Enterogermina 2 billion/5ml oral suspension 10 vials 5ml

Enterogermina 2 billion/5ml is a probiotic oral suspension based on Bacillus clausii , indicated for the rebalancing of intestinal flora altered by antibiotics, gastrointestinal disorders or irregular diet. It helps restore intestinal well-being, promoting regular digestion and supporting the immune system.

Thanks to its formulation in single-dose vials , Enterogermina is easy to take and suitable for adults and children . It does not contain gluten or lactose, making it ideal even for those with specific dietary needs. The format of 10 5ml vials is practical and perfect for a complete treatment.

ACTIVE INGREDIENTS

Active ingredients contained in Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - What is the active ingredient of Enterogermina 2 billion/5ml oral suspension 10 vials 5ml?

One vial contains: Active substance Spores of polyantibiotic-resistant Bacillus clausii (strains SIN, O/C, T, N/R): 2 billion One hard capsule contains: Active substance Spores of polyantibiotic-resistant Bacillus clausii (strains SIN, O/C, T, N/R): 2 billion For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - What does Enterogermina 2 billion/5ml oral suspension 10 vials 5ml contain?

Vials: purified water. Capsules: microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171), purified water.

DIRECTIONS

Therapeutic indications Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - Why is Enterogermina 2 billion/5ml oral suspension 10 vials 5ml used? What is it used for?

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-intestinal disorders in infants, attributable to intoxications or intestinal dysmicrobism and dysvitaminosis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - When should Enterogermina 2 billion/5ml oral suspension 10 vials 5ml not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - How do you take Enterogermina 2 billion/5ml oral suspension 10 vials 5ml?

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. Take the contents of the vial as is or diluted in water or other drinks (e.g. milk, tea, orange juice). Capsules: swallow with a sip of water or other drinks. Especially in younger children, in case of difficulty swallowing the hard capsules, it is advisable to use the oral suspension. This medicine is for oral use only. Do not inject or administer in any other way (see section 4.4).

CONSERVATION

Storage Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - How is Enterogermina 2 billion/5ml oral suspension 10 vials 5ml stored?

Store below 30°C.

WARNINGS

Warnings Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - About Enterogermina 2 billion/5ml oral suspension 10 vials 5ml it is important to know that:

Special warnings Bacteremia/sepsis Cases of bacteremia, septicaemia and sepsis have been reported in immunocompromised or critically ill patients and in preterm neonates since the introduction into the market. In some critically ill patients, the outcome was fatal. ENTEROGERMINA should be avoided in these groups of patients (see section 4.8). This medicinal product is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicinal product has caused serious anaphylactic reactions such as anaphylactic shock. Precautions for use During antibiotic therapy, it is advisable to administer the preparation in the interval between one antibiotic administration and the other. Any visible corpuscles in the vials of ENTEROGERMINA are due to aggregates of Bacillus clausii spores; therefore, they do not indicate an altered product. Shake the vial before use.

INTERACTIONS

Interactions Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - Which medicines or foods can modify the effect of Enterogermina 2 billion/5ml oral suspension 10 vials 5ml?

No interaction studies have been performed.

SIDE EFFECTS

Like all medicines, Enterogermina 2 billion/5ml oral suspension 10 vials 5ml can cause side effects - What are the side effects of Enterogermina 2 billion/5ml oral suspension 10 vials 5ml?

The following undesirable effects have been observed during treatment with this medicinal product, classified according to the MedDRA organ class and frequency categories: Very common (≥1/10); common (≥1/100,<1/10); uncommon (≥1/1,000,<1/100); rare (≥1/10,000,<1/1,000); very rare <1/10,000); not known (frequency cannot be estimated from the available data).

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

OVERDOSE

Overdose Enterogermina 2 billion/5ml oral suspension 10 vials 5ml - What are the risks of Enterogermina 2 billion/5ml oral suspension 10 vials 5ml in case of overdose?

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Enterogermina 2 billion/5ml oral suspension 10 vials 5ml

Pregnancy There are no data available on the use of Enterogermina in pregnant women; therefore, no conclusions can be drawn on the safety of using Enterogermina 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. Breastfeeding There are no data available on the use of Enterogermina during breastfeeding regarding the composition of breast milk and the effects on the infant. No conclusions can be drawn on the safety of using Enterogermina 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 infant. Fertility There are no data available on the effect of Enterogermina on human fertility.

DRIVING AND USE OF MACHINERY

Take Enterogermina 2 billion/5ml oral suspension 10 vials 5ml before driving or using machines - Does Enterogermina 2 billion/5ml oral suspension 10 vials 5ml affect driving or using machines?

Enterogermina does not alter the ability to drive vehicles or use machinery.