ENTEROGERMINA*ORAL SUSP 10 VIALS 2BILLION/5ML

Enterogermina - 2 billion hard capsules
Bacillus clausii spores polyantibiotic resistant – Oral use

What it is and what it is used for
Enterogermina is a medicine consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of Bacillus clausii spores, commonly found in the intestine, without the ability to cause disease (non-pathogenic).
Enterogermina is used for:
- the prevention and treatment of intestinal disorders related to alterations of the intestinal bacterial flora, which manifest with symptoms such as diarrhea, abdominal pain, increased gas in the intestine (intestinal dysbiosis) and vitamin deficiencies in the body resulting from the imbalance of the intestinal bacterial flora (endogenous dysvitaminosis);
- adjuvant therapy for the restoration of the intestinal microbial flora, altered during antibiotic or chemotherapy treatments;
- the treatment of acute and chronic gastrointestinal diseases in infants caused by intoxications or alterations of the normal balance of the intestinal bacterial flora that manifest with symptoms such as diarrhea, abdominal pain, increased gas in the intestine (intestinal dysbiosis) or vitamin deficiencies in the body (dysvitaminosis).

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 before taking Enterogermina:
- if your doctor has told 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 administration of the antibiotic and the next.
If you notice the possible presence of corpuscles, i.e., tiny particles in the Enterogermina vials, this does not mean that the medicine is altered, but that these are simply aggregates of Bacillus clausii spores.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice the onset of any of the following serious side effects:
Localized and mostly temporary swelling (hours or days) 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 of side effects not known (may affect less than 1 in 10,000 people): - allergic reactions (hypersensitivity), including skin redness and hives;
- in case of reduced body defense mechanisms or severe illness and if you are taking Enterogermina, Bacillus clausii can 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/segnalazioni -reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.