Dentoblis (Tablets) Instructions for Use

Marketing Authorization Holder

R-Pharm JSC (Russia)

Manufactured By

Medico Domus, LLC (Serbia)

On Behalf Of

BLUESTONE PHARMA (Switzerland)

Contact Information

R-PHARM JSC (Russia)

Dosage Forms

	Dentoblis	Lozenges with mint flavor: 30 pcs.
		Lozenges with strawberry flavor: 30 pcs.

Dosage Form, Packaging, and Product Composition

Lozenges with mint flavor, weighing 810 mg.

Composition sweetener – isomalt, Streptococcus salivarius M18, anti-caking agent – magnesium stearate, natural flavor “Mint”, ready-made vitamin D₃ mixture (sucrose, thickener – gum arabic, corn starch, medium-chain triglycerides, carrier – tricalcium phosphate, vitamin D₃ (cholecalciferol) – 200 IU (5 mcg), DL-alpha-tocopherol, water).

10 pcs. – blisters (3) – cardboard packs.

Lozenges with strawberry flavor, weighing 810 mg.

Composition sweetener – isomalt, Streptococcus salivarius M18, anti-caking agent – magnesium stearate, natural flavor “Strawberry”, ready-made vitamin D₃ mixture (sucrose, thickener – gum arabic, corn starch, medium-chain triglycerides, carrier – tricalcium phosphate, vitamin D₃ (cholecalciferol), DL-alpha-tocopherol, water).

10 pcs. – blisters (3) – cardboard packs.

May contain residues/traces of milk protein.

Therapeutic Category

Dietary supplement for maintaining oral microflora

Properties

Streptococcus salivarius M18 is one of the main representatives of the healthy oral microflora. It effectively colonizes the oral cavity, produces salivaricins, including salivaricin M – lantibiotics, local antibacterial substances that can suppress the growth of oral infection pathogens (for example, Streptococcus spp., Actinomyces spp., Porphyromonas spp., Aggregatibacter spp.); produces enzymes that help break down dental plaque (dextranase) and neutralize oral acidity (urease).

Probiotic bacteria Streptococcus salivarius M18 contribute to

• Establishing and maintaining the functional state of the oral microflora (including after a course of antibiotic therapy);
• Reducing the number of major pathogens causing caries and gingivitis in adults and children;
• Reducing gum inflammation;
• Reducing dental plaque, normalizing oral acidity;
• Prevention of caries.

Dentoblis can be used

• For the prevention of caries and inflammatory gum diseases (periodontitis, gingivitis);
• As a daily oral hygiene practice;
• To reduce dental plaque, normalize oral acidity;
• After professional dental hygiene.

The strain Streptococcus salivarius M18 is included in the collections of the American Type Culture Collection (ATCCBAA-2593); conducted examination showed no negative effects on the human body. The Food and Drug Administration (FDA) has granted the product GRAS status (Generally Regarded As Safe); GRAS Notice No. GRN 000807, 2019.

Scope of Application

Of the Dentoblis product

• As a dietary supplement – a source of live probiotic bacteria ( Streptococcus salivarius M18), contributing to the reduction of dental plaque, prevention of caries and periodontal diseases, restoration of the alkaline environment of the oral cavity in children over 3 years of age and adults.

ICD codes

Dosage Regimen

Slowly dissolve in the mouth until the tablet is completely dissolved.

Adults and children aged 3 years and older – 1 tablet/day, preferably in the evening, before bedtime, after brushing teeth. After taking the Dentoblis product, it is not recommended to drink or eat for at least an hour.

Duration of use – 1-3 months or as recommended by a doctor. If necessary, the course can be repeated.

The daily dose of the dietary supplement provides

* physiological requirement norm for children and adolescents according to MR 2.3.1.0253-21 “Norms of physiological requirements for energy and nutrients for various groups of the population of the Russian Federation”;
** recommended daily intake level according to TR CU 022/2011 “Food products regarding their labeling”, Appendix 2;
*** adequate intake level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5;
**** upper permissible intake level according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”, Chapter II, Section 1, Appendix 5.
CFU – colony-forming unit (an indicator of the number of viable microorganisms).

Contraindications

• Individual intolerance to the components.

With caution , under medical supervision

• Persons with impaired normal immune status;
• When taking immunosuppressants.

Children under 14 years of age should take the dietary supplement in agreement with and under the supervision of a pediatrician.

Special instructions

Dietary supplement, not a medicinal product.

It is recommended to consult a doctor before use.

Before giving the dietary supplement to children, it is necessary to consult a pediatrician.

The product may contain traces of milk protein. In case of individual intolerance to dairy products or other components of the product, it is necessary to consult a doctor before use.

Drug Interactions

Currently, there are no data on the interaction of the Dentoblis product with medicinal products and other dietary supplements and contraindications for concomitant use.

Dispensing Status

Sold through pharmacy chains, specialized departments of the retail network.

Storage Conditions

The product should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

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.