ENTEROGERMINA 2 BILLION/5 ML ORAL SUSPENSION 10 VIALS 5 ML

Name
Enterogermina 2 billion/5 ml oral suspension
Enterogermina 2 billion/5 ml hard capsules
Spores of polyantibiotic-resistant Bacillus clausii - Oral use


What is it and what is it for?
Enterogermina is a medicine consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of Bacillus clausii spores, normally present in the intestine, which have no ability to cause disease (non-pathogenic).
Enterogermina is used for:
- the prevention and treatment of intestinal disorders related to alterations in the intestinal bacterial flora, which manifest themselves with symptoms such as diarrhea, abdominal pain, increased intestinal gas (intestinal dysbiosis) and vitamin deficiencies in the body resulting from an imbalance of the intestinal bacterial flora (endogenous vitamin deficiencies);
- 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 intoxication or alterations in the normal balance of intestinal bacterial flora which manifest themselves 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 spores of multidrug-resistant Bacillus clausii or to 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 (reduction of the body's natural defences) (see section 4);
- before giving Enterogermina to a preterm infant;

This medicine is for oral use only. Do not inject or administer by any other route. Misuse of this medicine has caused serious anaphylactic reactions, including anaphylactic shock. During antibiotic therapy, take Enterogermina between antibiotic doses.

If you observe the presence of corpuscles, i.e. tiny particles, in the Enterogermina vials, this does not mean that the medicine is altered, but rather that they 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 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 of side effects unknown (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 experience 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.