Active ingredients: Polybiotic resistant B. clausii spores
ENTEROGERMINA 2 billion / 5 ml oral suspension ENTEROGERMINA 2 billion hard capsules
Enterogermina package inserts are available for pack sizes:- ENTEROGERMINA 2 billion / 5 ml oral suspension ENTEROGERMINA 2 billion hard capsules
- ENTEROGERMINA 1 billion / 5 ml oral suspension
Indications Why is Enterogermina used? What is it for?
ENTEROGERMINA is a preparation consisting of a suspension of Bacillus clausii spores, habitual host of the intestine, devoid of pathogenic power.
Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous vitaminosis. Adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-enteric disorders of infants, attributable to intestinal poisoning or dysmicrobism and disvitaminosis.
Contraindications When Enterogermina should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Enterogermina
During antibiotic therapy, it is advisable to administer Enterogermina in the interval between one antibiotic and the other.
Interactions Which drugs or foods can modify the effect of Enterogermina
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. There are no known medicines or foods that can modify the effect of Enterogermina.
Warnings It is important to know that:
It is important to know that: If you observe the possible presence of corpuscles, ie tiny particles in the Enterogermina vials, this does not mean that the product is altered, but it is only aggregates of Bacillus clausii spores.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Enterogermina can be used during pregnancy and breastfeeding.
Effects on ability to drive and use machines
Enterogermina does not affect the ability to drive or use machines.
Health education notes
The intestinal bacterial flora constitutes a real defensive barrier against harmful bacteria. Its balance can be damaged by intestinal infections, poisoning, eating disorders, diet alterations, use of antibiotics. This imbalance manifests itself with diarrhea, abdominal pain, increased air in the intestine.
Dosage and method of use How to use Enterogermina: Dosage
How many:
Adult: 2 - 3 vials per day or 2 - 3 capsules per day
Children: 1 - 2 vials per day or 1 - 2 capsules per day
Infants: 1 - 2 vials per day
Warning: do not exceed the indicated doses without medical advice.
When and for how long
Take Enterogermina at regular intervals throughout the day. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Warning: use only for short periods of treatment. Like
Vials
This medicine is for oral use only. Do not inject or administer in any other way.
It is advisable to shake before use. To open the vial, rotate the top and detach it. Take the content as it is or dilute it in water or other drinks (eg milk, tea, orange juice).
Once opened, take the drug within a short time to avoid contamination of the suspension.
Capsules
Swallow the capsules accompanied by a sip of water or other drinks. Especially in younger children, in case of difficulty in swallowing the hard capsules, it is advisable to use the oral suspension.
Overdose What to do if you have taken too much Enterogermina
Excessive doses of Enterogermina usually do not cause side effects. However, it is good to stick to the recommended doses.
In case of accidental ingestion / intake of an excessive dose of Enterogermina, notify your doctor immediately or go to the nearest hospital.
What to do if you have forgotten to take one or more doses There are no particular problems. However, it should be remembered that the correct and scrupulous intake of the medicine favors the therapeutic effect.
Effects due to discontinuation of treatment No particular effects have been reported, apart from the lack of therapeutic effect.
Side Effects What are the side effects of Enterogermina
Like all medicines, Enterogermina can cause side effects, although not everybody gets them.
During the marketing of the product, cases of hypersensitivity reactions, including rash and urticaria have been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store below 30 ° C.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ENTEROGERMINA 2 billion
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains, active principle:
Spores of polyantibiotic resistant Bacillus clausii 2 billion
One hard capsule contains, active principle:
Spores of polyantibiotic resistant Bacillus clausii 2 billion
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Oral suspension.
Hard capsules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous vitaminosis.
Adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapy treatments.
Acute and chronic gastro-enteric disorders of infants, attributable to intestinal poisoning or dysmicrobism and disvitaminosis.
04.2 Posology and method of administration
Adults: 2-3 vials per day or 2-3 capsules per day; children: 1-2 vials per day or 1-2 capsules per day; infants: 1-2 vials per day.
Vials: administration at regular intervals (3-4 hours), taking the contents of the vial as it is or diluting in water or other drinks (eg milk, tea, orange juice).
Capsules: swallow with a sip of water or other drinks.
Especially in younger children, in case of difficulty in swallowing the hard capsules, the oral suspension should be used.
This medicine is for oral use only. Do not inject or administer in any other way.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Special warnings
The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of Bacillus clausii spores; therefore it is not an indication of an altered product.
Shake the vial before use.
Precautions for use
During antibiotic therapy it is recommended to administer the preparation in the interval between one antibiotic and the other.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known drug interactions following concomitant administration of other drugs.
04.6 Pregnancy and lactation
There are no restrictions on the use of the preparation during pregnancy or during breastfeeding.
04.7 Effects on ability to drive and use machines
The drug does not interfere with the ability to drive and use machines.
04.8 Undesirable effects
During the marketing of the product, cases of hypersensitivity reactions, including rash and urticaria have been reported.
04.9 Overdose
To date, no clinical manifestations of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: A07FA49 - antidiarrheal microorganisms.
ENTEROGERMINA is a preparation consisting of a suspension of Bacillus clausii spores, habitual host of the intestine, devoid of pathogenic power.
Administered orally, Bacillus clausii spores, thanks to their high resistance to both chemical and physical agents, overcome the acid gastric juice barrier, reaching the intestinal tract unscathed where they are transformed into vegetative, metabolically active cells.
The administration of ENTEROGERMINA contributes to the restoration of the intestinal microbial flora altered in the course of dysmicrobisms of different origins, by virtue of the activities carried out by Bacillus clausii. Furthermore, since Bacillus clausii is capable of producing various vitamins, in particular of the B group, ENTEROGERMINA helps to correct the disvitaminosis from antibiotics and chemotherapy in general. ENTEROGERMINA allows to obtain a non-specific and antitoxic antigenic action, strictly connected to the metabolic action of the clausii.
Furthermore, the high degree of heterologous resistance to antibiotics induced artificially, allows to create the therapeutic premises to prevent the alteration of the intestinal microbial flora, following the selective action of antibiotics, especially those with a broad spectrum of action, or to restore the same.
ENTEROGERMINA, due to this antibiotic resistance, can be administered between two successive antibiotic administrations. Antibiotic resistance refers to: penicillins, cephalosporins, tetracyclines, macrolides, aminoglycosides, novobiocin, chloramphenicol, thiamphenicol, lincomycin, isoniazid, cycloserine, rifampicin, nalidixic acid and pipemidic acid.
05.2 Pharmacokinetic properties
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05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Vials: purified water.
Capsules: kaolin, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171), purified water.
06.2 Incompatibility
There are no known incompatibilities.
06.3 Period of validity
Vials: 2 years.
After opening the vial it is advisable to take the preparation shortly to avoid contamination of the suspension.
Capsules: 3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Vials: lithographed cardboard box containing 10 or 20 vials.
Capsules: lithographed cardboard box containing 1 or 2 blisters of 12 capsules each.
06.6 Instructions for use and handling
Vials: Shake the vial before use.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi-aventis S.p.A. - Viale L. Bodio, 37 / b - IT-20158 Milan (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
AIC 013046038 - box of 10 vials
AIC 013046040 - box of 20 vials
AIC 013046053 - box of 12 capsules
AIC 013046065 - box of 24 capsules
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization
Oral suspension November 14, 2001
Capsules December 9, 2004
Last renewal date: July 30, 2008
10.0 DATE OF REVISION OF THE TEXT
February 2010
