Index
- Introduction: what is it?
- Dosage: how is it used and how does it work?
- Warnings and Precautions
- Interactions and side effects
- Pregnancy and breastfeeding
- Notes (validity and storage conditions)
Questions and answers
Introduction: what is it?
Enterogermina is a self-medication used for the prevention and treatment of intestinal dysmicrobism (the alteration of the normal balance of the intestinal bacterial flora) and of endogenous disvitaminosis (the lack of vitamins in the body) resulting from an imbalance of the intestinal bacterial flora. In addition, it can be useful:
- In adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapy treatments;
- In the treatment of acute and chronic gastro-intestinal diseases of infants caused by intoxication or alterations in the normal balance of the intestinal bacterial flora or vitamin deficiencies in the body.
Our intestinal bacterial flora is subject to numerous and continuous alterations due for example to seasonal changes, the consequences of antibiotic therapy or prolonged periods of stress. Enterogermina contains a suspension of 4 strains (SIN, O / C, T, N / R) of Bacillus clausii spores belonging to the category of antidiarrheal microorganisms and is resistant to different types of antibiotics. The Bacillus clausii is a Gram-positive bacterium that lives mainly in the ground, but can be taken to improve the health of our intestines. It belongs in fact to the class of probiotics, that is all those “live microorganisms which, administered in adequate quantities, bring a benefit to the health of the host”, according to the official definition of the World Health Organization (WHO). These bacteria can usually be present in the human intestine and are devoid of pathogenic power (ie they lack the ability to cause disease). The spores are not absorbed but act directly in the intestine.
The Bacillus clausii serves to restore the f intestinal lora , whose impairment may be linked to the use of antibiotics, intestinal poisoning, improper diet and lifestyle and more. These conditions can lead to diarrhea, even very severe abdominal pain , constipation , bloating , swelling and so on. By introducing billions of these non-pathogenic bacteria, it is possible to rebalance the intestinal microbiome and thus eliminate the symptoms that the alteration entails.
Enterogermina can be especially useful in children, in which the balance of the intestinal flora is extremely delicate and easily altered, often for reasons that are difficult to diagnose. In children, the alteration of the intestinal flora can be accompanied by abdominal pain, abdominal pain, poor appetite, nausea and bouts of diarrhea and vomiting. In these cases, it is essential to intervene trying to rebalance the intestinal flora to maintain the natural balance or to restore it to its original state when this is altered.
Enterogermina is commercially available in different strengths :
- 1 billion, 2 billion, 4 billion spores / 5 mL oral suspension
- 2 billion spores in hard capsules
- 6 billion spores / 2 g of powder for oral suspension
- 6 billion spores / 2 g oral powder
Enterogermina can be prescribed with OTC Recipe – non-prescription over-the-counter medicines . There is also a variant on the market, called Enterogermina Gonfiore . This is a food supplement based on enzymes, probiotics and plant extracts that eliminates excess air in the intestine, promoting the balance of the intestinal bacterial flora, regular motility and the elimination of gases that cause abdominal bloating.
Dosage: how is it used and how does it work?
It is advisable to ask your doctor or pharmacist for advice before taking Enterogermina.
The recommended dosages are :
Adults
- 4-6 (1 billion spore vials), or 2-3 (2 billion spore vials), or 1 (4 billion spore vials) per day;
- 2-3 capsules of 2 billion spores per day;
- 1 sachet of 6 billion spores to be dissolved in water or 1 sachet of oral powder per day.
Enterogermina 6 billion is indicated in adult patients only .
Children
- 3-4 (1 billion spore vials), or 1-2 (2 billion spore vials), or 1 (4 billion spore vials) per day;
- 1-2 capsules of 2 billion spores
Infants
- 2-3 (1 billion spore vials) or 1-2 (2 billion spore vials), or 1 (4 billion spore vials) per day
These are the dosages normally recommended , unless otherwise prescribed.
Enterogermina should be administered at regular intervals (every 3-4 hours) throughout the day, taking the contents of the vial as it is or diluting it in water or other drinks (eg milk, tea, orange juice). The capsules should be swallowed with a sip of water or other drinks. The oral powder can be dissolved directly in the mouth with saliva and does not need to be taken together with water or other liquids.
In younger children, in case of difficulty in swallowing the hard capsules, the oral suspension should be used .
This medicine isfor oral use only . Do not inject or administer by any other route. Incorrect use of the medicine has resulted in severe anaphylactic reactions such as anaphylactic shock .
Do not exceed the indicated doses without medical advice. Use only for short periods of treatment. Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
To date, no clinical manifestations of overdose have been reported . In case of accidental ingestion / intake of an excessive dose of Enterogermina, notify your doctor immediately or go to the nearest hospital. If you forgettaking Enterogermina, do not take a double dose to make up for a forgotten dose. Correct and regular intake of the medicine promotes the therapeutic effect. If treatment with Enterogermina is discontinued, no particular effects have been reported, other than the lack of therapeutic effect.
The Bacillus clausii is a alcalofilo and possesses a coating that allows it to resist the strong acidity of the gastric juices . After oral administration of enterogemin, Bacillus clausii spores overcome the acid barrier of gastric juice, thanks to their high resistance to both chemical and physical agents, reaching the intestinal tract unscathed.where they transform into vegetative , metabolically active cells . Here the bacteria favor the production of vitamin B and other active metabolites that improve the functionality of the intestinal mucosa, for example by promoting the absorption of vitamins. These bacteria also produce antimicrobial substances – immunoglobulins – which counter the growth of other intestinal microorganisms, some of which may be pathogens, with which they enter into direct competition both for the space occupied on the mucosa and for the nutrients to be taken.
The intestinal bacterial flora constitutes a real defensive barrier against bacteriaharmful. Its balance can be damaged by intestinal infections, poisoning, eating disorders, diet changes, use of antibiotics. This imbalance is manifested by diarrhea, abdominal pain, swelling due to increased air in the intestine.
The administration of Enterogermina contributes to the restoration of intestinal microbial flora altered in the course of dysmicrobisms of different origins, by virtue of the activities carried out by Bacillus clausii . Furthermore, thanks to the ability of Bacillus clausii to produce various vitamins, in particular of the B group , Enterogermina helps to correct disvitaminosis from antibiotics and chemotherapy in general. Enterogermina allows to obtain anon-specific antigenic and antitoxic action, strictly connected to the metabolic action of Bacillus clausii . Furthermore, the high degree of artificially induced heterologous resistance to antibiotics allows for the creation of 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 for restore the flora itself.
Enterogermina, thanks to its resistance to antibiotics , can be administered between two successive administrations of antibiotics. The bacteria is resistant to various antibiotics, including: Penicillins (if not in combination with beta-lactamase inhibitors), Cephalosporins(partial resistance in most cases), Tetracyclines , Macrolides , Aminoglycosides (except gentamicin and amikacin), Novobiocin , Chloramphenicol , Thiamphenicol , Lincomycin, Clindamycin, Isoniazid, Cycloserine, Rifampicin, Nalidixic Acid (intermediate resistance Pipemid), Metronidazole.
Contact your doctor if you do not notice any improvement or if you notice your symptoms worsening after a short period of treatment.
Warnings and Precautions
During an antibiotic therapy it is recommended to administer the preparation in the interval between one antibiotic and the other administration.
The possible presence of visible corpuscles in the Enterogermina vials is due to aggregates of Bacillus clausii spores ; therefore it does not indicate an alteration of the drug. Shake the vial of the oral suspension well before use. Do not use in patients with hypersensitivity to the active substance or to any of the excipients. The drug does not interfere with the ability to drive and use machines. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month and with an intact, properly stored product. Do not dispose of any medicines via wastewater and household waste. Ask your pharmacist how to throw away medicines that are no longer used .
Interactions and side effects
No interactions are known following concomitant administration of other drugs. However, it is a good idea to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those without a prescription.
In some patients it may trigger hypersensitivity reactions , including skin rashes, hives and angioedema. In immunocompromised patients it could cause bacteremia (presence of bacteria in the blood, detectable with a blood culture).
In case of adverse or unexpected reactions, it is important to notify the attending physicianor the pharmacist. The reports of suspected adverse reactions (ADR, Adverse Drug Reaction in English) are a fundamental source of information for pharmacovigilance activities, as they allow the detection of potential alarm signals relating to the use of medicines so as to make them safer, for the benefit of of all patients. The reporting of suspected adverse reactions occurring after the marketing authorization of the medicine is important, as it allows continuous monitoringthe benefit / risk ratio of the medicine itself. European pharmacovigilance legislation requires all healthcare professionals and citizens to report any suspected suspected adverse reactions (serious and non-serious, known and unknown) via the national reporting system to the appropriate address .
Pregnancy and breastfeeding
There are no foreclosures from the use of the preparation during pregnancy or breastfeeding. No data are available on the effect of Enterogermina on human fertility. However, you should ask your doctor or pharmacist for advice if you are pregnant, suspect or are planning to become pregnant, or if you are breast-feeding before taking this medicine.
Notes (validity and storage conditions)
Enterogermina in vials is valid for 2 years . After opening the vial it is advisable to take the preparation shortly to avoid contamination of the suspension.
The capsules , sachets of powder for oral suspension and oral powder are valid for 3 years .
Store at a temperature below 30 ° C. Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
Questions and answers
WHEN SHOULD IT BE USED?
Enterogermina is a self-medication used for the prevention and treatment of the alteration of the normal balance of our intestinal bacterial flora and of the deficiencies of vitamins in the organism resulting from an imbalance of the intestinal bacterial flora. Furthermore, it can be useful in the adjuvant therapy of the restoration of the intestinal microbial flora, which may have been altered during antibiotic or chemotherapy treatments. Enterogermina can also be used in the treatment of acute and chronic gastro-intestinal diseases of children and infants caused by intoxication or alterations in the normal balance of the intestinal bacterial flora or vitamin deficiencies in the body.
CAN IT BE GIVEN TO CHILDREN?
Enterogermina can also be administered to children, but it is necessary not to exceed the maximum recommended daily dosage (do not administer more than 4 billion spores per day, even if combined). The pharmaceutical form of Enterogermina 6 billion is only indicated in adult patients.
