Codex 12 capsules 5mld 250mg

CODEX * 12CPS 5MLD 250MG

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, preferably on an empty stomach or 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 environments. When handling probiotics for administration to patients, healthcare professionals 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 central venous catheter. Allergy to yeasts, especially aSaccharomyces boulardii. Critically ill or immunocompromised patients due to the risk of fungemia (see section 4.4).

Side effects

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

Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

Do not mix Codex with too hot liquids or with alcoholic solutions. In view of the fungal nature ofSaccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy. General informations - 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 very rare cases of fungemia (and positive blood cultures forSaccharomyces) and sepsis mostly in patients with central venous catheter, critically ill or immunocompromised, resulting in most cases in pyrexia. In the majority of cases the outcome was satisfactory after discontinuation of treatment withSaccharomyces boulardii, the administration of antifungal treatment and the removal of the catheter, if necessary. However, the outcome was fatal in some critically ill patients (see sections 4.3 and 4.8). - As with all drugs based on live microorganisms, special care must be taken 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 withSaccharomyces boulardii, in order to avoid contact contamination and / or spread of microorganisms by air (see section 4.2). Important information about some of the ingredients CODEX 5 billion hard capsules- containslactose.Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine - it 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, as there are insufficient data from the monitoring of pregnant women exposed to the medicinal product, all risks cannot be excluded. Despite theSaccharomyces boulardiiis not absorbed, its administration during pregnancy and during the lactation 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.

Expiry and retention

No special storage precautions.

Interactions with other drugs

In view of the fungal nature ofSaccharomyces 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 capsulesEach capsule contains: active ingredient:Saccharomyces boulardii5 billion live germs (in the form of 250 mg of lyophilized powder) Excipient with known effect: lactose. For the full list of excipients, see section 6.1

Excipients

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