ENTEROGERMINA OS 9BS 6MLD/2G

ENTEROGERMINA 6 MILIARD/2 G ORAL POOLVERS

active ingredients

Each bag contains 6 billion spores of Bacillus clausii resistant polybiotic. Excipient with known effects: Sorbitol (E420) 2,28 mg (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

Microcrystalline cellulose, xylitol, colloidal silica anidra, orange aroma (containing natural aromas, maltodextrin, acacia gum (E414), sorbitol (E420), butilidroxyanisolo (E320).

Therapeutic indications

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Therapy helps restore the intestinal microbial flora, altered during antibiotic or chemotherapy treatments.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Adults: 1 bag per day. Pediatric population Enterogermina 6 billion is indicated only in adult patients. Method of administration The powder can be dissolved directly in the mouth with the saliva and it is not necessary to take it together with water or other liquid. This medicine is for exclusive oral use.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Special warnings Batteriemia/sepsi After placing on the market, cases of bacterimia, sepsis and sepsis were reported in immunocompromised or severely ill patients and in pretermined infants. In the case of some patients in critical condition, the outcome was fatal. ENTEROGERMINA should be avoided in these groups of patients (see paragraph 4.8). This medicine is only for oral use. Do not inject or administer in other ways. An incorrect use of the medicinal product has caused severe anaphylactic reactions such as anaphylactic shock. This medicine contains 2,28 mg sorbitol per sachet equivalent to 0.00114 mg sorbitol /mg. Precautions for use In the course of antibiotic therapy it is recommended to administer the preparation in the interval between one and the other administration of antibiotic.

Interactions

No interaction studies have been carried out.

Effects

During treatment with this medicine, the following side effects were observed, classified according to the MedDRA classification by organ class and according to the following frequency classes: Very common (≥1/10); Common (≥1/100, Classification for systems and organs Town Not common Rare Very rare Notable Infections and infestations         Bacteriemia, septicemia and sepsis (in immunocompromised or severely ill patients) (see paragraph 4.4) Pathologies of skin and subcutaneous tissue         hypersensitivity reactions, including rash, hives and angioedema Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

Pregnancy

Data relating to the use of Enterogermina in pregnant women are not available; therefore it is not possible to draw conclusions on the safety of the use of Enterogermina during pregnancy. Enterogermina should only be used during pregnancy if potential benefits for the mother exceed potential risks, including those for the fetus.

Food

Data relating to the use of Enterogermina during breast milk composition and effects on the child are not available. It is not possible to draw conclusions on the safety of the use of Enterogermina during lactation. Enterogermina should only be used during breastfeeding if the potential benefits for the mother exceed potential risks, including those for breast-feededed baby.

Fertility

Data on the effect of Enterogermina on human fertility are not available.

Source: Farmadati