Codex

Package leaflet: Information for the patient

Codex 5 billion hard capsules

Saccharomyces boulardii
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms.

Contents of this leaflet:

1. What Codex is and what it is used for
2. What you need to know before taking Codex
3. How to take Codex
4. Possible side effects
5. How to store Codex
6. Contents of the pack and other information

1. What Codex is and what it is used for

Codex contains the active substance Saccharomyces boulardii, a yeast.
This medicinal product is used for the following conditions:

• prevention and treatment of disturbances in the normal balance of intestinal bacterial flora (intestinal dysbiosis);
• prevention and treatment of diarrhoea associated with intestinal dysbiosis.

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

2. What you need to know before taking Codex

Do not take Codex

• if you are allergic to Saccharomyces boulardii or to any of the other ingredients of this medicine (listed in section 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 medicines against fungal infections (see "Other medicines and Codex");
• if you are an immunocompromised patient or hospitalized (due to severe illnesses or with altered/weakened immune system).

Warnings and precautions
Talk to your doctor or pharmacist before taking Codex.
During treatment for diarrhoea, consult your doctor about fluid intake (hydration) and the route of administration, as rehydration needs must be determined based on the severity of diarrhoea, your age, and your general health status.
As with all medicines containing live microorganisms, take particular 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 dispersion of spores), because the active ingredient (the fungus Saccharomyces boulardii) may enter the bloodstream and rapidly replicate, causing infection.
Indeed, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungaemia (yeast dissemination into the blood) have been reported, which often present with fever and positive blood tests for Saccharomyces strains. All these cases resolved favourably following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Codex if you are being treated with medicines against fungal infections, as antifungal treatment inhibits the action of Codex.

Codex with beverages and alcohol
Do not mix this medicine with very hot liquids or alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if strictly necessary and under medical supervision.

Driving and using machines
No studies on the ability to drive or use machinery have been conducted.

Codex contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Codex

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
Adults: 1-2 capsules, twice daily. Swallow the capsule whole.
Take Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
If you are undergoing antibiotic therapy, take Codex at the same time as the antibiotics.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
Warning: use Codex only for short-term treatment.
Instructions for opening the blister pack
To properly open the blister, lift the corner and peel as shown below:

If you take more Codex than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Codex
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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)
• Yeast entering the bloodstream (fungaemia)
• Allergic reactions such as:
• swelling of the face (angioedema),
• itching,
• hives (urticaria),
• localized or generalized skin redness (rash),
• severe, rapidly developing allergic reaction (anaphylactic reaction or shock).
  Frequency not known
• Constipation,
• Severe blood infection (sepsis).

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

5. How to store Codex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "exp". The expiry date refers to the last day of that month. The indicated expiry date applies to the product in its original, undamaged packaging, properly stored.
Capsules in bottle:
After the first opening of the bottle, the medicine should be used within 30 days; after this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Codex contains

• The active substance is Saccharomyces boulardii. Each capsule contains 5 billion live germs (in the form of 250 mg of lyophilized powder).
• The other ingredients are: lactose, magnesium stearate, gelatin, titanium dioxide.

Codex does not contain gluten.
Description of the appearance of Codex and contents of the pack
Pack sizes of 10, 12, 20 or 30 capsules.
Codex capsules may be packaged in PVC-aluminum blisters or in glass bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Biocodex S.A.S. - 7 avenue Gallieni, 94250 Gentilly – France
Distribution Licensee
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI), Italy
Manufacturer
Biocodex S.A.S., 1 Avenue Blaise Pascal – BEAUVAIS (France)

Patient Information Leaflet

Codex 5 billion powder for oral suspension

Saccharomyces boulardii
Please read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What Codex is and what it is used for
2. What you need to know before taking Codex
3. How to take Codex
4. Possible side effects
5. How to store Codex
6. Contents of the pack and other information

1. What Codex 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 disturbances in the normal balance of intestinal bacterial flora (intestinal dysbiosis) caused by the use of antibiotics and sulfonamides (medicines for infections);
• prevention and treatment of vitamin deficiencies in the body (avitaminosis) caused by the use of antibiotics and sulfonamides;
• prevention and treatment of "traveler's diarrhoea";
• treatment of acute diarrhoea of various origins;
• treatment of irritable bowel syndrome with altered bowel function;
• treatment of fungal infections (candidiasis) of the gastrointestinal tract.

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

2. What you need to know before taking Codex

Do not take Codex

• if you are allergic to Saccharomyces boulardii or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to yeasts;
• if you have a central venous catheter (a catheter used to administer fluids directly into a central vein);
• if you are being treated with medicines for fungal infections (see "Other medicines and Codex");
• if you are an immunocompromised patient or hospitalized (due to severe illness or with a weakened/altered immune system).

Warnings and precautions
Talk to your doctor or pharmacist before taking Codex.
During treatment for diarrhoea, consult your doctor about fluid intake (hydration) and the route of administration, as rehydration needs must be determined based on the severity of diarrhoea, your age, and your general health status.
As with all medicines containing live microorganisms, take particular care when handling this medicine in patients with a central venous catheter (a catheter used to administer fluids directly into a central vein). Avoid any contact between Codex and the catheter (including airborne dispersion of spores), since the active ingredient (the fungus Saccharomyces boulardii) may enter the bloodstream and rapidly multiply, leading to infection.
Indeed, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungaemia (yeast spreading into the blood) have been reported, which usually manifest with fever and positive tests for Saccharomyces strains. All these cases resolved successfully following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Codex if you are being treated with medicines for fungal infections, as antifungal treatment inhibits the action of Codex.

Codex with food and alcohol
Do not mix this medicine with very hot liquids or alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if strictly necessary and under medical supervision.

Driving and using machines
No studies on the ability to drive vehicles or use machinery have been conducted.

Codex contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Codex contains fructose
Codex contains 471.90 mg of fructose per sachet. With frequent or prolonged use (e.g. for two weeks or more), fructose may damage the teeth. If your doctor has told you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.

Codex contains sorbitol
This medicine contains 0.1 mg of sorbitol per sachet.

3. How to take Codex

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
Adults and adolescents over 12 years: 1-2 sachets, twice daily.
Use in children
Children from 0 to 3 years: 1 sachet, twice daily.
Children from 3 to 12 years: 1 sachet, three times daily.
For infants and children, it is recommended to pour the contents of the sachet into a baby bottle or a small amount of sweetened liquid.
Take Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
If you are undergoing antibiotic therapy, take Codex at the same time as the antibiotics.
If you take more Codex than you should
In case of accidental ingestion/overdose of the medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Codex
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. 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)

• Yeast entering the bloodstream (fungemia)
• Allergic reactions such as:
• swelling of the face (angioedema),
• itching,
• skin lumps (urticaria),
• localized or generalized skin redness (rash),
• severe and rapidly developing allergic reaction (anaphylactic reaction or shock).

Frequency not known

• Constipation,
• Severe blood infection (sepsis).

Reporting of side effects
If you experience any side effect, 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Codex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after "exp.".
The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, unopened packaging and stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Codex contains

• The active substance is Saccharomyces boulardii. Each sachet contains 5 billion live germs (in the form of 250 mg of freeze-dried powder).
• The other ingredients are: lactose monohydrate, fructose, anhydrous colloidal silica, "all fruits" flavour (containing sorbitol).

Codex does not contain gluten.
Description of the appearance of Codex and contents of the pack
Codex is a powder for oral suspension.
A carton contains 10 or 20 sachets of powder for oral suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biocodex S.A.S. - 7 avenue Gallieni, 94250 Gentilly – France
Selling Agent
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI), Italy
Manufacturer
Biocodex S.A.S, 1 Avenue Blaise Pascal – BEAUVAIS (France)

Patient Information Leaflet

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

Saccharomyces boulardii
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

1. What Codex is and what it is used for
2. What you need to know before taking Codex
3. How to take Codex
4. Possible side effects
5. How to store Codex
6. Contents of the pack and other information

1. What Codex 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 altered normal balance of intestinal bacterial flora (intestinal dysbiosis) caused by the use of antibiotics and sulfonamides (medicines against infections);
• prevention and treatment of vitamin deficiencies in the body (avitaminosis) caused by the use of antibiotics and sulfonamides;
• prevention and treatment of "traveler's diarrhoea";
• treatment of acute diarrhoea of various origins;
• treatment of irritable bowel syndrome with alternating bowel habits;
• treatment of fungal infections (candidiasis) of the gastrointestinal tract.

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

2. What you need to know before taking Codex

Do not take Codex

• if you are allergic to Saccharomyces boulardii or to 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 for fungal infections (see "Other medicines and Codex");
• if you are immunocompromised or hospitalized (due to severe illness or with impaired/weakened immune system);
• if you are under 3 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Codex.
During treatment for diarrhoea, consult your doctor about fluid intake (hydration) and the route of administration, as rehydration needs must be determined based on the severity of diarrhoea, your age, and your general health status.
As with all medicines containing live 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 dispersion of spores), as the active ingredient (the fungus Saccharomyces boulardii) may enter the bloodstream and replicate rapidly, causing infection.
Indeed, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungaemia (yeast dissemination into the blood) have been reported, which often present with fever and positive tests for Saccharomyces strains. All these cases resolved successfully following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Codex if you are being treated with antifungal medicines, as antifungal treatment inhibits the action of Codex.

Codex with drinks and alcohol
Do not mix this medicine with very hot liquids or alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if absolutely necessary and under medical supervision.

Driving and using machines
No studies have been conducted on the ability to drive or use machinery.

Codex contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Codex contains fructose
Codex contains 1520.0 mg of fructose per vial. With frequent or long-term use (e.g., for two weeks or more), fructose may damage teeth. If your doctor has told you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.

Codex contains sodium benzoate
Codex contains 8 mg of sodium benzoate per vial.

Codex contains propylene glycol
This medicine contains 10 mg of propylene glycol per vial.

Codex contains benzyl alcohol
This medicine contains 1.2 mg of benzyl alcohol per vial.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

Codex contains ethanol
This medicine contains 1.6 mg of alcohol (ethanol) in each vial. The amount in one vial of this medicine is equivalent to less than 1.5 ml of beer or 0.5 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Codex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to take Codex

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
Adults and adolescents over 12 years: 1–2 vials, twice daily.
Use in children
Children from 3 to 12 years: 1 vial, twice daily.
Take Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
If you are undergoing antibiotic therapy, take Codex simultaneously with antibiotics.
Instructions for use of Codex 5 billion/8 ml powder and solvent for oral suspension

1. Screw the cap to break the safety seal; the powder is released into the liquid inside the vial.
2. Shake the vial to mix the powder with the liquid.
3. Unscrew the cap to open the vial.
4. Drink the contents.

If you take more Codex than you should
In case of accidental ingestion/overdose of the medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Codex
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 bloodstream (fungaemia)
• Allergic reactions such as:
• swelling of the face (angioedema),
• itching,
• skin welts (urticaria),
• localized or generalized skin redness (rash),
• severe, rapidly developing allergic reaction (anaphylactic reaction or shock).

Frequency not known

• Constipation,
• Severe blood infection (sepsis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Codex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "exp.". The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, unopened packaging, properly stored.
Keep the product in its outer packaging to protect it from light.
After reconstitution, the suspension should be taken immediately.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Codex contains

• The active substance is Saccharomyces boulardii. Each vial contains 5 billion live germs (in the form of 250 mg of lyophilized powder).
• The other components are: lactose monohydrate, fructose, forest fruit flavour (containing propylene glycol, benzyl alcohol, ethanol), citric acid, potassium sorbate, sodium benzoate, purified water.

Codex does not contain gluten.
Description of the appearance of Codex and contents of the pack
Codex is supplied in vials assembled with a cap containing the pharmaceutical substance. The vial,
closed with the cap, contains 8 ml of sugared solution.
A carton contains 10 or 14 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Biocodex S.A.S. - 7 avenue Gallieni 94250 Gentilly – France
Marketing Authorization Representative
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)
Manufacturer
Biocodex S.A.S, 1 Avenue Blaise Pascal – BEAUVAIS (France)