ENTEROGERMINA*ORAL SOL 10FL 2BLN/5ML

Enterogermina 2 billion/5 ml oral suspension
Spores of Bacillus clausii polyantibiotic resistant - 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, commonly found in the intestine, and lacking 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 dysmicrobism) and vitamin deficiencies in the body resulting from the imbalance of the intestinal bacterial flora (endogenous dysvitaminosis);
- adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapeutic 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 which manifest with symptoms such as diarrhea, abdominal pain, increased gas in the intestine (intestinal dysmicrobism) and 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 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 (reduction of the body's natural defenses);
- 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 administration and the next.
If you observe the possible presence of corpuscles, i.e. tiny particles in the Enterogermina vials, this does not mean that the medicine is altered, but it is only aggregates of Bacillus clausii.

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 appearance of any of the following serious side effects:
Circumscribed and mostly temporary (hours or days) swelling of the skin or mucous membranes, with or without itching (angioedema). When located on the face, lips and throat, it can make swallowing 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 urticaria;
- in case of reduced body defense mechanisms or serious illness and if you are taking Enterogermina, Bacillus clausii may be found in the blood and may lead to a serious blood infection (see section 2).

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