ENTEROGERMINA "4 BILLION/5 ML ORAL SUSPENSION" 10 VIALS"

Name
Enterogermina 4 billion / 5 ml oral suspension
Spores of multiantibiotic-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:
• 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 those caused by ongoing antibiotic therapy,
• treatment of acute and chronic gastrointestinal disorders in infants related to intoxications, alterations of the intestinal bacterial flora which manifest themselves with symptoms such as diarrhea, abdominal pain, gas in the intestine or vitamin deficiencies.

Health education notes
The intestinal bacterial flora acts as a protective barrier against harmful bacteria. Its balance can be disrupted by intestinal infections, poisoning, eating disorders, dietary changes, and antibiotic use. Consult your doctor if you experience no improvement or worsening of symptoms after a short period of treatment.

Caution: Use only for short periods of treatment unless otherwise prescribed by your doctor.


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 or pharmacist 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 in between antibiotic administrations.

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 not known (the frequency of side effects cannot be estimated from the available data):
• allergic reactions (hypersensitivity), including skin redness and hives;
• if you have reduced body defense mechanisms or severe illness and you are taking Enterogermina, Bacillus clausii may be found in your blood and may 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.