CODEX*30CPS 5MLD 250MG BLISTER

Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.

Therapeutic indications

Prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.

Dosage and method of use

Adults: 1-2 capsules 2 times a day. Unless otherwise prescribed by a doctor. It is advisable to administer Codex at regular intervals, possibly on an empty stomach or in any case at least 15 minutes before meals. During therapy with antibiotics, administer Codex at the same time as these. Due to the risk of airborne contamination, the capsules should not be opened in patient rooms. When handling probiotics to be administered to patients, healthcare personnel should wear disposable gloves, dispose of them immediately after use and wash their hands thoroughly (see section 4.4).

Contraindications

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

Side effects

The following undesirable effects have been reported following the administration of Codex:

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Do not mix Codex with too hot liquids or with 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 needed. The extent of rehydration and its route of administration should be commensurate with the severity of the diarrhea and the age and state of health of the patient. - There have been rare cases offungaemia (and positive blood cultures for Saccharomyces strains) mostly in patients with central venous catheter, critically ill or immunocompromised patients, resulting in most cases in pyrexia. In the majority of cases the outcome was satisfactory after discontinuation of Saccharomyces boulardii treatment, administration of antifungal treatment and removal of the catheter, if 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 care must be taken when handling the product, mainly in the presence of patients with central venous catheter, but also in the presence of patients with peripheral venous catheter, even if not treated with Saccharomyces boulardii , in order to avoid contamination by contact and/or the spread of microorganisms by air (see section 4.2). Important information about some of the excipients CODEX 5 billion hard capsules - contains lactose and is therefore not suitable for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption. - does not contain gluten.

Pregnancy and breastfeeding

No reliable information is available regarding teratogenicity in animals. Clinically no cases of malformations and foetotoxic effects have been reported. However, since there are insufficient data from monitoring of exposed pregnant women, any risk cannot be excluded. Although Saccharomyces boulardii is not absorbed, its administration during pregnancy and during the breastfeeding period should be carried out only in case of real need under the direct supervision of the doctor who will evaluate the risk/benefit ratio.

Expiration and conservation

No special precautions for storage.

Interactions with other drugs

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

Overdose

In the event of an overdose, no special interventions are required.

Active principles

Codex 5 billion hard capsules Each capsule contains: active substance: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilised powder) For the full list of excipients, see section 6.1

Excipients

Codex 5 billion hard capsules Each capsule contains: lactose; magnesium stearate; jelly; titanium dioxide