Helinorm^® (Capsules) Instructions for Use

Marketing Authorization Holder

Kraft Group, LLC (Russia)

Contact Information

Dr. Reddy’s Laboratories Ltd. (India)

Dosage Form

Helinorm®

Capsules 200 mg: 28 pcs.

Dosage Form, Packaging, and Product Composition

Capsules with a mass of 324 mg.

Excipients: lactose (carrier), capsule components: gelatin, titanium dioxide (E171) (colorant)*; silicon dioxide (E551) (anti-caking agent).

* for white capsules.

14 pcs. – blisters (2) – cardboard packs.

Therapeutic Category

Dietary supplement for restoring stomach microflora

Properties

The Helinorm^® dietary supplement is an innovative agent for combating Helicobacter pylori bacteria, the main cause of ulcers and gastritis.

Helicobacter pylori is a pathogenic bacterium that infects more than 50% of the world’s population*. Infection with Helicobacter pylori can lead to inflammation of the gastric and duodenal mucosa.

Many cases of gastric and duodenal ulcers, gastritis, duodenitis, and stomach cancer are etiologically linked to Helicobacter pylori infection.

As a result of many years of research, German scientists discovered a special strain of lactobacilli that has a specific anti-Helicobacter action. This strain is the active principle of Helinorm^®.

The peculiarity of these lactobacilli is that they recognize the surface receptors of the Helicobacter pylori cell wall and bind to them. So-called co-aggregates are formed, which are naturally eliminated from the body through the gastrointestinal tract. As a result, the level of Helicobacter pylori in the body decreases, which helps reduce the risk of developing gastric and duodenal diseases.

Helinorm^® is a metabiotic (contains not live bacteria but their metabolites, in this case, lactobacillus metabolites), therefore, upon entering the stomach, it begins to act immediately and contributes to

• Reducing the amount of Helicobacter pylori in the stomach;
• Reducing the risk of ulcers and gastritis;
• Eliminating stomach discomfort and improving digestion;
• Supporting the balance of the stomach microflora.

Scope of Application

Of the Helinorm^® product

• As a dietary supplement – containing metabolites of the probiotic strain of lactobacilli (including nucleotides).

Indications

• Use as a dietary supplement to food as a source of inactivated probiotic bacteria Lactobacillus reuteri DSM 17648.
• Employ for the purpose of reducing the colonization level of Helicobacter pylori in the gastric mucosa.
• Utilize as a supportive measure for maintaining a balanced gastric microflora and improving digestive comfort.

ICD codes

Dosage Regimen

Administer orally with meals.

For adults, take one capsule twice daily. For children over 6 years of age, take one capsule once daily.

Continue the treatment course for a duration of four weeks. Adhere strictly to the prescribed dosage and schedule.

Adverse Reactions

Adverse reactions are not commonly reported with this dietary supplement.

Monitor for any signs of gastrointestinal discomfort, such as bloating or changes in bowel habits. Discontinue use immediately if any allergic reactions, including rash, itching, or swelling, occur.

Report any persistent or severe adverse effects to a healthcare professional.

Drug Interactions

Formal studies on drug interactions have not been conducted.

Exercise caution when taking concurrently with antibacterial agents, as the theoretical efficacy of the supplement may be affected.

Maintain a time interval of at least two to three hours between the intake of this supplement and any other oral medications to avoid potential interference with absorption.

Contraindications

• Do not use in cases of known hypersensitivity to any component of the product, including the active substance or excipients such as lactose and gelatin.
• Contraindicated in patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption due to the lactose content.
• Not recommended for use in children under 6 years of age due to the lack of data on safety and efficacy in this population group.

Overdose

No cases of overdose have been reported. The product has a wide safety margin due to its mechanism of action and composition.

In the event of consumption significantly exceeding the recommended dose, monitor for potential gastrointestinal symptoms. Institute supportive measures and symptomatic treatment as required.

Contact a poison control center or physician for advice if a massive overdose is suspected.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

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.