ENTEROGERMINA*ORAL SUSPENSION 10 VIALS 4 BILLION 5ML

Enterogermina 4 billion / 5 ml oral suspension
Spores of polyantibiotic-resistant Bacillus clausii – Oral use

What it is and what it is used for
Enterogermina is a medicinal product consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of Bacillus clausii spores, habitually present in the intestine, devoid of the ability to cause diseases (non-pathogenic).

Enterogermina is used for:
• Prevention and treatment of intestinal disorders such as diarrhea, abdominal pain, gas in the intestine, and vitamin deficiencies related to alterations of the intestinal bacterial flora of various origins, such as that caused by ongoing antibiotic therapy,
• Treatment of acute and chronic gastrointestinal disorders in infants related to intoxications, alterations of the intestinal bacterial flora that manifest with symptoms such as diarrhea, abdominal pain, gas in the intestine, or vitamin deficiencies.

Health Education Notes
The intestinal bacterial flora constitutes a real defensive barrier against harmful bacteria. Its balance can be damaged by intestinal infections, intoxications, dietary disorders, changes in diet, and the use of antibiotics. Consult your doctor if you do not notice improvements or if you notice a worsening of symptoms after a short period of treatment.

Warning: use only for short periods of treatment unless otherwise prescribed by a doctor.

What you need to know before taking the medicine
Do not take Enterogermina
• if you are allergic to polyantibiotic-resistant Bacillus clausii spores or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enterogermina.

• if your doctor has informed you that your immune system may be weakened (reduced natural defenses of the body) (see section 4).
• before giving Enterogermina to a premature infant.

This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has caused severe anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one antibiotic dose and the next.

If you observe the possible presence of particles, i.e., tiny specks in the Enterogermina vials, this does not mean that the medicine is altered, but rather that these are simply aggregates of Bacillus clausii spores.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor immediately if you notice any of the following serious side effects:
Localized and mostly temporary (hours or days) swelling of the skin or mucous membranes, with or without itching (angioedema). When localized to the face, lips, and throat, it can make swallowing and breathing difficult.

Other side effects include:
Frequency not known (the frequency of side effects cannot be estimated from the available data):
• allergic reactions (hypersensitivity), including skin redness and hives;
• in cases of reduced body defense mechanisms or severe illness, and if you are taking Enterogermina, Bacillus clausii may be found in the blood and can lead to a serious blood infection (see section 2).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.