Acipol^® Active (Suspension) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Erbozeta, S.p.A. (Republic of San Marino)

Dosage Form

Acipol® Active

Suspension: fl. 1, 5, or 10 pcs.

Dosage Form, Packaging, and Product Composition

Suspension for oral administration, prepared from a concentrate of active substances for suspension preparation (in the cap) and a liquid filler (in the bottle).

Composition solvent water; sweetener fructose; Inulin; lactobacilli Lactobacillus rhamnosus ATCC 53103; bifidobacteria Bifidobacterium longum CECT 7894; filler maltodextrin; acidity regulator citric acid (E330); natural flavor pear; zinc citrate; preservative potassium sorbate (E202); preservative sodium benzoate (E211); anti-caking agent silicon dioxide (E551); emulsifier magnesium stearate (E470).

* – % of the Recommended Daily Intake (RDI) in accordance with TR CU 022/2011 “Food Products Regarding Their Labeling” (Appendix 2).
** – % of the Adequate Intake Level (AI) in accordance with the “Unified Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary-Epidemiological Surveillance (Control)” of the EurAsEC Customs Union (Chapter II, Section 1, Appendix 5).

Nutritional value per 1 fl. (1 serving): proteins – <0.01 g, fats – <0.01 g, carbohydrates – 3.34 g, incl. sugars – <2.3 g.
Energy value: 13.38 kcal/56.02 kJ.

10 ml bottles with a cap (1) – packages.
10 ml bottles with a cap (5) – packages.
10 ml bottles with a cap (10) – packages.

Therapeutic Category

Dietary supplement – source of bifidobacteria and lactobacilli

Properties

Acipol^® Active suspension is an innovative complex composition and action product containing probiotics Lactobacillus rhamnosus and Bifidobacterium longum, prebiotic Inulin, and the mineral Zinc. The action of the Acipol^® Active product is due to the properties of its active components, which enhance and complement each other’s action (according to scientific data).

Lactobacilli (Lactobacillus rhamnosus)

According to the results of clinical studies on the use of lactobacilli, the following was shown

• Reduction in the risk of developing microflora imbalance, including after taking medications and agents that cause adverse changes in the qualitative or quantitative composition of the gastrointestinal tract microbiocenosis; against the background of stress and dietary errors;
• Reduction in the frequency of colds;
• Increase in the body’s nonspecific resistance.

Lactobacilli produce metabolites that selectively suppress the growth of pathogenic microflora. They have an immunomodulatory effect.

One study showed a significant reduction in body weight and fat mass when taking the prebiotic Lactobacillus rhamnosus.

Lactobacilli contribute to the formation of lactic acid, and the acidic environment thus created has a beneficial effect on the development of bifidobacteria, which are also present in the Acipol^® Active suspension.

Bifidobacteria (Bifidobacterium longum)

According to the results of clinical studies, the use of bifidobacteria contributes to the normalization of enzymatic digestion processes, peristalsis, and evacuation of intestinal contents. Along with other representatives of the normal intestinal flora, bifidobacteria are actively involved in digestion and absorption.

The presence of a sufficient number of bifidobacteria in the intestine and the normal state of the intestinal microflora contribute to the synthesis of vitamins in the intestine, better absorption of food components, and optimization of metabolic processes in the body.

Bifidobacteria support normal processes of parietal digestion in the intestine. A deficiency of bifidobacteria in the intestine can lead to impaired gastrointestinal function.

Complexes containing lactobacilli and bifidobacteria (including Lactobacillus rhamnosus and Bifidobacterium longum), according to a number of studies, are characterized by good tolerability, a favorable safety profile, and the ability to reduce the risk of developing functional gastrointestinal disorders. An important property of the probiotics Lactobacillus rhamnosus and Bifidobacterium longum is their ability to adhere to the intestinal epithelium, thereby ensuring and enhancing its barrier functions, as well as supporting immunity.

Inulin

Inulin is a prebiotic found in many plants. It serves as a food base for the growth and reproduction of representatives of the normal intestinal microflora (probiotics). Inulin not only promotes the growth and reproduction of the body’s own beneficial intestinal microflora but also stimulates intestinal motor activity, peristalsis, and optimizes the digestion process.

Clinical studies have shown that Inulin stimulates the growth and activity of bifidobacteria and lactobacilli, which helps maintain the normal composition of the microbiota. One of the main features of the substance is that it reaches the intestine practically unchanged, where it becomes a nutrient medium for bifidobacteria and lactobacilli.

Inulin affects lipid metabolism, which helps reduce the risk of developing cardiovascular diseases and diabetes mellitus.

Zinc

It is part of the main enzymes, participates in various biochemical reactions, processes of synthesis and breakdown of carbohydrates, proteins, fats, nucleic acids, stabilization of cell membranes, has immunomodulatory properties, and is necessary for repair (healing) processes.

The ingredients of Acipol^® Active comprehensively contribute to the restoration of intestinal microflora balance, strengthening immunity, and accelerating the body’s adaptation processes.

Acipol^® Active is convenient to use – only once a day. You can take it with you (on vacation, to work, on the road).

Thanks to the unique technology (Longlifecup) for preserving the potency of the live beneficial bacteria included in the complex, the product’s activity is ensured throughout its entire shelf life.

Scope of Application

Of the Acipol^® Active product

As a dietary supplement – an additional source of probiotic microorganisms (lactobacilli and bifidobacteria), zinc, inulin

• In case of intestinal microflora imbalance associated with the intake of agents that suppress the body’s own normal microflora (including antibiotics);
• During climate change, changes in the usual diet;
• In case of manifestations of atopic reactions;
• During seasonal peaks of colds.

ICD codes

Dosage Regimen

Acipol^® Active is taken orally, with meals.

Adults are prescribed 1 bottle once a day.

The duration of administration is 1 month.

Method of application

Before use, it is necessary to combine/mix the filler in the bottle and the concentrate of active substances contained in the cap

• Press firmly on the dosing cap;
• Wait for the contents of the dosing cap to enter the bottle;
• Shake the bottle thoroughly;
• Open the cap and drink the suspension;
• The prepared suspension can, if desired, be mixed with beverages at room temperature (water, fruit juice, yogurt). It should not be mixed with hot milk or other hot liquids.

The suspension must be consumed immediately after preparation.

Contraindications

• Individual intolerance to the components.

Special Instructions

Not a medicinal product.

Consultation with a doctor is recommended before use.

The prepared suspension is not subject to storage.

Storage Conditions

Acipol^® Active should be stored in the original unopened packaging in a place inaccessible to children at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years from the date of manufacture.

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.