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Normospectrum® for adults (Capsules) Instructions for Use

Marketing Authorization Holder

Amphita JSC (Russia)

Manufactured By

Amphita JSC (Russia)

Or

V-MIN+, LLC (Russia)

Dosage Form

Bottle OTC Icon Normospectrum® for adults Capsules 400 mg: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 400 mg.

Composition: multi-probiotic complex of bifidobacteria and lactobacilli (based on 11 strains belonging to the species B.adolescentis, B.bifidum, B.longum, L.acidophilus, L.plantarum, L.casei), oligofructose, inulin, vitamin-mineral premix, standardized in composition (maltodextrin, vitamins: D3, E, C, B1, B2, B6, B12, nicotinamide, pantothenic acid, folic acid, biotin; minerals: zinc, selenium), corn starch and microcrystalline cellulose (carrier), aerosil or magnesium stearate (anti-caking agent), gelatin or cellulose (capsule).

The content of bifidobacteria is not less than 2.5×108 CFU/g, lactobacilli is not less than 2.5×107 CFU/g.

10 pcs. – blisters (3) – cardboard packs.

Properties

Dietary supplement.

Probiotic microorganisms (probiotics) are non-pathogenic, non-toxigenic microorganisms that enter the human intestine with food, have a beneficial effect on the human body and normalize the composition and biological activity of the microflora of the digestive tract: mainly microorganisms of the genera Bifidobacterium, Lactobacillus, Propionibacterium, Lactococcus.

Bifidobacteria preserve and improve the physiological balance of the intestinal microflora and restore the deficiency of bifidobacteria; exhibit antagonistic activity against a wide range of pathogenic and opportunistic microorganisms; neutralize toxic metabolic products; promote the absorption of minerals (including iron), proteins, carbohydrates; possess vitamin-forming activity, in particular of group B; prevent the formation of protracted forms of intestinal infections; increase the non-specific resistance of the body.

Lactobacilli are an important component of the normal microflora of the digestive and genital tract of mammals. They have diverse biological properties and actively participate in metabolic and regulatory processes. They exhibit pronounced antagonistic activity against a wide range of aerobic and facultative anaerobic gram-negative and gram-positive bacteria, as well as some obligate anaerobic microorganisms. This activity is most pronounced in representatives of the species Lactobacillus acidophilus, L. plantarum, L. casei, L. fermentii, L. buchneri.

Lactobacilli and bifidobacteria, synergistically interacting, maintain and regulate the physiological balance of the intestinal microflora, increasing the resistance of the intestinal mucosa to pathogenic microorganisms; inhibit the translocation of pathogenic bacteria in the colon, possess antagonistic activity against many pathogenic and opportunistic microorganisms, and normalize immunity indicators when it is suppressed.

Polyfructosans (inulin and oligofructose) are prebiotics.

They are soluble dietary fibers, usually obtained from chicory or Jerusalem artichoke, and are a mixture of short chains of glucose and fructose. Hydrolyzed in the lower intestines, they promote enhanced growth of bifidobacteria and lactobacilli, being a nutrient substrate for their growth, which increases the number of beneficial microflora by 10-100 times.

Organic acids are produced, which form salts of calcium, iron, magnesium, thereby increasing their absorption by at least 20%, strengthening bone tissue and contributing to the prevention of osteoporosis, increasing the availability of vitamin D. Prebiotics improve intestinal peristalsis; reduce the level of glucose, cholesterol and triglycerides in the blood serum.

The vitamin-mineral complex included in the product is aimed, first of all, at activating the immune system, normalizing metabolism, and replenishing the deficiency of micronutrients.

Scope of Application

As part of complex therapy for the normalization and restoration of microflora and functional state of the gastrointestinal tract; as an additional source of vitamins C, E, D3, B1, B2, B6, B12, nicotinamide, pantothenic acid, folic acid and biotin, minerals: zinc and selenium, a source of probiotic microorganisms (bifidobacteria and lactobacilli) and polyfructosans (inulin and oligofructose): for dysbiosis of various etiologies, due to the intake of antibiotics, antidepressants, hormonal agents, sulfonamides and other chemotherapeutic drugs, due to improper nutrition, stress and other reasons; for manifestations of intestinal dyspepsia (bloating, rumbling, pain syndrome, diarrhea); for chronic constipation; for intestinal infections of established and unestablished etiology, including rotavirus infection; for chronic colitis of various etiologies, including ulcerative colitis and Crohn’s disease, diverticulitis; for chronic enterocolitis; irritable bowel syndrome; for respiratory infections, influenza and for their prevention; as a general tonic that increases non-specific resistance and immunological status of the body, especially in the recovery period after illnesses of any origin; for vitamin and mineral deficiency; for allergic diseases (atopic dermatitis/neurodermatitis, allergic rhinoconjunctivitis, bronchial asthma), including those caused by food factors; for chronic inflammatory skin diseases (acne, furunculosis); for normalization of metabolism; for chronic metabolic diseases (obesity, atherosclerosis, dyslipidemia, type 2 diabetes mellitus); in the pre-operative period and after surgery; in pregnant women during preparation for childbirth and after childbirth; during sports, increased physical and mental stress; for helminthic invasions; in weight loss programs; when changing climatic zones.

ICD codes

ICD-10 code Indication
A08.0 Rotaviral enteritis
A09.0 Other and unspecified gastroenteritis and colitis of infectious origin (infectious diarrhea NOS)
B83.9 Helminthiases, unspecified
E11 Type 2 diabetes mellitus
E50-E64 Other types of nutritional deficiencies (E50-E64)
E66 Obesity
E78.5 Hyperlipidemia, unspecified
E88.9 Metabolic disorder, unspecified
H10.1 Acute atopic (allergic) conjunctivitis
I70 Atherosclerosis
J06.9 Acute upper respiratory infection, unspecified
J10 Influenza due to identified seasonal influenza virus
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J45 Asthma
K30 Functional dyspepsia (digestive disorder)
K50 Crohn's disease [regional enteritis]
K51 Ulcerative colitis
K52 Other noninfectious gastroenteritis and colitis
K57 Diverticular disease of intestine
K58 Irritable bowel syndrome
K59.0 Constipation
K59.1 Functional diarrhea
K63.8 Other specified diseases of intestine
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L70 Acne
O25 Nutritional deficiencies in pregnancy
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z54 Convalescence
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
1A22 Gastroenteritis due to Rotavirus
1A40.Z Infectious gastroenteritis or colitis, unspecified
1E30 Influenza due to identified seasonal influenza virus
1F9Z Helminthiases, unspecified
5A11 Type 2 diabetes mellitus
5B7Z Malnutrition, unspecified
5B81.Z Obesity, unspecified
5C80.Z Hyperlipoproteinaemia, unspecified
5D2Z Metabolic disorders, unspecified
9A06.70 Atopic eczema of the eyelids
9A60.01 Acute atopic conjunctivitis
9A60.02 Allergic conjunctivitis
9A60.0Y Other specified papillary conjunctivitis
9A60.0Z Papillary conjunctivitis, unspecified
BD40.Z Atherosclerosis of peripheral arteries, unspecified
CA07.0 Acute upper respiratory tract infection of unspecified site
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA23 Asthma
DA42.81 Radiation gastritis
DA42.8Z Gastritis due to external causes, unspecified
DA51.53 Radiation duodenitis
DA51.5Z Duodenitis due to external causes, unspecified
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB32.1 Slow-transit constipation
DB33.2Z Allergic or alimentary colitis, unspecified
DB33.4Y Other specified colitis or proctitis caused by external agents
DB33.4Z Colitis or proctitis caused by external agents, unspecified
DB36.Z Certain infections of the colon, unspecified
DD1Z Diverticular disease of intestine, unspecified
DD70.Z Crohn's disease, unspecified location
DD71.Z Ulcerative colitis, unspecified
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
DD91.0Z Irritable bowel syndrome, unspecified
DD91.1 Functional constipation
DD91.2 Functional diarrhea
DD93.Y Other specified functional gastrointestinal disorders in infants, toddlers and school-age children
DD9Z Functional gastrointestinal disorders, unspecified
DE2Z Diseases of the digestive system, unspecified
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA85.20 Atopic hand eczema
ED80.Z Acne, unspecified
JA64 Nutritional disorders during pregnancy
QB7Z Convalescence, unspecified
QB9A Preparatory procedures for subsequent treatment
QE01 Stress, 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.

Take orally 3 times/day with meals, with water at room temperature. Do not take with hot food or liquid. The duration of administration is 20-30 days. It is recommended to repeat the intake 2-3 times a year.

Side effects

Possible allergic reactions.

Contraindications

Hypersensitivity to the product components.

Use during pregnancy and breastfeeding

Use during pregnancy is possible according to indications.

Special instructions

This is not a medicinal product.

Before using the product, consult a doctor.

Do not exceed the recommended dose of the product used.

In children, use only dietary supplements intended for the corresponding age group.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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

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