Mastodon

Enterolactis® Duo (Powder) Instructions for Use

Marketing Authorization Holder

Alfasigma Rus LLC (Russia)

Manufactured By

Sofar, S.p.A. (Italy)

Contact Information

ALFASIGMA RUS LLC (Russia)

Dosage Form

Bottle OTC Icon Enterolactis® Duo Powder: sachet 5 g 20 pcs.

Dosage Form, Packaging, and Product Composition

Powder for the preparation of an oral suspension.

1 sachet
Probiotic lactobacilli Lacticaseibacillus paracasei DG I-1572 DSM 34154 (L.casei DG) Not less than 8×109 CFU
Inulin 4 g

5 g – sachets (20) – cardboard packs.

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

The Enterolactis® Duo dietary supplement is a synbiotic, which is a combination of live human-origin dairy enzymes (probiotic component), characterized by high viability/adhesion, and inulin, a dietary fiber that is not absorbed in the gastrointestinal tract.

Enterolactis® Duo contains L. casei DG (Lacticaseibacillus paracasei DG I-1572 DSM 34154 (L.casei DG®)) – a product of the developer company’s research.

Due to strong adhesion to the mucosa, Enterolactis® Duo remains active in the intestine, where it rapidly multiplies.

The specific characteristic of the L. casei DG strain characterizes Enterolactis® Duo as a true probiotic – that is, as a live, viable, and stable organism capable of safely restoring the physiological level of the intestinal flora, disrupted for various reasons.

Key characteristics of the Lacticaseibacillus paracasei DG I-1572 DSM 34154 strain

  • It is of human origin (species-specific), which guarantees long-term intestinal colonization;
  • It is resistant to low gastric pH and bile salts – the main condition for the bacteria to reach the intestine alive after oral intake;
  • It has a high capacity to adhere to intestinal mucosal cells, which is absolutely necessary for good colonization;
  • It has a high growth potential;
  • It is resistant to lyophilization, which ensures a final product with a high concentration of live microorganisms;
  • It remains stable over time, so there is no need for special storage conditions.

The L. casei DG contained in Enterolactis® Duo are capable of effectively restoring the microbial balance in the intestine and playing an important role in forming a barrier that protects against pathogenic agents. This result is also achieved due to the high content of live L. casei DG cells in each dose: not less than 8 billion in 1 sachet.

Inulin is a dietary fiber that passes unchanged through the stomach and small intestine and reaches the large intestine, increasing fecal bulk.

One sachet of Enterolactis® Duo contains 4 g of inulin.

Enterolactis® Duo is a probiotic enzyme, excellent for proper intestinal colonization. Soluble fiber is necessary in case of insufficient dietary fiber intake.

Together with adequate fluid intake, Enterolactis® Duo is particularly indicated for stimulating intestinal peristalsis and balancing disturbed microflora. Enterolactis® Duo has a positive effect on bowel function (frequency and consistency of stool) in patients with chronic constipation.

Scope of Application

Of the Enterolactis® Duo product

  • As a dietary supplement – a source of probiotic lactobacilli and the prebiotic inulin (polyfructosans).

Contributes to

  • Normalization of the balance of intestinal microflora, including in diverticular disease and irritable bowel syndrome;
  • Increasing the effectiveness of Helicobacter pylori eradication;
  • Strengthening the immune intestinal barrier and the state of the immune system.

Reduces the risk of side effects from taking antibiotics, which may manifest as bloating and/or constipation.

ICD codes

ICD-10 code Indication
E63 Other nutritional deficiencies
K58 Irritable bowel syndrome

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 orally, with meals.

Adults and children over 6 years 1 sachet/day. Dissolve the contents of the sachet in a glass of water at room temperature and drink. Should not be taken with hot food or liquid.

The duration of intake is 1 month.

In case of simultaneous administration of antibacterial drugs, Enterolactis® Duo should be taken at least 3 hours before taking the antibiotic.

Contraindications

  • Individual intolerance to the product components.

Use during pregnancy and breastfeeding

Enterolactis® Duo can be used during pregnancy and breastfeeding, on the recommendation and under the supervision of a physician.

Special instructions

A dietary supplement, not a medicinal product.

It is recommended to consult a doctor before use.

Enterolactis® Duo is well absorbed by adults of all ages and children over 6 years.

Before giving the dietary supplement to children, it is necessary to consult a pediatrician; children under 14 years of age should take the dietary supplement in agreement with and under the supervision of a pediatrician.

Does not contain lactose. Does not contain gluten and can be consumed by patients suffering from celiac disease.

The product does not affect the ability to drive or operate machinery.

Dispensing Status

Through pharmacy networks and specialized stores, departments of the retail chain.

Storage Conditions

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

Shelf Life

Shelf life – 2 years.

An opened sachet should not be stored.

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

Table of Contents

→ TABLE OF CONTENTS