

Bayer Consumer Care, AG (Switzerland)

Manufactured By

A. Nattermann and Cie., GmbH (Germany)

Dosage Form

Bottle OTC Icon Biovital® Gel for children (Kinder Biovital®) Oral gel for children: tube 175 g

Dosage Form, Packaging, and Composition

Oral gel for children light yellow, homogeneous, viscous, containing a large number of air bubbles, with a weak fruity (orange) odor and a sweet and sour fruity (orange) taste.

10 g
Retinyl palmitate 2.75 mg (5000 IU)
Colecalciferol 600 IU
α-Tocopherol acetate 1.65 mg
Ascorbic acid 100 mg
Thiamine hydrochloride 330 mcg
Riboflavin 330 mcg
Calcium pantothenate 1 mg
Pyridoxine hydrochloride 1.5 mg
Cyanocobalamin 1 mcg
Nicotinamide 5 mg
Calcium phosphinate 2.5 mg
Manganese citrate soluble 6 mg
Sodium molybdate 250 mcg
Lecithin (phospholipids from soybeans) 200 mg

Excipients : ethanol, red orange flavor, isopropyl myristate, potassium sorbate, sodium benzoate, sucrose, sodium carboxymethylcellulose, vanillin, demineralized water.

175 g – aluminum tubes (1) – cardboard boxes.

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