ProbioLog IBS (Capsules) Instructions for Use

Marketing Authorization Holder

Maoli Spindler, LLC (Russia)

Manufactured By

Alifarm S.A. (Spain)

On Behalf Of

AB-BIOTICS, S.A. (Spain)

For

Laboratoires MAYOLY-SPINDLER (France)

Contact Information

MAYOLY PHARMA LLC (Russia)

Dosage Form

ProbioLog IBS

Capsules: 15 pcs.

Dosage Form, Packaging, and Product Composition

Capsules with a mass of 435.5 mg.

Excipients: maltodextrin, magnesium stearate (E470b), silicon dioxide (E551).

Capsule shell composition: hypromellose (E464), titanium dioxide (E171).

Does not contain sugar, gluten, GMOs.

15 pcs. – blisters (1) – cardboard packs.

Therapeutic Category

Dietary supplement – a source of probiotic bacteria and lactic acid microorganisms

Properties

ProbioLog IBS consists of a combination of 3 strains of lactic acid bacteria: Lactobacillus plantarum (CECT 7484 and 7485) and Pediococcus acidi lactici (CECT 7483).

One capsule contains at least 3 billion live microorganisms.

The bacterial strains in the ProbioLog IBS product have acid-resistant properties, which allow them to maintain their viability when passing through the acidic environment of the stomach.

A large number of species of lactic acid bacteria have a long history of documented safe use.

The European Food Safety Authority has developed a system that provides a “Qualified Presumption of Safety” (QPS) status to taxonomic units with a confirmed long history of documented safe use.

The strains CECT 7483, CECT 7484, and CECT 7485 belong to bacterial species that have QPS status.

Irritable bowel syndrome (IBS) is a condition characterized by abdominal discomfort and pain, bloating, altered bowel motility and transit, where symptoms cannot be explained by structural abnormalities.

The WGO¹ recommends for irritable bowel syndrome taking the combination of bacterial strains of the ProbioLog IBS product at a dose of at least 3 billion CFU/capsule once daily.

These strains are capable of fermenting fibers, commonly included in the diet, to produce a large amount of short-chain fatty acids, especially butyric acid.

Butyric acid modulates intestinal motility and reduces visceral pain.

The bacterial strains included in the ProbioLog IBS product are also capable of reducing inflammation of the intestinal mucosa, reducing diarrhea, and improving quality of life with regular use for at least 3 weeks.

¹ World Gastroenterology Organisation Global Guidelines. Probiotics and prebiotics. February, 2017. Page 22.

Scope of Application

Of the ProbioLog IBS product

As a dietary supplement – a source of probiotic microorganisms (lactobacilli) and lactic acid microorganisms (Pediococcus acidi lactici) for

• Normalizing intestinal function in people with functional intestinal disorders, including irritable bowel syndrome;
• Reducing inflammation of the intestinal mucosa;
• Improving quality of life in cases of functional abdominal pain.

ICD codes

Dosage Regimen

ProbioLog IBS is taken orally, with meals (the capsule can be opened and the contents poured into non-hot food).

Adults and children over 14 years are recommended to take 1 capsule/day.

The duration of use is at least 3 weeks, optimally 6 weeks. If necessary, the course of the product can be repeated.

Contraindications

• Individual intolerance to the components.

Special Instructions

A dietary supplement to food; is not a medicinal product.

It is recommended to consult a doctor before use.

Storage Conditions

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

Shelf Life

Shelf life – 2 years.

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.