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Bactibillak Maxi (Capsules) Instructions for Use

Marketing Authorization Holder

MDP-Group, LLC (Russia)

Manufactured By

Mystical Biotech, Pvt. Ltd. (India)

Contact Information

EVRAZFARM LLC (Russia)

Dosage Form

Bottle OTC Icon Bactibillak Maxi Capsules: 10 pcs.

Dosage Form, Packaging, and Product Composition

Capsules with a mass of 500 mg.

1 capsule
Live lyophilized bacteria (probiotics) ≥4.5×109 CFU
   Lactobacillus helveticus 0.9×109 CFU
   Lactobacillus lactis 0.9×109 CFU
   Lactobacillus rhamnosus 0.675×109 CFU
   Lactobacillus casei 0.45×109 CFU
   Lactobacillus plantarum 0.225×109 CFU
   Bifidobacterium longum 0.675×109 CFU
   Bifidobacterium breve 0.45×109 CFU
   Bifidobacterium bifidum 0.225×109 CFU
   Streptococcus thermophilus 0.45×109 CFU
Fructooligosaccharides (prebiotics) 100 mg

Nutritional value (1 capsule): proteins – 0.069 g, fats – 0 g, carbohydrates – 0.45 g.
Energy value (1 capsule): 1.8 kcal/4.2 kJ.

Excipients: talc, magnesium stearate, maltodextrin, lactose.

Capsule shell composition: gelatin, purified water, titanium dioxide.

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

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

Bactibillak Maxi – capsules containing Live lyophilized bacteria (probiotics) and Fructooligosaccharides (prebiotics).

Probiotics are beneficial live microorganisms that have a favorable effect on the human body by normalizing the composition or increasing the activity of the normal intestinal microflora. Most probiotics belong to two genera: lactobacilli (Lactobacillus) and bifidobacteria (Bifidobacterium).

Lactobacilli are among the most important in the group of lactic acid bacteria. Many species of lactobacilli are representatives of the normal microflora of the gastrointestinal tract, from the oral cavity to the large intestine. Strains of lactobacilli adapted to exist in the highly acidic environment of the stomach have been found in the stomachs of healthy people. There is a small number of lactobacilli in the small intestine, located in the parietal layer. There are significantly more lactobacilli in the large intestine (106-107 CFU/g of large intestine content), represented by species: Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus reuteri, Lactobacillus rhamnosus and others. Lactobacilli are the predominant type of normal microflora of the vulva and vagina, also inhabit the oral cavity and nasopharynx, and are found in breast milk.

Bifidobacteria are the most important representatives of human microflora. Their proportion ranges from 85% to 98%. Most bifidobacteria are located in the large intestine, being its main parietal and luminal microflora. Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve in total reach 108-1011 CFU per 1 g of large intestine content.

Streptococcus thermophilus belongs to the group of lactic acid bacteria that ferment carbohydrates with the formation of lactic acid. It absorbs and processes lactose (milk sugar) and is therefore used in lactase deficiency; it has an acidifying effect, providing a bactericidal effect against pathogenic microorganisms.

Prebiotics are food ingredients that have a beneficial effect on the human body as a result of selective stimulation of the growth and/or increase in the biological activity of the normal intestinal microflora.

Fructooligosaccharides are natural substances contained in many plants included in the human diet (including bananas, artichokes, onions, tomatoes, asparagus, garlic, wheat, barley, chicory). Along with direct positive effects on the digestive system (improving intestinal peristalsis and microflora composition), Fructooligosaccharides also have a number of indirect effects: strengthening immunity, improving the absorption of the most important minerals (primarily calcium and magnesium), reducing the content of cholesterol, triglycerides in the blood, glucose concentration in patients with diabetes mellitus, and even reducing the risk of intestinal cancer.

Synbiotics are products containing probiotics and prebiotics.

The components of the synbiotic Bactibillak Maxi have a mutually reinforcing effect on the metabolic processes in the human body.

Thanks to the production technology of Bactibillak Maxi capsules, the bacteria are protected from the action of gastric juice, bile, pancreatic and intestinal juices, which allows the bacteria to pass unimpeded through the stomach, the upper parts of the small intestine, and successfully adapt and colonize in the intestine.

Taking 1 capsule of the Bactibillak Maxi product fully provides the daily intake level of beneficial intestinal microflora bacteria (Lactobacillus helveticus, Lactobacillus lactis, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Bifidobacterium longum, Bifidobacterium breve, Bifidobacterium bifidum, Streptococcus thermophilus), and also provides 0.1% of the adequate daily intake level of fructooligosaccharides.

Scope of Application

Of the Bactibillak Maxi product

As a dietary supplement – a source of probiotic microorganisms (bifidobacteria and lactobacilli) and lactic acid microorganisms (Streptococcus thermophilus)

  • To normalize intestinal microflora when taking drugs that suppress normal intestinal microflora (for example, after taking antibiotics, after and/or during the use of hormonal drugs, NSAIDs, antimicrobial agents, acne treatments);
  • For the prevention of intestinal disorders during travel;
  • During seasonal outbreaks of infectious diseases and allergies;
  • During chronic stress.

ICD codes

ICD-10 code Indication
E63.8 Other specified types of nutritional deficiency
ICD-11 code Indication
5B7Z Malnutrition, unspecified
8D40.0 Encephalopathy due to nutritional deficiency

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.

Bactibillak Maxi is taken orally, with meals (preferably in the evening).

Adults and children over 3 years are prescribed 1 capsule 1 time/day.

For children under 5 years of age, the capsule contents should be poured into water or milk at room temperature, mixed, and given to drink immediately.

The duration of use is 10-30 days. If necessary, the course can be repeated.

Side Effects

With significant overdose, bloating, diarrhea, abdominal pain, and rarely – nausea and vomiting are possible. These symptoms are usually associated with a diet rich in carbohydrates and fats.

Contraindications

  • Individual intolerance to the components of the product, including any conditions associated with lactose/galactose intolerance.

Use During Pregnancy and Breastfeeding

Pregnancy and breastfeeding are not contraindications; however, a pregnant or breastfeeding woman should consult a doctor, as when taking any dietary supplement.

Special Instructions

Bactibillak Maxi is not a medicinal product.

It is recommended to consult a doctor before use.

Use in Pediatrics

For children under 14 years of age, Bactibillak Maxi should be taken in consultation with a pediatrician.

Drug Interactions

It is necessary to avoid simultaneous use of the Bactibillak Maxi product and antibiotics due to the possible decrease in the effectiveness of antibacterial drugs. Bactibillak Maxi is recommended to be used after the completion of the antibiotic course.

Storage Conditions

Bactibillak Maxi 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 – 3 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.

Medical Disclaimer

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