Active ingredients: Lactic ferments (Saccharomyces boulardii)
CODEX 5 billion hard capsules
Codex package inserts are available for pack sizes:- CODEX 5 billion hard capsules
- CODEX 5 billion powder for oral suspension
Indications Why is Codex used? What is it for?
WHAT IS IT
Codex is a medicine belonging to the category of antidiarrheal microorganisms
The active ingredient of Codex is a yeast of a selected species, Saccharomyces boulardii, which is genetically resistant to antibiotics.
WHY IT IS USED
Codex is used for the prophylaxis and treatment of intestinal dysmicrobism and related diarrheal syndromes.
Contraindications When Codex should not be used
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with central venous catheter.
- Allergy to yeasts.
Precautions for use What you need to know before taking Codex
Do not mix Codex with too hot liquids or with alcoholic solutions
Interactions Which drugs or foods can modify the effect of Codex
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy.
Warnings It is important to know that:
- Treatment of diarrhea is not a substitute for rehydration when needed. The extent of rehydration and its route of administration must be commensurate with the severity of the diarrhea and with the age and state of health of the patient.
- As with all medicines based on living microorganisms, special attention must be paid to handling the product in the presence of patients with central venous catheters to avoid any contamination involving the hands and / or the spread of spores by air. In fact, very rare cases of fungemia (spread of yeast in the blood) have been reported in patients with central venous catheter, even if not treated with Saccharomyces boulardii, which very often manifests itself with pyrexia and blood culture positive for Saccharomyces strains. All of these cases resolved favorably following treatment with antifungals and, where necessary, removal of the catheter.
When it can be used only after consulting your doctor
Patients with central venous catheters and patients allergic to yeast should consult their doctor before using the medicine
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
No reliable information is available regarding teratogenicity in animals.
Clinically no cases of malformations and foetotoxic effects have been reported. However, as there are insufficient data from monitoring of pregnant women exposed to the medicinal product, all risks cannot be excluded. Although Saccharomyces boulardii is not absorbed, its administration during pregnancy and during the lactation period, should be carried out only in case of real need under the direct supervision of the doctor who will evaluate the risk / benefit ratio.
Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
Important information about some of the ingredients
In case of ascertained intolerance to sugars, contact your doctor before taking the medicine.
The product does not contain gluten.
Doping warning
Not relevant
Dosage and method of use How to use Codex: Dosage
HOW MUCH
Adults: 1-2 capsules 2 times a day
Unless otherwise prescribed by a doctor
WHEN AND FOR HOW LONG
It is advisable to administer Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Warning: use only for short periods of treatment
LIKE
Swallow the capsule whole.
During therapy with antibiotics, administer Codex at the same time as these.
Overdose What to do if you have taken an overdose of Codex
In case of accidental ingestion / intake of an excessive dose of medicine, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF CODEX, PLEASE ASK YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Codex
Like all medicines, Codex can cause side effects, although not everybody gets them.
Rare cases of flatulence, and very rare cases of allergic reactions in the form of face edema (angioedema) and / or pruritus, wheals (urticaria) and localized or systemic rash have been reported following the administration of Codex. In addition, very rare cases of anaphylactic reaction or shock have been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. Undesirable effects can also be reported 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.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children
It is important to always have the information on the medicine available, so keep both the box and the package leaflet
Composition and pharmaceutical form
COMPOSITION
Each capsule contains:
Active ingredient: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder)
Excipients: lactose; magnesium stearate; jelly; titanium dioxide
HOW IT LOOKS
Codex capsules can be packaged in blisters or in bottles of 10 or 20 capsules
Instructions for opening the blister
To open the blister correctly, lift the corner and pull as follows:
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CODEX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Codex 5 billion hard capsules
Each capsule contains:
active principle: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder)
Codex 5 billion powder for oral suspension
Each sachet contains:
active principle: Saccharomyces boulardii 5 billion live germs (in the form of 250 mg of lyophilized powder)
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Hard capsules.
Powder for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
- Prophylaxis and treatment of intestinal dysmicrobism induced by antibiotics and sulfonamides and of the disvitaminosis caused by them.
- Therapy of acute diarrhea of various etiology.
- Prophylaxis and treatment of "traveler's diarrhea".
- Treatment of irritable bowel syndrome with altered alvus.
- Treatment of candidiasis of the gastrointestinal tract.
04.2 Posology and method of administration
Adults: 1-2 capsules / sachets 2 times a day.
Children from 0 to 3 years: 1 sachet 2 times a day.
Children from 3 to 12 years: 1 sachet 3 times a day.
Unless otherwise prescribed by a doctor.
It is advisable to administer Codex at regular intervals, preferably on an empty stomach or at least 15 minutes before meals.
During therapy with antibiotics, administer Codex at the same time as these.
For infants or children it is recommended to pour the contents of the sachet into the bottle, or into a little sweetened liquid.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients with central venous catheter.
Allergy to yeasts.
04.4 Special warnings and appropriate precautions for use
Do not mix Codex with too hot liquids or with alcoholic solutions.
In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy.
General informations
- Treatment of diarrhea is not a substitute for rehydration when needed. The extent of rehydration and its route of administration must be commensurate with the severity of the diarrhea and with the age and state of health of the patient.
- As for all medicines based on living microorganisms, special attention must be paid to handling the product in the presence of patients with central venous catheters to avoid any contamination involving the hands and / or the spread of spores by air. In fact, in patients with central venous catheter, even if not treated with Saccharomyces boulardii, very rare cases of fungemia (spread of yeast in the blood) have been reported which are very often manifested by pyrexia and blood culture positive for strains of Saccharomyces. All of these cases resolved favorably following treatment with antifungals and, where necessary, removal of the catheter.
Important information about some of the ingredients
CODEX 5 billion hard capsules
- contains lactose it is therefore not suitable for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose / galactose malabsorption.
- does not contain gluten.
CODEX 5 billion powder for oral suspension
- contains lactose and fructose it is therefore not suitable for patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose / galactose malabsorption.
- does not contain gluten.
04.5 Interactions with other medicinal products and other forms of interaction
In view of the fungal nature of Saccharomyces boulardii, Codex should not be administered during topical or systemic antifungal therapy.
04.6 Pregnancy and lactation
No reliable information is available regarding teratogenicity in animals. Clinically no cases of malformations and foetotoxic effects have been reported. However, as there are insufficient data from the monitoring of pregnant women exposed to the medicinal product, all risks cannot be excluded. Despite the Saccharomyces boulardii its administration is not absorbed during pregnancy and during the lactation period, it should be carried out only in case of real need under the direct supervision of the doctor who will evaluate the risk / benefit ratio.
04.7 Effects on ability to drive and use machines
There are no assumptions or evidence to hypothesize that the drug can modify attention and reaction times.
04.8 Undesirable effects
Rare cases of flatulence, and very rare cases of allergic reactions in the form of face edema (angioedema) and / or pruritus, wheals (urticaria) and localized or systemic rash have been reported following the administration of Codex. In addition, very rare cases of anaphylactic reaction or shock have been reported.
04.9 Overdose
In case of overdosing, no special interventions are required.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antidiarrheal microorganisms. ATC code: A07FA02
The active ingredient of Codex is a yeast of a selected species, the Saccharomyces boulardii, genetically resistant to antibiotics.
It carries out its business through:
- the inhibition of the growth of some "pathogenic" microorganisms (Staphylococcus, E. coli, Proteus, Candida albicans, Shigella, Salmonella, Pseudomonas).
- Stimulation of the immunological defense mechanisms against infections: activation of the complement system and stimulation of phagocytosis.
- The increase in the enzymatic activity (disaccharidase) of the intestinal mucosa.
- The inhibition of the production and activity of pathogenic enterotoxins.
- The synthesis of vitamins of the B complex.
The administration of Codex decreases the risks related to the virulentation and proliferation of normal intestinal saprophytes which, under certain conditions, can become pathogenic. This happens above all following chemotherapy and antibiotic treatments which, by profoundly altering the normal saprophytic flora, favor intestinal colonization and the virulentation of resistant fungi and germs, responsible for antibiotic diarrhea.
Codex therefore realizes an "effective prophylaxis of enterocolic complications in antibiotic therapy and is a valid adjuvant in bacillary diarrhea.
It is also useful in the treatment of diarrhea of viral origin in which the intestinal mucosa has reduced enzymatic activities (disaccharidase) with a consequent decrease in the absorption of water and carbohydrates. Thanks to its excellent tolerability, Codex can be administered to newborns, elderly patients and during the period of pregnancy and breastfeeding even for long periods.
05.2 Pharmacokinetic properties
Given its particular nature, yeast is not absorbed and maintains its vitality throughout the digestive tract.
05.3 Preclinical safety data
No toxic effect of the product was found in both acute and chronic toxicity studies.
The complete non-toxicity of the product prevented the determination of the LD50 in the experimental animal.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Codex 5 billion hard capsules
Each capsule contains:
lactose; magnesium stearate; jelly; titanium dioxide
Codex 5 billion powder for oral suspension
Each sachet contains:
lactose monohydrate, fructose, anhydrous colloidal silica, all fruit flavor.
06.2 Incompatibility
None known.
06.3 Period of validity
CODEX 5 billion hard capsules: 2 years
CODEX 5 billion powder for oral suspension: 3 years
In intact packaging, properly stored.
06.4 Special precautions for storage
No special storage precautions
06.5 Nature of the immediate packaging and contents of the package
CODEX 5 billion hard capsules:
- Neutral glass bottle with polyethylene cap of 10 or 20 capsules
- Blister packs of 10 or 20 capsules
CODEX 5 billion powder for oral suspension
Box of 10 or 20 sachets
06.6 Instructions for use and handling
Instructions for opening the blister
To open the blister correctly, lift the corner and pull
07.0 MARKETING AUTHORIZATION HOLDER
Zambon Italia s.r.l.
Via Lillo del Duca 10 - 20091 Bresso (MI)
08.0 MARKETING AUTHORIZATION NUMBER
CODEX 5 billion hard capsules - bottle of 10 capsules - A.I.C. n. 029032012
CODEX 5 billion hard capsules - bottle of 20 capsules - A.I.C. n. 029032024
CODEX 5 billion hard capsules - blister of 10 capsules - A.I.C. n. 029032051
CODEX 5 billion hard capsules - blister of 20 capsules - A.I.C. n. 029032063
CODEX 5 billion powder for oral suspension - 10 sachets - A.I.C. n. 029032036
CODEX 5 billion powder for oral suspension - 20 sachets - A.I.C. n. 029032048
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
CODEX 5 billion hard capsules - bottle of 10 capsules - 25.06.1993 / 16.07.2008
CODEX 5 billion hard capsules - bottle of 20 capsules - 25.06.1993 / 16.07.2008
CODEX 5 billion powder for oral suspension 10 sachets - 25.06.1993 / 16.07.2008
CODEX 5 billion powder for oral suspension 20 sachets - 25.06.1993 / 16.07.2008
CODEX 5 billion hard capsules - blister of 10 capsules - 29.10.2013
CODEX 5 billion hard capsules - blister of 20 capsules - 29.10.2013
10.0 DATE OF REVISION OF THE TEXT
24 April 2014
