Enterogermina 4 Billion/5 Ml 20 Vials

INDICATIONS

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous vitamin deficiency. Therapy assists the restoration of the intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastrointestinal disorders in infants, attributable to intoxications or intestinal dysmicrobisms and vitamin deficiency.

ACTIVE INGREDIENTS

One vial contains the active ingredient: polyantibiotic resistant Bacillus clausii spores (SIN, O/C, T, N/R strains) 4 billion. For the full list of excipients, see section 6.1

EXCIPIENTS

Vials: Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Dosage Adults: 1 vial per day. Infants and children: 1 vial per day. Method of administration Take the contents of the vial as is or diluted in water or other drinks (e.g. milk, tea, orange juice). This medicine is for oral use only. Do not inject or administer in any other way (see section 4.4).

CONSERVATION

Store below 30°C.

WARNINGS

Special warnings Bacteremia/sepsis Post-marketing cases of bacteremia, septicemia and sepsis have been reported in immunocompromised or seriously ill patients and in preterm infants. In the case of some critically ill patients, the outcome was fatal. ENTEROGERMINA should be avoided in these patient groups (see section 4.8). This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock. Precautions for use During antibiotic therapy it is advisable to administer the preparation in the interval between one antibiotic administration and the next. The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of spores of Bacillus clausii; it is therefore not an indication of an altered product. Shake the vial before use.

INTERACTIONS

No interaction studies have been performed.

SIDE EFFECTS

The following side effects have been observed during treatment with this medicine, classified according to the MedDRA classification by organ class and according to the following frequency classes: very common (≥1/10); common (≥1/100,<1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000,<1/1,000); very rare <1/10,000); not known (frequency cannot be estimated from the available data).

Infections and infestations - Not known: Bacteremia, septicemia and sepsis (in immunocompromised or seriously ill patients) (see section 4.4).

Skin and subcutaneous tissue disorders - Not known: hypersensitivity reactions, including rash, urticaria and angioedema.

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

Pregnancy There are no data available regarding the use of Enterogermina in pregnant women; therefore it is not possible to draw conclusions on the safety of the use of Enterogermina during pregnancy. Enterogermina should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. Breastfeeding There are no data available regarding the use of Enterogermina during breastfeeding regarding the composition of breast milk and the effects on the baby. It is not possible to draw any conclusions about the safety of using Enterogermina during breastfeeding. Enterogermina should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed baby. Fertility No data are available on the effect of Enterogermina on human fertility.

EFFECTS ON DRIVING ABILITY

Enterogermina does not alter the ability to drive or use machines.