Codex 5 billion 12 hard capsules

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Patients with central venous catheters. Allergy to yeasts, in particular to Saccharomyces boulardii. Critically ill patients or immunocompromised patients, due to the risk of fungaemia (see section 4.4.).

WARNINGS AND PRECAUTIONS FOR USE

Do not mix Codex with too hot liquids or alcoholic solutions. In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy. General information - Treatment of diarrhea is not a substitute for rehydration, when necessary. The extent of rehydration and its route of administration must be commensurate with the severity of the diarrhea and the age and state of health of the patient. - Very rare cases of fungaemia have occurred (and positive blood cultures for strains of Saccharomyces) and sepsis mostly in patients with a central venous catheter, critically ill or immunocompromised, resulting in pyrexia in most cases. In the majority of cases the outcome was satisfactory after stopping treatment with Saccharomyces boulardii, administration of antifungal treatment and removal of the catheter where necessary. However, the outcome has been fatal in some critically ill patients (see sections 4.3 and 4.8). - As with all drugs based on live microorganisms, particular attention must be paid when handling the product, mainly in the presence of patients with a central venous catheter, but also in the presence of patients with a peripheral venous catheter, even if not treated with Saccharomyces boulardii, in order to avoid contact contamination and/or the spread of microorganisms by air (see paragraph 4.2). Important information about some excipients CODEX 5 billion hard capsules - contains lactose. Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine - it does not contain gluten.

INTERACTIONS

In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy.

SIDE EFFECTS

The following side effects have been reported following administration of Codex:

Systemic organic classification | Rare | Very rare | Frequency not known

Skin and subcutaneous tissue disorders | Very rare: allergic reactions: facial edema (angioedema), itching, hives (urticaria) and localized or systemic rashes.

Immune system disorders | Very rare: Anaphylactic reaction or shock.

Gastrointestinal disorders | Rare: Flatulence | Frequency not known: Constipation

Infections and infestations | Very rare: Fungemia in patients with central venous catheters and in critically ill or immunocompromised patients (see section 4.4). | Frequency not known: Sepsis in critically ill or immunocompromised patients (see section 4.4)

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.