CODEX "5 BILLION POWDER FOR ORAL SUSPENSION" 20 SACHETS"

Name
Codex 5 billion powder for oral suspension
Saccharomyces boulardii


What is it and what is it 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";
- 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.

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 hospitalized (due to serious illnesses or with an altered/weakened immune system).


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

While you are being treated for diarrhea, ask your doctor about fluid intake (hydration) and the route of administration, as your rehydration needs will depend on the severity of your diarrhea, 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 ingredient (the fungus Saccharomyces boulardii ) can enter the bloodstream and rapidly replicate, resulting in infection.
In fact, very rare cases of fungemia (spread of yeast into the blood) have been reported in patients with central venous catheters, even if not treated with Saccharomyces boulardii . This often manifests as fever and positive tests for Saccharomyces strains. All these cases resolved favorably following treatment with antifungal medications 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 people):
- presence of gas in the intestine (flatulence).

Very rare (may affect up to 1 in 10,000 people):
- 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 developing allergic reaction (anaphylactic reaction or shock).

Frequency unknown
- Constipation (constipation);
- Severe blood infection (sepsis).

Reporting of side effects
If you experience 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.