CODEX*OS 10FL 5BLN 8ML

Codex 5 billion/8 ml powder and solvent for oral suspension
Saccharomyces boulardii

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

This medicine is used for the following conditions:
- prevention and treatment of alterations in the normal balance of intestinal bacterial flora (intestinal dysbiosis) induced by the use of antibiotics and sulfonamides (medicines against infections);
- prevention and treatment of vitamin deficiencies in the body (dysvitaminosis) caused by the use of antibiotics and sulfonamides;
- prevention and treatment of traveler's diarrhea;
- treatment of acute diarrhea of various origins;
- treatment of irritable bowel syndrome with altered bowel habits;
- treatment of fungal infections (candidiasis) of the digestive tract.

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 section 6);
- if you are allergic to yeast;
- 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 or hospitalized patient (due to serious illnesses or with an altered/weakened immune system);
- if you are under 3 years of age.

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

During treatment for diarrhea, ask your doctor for information regarding fluid intake (hydration) and its route of administration, as rehydration needs must be determined based on the severity of the diarrhea, your age, and your general health.

As with all medicines containing live microorganisms, pay particular attention to the handling of 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 ingredient (the fungus Saccharomyces boulardii) can enter the bloodstream and replicate quickly, leading to an infection.
In fact, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungemia (spread of yeast in the blood) have been reported, which very often manifests with fever and positive test results for Saccharomyces strains. All these cases resolved favorably following treatment with antifungal medicines and, where necessary, removal of the catheter.

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 intestine (flatulence).

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.