Bac-Set^® forte (Capsules) Instructions for Use

Marketing Authorization Holder

Pharmamed, JSC (Russia)

Manufactured By

Adm Protexin, Ltd. (United Kingdom)

Packaged By

BIOVID, LLC (Russia)

ALINA PHARMA, LLC (Russia)

Contact Information

PHARMAMED JSC (Russia)

Dosage Form

	Bac-Set^® Forte	Capsules 2×10⁹ CFU: 10 or 20 pcs.
		Capsules 2×10⁹ CFU: 10 or 20 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 210 mg.

	1 caps.	ALI-UDLI*
Probiotic complex (probiotic and lactic acid microorganisms)	2×10⁹ CFU
Lactobacillus casei PXN37	5.8×10⁸ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus plantarum PXN47	3.2×10⁸ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus rhamnosus PXN54	3.2×10⁸ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus acidophilus PXN35	1×10⁸ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus bulgaricus PXN39	2×10⁷ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus helveticus PXN45	2×10⁷ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus salivarius PXN57	2×10⁷ CFU	5×10⁷-5×10⁹ CFU
Lactobacillus fermentum PXN44	1×10⁷ CFU	5×10⁷-5×10⁹ CFU
Bifidobacterium bifidum PXN23	1×10⁸ CFU	5×10⁸-5×10¹⁰ CFU
Bifidobacterium breve PXN25	1×10⁸ CFU	5×10⁸-5×10¹⁰ CFU
Bifidobacterium longum PXN30	1×10⁸ CFU	5×10⁸-5×10¹⁰ CFU
Bifidobacterium infantis PXN27	2×10⁷ CFU	5×10⁸-5×10¹⁰ CFU
Lactococcus lactis ssp. lactis PXN63	4×10⁷ CFU	1×10⁷-1×10⁹ CFU
Streptococcus thermophilus PXN66	4×10⁷ CFU	1×10⁷-1×10⁹ CFU

* adequate level of daily intake;
** upper permissible level of daily intake.

Excipients: microcrystalline cellulose, emulsifier (E460), hypromellose, capsule shell (E464).

Does not contain artificial colors, flavors, or genetically modified organisms.

10 pcs. – blisters (1) – cardboard boxes.
10 pcs. – blisters (2) – cardboard boxes.

Therapeutic Category

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

Properties

Bac-Set^® Forte is a new-generation multi-probiotic for adults and children from 3 years of age.

The complex contains 14 types of live probiotic bacteria that enhance and complement each other’s action. Bac-Set^® Forte helps restore intestinal microflora and normalize digestion in cases of dysbiosis, constipation, antibiotic use, intestinal infections, and allergic conditions in children over 3 years of age and adults.

Thanks to the improved microencapsulated production technology, the beneficial bacteria included in the complex retain their viability and activity throughout the entire shelf life and do not require refrigeration.

Bac-Set^® Forte is a 14-strain probiotic, all bacteria of which are genetically identified and certified; stored in the UK National Collection of Industrial, Food and Marine Bacteria (NCIMB).

Can be used for lactase deficiency.

Scope of Application

Of the Bac-Set^® Forte product

As a dietary supplement – a source of lactobacilli, bifidobacteria, and lactic acid microorganisms for:

Dysbiosis;
Antibiotic use;
Intestinal infections and poisonings;
Bowel movement disorders (diarrhea, constipation);
Digestive disorders (pain, cramps, bloating);
Food allergies, dermatitis;
Changes in diet and eating habits (attending children’s organized groups, travel).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A05	Other bacterial food poisonings, not elsewhere classified
A09	Other and unspecified gastroenteritis and colitis of infectious origin
K30	Functional dyspepsia (digestive disorder)
K59.0	Constipation
K59.1	Functional diarrhea
K63.8	Other specified diseases of intestine
L20.8	Other atopic dermatitis (neurodermatitis, eczema)
T78.1	Other adverse food reactions, not elsewhere classified

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.

Capsules should be swallowed whole with water. When using the complex in children under 5 years of age, the contents of the capsule should be poured into any drink and given to the child to drink during a meal.

Children aged 3 to 12 years are prescribed 1 capsule once a day with meals.

Children over 12 years of age and adults – 2 capsules 1-2 times a day with meals.

The recommended duration of use is 1 month.

During antibiotic therapy, Bac-Set^® Forte should be started simultaneously with antibiotics and continued for another 2 weeks after the end of antibiotic therapy.

Before visiting a preschool institution or traveling, it is recommended to start taking Bac-Set^® Forte 3-4 days before the upcoming event and take it for 1-2 weeks.

Contraindications

Individual intolerance to the components of the complex.

Use during pregnancy and lactation

Bac-Set^® Forte can be used during pregnancy and breastfeeding.

Special instructions

A dietary supplement to food. Is not a medicinal product.

It is recommended to consult a doctor before use.

Bac-Set^® Forte does not require refrigeration.

Use in pediatrics

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

Storage Conditions

The product should be stored in the unopened original packaging in a dry place at room temperature. Avoid direct sunlight.

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.

Medical Disclaimer