Enterogermina Oral Suspension - 2 Billion - 20 Vials - 5Ml

Active principles

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

Excipients

Vials: Purified water. Capsules: Heavy kaolin, Microcrystalline cellulose, Magnesium stearate, Gelatin, Titanium dioxide (E171), Purified water.

Therapeutic indications

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

Contraindications

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

Posology

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 it is or by diluting it in water or other beverages (e.g. milk, tea, orange juice). Capsules: swallow with a sip of water or other beverage. Especially in younger children, in case of difficulty swallowing the hard capsules, it is advisable to use the oral suspension. This medicinal product is for oral use only. Do not inject or otherwise administer (see section 4.4).

storage

Store below 30°C.

Warnings and Precautions

Special warnings The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of Bacillus clausii spores; it is therefore not an indication of an altered product. Shake the vial before use. This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has resulted in severe anaphylactic reactions such as anaphylactic shock. Precautions for use In the course of antibiotic therapy it is advisable to administer the preparation in the interval between one and the other administration of antibiotic.

Interactions

No interaction studies have been performed.

Side effects

The following undesirable effects, classified according to the MedDRA organ class and according to the following frequency categories, have been observed during treatment with this medicinal product: 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 after authorization of the medicinal product is important, as it allows continuous 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

No cases of overdose have been reported.

Pregnancy and breastfeeding

Pregnancy There are no data on the use of Enterogermina in pregnant women; therefore it is not possible to draw conclusions about the safety of the use of Enterogermina during pregnancy. Enterogermina should only be used during pregnancy if the potential benefits to the mother outweigh the potential risks, including those to the foetus. Breastfeeding No data are 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 about the safety of using Enterogermina during breastfeeding. Enterogermina should only be used during lactation if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child. Fertility There are no data on the effect of Enterogermina on human fertility.