Pharmanex^® Pro-B (Capsules) Instructions for Use

Marketing Authorization Holder

Nu Skin Enterprises Rs, LLC (Russia)

Manufactured By

Deseret Laboratories Inc. (USA)

For

NSE Products, Inc. (USA)

Contact Information

Nu Skin Enterprises Rs LLC (Russia)

Dosage Form

Pharmanex^® Pro-B

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules transparent; capsule contents – powder of almost white color; weighing 344 mg.

	1 caps.
Lactobacillus fermentum PCC	30-90 mg (≥2×10⁹ CFU)*

Excipients: microcrystalline cellulose – 174-234 mg*, stearic acid – 6 mg, silicon dioxide – 4 mg.

Capsule shell composition: hypromellose, water, carrageenan, potassium chloride.

30 pcs. – plastic bottles (1) – cardboard packs.

* The weight of the ingredients Lactobacillus fermentum PCC and microcrystalline cellulose may vary in different batches depending on the activity and density of the Lactobacillus fermentum preparation to maintain a probiotic dose of ≥2×10⁹ CFU per capsule throughout the shelf life and a total capsule weight of 344 mg.

Therapeutic Category

Dietary supplement – source of probiotic lactobacilli

Properties

A biologically derived product that regulates the balance of intestinal microflora, a probiotic.

It contains a live culture of Lactobacillus fermentum PCC bacteria resistant to the acidic environment of the stomach. Lactobacilli have high adhesion to mucous membranes, which contributes to the formation of a protective surface biolayer on the intestinal walls. They have antagonistic activity against pathogenic and opportunistic microorganisms due to the production of organic acids (mainly lactic acid) and bacteriocins during metabolism.

The anti-inflammatory effect of the drug is due to the inhibition of the synthesis of pro-inflammatory cytokines TNF, γ-interferon, IL-1β, IL-6, IL-12 and stimulation of interleukin-10 synthesis. Exopolysaccharides of Lactobacillus fermentum reduce the severity of oxidative stress by increasing the activity of superoxide dismutase and catalase and reducing the content of malondialdehyde and the activity of myeloperoxidase.

The immunostimulating and immunomodulatory effect of Lactobacillus fermentum is associated with the presence of peptidoglycans and teichoic acids in their cell wall, the formation of arginine and nitric oxide, as well as the prevention of adhesion of pathogenic and opportunistic microorganisms to the intestinal walls and their formation of endotoxin.

Studies have been conducted showing the positive effect of Lactobacillus on increasing insulin sensitivity, vitamin D metabolism, and reducing cholesterol and LDL levels.

Scope of Application

Of Pharmanex^® Pro-B product

As a dietary supplement – an additional source of probiotic lactobacilli

For the prevention and treatment of dysbiosis, incl. associated with antibiotic use;
As part of complex therapy:
- Inflammatory diseases of the gastrointestinal tract (enteritis, colitis);
- Allergic reactions;
- Irritable bowel syndrome.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A09	Other and unspecified gastroenteritis and colitis of infectious origin
K52.8	Other specified noninfective gastroenteritis and colitis
K58	Irritable bowel syndrome
K63.8	Other specified diseases of intestine

ICD-11 code	Indication
1A40.Z	Infectious gastroenteritis or colitis, unspecified
DA42.Z	Gastritis, unspecified
DA92.1	Pneumatosis intestinalis of the small intestine
DA98.Z	Polyps of small intestine, unspecified
DB31.1	Pneumatosis of the colon
DB36.Z	Certain infections of the colon, unspecified
DD91.0Z	Irritable bowel syndrome, unspecified
DE2Z	Diseases of the digestive system, unspecified

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.

Administer orally. Take with a meal to enhance bacterial survival through the gastrointestinal tract.

The standard recommended daily dose for adults and adolescents is one capsule. Do not exceed this dosage.

For use during a course of antibiotic therapy, take the capsule at least 2-3 hours before or after the antibiotic dose to prevent inactivation of the probiotic.

Continue administration for the duration recommended by a healthcare provider, typically for several weeks, to support gut flora restoration.

Swallow the capsule whole with a full glass of water. Do not crush or chew the capsule.

For individuals with difficulty swallowing, the capsule may be opened and the contents mixed with a small amount of cool, non-carbonated liquid or soft food (e.g., yogurt, applesauce) and consumed immediately.

Initiate use only after verifying no contraindications, such as known hypersensitivity to any component. Discontinue use if any adverse reactions occur and seek medical advice.

Store the bottle tightly closed in the original packaging at the recommended temperature to preserve the viability of the live bacteria until the expiration date.

Storage Conditions

The product should be stored at a temperature not exceeding 20°C (68°F), away from heat sources, sunlight, and high humidity.

Shelf Life

Shelf life – 18 months.

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