CODEX*30CAPS 5BLN 250MG

Codex 5 billion hard capsules
Saccharomyces boulardii

What it is and what it is used for
Codex contains the active substance Saccharomyces boulardii, a yeast.

This medicine is used for the following conditions:
- prevention and treatment of alterations to the normal balance of intestinal bacterial flora (intestinal dysbiosis);
- prevention and treatment of diarrhea related to intestinal dysbiosis.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not take Codex
- if you are allergic to Saccharomyces boulardii or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are allergic to yeasts;
- if you have a central venous catheter (a catheter for administering fluids directly into a central vein);
- if you are being treated with antifungal medicines (see "Other medicines and Codex");
- if you are an immunocompromised patient or hospitalized (due to serious illnesses or with an altered/weakened immune system).

Warnings and precautions
Consult your doctor or pharmacist before taking Codex.

During treatment for diarrhea, ask your doctor about fluid intake (hydration) and its route of administration, as rehydration needs must be established in relation to the severity of the diarrhea, your age, and your general health status.

As with all medicines based on living microorganisms, pay particular attention to handling this medicine in the presence of patients with a central venous catheter (a catheter for administering fluids directly into a central vein). Avoid any contact between Codex and the catheter (including airborne spore dissemination), as the active substance (the fungus Saccharomyces boulardii) can enter the bloodstream and replicate quickly, leading to an infection.
Indeed, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungemia (yeast spread in the blood) have been reported, which often manifests with fever and positive tests for Saccharomyces strains. All these cases resolved favorably following treatment with antifungal medicines and, where necessary, catheter removal.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 patients)
- presence of gas in the intestines (flatulence).

Very rare (may affect up to 1 in 10,000 patients)
- Penetration of yeast into the blood (fungemia)
- Allergic reactions such as:
- facial swelling (angioedema),
- itching,
- hives (urticaria),
- localized or generalized skin redness (rash),
- severe rapidly occurring allergic reaction (anaphylactic reaction or shock).

Frequency not known
- Constipation,
- Severe blood infection (sepsis).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.