Lacteol 10 billion oral powder + 5 billion hard capsules 20 capsules

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Diarrheal and dyspeptic syndromes due to altered bacterial flora (diarrhoea, non-specific enteritis in infants and adults, colitis). Intestinal dysmicrobism caused by antibiotics. Digestive disorders in artificially fed infants. Adjuvant in the elimination of pathogenic enterobacteria resistant to chemoantibiotics.

ACTIVE INGREDIENTS

One capsule contains: - Active ingredient: Lactobacillus LB* powder (inactivated and freeze-dried microbial bodies) in fermented culture medium 170 mg, corresponding to: - 5 billion Lactobacillus LB* One sachet contains: - Active ingredient: Lactobacillus LB* powder (inactivated and freeze-dried microbial bodies) in fermented culture medium 340 mg, corresponding to: - 10 billion Lactobacillus LB* * Lactobacillus fermentum e Lactobacillus delbrueckii For excipients see par. 6.1

EXCIPIENTS

Capsules: Fermented and freeze-dried culture medium, lactose monohydrate, calcium carbonate, silicic acid, talc, magnesium stearate, anhydrous lactose, gelatin. Sachets: Fermented and freeze-dried culture medium, lactose monohydrate, calcium carbonate, silicic acid, banana-orange flavor, sucrose.

CONTRAINDICATIONS AND SIDE EFFECTS

Individual hypersensitivity to the drug.

DOSAGE

5 billion hard capsules: 2 to 4 capsules per day. In case of acute diarrhea: 2 capsules 3 times a day on the first day, 2 capsules twice a day until the second day after the disappearance of symptoms. Swallow one capsule while drinking water. The contents of the capsule can be dissolved in the bottle with water or milk. 10 billion oral powder: 1 to 2 sachets per day. In case of acute diarrhea: 1 sachet 3 times a day on the first day, 2 times until the second day after the symptoms have disappeared. Dissolve the granules in the sachet in half a glass of water. The contents of a sachet can be dissolved in the bottle with water or milk. If the patient does not respond to treatment and diarrhea continues 2-3 days after starting to take LACTEOL, it is recommended to contact the doctor or pharmacist.

CONSERVATION

Lacteol capsules: store at temperatures not exceeding 25°C. Lacteol sachets: no special precautions for storage.

WARNINGS

Keep out of the sight and reach of children. In the case of symptoms in infants, it is necessary to consult the doctor in order to exclude differential diagnoses. N.B.: the product must be used together with rehydration therapy, particularly in children under the age of two years. The degree and method of rehydration (oral or intravenous) must be established by the doctor who will evaluate the severity of the diarrhea, the age and health conditions of the patient. LACTEOL capsules and LACTEOL sachets contain lactose, patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. LACTEOL sachets contain sucrose, patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.

INTERACTIONS

No interactions have been reported with the use of other systemic or topical drugs.

SIDE EFFECTS

They are not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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/web/guest/content/segnalazioni-reazioni-avverse

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

Pregnancy Data relating to the use of LACTEOL in pregnant women are not sufficient. Animal studies are insufficient to demonstrate reproductive toxicity. In clinical practice, to date, no fetal malformations or specific fetus toxicity have been recorded. As a precaution, it is preferable to avoid the use of LACTEOL during pregnancy Breastfeeding There is insufficient information on the excretion of LACTEOL and its metabolism in breast milk. The risk to newborns/infants cannot be excluded. As a precaution, it is preferable to avoid the use of LACTEOL during breastfeeding.

EFFECTS ON DRIVING ABILITY

The product does not interfere with driving ability or the use of machines.