ENTEROGERMINA 2 BILLION

ENTEROGERMINA 2 BILLION

Therapeutic 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.

Dosage and method of use

Adults: 2-3 vials per day or 2-3 capsules per day. Children: 1-2 vials per day or 1-2 capsules per day. Infants: 1-2 vials per day. Vials: administration at regular intervals. Take the contents of the vial as is or diluted in water or other drinks (e.g. milk, tea, orange juice). Capsules: swallow with a sip of water or other beverage. Especially in younger children, in case of difficulty swallowing hard capsules, it is advisable to use the oral suspension. This medicine is for oral use only. Do not inject or administer in any other way (see section 4.4).

Contraindications

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

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,

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

Special warnings

Special warningsBacteremia/sepsis Post-marketing cases of bacteremia, septicemia and sepsis have been reported in immunocompromised or critically 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 useDuring 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 ofBacillus clausii; it is therefore not an indication of an altered product. Shake the vial before use.

Pregnancy and breastfeeding

PregnancyThere are no data available regarding the use of Enterogermina in pregnant women; therefore it is not possible to draw conclusions about 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.Feeding timeThere 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.FertilityNo data are available on the effect of Enterogermina on human fertility.

Expiration and conservation

Store below 30°C.

Interactions with other drugs

No interaction studies have been performed.

Overdose

No cases of overdose have been reported.

Active principles

One vial contains: Active principleSpores ofBacillus clausiiresistant polyantibiotic (SIN, O/C, T, N/R strains): 2 billionOne hard capsule contains: Active principleSpores ofBacillus clausiiresistant polyantibiotic (SIN, O/C, T, N/R strains): 2 billion For the full list of excipients, see section 6.1

Excipients

Vials: purified water. Capsules: Microcrystalline cellulose, Magnesium stearate, Gelatin, Titanium dioxide (E171), Purified water.