Enterogermina capsules blister No. 12

Instructions for Enterogermina capsules blister No. 12

Composition

active ingredient: 1 capsule contains a mixture of spores of the multi-resistant strain Bacillus clausii 2x109;

excipients: kaolin, microcrystalline cellulose, magnesium stearate;

capsule: gelatin, titanium dioxide (E 171), purified water.

Dosage form

Capsules.

Main physicochemical properties: hard white gelatin capsules containing fine powder from whitish to ivory color.

Pharmacotherapeutic group

Antidiarrheal microbial preparations. ATX code A07FA.

Pharmacological properties

Pharmacodynamics

The drug Enterogermina® is a suspension of Bacillus clausii spores, which are normally present in the intestines and do not exhibit pathogenic activity.

Due to the action of Bacillus clausii, the drug restores the intestinal microflora changed as a result of treatment with drugs that lead to dysbacteriosis. In addition, due to the ability of Bacillus clausii to synthesize various vitamins, especially group B, the drug helps to correct dysvitaminosis caused by the use of antibiotics or chemotherapeutic drugs. Due to the metabolic activity of Bacillus clausii, the use of the drug makes it possible to achieve a non-specific antigenic and antitoxic effect.

Due to their high resistance to chemical and physical agents, Bacillus clausii spores pass intact through the gastric juice barrier into the intestine, where they transform into metabolically active vegetative cells.

Pharmacokinetics

No data.

Indication

Treatment and prevention of intestinal dysbacteriosis and associated endogenous dysvitaminosis. Adjunctive therapy aimed at restoring normal intestinal microflora, which is disrupted during treatment with antibiotics or chemotherapeutic drugs.

Contraindication

Hypersensitivity to the active substance or to any of the excipients. Children up to 5 years of age.

Special safety precautions

The drug has a high degree of heterologous resistance to antibiotics, which allows it to be used both for the prevention of changes in the intestinal microflora caused by the selective action of antibiotics (especially broad-spectrum antibiotics), and for the restoration of an already disturbed balance of the intestinal microflora.

The drug does not interact with the following antibiotics: penicillin, cephalosporins, tetracyclines, macrolides, aminoglycosides, novobiocin, chloramphenicol, thiamphenicol, lincomycin, isoniazid, cycloserine, rifampicin, nalidixic acid and pipemidic acid.

If the drug is prescribed simultaneously with antibiotics, it should be used between two doses of the antibiotic.

This medicine is for oral use only. It should not be administered by injection or any other route. Incorrect use of this medicine has resulted in severe anaphylactic reactions, such as anaphylactic shock.

Interaction with other medicinal products and other types of interactions

There is no data on the interaction of the drug with other medicines.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

There are no contraindications to the use of the drug during pregnancy or breastfeeding.

Method of administration and doses

Adults – 2-3 capsules per day; children over 5 years old – 1-2 capsules per day.

Swallow the capsules whole with a small amount of water or other beverage.

If the patient has difficulty swallowing hard capsules (especially if it is a young child), it is better to use the oral suspension.

The duration of use is determined by the doctor depending on the patient's condition and the course of the disease.

Children

The drug should be used in children over 5 years of age.

Children under 5 years of age should be prescribed the drug in the form of a suspension for oral administration.

Overdose

To date, there have been no reports of clinical manifestations of overdose with this drug.

Adverse reactions

Skin and subcutaneous tissue disorders:

frequency unknown: hypersensitivity reactions, including rash and urticaria, angioedema.

Reporting of suspected adverse reactions

It is very important to report suspected adverse reactions that have occurred after the registration of a drug, as this allows for continuous monitoring of the benefit/risk ratio of this medicinal product.

Expiration date

3 years.

Storage conditions

Keep out of reach of children.

Store at a temperature not exceeding 30 ºС.

Packaging

12 capsules in a blister, 1 blister in a cardboard box.

Vacation category

Without a prescription.

Producer

Sanofi S.p.A.

Location of the manufacturer and its business address

Viale Europa, 11 - 21040 Origgio (VA), Italy.