Maxilac^® (Capsules) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Manufactured By

Danisco France, SAS (France)

Contact Information

BINNOPHARM GROUP LLC (Russia)

Dosage Form

Maxilac®

Capsules: 10 pcs.

Dosage Form, Packaging, and Product Composition

* CFU – colony-forming unit (a measure of the number of viable microorganisms).

Excipients: microcrystalline cellulose (E450(i), carrier), gellan gum (E418, thickener), titanium dioxide (E171, colorant), magnesium salts of fatty acids (magnesium stearate) (E572, emulsifier), amorphous silicon dioxide (E551, anticaking agent).

Does not contain lactose, sucrose, casein, gluten, or GMOs.

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

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

The synbiotic Maxilac^® is a complex of 9 probiotic strains at a concentration of 4.5 billion CFU and a prebiotic (fructooligosaccharides), which complement and enhance each other’s action. It is a universal means for restoring the normal balance of intestinal microflora.

The lacto- and Bifidobacteria (probiotic component) included in the composition of the synbiotic Maxilac^® suppress the growth of various types of pathogenic bacteria, restore the balance of the intestinal microflora, improve metabolic processes, strengthen immunity, and increase the body’s resistance to colds and infectious diseases.

The effectiveness of probiotics, which include several different strains of lacto- and bifidobacteria, is achieved through the synergy of their components. Lactic acid, synthesized by lactobacilli, inhibits the growth of pathogenic flora and also promotes the absorption of vitamin D, iron, and calcium.

Fructooligosaccharides (the prebiotic in the Maxilac^® product) supply probiotic bacteria with energy and nutrients, stimulating their reproduction 1.5-2 times faster. Fructooligosaccharides improve and normalize bowel function, stimulate peristalsis, serve to prevent constipation and diarrhea, and contribute to the normalization of the functions of the entire gastrointestinal tract.

The bacteria included in the synbiotic Maxilac^® are supplied by the world leader in probiotic production and undergo regular genetic purity control, which guarantees high quality and stability of the bacterial strains.

The patented DuPont lyophilization technology ensures the preservation of bacterial cells, maintaining high viability of beneficial bacteria for a long time, including at elevated temperatures and varying humidity levels. The SFERA (Surrounded Freeze Release Armour) protection technology helps preserve the beneficial bacteria in the synbiotic Maxilac^®, neutralizes the negative effects of the acidic stomach contents, bile salts, and digestive enzymes on the probiotic bacteria in the product, helping them to pass through the stomach without loss, adapt in the intestinal lumen, and retain high biological activity, which positively affects the restoration of the normal balance of the gastrointestinal microflora. The active components of the synbiotic exert their action directly in the area of microflora disturbance.

The synbiotic Maxilac^® does not contain lactose, sucrose, casein, or gluten and can be used by individuals with intolerance to these components.

Scope of Application

Of the Maxilac^® product

As a source of probiotic microorganisms (Bifidobacteria, lactobacilli) and lactic acid microorganisms for adults and children from 3 years of age

• During and/or after taking medications (including antibiotics) that may cause changes in the qualitative and/or quantitative composition of the gastrointestinal microflora;
• As part of complex correction of conditions requiring Helicobacter pylori eradication;
• For manifestations of intestinal infections and food poisoning;
• For functional intestinal disorders: diarrhea, indigestion, constipation, flatulence (bloating), nausea, belching, vomiting, abdominal pain and discomfort;
• For manifestations associated with food allergies, dermatitis;
• During seasonal outbreaks of infectious diseases to support immunity.

Probiotic strains of lacto- and bifidobacteria provide additional protection during stress, climate change, change of location, diet, and eating habits, including during travel, dieting, and when children join organized groups.

ICD codes

Dosage Regimen

Take orally with meals (preferably in the evening). The capsule should be swallowed whole with water at room temperature.

Adults and children over 3 years are prescribed 1 capsule once a day.

When administered to children, parents should ensure that the child is able to swallow the capsule. If children are unable to swallow the capsule, it is recommended to use the Synbiotic Maxilac^® Baby in powder form.

The duration of administration is at least 10 days; if necessary, the intake can be extended up to 1 month. The course can be repeated 2-3 times a year.

The synbiotic Maxilac^® can be taken from the first day of antibiotic use and continued for 2-4 weeks after the end of the antibiotic therapy course.

Use of the synbiotic Maxilac^® in the complex correction of the following conditions

• For Helicobacter pylori eradication as an additional agent for 7-10 or 14 days depending on the main treatment regimen.
• For gastrointestinal disorders caused by intestinal infections or associated with antibiotic use (antibiotic-associated diarrhea), which are accompanied by stool disorders, abdominal pain for 5-10 days in the first days and continue intake for up to 4 weeks during the recovery (convalescence) period.
• To reduce the risk of intestinal disorders when changing climate, diet, and eating habits (travel, diets, joining children’s organized groups, etc.) – start taking Maxilac^® 3-5 days before the upcoming event and continue for 1-2 weeks after (or throughout the entire trip).
• During seasonal outbreaks of respiratory infectious diseases to support immunity and reduce the incidence of acute respiratory viral infections, the intake of Maxilac^® can be up to 2 months.
• For manifestations associated with food allergies and dermatitis – take for 1 month. If necessary, the intake period can be extended as prescribed by a doctor.

Contraindications

• Individual intolerance to the product components.

Use during pregnancy and breastfeeding

Maxilac^® can be used during pregnancy and breastfeeding.

Special instructions

Dietary supplement. Not a medicinal product.

Consult a doctor before use.

Do not use as the main source of nutrition.

Dispensing Status

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

Storage Conditions

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

Shelf Life

Shelf life – 24 months.

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.