Name
Codex 5 billion powder 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 sulphonamides (medicines against infections);
- prevention and treatment of vitamin deficiencies in the body (dysvitaminosis) caused by the use of antibiotics and sulphonamides;
- prevention and treatment of "traveler's diarrhea";
- therapy of acute diarrhea of ​​various origins;
- therapy of irritable bowel syndrome with altered bowel habits;
- treatment of fungal infections (candidiasis) of the digestive tract.

Talk to 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 medicines against fungal infections (see "Other medicines and Codex");
- if you are an immunocompromised patient or hospitalised (due to serious pathologies or with an altered/weakened immune system).


Warnings and precautions
Talk to your doctor or pharmacist before taking Codex.

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

As with all medicines containing living microorganisms, take special care when handling this medicine in 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 spread of spores), as the active substance (the fungus Saccharomyces boulardii ) can enter the bloodstream and rapidly multiply, resulting in an infection.
In fact, in patients with central venous catheters, 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 itself with fever and positive results in tests for strains of Saccharomyces . All these cases resolved favorably following treatment with drugs against fungi (antifungals) 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 redness of the skin (rash);
- severe, rapidly occurring allergic reaction (anaphylactic reaction or shock).

Frequency not known
- Constipation (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.