CODEX*20BUST 5BLN 250MG

Codex 5 billion powder for oral suspension
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) 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 traveller's diarrhoea;
- treatment of acute diarrhoea of various origins;
- treatment of irritable bowel syndrome with altered bowel habits;
- treatment of fungal infections (candidiasis) of the digestive tract.

Contact 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 or hospitalised patient (due to severe conditions 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 for information regarding fluid intake (hydration) and its route of administration, as rehydration needs must be determined in relation to the severity of the diarrhoea, your age and your general health status.

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 spread of spores), as the active ingredient (the fungus Saccharomyces boulardii) can enter the bloodstream and multiply rapidly, leading to an infection.
Indeed, in patients with central venous catheters, even if not treated with Saccharomyces boulardii, very rare cases of fungaemia (spread of yeast in the blood) have been reported, which often manifests with fever and positive test results for Saccharomyces strains. All these cases resolved favourably 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 everyone 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 (fungaemia);
- Allergic reactions such as:
- facial swelling (angioedema);
- itching;
- hives (urticaria);
- localised or generalised 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, including those 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.