Note: Leaflet for RMP is discontinued in the commercial and PS pack.
This is only relevant for HCP promotion purpose.
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
Spores of Poly-antibiotic resistant Bacillus Clausii
ENTEROGERMINA® FOR ORAL USE
2 billions / 5 mL oral suspension. DO NOT INJECT
COMPOSITION
One 5ml mini bottle contains spores of polyantibiotic-resistant Bacillus clausii - 2 billion.
(strains: O/C, N/R, SIN and T)
PHARMACEUTICAL FORM
Oral suspension
CLINICAL PARTICULARS
Therapeutic indications
For the treatment of alterations in the intestinal bacterial flora.
Posology and method of administration
Adults: 2-3 mini bottles per day
Children: 1-2 mini bottles per day
Infants: 1-2 mini bottles per day
unless prescribed otherwise by the doctor.
Administration at regular intervals (3-4 hours), diluting the content of the mini bottle in sweetened water,
milk, tea, orange juice.
This medicinal product is for oral use only. Do not inject or administer in any other way (see Section
Special warnings and special precautions for use)
Contraindications
Ascertained hypersensitivity towards the components of the product.
Special warnings and special precautions for use
Special warnings
The possible presence of corpuscles visible in the mini bottles of Enterogermina® is due to aggregates of
Bacillus clausii spores and does not therefore indicate that the product has undergone any changes.
Shake the mini bottle before use.
This medicine is for oral use only. Do not inject or administer in any other way. Severe anaphylactic
reactions, such as anaphylactic shock, have occurred with incorrect route of administration.
There have been reports of bacteremia, septicemia or sepsis in patients taking Bacillus clausii who are
immunocompromised or are hospitalized due to a serious illness. ENTEROGERMINA® should be used in these
patients only if the potential benefits outweigh the potential risks.
Precautions for use
During antibiotic therapy, the product should be administered in the interval between one dose of antibiotic
and the next.
Interactions with other medicinal products and other forms of interaction.
There are no known medicinal interactions subsequent to the concomitant administration of other drugs.
Pregnancy and lactation
Limited data are available on the use of probiotics including Enterogermina® in pregnant women. However,
no conclusions can be drawn regarding whether or not Enterogermina® is safe for use during pregnancy.
Enterogermina® should be used during pregnancy only if the potential benefits to the mother outweigh the
potential risks, including those to the fetus.
There are limited available data on the presence of Enterogermina® in human milk, milk production, or the
effects on the breastfed infant. However, no conclusions can be drawn regarding whether or not
Enterogermina® is safe for use during breastfeeding. Enterogermina® should be used during breastfeeding
only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed
child.
Effects on ability to drive and use machines
The drug does not interfere with the ability to drive or use machinery.
Undesirable effects
During post marketing experience, hypersensitivity reactions, including rash urticaria and angioedema have
been reported.
Bacteremia, septicemia or sepsis in immunocompromised patients or those hospitalized due to a serious
illness.
Overdose
Up to the present time no clinical manifestations of overdose have been reported.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
ENTEROGERMINA® is a preparation consisting of a suspension of Bacillus clausii spores, normal
inhabitants of the intestine, with no pathogenic properties.
Administered orally, Bacillus clausii spores, due to their high resistance to both chemical and physical
agents, cross the barrier of the acid gastric juices reaching, unharmed, the intestinal tract where they are
transformed into metabolically active vegetative cells. The administration of ENTEROGERMINA®
contributes to the recovery of the intestinal microbial flora altered during the course of intestinal microbial
imbalance of diverse origin, due to the action of the Bacillus clausii. Furthermore, since the Bacillus clausii
is capable of producing various vitamins, in particular group B vitamins, it contributes to correcting the
dysvitaminosis caused by antibiotics and chemotherapeutic agents in general.
ENTEROGERMINA® makes it possible to obtain an aspecific antigenic and antitoxic action, closely
connected with the metabolic action of the B. clausii.
In addition, the high degree of heterologous resistance to the antibiotics, induced artificially, provides for
the creation of the therapeutic basis for preventing the alteration of the intestinal microbial flora, following
the selective action of antibiotics, especially the broad spectrum ones, or to re-establish its balance.
Because of this antibiotic-resistance, ENTEROGERMINA® can be administered in the interval between
two doses of antibiotic. The antibiotic-resistance refers to: Penicillin, the Cephalosporins, Tetracyclines,
Macrolides, Aminoglycosides, Novobiocin, Chloramphenicol, Thiamphenicol, Lincomycin, Isoniazid,
Cycloserine, Rifampicin, Nalidixic acid and Pipemidic acid.
PHARMACEUTICAL PARTICULARS
List of excipients
Purified water Ph. Eur
Incompatibilities
There is no known incompatibility.
Storage
Do not store above 30 °C.
KEEP OUT OF THE REACH OF CHILDREN.
Instructions for use
Shake the mini bottle before use. After mini bottle has been opened, the preparation should be consumed
within a very short period of time to avoid deterioration of the suspension.
For oral use only. Do not inject.
Manufactured by:
Sanofi S.R.L., Viale Europa,11 - 21040 Origgio (VA) – Italy
Importer:
Sanofi Healthcare India Private Limited, Gala No.4, Ground Floor, Building No B1, City Link
Warehousing Complex, S No. 121/10/A, 121/10/B And 69, NH3 Vadape Tal- Bhiwandi 16, Thane Z5,
Pin :421302.
Source:
1. Bacillus clausii CCSI v3 LRC dated 12 Mar 2020
2. SmPC dated January 2012
Updated: Jan 2022
