CODEX 250 mg Hard Capsule

Зміст інструкції

1. Codex 5 miliardi capsule rigide
   1. What is Codex and what is it used for
   2. What you need to know before you take Codex
   3. How to take Codex
   4. Possible side effects
   5. How to store Codex
   6. Contents of the pack and other information
2. Codex 5 miliardi powder for oral suspension
   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
3. Codex 5 billion/8 ml powder and solvent for oral suspension
   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

Codex 5 miliardi capsule rigide

Saccharomyces boulardii

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 told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take 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 is Codex and what is it used for

Codex contains the active ingredient Saccharomyces boulardii, a yeast.
This medicine is used for the following conditions:

• prevention and treatment of alteration of the normal balance of the intestinal bacterial flora (intestinal dysbiosis);
• prevention and treatment of diarrhea related to intestinal dysbiosis.

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

2. What you need to know before you take Codex

Do not take Codex

• if you are allergic to Saccharomyces boulardiior 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 are hospitalized (due to serious illnesses or with an altered/weakened immune system).

Warnings and precautions
Talk to your doctor or pharmacist before taking Codex.
During treatment for diarrhea, ask your doctor about fluid intake
(hydration) and how it is administered, as rehydration needs must be established in
relation to the severity of the diarrhea, your age and your general health condition.
As with all medicines containing living microorganisms, pay particular attention to handling
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 (even the spread of spores through the air), 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 into the blood) have been reported, which very often manifests
with fever and positive tests for Saccharomycesstrains. All these cases have resolved
favorably following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Tell 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 food and alcohol
Do not mix this medicine with liquids that are too hot or with alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if absolutely
necessary and under the supervision of your doctor.

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

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

3. How to take Codex

Take this medicine following the instructions provided in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:
Adults: 1-2 capsules, twice a day. Swallow the capsule whole.
Take Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
If you are taking antibiotic therapy, take Codex simultaneously with the antibiotics.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Caution: use Codex only for short periods of treatment.

Instructions for opening the blister
To correctly open the blister, lift the corner and pull as shown below:

If you take more Codex than you should
In case of accidental ingestion/intake of an excessive dose of the medicine, immediately notify your doctor or go to the nearest hospital.

If you forget to take Codex
Do not take a double dose to make up for a 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 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 bloodstream (fungemia)
• Allergic reactions such as:
• swelling of the face (angioedema),
• itching,
• hives (urticaria),
• localized or generalized skin redness (rash),
• severe allergic reaction with rapid onset (anaphylactic reaction or shock). Frequency not known
• Constipation,
• Severe blood infection (sepsis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “exp”. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in
intact packaging, correctly stored.
Capsules in a bottle:
After the first opening of the bottle, the medicine must be used within 30 days; after this period, any remaining medicine must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Codex contains

• The active ingredient 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 of 10, 12, 20 or 30 capsules.
Codex capsules may be packaged in PVC-Aluminum blisters or glass bottles.

Marketing authorization holder and manufacturer

Marketing authorization holder
Biocodex S.A.S. - 7 avenue Gallieni 94250 Gentilly – France

Sales 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)

Codex 5 miliardi powder for oral suspension

Saccharomyces boulardii

Read this leaflet carefully before you start 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 told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse.

Contents of this leaflet:

• 1. What Codex is and what it is used for
• 2. What you need to know before you take 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 ingredient Saccharomyces boulardii, a yeast.
This medicine is used for the following conditions:

• prevention and treatment of alteration of the normal balance of the 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 (hypovitaminosis) determined 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 (candidiasis) infections of the digestive tract.

See 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 boulardiior 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 are hospitalised (due to serious illnesses 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 how it should be administered, as rehydration needs must be established in
relation to the severity of the diarrhoea, your age and your general state of health.
As with all medicines containing live microorganisms, pay particular attention to handling
this medicine in the presence of patients with a central venous catheter (a catheter for the
administration of fluids directly into a central vein). Avoid any contact between Codex and the
catheter (even the spread of spores through the air), as the active ingredient (the fungus Saccharomyces

boulardii) may 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 fungaemia (spread of yeast in the blood) have been reported, which very often manifests
with fever and positive tests for Saccharomycesstrains. All these cases have resolved
favourably following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Tell 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 drinks and alcohol
Do not mix this medicine with liquids that are too hot or with alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if absolutely
necessary and under the control of your doctor.

Driving and operating machinery
No studies have been performed on the ability to drive and operate machinery.

Codex contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

Codex contains fructose
Codex contains 471.90 mg of fructose per sachet. In case of frequent or prolonged use
(e.g. for two weeks or more), fructose can damage teeth. If your doctor has told you that you (or
the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a
rare genetic disease in which patients cannot metabolise fructose, talk to 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 following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:
Adults and adolescents over 12 years: 1-2 sachets, twice a day.

Use in children
Children from 0 to 3 years: 1 sachet, twice a day.
Children from 3 to 12 years: 1 sachet, three times a day.
For infants and children, it is recommended to pour the contents of the sachet into the 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 taking antibiotics, take Codex at the same time as the antibiotics.

If you take more Codex than you should
In case of accidental ingestion/intake of an excessive dose of the medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to take Codex
Do not take a double dose to make up for a 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 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 the yeast into the blood (fungemia)
• Allergic reactions such as:
• swelling of the face (angioedema),
• itching,
• hives (urticaria),
• localized or widespread skin redness (rash),
• severe allergic reaction with rapid onset (anaphylactic reaction or shock). Frequency not known
• Constipation,
• Severe blood infection (sepsis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 that is stated on the sachet and the carton after “exp.”.
The expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Codex contains

• The active ingredient is Saccharomyces boulardii. Each sachet contains 5 billion live germs (in the form of 250 mg of lyophilized 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 presented as a powder for oral suspension.
One pack 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
Sales 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)

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

Saccharomyces boulardii

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 told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Codex is and what it is used for
• 2. What you need to know before you take 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 ingredient Saccharomyces boulardii, a yeast.
This medicine is used for the following conditions:

• prevention and treatment of alteration of the normal balance of the 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 (avitaminosis) determined 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 (candidiasis) infections of the digestive tract.

See 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 boulardiior 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 hospitalised (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 diarrhoea, ask your doctor about fluid intake
(hydration) and its route of administration, as rehydration needs must be established in
relation to the severity of the diarrhoea, your age and your general health condition.
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 the
administration of fluids directly into a central vein). Avoid any contact between Codex and the
catheter (even the spread of spores through the air), as the active ingredient (the fungus Saccharomyces

boulardii) may enter the bloodstream and replicate rapidly, leading to an infection.
Indeed, in patients with a central venous catheter, even if not treated with Saccharomyces boulardii,
very rare cases of fungaemia (spread of yeast into the blood) have been reported, which very often
manifests with fever and positive test results for Saccharomycesstrains. All these cases resolved
favourably following treatment with antifungal medicines and, where necessary, removal of the catheter.

Other medicines and Codex
Tell 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 drinks and alcohol
Do not mix this medicine with liquids that are too hot or with alcoholic solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if absolutely
necessary and under the supervision of your doctor.

Driving and operating machinery
No studies have been performed on the ability to drive vehicles and operate machinery.

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

Codex contains fructose
Codex contains 1520.0 mg of fructose per vial. In case of frequent or prolonged use (e.g. for two weeks or more),
fructose can damage teeth. If your doctor has told you that you (or your child) are intolerant to certain sugars,
or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
break down fructose, talk to your doctor before you (or your 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 can cause allergic reactions.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large
amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic
acidosis).
Ask your doctor or pharmacist if you have liver or kidney problems. This is because large
amounts of benzyl alcohol can 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 a 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 following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:
Adults and adolescents over 12 years: 1-2 vials, twice a day.

Use in children
Children from 3 to 12 years: 1 vial, twice a day.
Take Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
If you are taking antibiotic therapy, take Codex simultaneously with the antibiotics.

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

• 1. Screw on 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 into 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/intake of an excessive dose of the medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to take Codex
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 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 widespread skin redness (rash),
• severe allergic reaction with rapid onset (anaphylactic reaction or shock). Frequency not known
• Constipation,
• Severe blood infection (sepsis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the vial and the packaging after
“exp.”. The expiry date refers to the last day of that month. The expiry date indicated
refers to the product in intact packaging, correctly stored.
Keep the product in the outer packaging to protect it from light.
After reconstitution, the suspension must be drunk immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Codex contains

• The active ingredient is Saccharomyces boulardii. Each vial contains 5 billion live germs (in the form of 250 mg of lyophilized powder).
• The other ingredients 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 presented in vials assembled with a cap containing the pharmaceutical substance. The vial,
closed with the cap, contains 8 ml of sugary solution.
A carton contains 10 or 14 vials.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Biocodex S.A.S. - 7 avenue Gallieni 94250 Gentilly – France
Distributor for sales
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
Biocodex S.A.S, 1 Avenue Blaise Pascal – BEAUVAIS (France)