ENTEROGERMINA*OS 9BT 6MLD/2G

Enterogermina 6 billion/2 g oral powder
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 Bacillus clausii spores, habitually present in the intestine, and unable to cause disease (non-pathogenic).
Enterogermina is used in adult patients for:
• Prevention and treatment of intestinal disorders such as diarrhoea, abdominal pain, bloating, and vitamin deficiencies related to alteration of the intestinal bacterial flora of various origins, such as that caused by ongoing antibiotic therapy.

Health education notes
The intestinal bacterial flora constitutes a true defensive barrier against harmful bacteria. Its balance can be damaged by intestinal infections, intoxications, dietary disorders, changes in diet, or 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 told you that your immune system may be weakened (reduced natural body defences) (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 administration and another.

Children and adolescents
This medicine is indicated for adult patients only.

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:
Localised 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 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 case of reduced body defence 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.